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Pancreatic Neoplasms: HELP
Articles by Kenji Hirano
Based on 41 articles published since 2010
(Why 41 articles?)
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Between 2010 and 2020, Kenji Hirano wrote the following 41 articles about Pancreatic Neoplasms.
 
+ Citations + Abstracts
Pages: 1 · 2
1 Guideline Clinical diagnostic criteria of IgG4-related sclerosing cholangitis 2012. 2012

Ohara, Hirotaka / Okazaki, Kazuichi / Tsubouchi, Hirohito / Inui, Kazuo / Kawa, Shigeyuki / Kamisawa, Terumi / Tazuma, Susumu / Uchida, Kazushige / Hirano, Kenji / Yoshida, Hitoshi / Nishino, Takayoshi / Ko, Shigeru B H / Mizuno, Nobumasa / Hamano, Hideaki / Kanno, Atsushi / Notohara, Kenji / Hasebe, Osamu / Nakazawa, Takahiro / Nakanuma, Yasuni / Takikawa, Hajime / Anonymous3940729 / Anonymous3950729 / Anonymous3960729 / Anonymous3970729. ·Department of Community-based Medical Education, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. hohara@med.nagoya-cu.ac.jp ·J Hepatobiliary Pancreat Sci · Pubmed #22717980.

ABSTRACT: BACKGROUND: IgG4-sclerosing cholangitis (IgG4-SC) patients have an increased level of serum IgG4, dense infiltration of IgG4-positive plasma cells with extensive fibrosis in the bile duct wall, and a good response to steroid therapy. However, it is not easy to distinguish IgG4-SC from primary sclerosing cholangitis, pancreatic cancer, and cholangiocarcinoma on the basis of cholangiographic findings alone because various cholangiographic features of IgG4-SC are similar to those of the above progressive or malignant diseases. METHODS: The Research Committee of IgG4-related Diseases and the Research Committee of Intractable Diseases of Liver and Biliary Tract in association with the Ministry of Health, Labor and Welfare, Japan and the Japan Biliary Association have set up a working group consisting of researchers specializing in IgG4-SC, and established the new clinical diagnostic criteria of IgG4-SC 2012. RESULTS: The diagnosis of IgG4-SC is based on the combination of the following 4 criteria: (1) characteristic biliary imaging findings, (2) elevation of serum IgG4 concentrations, (3) the coexistence of IgG4-related diseases except those of the biliary tract, and (4) characteristic histopathological features. Furthermore, the effectiveness of steroid therapy is an optional extra diagnostic criterion to confirm accurate diagnosis of IgG4-SC. CONCLUSION: These diagnostic criteria for IgG4-SC are useful in practice for general physicians and other nonspecialists.

2 Review Role of endoscopic ultrasonography in pancreatic cystic neoplasms: where do we stand and where will we go? 2014

Nakai, Yousuke / Isayama, Hiroyuki / Itoi, Takao / Yamamoto, Natsuyo / Kogure, Hirofumi / Sasaki, Takashi / Hirano, Kenji / Tada, Minoru / Koike, Kazuhiko. ·Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. ·Dig Endosc · Pubmed #24219338.

ABSTRACT: We increasingly encounter pancreatic cystic neoplasms (PCN) in clinical practice and the differential diagnoses vary widely from benign to malignant. There is no 'one and only' diagnostic procedure for PCN. Multiple modalities including computed tomography, magnetic resonance imaging, endoscopic retrograde cholangiopancreatography and endoscopic ultrasound (EUS) are widely used, but EUS has the advantage of anatomical proximity to the pancreas and upper gastrointestinal tract. In addition, EUS-guided fine-needle aspiration (EUS-FNA) provides both cytological evaluation and cyst fluid analysis. Although the role of EUS-FNA for PCN is established, the sensitivity of cytology is low and cyst fluid analysis is only useful for differentiation between mucinous and non-mucinous cysts. Recently, novel through-the-needle imaging under EUS-FNA, such as confocal laserendomicroscopy, is expected to attribute to a better diagnostic yield. Moreover, feasibility of cyst ablation has been reported and the role of EUS has expanded from diagnosis to treatment. However, clinical impact of cyst ablation in terms of safety, efficacy and cost-effectiveness should be validated further. In summary, EUS and EUS-guided intervention does and will play a central role in the management of PCN from surveillance to treatment, but many clinical questions remain unanswered, which warrants well-designed prospective clinical trials.

3 Review Endoscopic retrograde cholangiopancreatography for distal malignant biliary stricture. 2012

Isayama, Hiroyuki / Nakai, Yousuke / Kawakubo, Kazumichi / Kogure, Hirofumi / Hamada, Tsuyoshi / Togawa, Osamu / Sasahira, Naoki / Hirano, Kenji / Tsujino, Takeshi / Koike, Kazuhiko. ·Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. isayama-tky@umin.ac.jp ·Gastrointest Endosc Clin N Am · Pubmed #22748244.

ABSTRACT: Endoscopic biliary stent placement is widely accepted as palliation for malignant biliary obstruction or as a treatment of benign biliary stricture. Although various biliary stent designs have become available since self-expandable metallic stents were introduced, no single ideal stent has been developed. An ideal stent should be patent until death, or surgery, in patients with resectable malignant biliary obstruction. Fewer complications, maneuverability, cost-effectiveness, and removability are also important factors. Alternatively, should we develop a novel method for biliary drainage other than biliary stenting via endoscopic retrograde cholangiopancreatography? This article reviews the current status of biliary stenting for malignant biliary obstructions.

4 Clinical Trial A phase I trial of gemcitabine, S-1 and LV combination (GSL) therapy in advanced pancreatic cancer. 2014

Nakai, Yousuke / Isayama, Hiroyuki / Saito, Kei / Sasaki, Takashi / Takahara, Naminatsu / Hamada, Tsuyoshi / Mizuno, Suguru / Miyabayashi, Koji / Yamamoto, Keisuke / Mohri, Dai / Kogure, Hirofumi / Yamamoto, Natsuyo / Hirano, Kenji / Ijichi, Hideaki / Tateishi, Keisuke / Tada, Minoru / Koike, Kazuhiko. ·Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo Bunkyo-ku, Tokyo, 113-8655, Japan. ·Cancer Chemother Pharmacol · Pubmed #25143299.

ABSTRACT: PURPOSE: In our previous randomized controlled trial, the addition of S-1 to gemcitabine for advanced pancreatic cancer did not prolong overall survival (OS) significantly, despite its higher response rate and longer progression-free survival (PFS). Leucovorin is known to enhance efficacy of S-1, and we conducted this phase I trial of combination therapy of gemcitabine, S-1 and leucovorin (GSL). METHODS: Patients with advanced pancreatic cancer who had received no prior chemotherapy were eligible for this study. Gemcitabine was administered at an escalating dose of 600, 800 and 1,000 mg/m(2) over 30 min on day 1, and oral S-1 at a dose of 40 mg/m(2) twice daily and oral leucovorin at a dose of 25 mg twice daily on days 1-7, every 2 weeks. A standard "3 + 3" phase I dose escalation design was utilized. RESULTS: Fifteen patients were enrolled across three dose levels. Three patients developed DLTs: two patients in level 1 (grade 3 anorexia in 1 and grade 3 anorexia, stomatitis and diarrhea in 1) and one patient in level 2 (grade 3 deep vein thrombosis). No DLT was observed in level 3. Response rate and the disease control rate were 33 and 93 %, respectively. The median PFS and OS were 5.4 and 16.6 months. Ten of 12 patients (83 %) with elevated CA19-9 at baseline had a ≥ 50 % decline. CONCLUSIONS: RD of gemcitabine in GSL was determined as 1,000 mg/m(2). GSL was well tolerable and showed promising results in advanced pancreatic cancer.

5 Clinical Trial Intravenous and intraperitoneal paclitaxel with S-1 for refractory pancreatic cancer with malignant ascites: an interim analysis. 2014

Takahara, Naminatsu / Isayama, Hiroyuki / Nakai, Yousuke / Sasaki, Takashi / Ishigami, Hironori / Yamashita, Hiroharu / Yamaguchi, Hironori / Hamada, Tsuyoshi / Uchino, Rie / Mizuno, Suguru / Miyabayashi, Koji / Mohri, Dai / Kawakubo, Kazumichi / Kogure, Hirofumi / Yamamoto, Natsuyo / Sasahira, Naoki / Hirano, Kenji / Ijichi, Hideaki / Tateishi, Keisuke / Tada, Minoru / Kitayama, Joji / Watanabe, Toshiaki / Koike, Kazuhiko. ·Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, , Bunkyo-ku, Tokyo, 113-8655, Japan. ·J Gastrointest Cancer · Pubmed #24676891.

ABSTRACT: OBJECTIVES: Here, we reported an interim analysis of feasibility and safety in the first 10 cases of 30 cases in a phase II trial of intravenous and intraperitoneal paclitaxel combined with S-1 for gemcitabine-refractory pancreatic cancer with malignant ascites. METHODS: Paclitaxel was administered intravenously at 50 mg/m2 and intraperitoneally at 20 mg/m2 on days 1 and 8 every 3 weeks, and S-1 was administered at 80 mg/m2/day for 14 consecutive days, followed by 7-day rest. RESULTS: Between April 2011 and February 2012, ten patients were enrolled. A partial response was achieved in two patients (20%) and a disease control rate of 50%. The median time to progression and overall survival were 2.1 and 3.4 months, respectively. Malignant ascites was completely resolved in two patients (20%). Major grade 3/4 adverse events were myelosuppression including neutropenia (50%) and catheter-related infection (10%). CONCLUSIONS: This novel combination chemotherapy was feasible and showed promising results in pancreatic cancer patients with malignant ascites (clinical trial registration number: UMIN000005306).

6 Clinical Trial A multicenter phase II trial of gemcitabine and candesartan combination therapy in patients with advanced pancreatic cancer: GECA2. 2013

Nakai, Yousuke / Isayama, Hiroyuki / Ijichi, Hideaki / Sasaki, Takashi / Takahara, Naminatsu / Ito, Yukiko / Matsubara, Saburo / Uchino, Rie / Yagioka, Hiroshi / Arizumi, Toshihiko / Hamada, Tsuyoshi / Miyabayashi, Koji / Mizuno, Suguru / Yamamoto, Keisuke / Kogure, Hirofumi / Yamamoto, Natsuyo / Hirano, Kenji / Sasahira, Naoki / Tateishi, Keisuke / Tada, Minoru / Koike, Kazuhiko. ·Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo Bunkyo-ku, Tokyo, Japan, 113-8655. ·Invest New Drugs · Pubmed #23690239.

ABSTRACT: BACKGROUND: Our retrospective study and phase I trial of gemcitabine and candesartan combination therapy suggested the inhibition of renin-angiotensin system potentially has a role in the treatment of advanced pancreatic cancer. The aim of this multicenter phase II trial was to assess the efficacy and toxicity of gemcitabine and candesartan combination therapy for advanced pancreatic cancer. METHODS: Chemotherapy-naive patients with histologically or cytologically proven advanced pancreatic cancer were enrolled. Gemcitabine was administered at a dose of 1,000 mg/m(2) over 30 min on days 1, 8, and 15 and oral candesartan at a dose of 16 mg in normotensive patients, and 8 mg initially in hypertensive patients, with dose escalation to 16 mg allowed, from days 1 to 28, repeated every 4 weeks. RESULTS: A total of 35 patients with advanced pancreatic cancer were enrolled. Overall response rate and disease control rate were 11.4 % and 62.9 %. The median PFS and OS were 4.3 and 9.1 months with 1-year survival rate of 34.2 %. The median PFS was significantly longer in patients receiving 16 mg compared with 8 mg of candesartan (4.6 vs. 3.5 months, p=0.031). Major severe toxicities were neutropenia (23 %), leukopenia (17 %) and thrombocytopenia (11 %). Grade 2 hypotension was observed in 3 patients (9 %) and candesartan was discontinued in 2 patients due to hypotension. Conclusions In this multicenter phase 2 trial, gemcitabine and candesartan combination therapy was tolerable but failed to demonstrate activity against advanced pancreatic cancer. (UMIN CTR: UMIN000005580).

7 Clinical Trial Uridine diphosphate glucuronosyl transferase 1 family polypeptide A1 gene (UGT1A1) polymorphisms are associated with toxicity and efficacy in irinotecan monotherapy for refractory pancreatic cancer. 2013

Takahara, Naminatsu / Nakai, Yousuke / Isayama, Hiroyuki / Sasaki, Takashi / Satoh, Yumiko / Takai, Daiya / Hamada, Tsuyoshi / Uchino, Rie / Mizuno, Suguru / Miyabayashi, Koji / Mohri, Dai / Kawakubo, Kazumichi / Kogure, Hirofumi / Yamamoto, Natsuyo / Sasahira, Naoki / Hirano, Kenji / Ijichi, Hideaki / Tada, Minoru / Yatomi, Yutaka / Koike, Kazuhiko. ·Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. ·Cancer Chemother Pharmacol · Pubmed #23053265.

ABSTRACT: PURPOSE: The aim of this study was to evaluate the efficacy and safety of irinotecan monotherapy in patients with advanced pancreatic cancer (APC). METHODS: Patients with APC refractory to gemcitabine and S-1 were included. Irinotecan (100 mg/m(2)) was administered on days 1, 8, and 15 every 4 weeks until disease progression or unacceptable toxicity was observed. The relationship between uridine diphosphate glucuronosyl transferase 1 family polypeptide A1 gene (UGT1A1) polymorphisms and clinical outcomes was evaluated. RESULTS: Between January 2007 and December 2011, 231 cycles were delivered in 56 patients. Irinotecan was administered as second-line chemotherapy in 35.7% of patients and as third-line chemotherapy or later in 64.3%. A partial response was achieved in two (3.6%) and stable disease in 23 patients (41.0%), giving a disease control rate of 44.6%. The median time to progression (TTP) and overall survival (OS) were 2.9 (95% confidence interval [CI] 1.8-3.5) months and 5.3 (95% CI 4.5-6.8) months, respectively. Median survival from the first-line chemotherapy was 19.5 (95% CI 15.3-23.8) months. Major grade 3/4 adverse events included neutropenia (28.6%), anemia (12.5%), and anorexia (10.7%). Patients with *6 and/or *28 allele(s) (n = 15) were associated with grade 3/4 neutropenia and anorexia but showed longer TTP (5.3 vs. 1.8 months; p = 0.05), and OS (8.0 vs. 4.8 months; p = 0.09) than those without *6 and/or *28 (n = 29). CONCLUSIONS: Salvage chemotherapy with irinotecan was moderately effective and well-tolerated in patients with APC refractory to gemcitabine and S-1. UGT1A1 polymorphisms were associated with toxicity and efficacy.

8 Clinical Trial Phase I trial of gemcitabine and candesartan combination therapy in normotensive patients with advanced pancreatic cancer: GECA1. 2012

Nakai, Yousuke / Isayama, Hiroyuki / Ijichi, Hideaki / Sasaki, Takashi / Kogure, Hirofumi / Yagioka, Hiroshi / Miyabayashi, Koji / Mizuno, Suguru / Yamamoto, Keisuke / Mouri, Dai / Kawakubo, Kazumichi / Yamamoto, Natsuyo / Hirano, Kenji / Sasahira, Naoki / Tateishi, Keisuke / Tada, Minoru / Koike, Kazuhiko. ·Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. ·Cancer Sci · Pubmed #22515232.

ABSTRACT: Our retrospective study showed inhibition of the renin-angiotensin system was associated with better outcomes in patients with advanced pancreatic cancer receiving gemcitabine. The primary objective of this phase I study was to determine the recommended dose of candesartan in combination with gemcitabine in normotensive patients with advanced pancreatic cancer. Candesartan was given orally at an escalating dose (4, 8, 16, and 32 mg) q.d. daily, and gemcitabine was given 1000 mg/m(2) 30 min i.v. on days 1, 8, and 15, repeated every 4 weeks. Dose-limiting toxicity (DLT) was defined as grade 4 hematological toxicities, grade 2 hypotension, abnormal creatinine or potassium, and grade 3 or 4 other non-hematological toxicities. A standard "3+3" phase I dose-escalation design was used. A total of 14 patients (candesartan 4 mg, three patients; 8 mg, three patients; 16 mg, six patients; 32 mg, two patients) were enrolled. One of six patients at 16 mg showed DLT of grade 4 neutropenia and two of two patients at 32 mg showed DLT of grade 2 hypotension. Response rate and disease control rate were 0% and 79%, respectively. Progression-free survival and overall survival were 7.6 and 22.9 months, respectively. Candesartan 16 mg is the recommended dose in combination with gemcitabine in the treatment of advanced pancreatic cancer. (UMIN CTR: UMIN000002152).

9 Clinical Trial Management of malignant gastric outlet obstruction with a modified triple-layer covered metal stent. 2012

Isayama, Hiroyuki / Sasaki, Takashi / Nakai, Yousuke / Togawa, Osamu / Kogure, Hirofumi / Sasahira, Naoki / Yashima, Yoko / Kawakubo, Kazumichi / Ito, Yukiko / Hirano, Kenji / Tsujino, Takeshi / Toda, Nobuo / Tada, Minoru / Omata, Masao / Koike, Kazuhiko. ·Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. ·Gastrointest Endosc · Pubmed #22284092.

ABSTRACT: BACKGROUND: A high incidence of migration with covered metal stents has been reported in malignant gastric outlet obstruction (GOO). A newly modified, partially covered, triple-layer nitinol stent was developed that has a longer uncovered portion (5-15 mm) to prevent stent migration. OBJECTIVE: To estimate the efficacy and safety of the modified covered, triple-layer metal stent. DESIGN: Multicenter, prospective cohort study. SETTING: Three tertiary referral centers. PATIENTS: Fifty consecutive patients (26 with pancreatic carcinoma, 14 with gastric carcinoma, 9 with cholangiocarcinoma, 1 with a metastatic node) who presented with symptomatic unresectable malignant GOO between April 2007 and March 2010. INTERVENTIONS: Endoscopic placement of the modified covered, triple-layer metal stent. MAIN OUTCOME MEASUREMENTS: The primary endpoint was to improve the GOO scoring system (GOOSS) score. Secondary endpoints were success rate, patency, and complications. RESULTS: The median GOOSS score improved significantly (P < .0001) after stenting (from 0 to 3). The technical and clinical success rates were 100% and 90%, respectively. Stent occlusion by tumor overgrowth or ingrowth at the uncovered portion developed in 5 patients (10%). Asymptomatic stent migration occurred in 3 patients (6%) receiving chemotherapy at 95, 230, and 553 days after stent placement, but these patients tolerated solid food 68, 260, and 142 days after stent migration, respectively. Other complications occurred in 1 patient with insufficient expansion, cholangitis, and pancreatitis. No procedure-related deaths occurred. LIMITATIONS: A single-arm study in tertiary-care centers. CONCLUSIONS: The modified covered, triple-layer metal stent was effective and safe for managing malignant GOO and can prevent tumor ingrowth and stent migration. ( CLINICAL TRIAL REGISTRATION NUMBER: UMIN000004566.).

10 Clinical Trial Gemcitabine and oxaliplatin combination chemotherapy for patients with refractory pancreatic cancer. 2011

Isayama, Hiroyuki / Nakai, Yousuke / Yamamoto, Keisuke / Sasaki, Takashi / Mizuno, Suguru / Yagioka, Hiroshi / Yashima, Yoko / Kawakubo, Kazumichi / Kogure, Hirofumi / Arizumi, Toshihiko / Togawa, Osamu / Ito, Yukiko / Matsubara, Saburo / Yamamoto, Natsuyo / Sasahira, Naoki / Hirano, Kenji / Tsujino, Takeshi / Tada, Minoru / Omata, Masao / Koike, Kazuhiko. ·Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. isayama-tky@umin.ac.jp ·Oncology · Pubmed #21677453.

ABSTRACT: OBJECTIVE: The aim of this study was to investigate the effect of gemcitabine and oxaliplatin combination chemotherapy on refractory pancreatic cancer. METHODS: Patients with advanced pancreatic cancer refractory to gemcitabine and S-1 were treated with gemcitabine 1,000 mg/m² over 30 min and oxaliplatin 85 mg/m² over 120 min on days 1 and 15. Treatment was repeated every 4 weeks and tumor response was assessed every two cycles by RECIST version 1.0. RESULTS: Twenty-two patients with pathologically confirmed pancreatic cancer were enrolled. The treatment was administered as a second-line chemotherapy in eighteen patients (82%) and as a third-line chemotherapy in four patients (18%). Tumor response did not occur in any of the cases. Thirteen patients demonstrated stable diseases, and the disease control rate was 59%. Median overall survival and time to progression were 6.8 months (95% CI, 2.8-11.5) and 2.6 months (95% CI, 1.5-3.8), respectively. Median overall survival from the first-line chemotherapy was 22.7 months (95% CI, 14.8-24.4). The major grade 3/4 adverse events included neutropenia (14%), anorexia (23%), and peripheral neuropathy (14%). CONCLUSIONS: Gemcitabine and oxaliplatin combination chemotherapy was tolerable but had limited activity in patients with advanced pancreatic cancer in a refractory setting.

11 Clinical Trial Impact of S-1 in patients with gemcitabine-refractory pancreatic cancer in Japan. 2010

Nakai, Yousuke / Isayama, Hiroyuki / Sasaki, Takashi / Sasahira, Naoki / Kogure, Hirofumi / Hirano, Kenji / Tsujino, Takeshi / Ijichi, Hideaki / Tateishi, Keisuke / Tada, Minoru / Omata, Masao / Koike, Kazuhiko. ·Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo Bunkyo-ku, Tokyo 113-8655, Japan. ·Jpn J Clin Oncol · Pubmed #20462979.

ABSTRACT: OBJECTIVE: We investigated the impact of S-1 on the prognosis of patients with gemcitabine-refractory pancreatic cancer. METHODS: A total of 108 patients with gemcitabine-refractory pancreatic cancer were divided by the time of S-1 introduction in our institution: 47 patients who experienced progressive disease before February 2005 (pre-S-1 group) and 61 patients showed progressive disease after February 2005 (post-S-1 group). Introduction rates of second-line chemotherapy and survival were compared. Prognostic factors for residual survival were analyzed using the Cox proportional hazards model. RESULTS: Introduction rates of second-line chemotherapy were 12.8% in the pre-S-1 group and 45.9% in the post-S-1 group. Second-line chemotherapy was administered to 34 patients: 29 using S-1, 4 using 5-fluorouracil-based chemoradiation and 1 using 5-fluorouracil. The objective response rate, progression-free survival and overall survival for second-line chemotherapy with S-1 were 17.2%, 2.5 and 7.7 months, respectively. By the introduction of S-1 in our institution, residual survival was prolonged from 3.1 months in the pre-S-1 group to 6.7 months in the post-S-1 group (P < 0.001). Overall survival from the initiation of gemcitabine was 8.8 months in the pre-S-1 group and 11.3 months in the post-S-1 group (P = 0.013). Multivariate analysis identified the post-S-1 group (hazard ratio, 0.43; P = 0.001), gender, performance status, liver metastasis, and lactate dehydrogenase and C-reactive protein levels at progressive disease for gemcitabine to be prognostic factors for residual survival. CONCLUSIONS: The introduction of S-1 might improve the prognosis of patients with gemcitabine-refractory pancreatic cancer.

12 Article Antireflux covered metal stent for nonresectable distal malignant biliary obstruction: Multicenter randomized controlled trial. 2019

Hamada, Tsuyoshi / Isayama, Hiroyuki / Nakai, Yousuke / Iwashita, Takuji / Ito, Yukiko / Mukai, Tsuyoshi / Yagioka, Hiroshi / Saito, Tomotaka / Togawa, Osamu / Ryozawa, Shomei / Hirano, Kenji / Mizuno, Suguru / Yamamoto, Natsuyo / Kogure, Hirofumi / Yasuda, Ichiro / Koike, Kazuhiko. ·Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo. · Department of Oncologic Pathology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, USA. · Department of Gastroenterology, Graduate School of Medicine, Juntendo University. · First Department of Internal Medicine, Gifu University Hospital. · Department of Gastroenterology, Japanese Red Cross Medical Center. · Department of Gastroenterology, Gifu Municipal Hospital, Gifu. · Department of Gastroenterology, Tokyo Metropolitan Police Hospital. · Department of Gastroenterology, JR Tokyo General Hospital. · Department of Gastroenterology, Kanto Central Hospital. · Department of Gastroenterology, Saitama Medical University International Medical Center, Saitama. · Department of Gastroenterology, JCHO Tokyo Takanawa Hospital. · Department of Gastroenterology, Toshiba General Hospital, Tokyo. · Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa, Japan. ·Dig Endosc · Pubmed #30803046.

ABSTRACT: BACKGROUND AND AIM: An antireflux metal stent (ARMS) for nonresectable distal malignant biliary obstruction (MBO) may prevent recurrent biliary obstruction (RBO) as a result of duodenobiliary reflux and prolong time to RBO (TRBO). Superiority of ARMS over conventional covered self-expandable metal stents (SEMS) has not been fully examined. METHODS: We conducted a multicenter randomized controlled trial to examine whether TRBO of an ARMS with a funnel-shaped valve was longer than that of a covered SEMS in SEMS-naïve patients. We enrolled 104 patients (52 patients per arm) at 11 hospitals in Japan. Secondary outcomes included causes of RBO, adverse events, and patient survival. RESULTS: TRBO did not differ significantly between the ARMS and covered SEMS groups (median, 251 vs 351 days, respectively; P = 0.11). RBO as a result of biliary sludge or food impaction was observed in 13% and 9.8% of patients who received an ARMS and covered SEMS, respectively (P = 0.83). ARMS was associated with a higher rate of stent migration compared with the covered SEMS (31% vs 12%, P = 0.038). Overall rates of adverse events were 20% and 18% in the ARMS and covered SEMS groups, respectively (P = 0.97). No significant between-group difference in patient survival was observed (P = 0.26). CONCLUSIONS: The current ARMS was not associated with longer TRBO compared with the covered SEMS. Modifications including addition of an anti-migration system are required to use the current ARMS as first-line palliative treatment of distal MBO (UMIN-CTR clinical trial registration number: UMIN000014784).

13 Article A Multicenter Open-Label Randomized Controlled Trial of Pancreatic Enzyme Replacement Therapy in Unresectable Pancreatic Cancer. 2018

Saito, Tomotaka / Nakai, Yousuke / Isayama, Hiroyuki / Hirano, Kenji / Ishigaki, Kazunaga / Hakuta, Ryunosuke / Takeda, Tsuyoshi / Saito, Kei / Umefune, Gyotane / Akiyama, Dai / Watanabe, Takeo / Takagi, Kaoru / Takahara, Naminatsu / Hamada, Tsuyoshi / Uchino, Rie / Mizuno, Suguru / Mouri, Dai / Yagioka, Hiroshi / Kogure, Hirofumi / Togawa, Osamu / Matsubara, Saburo / Ito, Yukiko / Yamamoto, Natsuyo / Tada, Minoru / Koike, Kazuhiko. ·Department of Gastroenterology, Tokyo Takanawa Hospital. · Department of Gastroenterology, Japanese Red Cross Medical Center. · Department of Gastroenterology, JR Tokyo General Hospital. · Department of Gastroenterology, Tokyo Metropolitan Police Hospital. · Department of Gastroenterology, Kanto Central Hospital. · Department of Gastroenterology, Toshiba General Hospital, Tokyo, Japan. ·Pancreas · Pubmed #29851751.

ABSTRACT: OBJECTIVE: Exocrine pancreatic insufficiency may impair the nutritional status in pancreatic cancer (PC), but the role of pancreatic enzyme replacement therapy (PERT) is not fully evaluated. Therefore, we conducted this multicenter open-label randomized controlled trial to evaluate the role of PERT in PC patients. METHODS: Patients with unresectable PC receiving chemotherapy were randomly assigned to pancrelipase and nonpancrelipase groups. Patients in the pancrelipase group took oral pancrelipase of 48,000 lipase units per meal. N-benzoyl-tryrosyl para-aminobenzoic acid (NBT-PABA) test was performed at baseline. Our primary endpoint was change in body mass index (BMI) at 8 weeks. Secondary endpoints were change in other nutritional status at 8 weeks and overall survival. RESULTS: A total of 88 patients were enrolled between May 2014 and May 2016. The NBT-PABA test was lower than the normal range in 90%. There were no significant differences in change in BMI at 8 weeks: 0.975 and 0.980 in the pancrelipase and the nonpancrelipase groups, respectively (P = 0.780). The other nutritional markers were also comparable. The median overall survival was 19.0 and 12.0 months (P = 0.070). CONCLUSIONS: In this randomized controlled trial, pancrelipase failed to improve the change in BMI at 8 weeks in PC patients receiving chemotherapy.

14 Article The Role of Pancreatic Enzyme Replacement Therapy in Unresectable Pancreatic Cancer: A Prospective Cohort Study. 2017

Saito, Tomotaka / Hirano, Kenji / Isayama, Hiroyuki / Nakai, Yousuke / Saito, Kei / Umefune, Gyotane / Akiyama, Dai / Watanabe, Takeo / Takagi, Kaoru / Hamada, Tsuyoshi / Takahara, Naminatsu / Uchino, Rie / Mizuno, Suguru / Kogure, Hirofumi / Matsubara, Saburo / Yamamoto, Natsuyo / Tada, Minoru / Koike, Kazuhiko. ·From the *Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo; and †Department of Gastroenterology, Tokyo Takanawa Hospital, Tokyo, Japan. ·Pancreas · Pubmed #28099252.

ABSTRACT: OBJECTIVES: Although patients with pancreatic cancer (PC) are prone to exocrine pancreatic insufficiency, there are little evidence about pancreatic enzyme replacement therapy (PERT) in patients with PC, especially those receiving chemotherapy. METHODS: This is a prospective consecutive observational study of PERT in patients with unresectable PC. We prospectively enrolled patients receiving chemotherapy for unresectable PC from April 2012 to February 2014 and prescribed oral pancrelipase of 48,000 lipase units per meal (pancrelipase group). N-benzoyl-tryrosyl para-aminobenzoic acid test was performed at baseline. Patients receiving chemotherapy before April 2012 were retrospectively studied as a historical cohort. Data on the nutritional markers at baseline and 16 weeks were extracted, and serial changes, defined as the ratio of markers at 16 weeks/baseline, were compared between 2 groups. RESULTS: A total of 91 patients (46 in the pancrelipase group and 45 in the historical cohort) were analyzed. N-benzoyl-tryrosyl para-aminobenzoic acid test was low in 94% of the pancrelipase group. Serial change in the pancrelipase group versus historical cohort was 1.01 versus 0.95 in body mass index (P < 0.001) and 1.03 versus 0.97 in serum albumin (P = 0.131). CONCLUSIONS: The rate of exocrine pancreatic insufficiency in unresectable PC was high, and PERT can potentially improve the nutritional status during chemotherapy.

15 Article [IPMN and pancreatic cyst as high risk of pancreatic cancer]. 2015

Tada, Minoru / Takagi, Kaori / Kawakubo, Kazumichi / Hakuta, Ryunosuke / Ishigaki, Kazunaga / Takeda, Tsuyoshi / Fujiwara, Hiroaki / Umefune, Gyotane / Saito, Kei / Saito, Tomotaka / Watanabe, Takeo / Akiyama, Dai / Uchino, Rie / Kishikawa, Takahiro / Takahara, Naminatsu / Takahashi, Ryota / Yamamoto, Keisuke / Hamada, Tsuyoshi / Mizuno, Suguru / Miyabayashi, Koji / Mohri, Dai / Matsubara, Saburo / Kogure, Hirofumi / Nakai, Yousuke / Yamamoto, Natsuyo / Sasaki, Takashi / Sasahira, Naoki / Hirano, Kenji / Ijichi, Hideaki / Tateishi, Keisuke / Isayama, Hiroyuki / Koike, Kazuhiko. ·Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo. ·Nihon Shokakibyo Gakkai Zasshi · Pubmed #26250126.

ABSTRACT: -- No abstract --

16 Article Pancreatic cancer with malignant ascites: clinical features and outcomes. 2015

Takahara, Naminatsu / Isayama, Hiroyuki / Nakai, Yousuke / Sasaki, Takashi / Saito, Kei / Hamada, Tsuyoshi / Mizuno, Suguru / Miyabayashi, Koji / Mohri, Dai / Kogure, Hirofumi / Matsubara, Saburo / Yamamoto, Natsuyo / Hirano, Kenji / Ijichi, Hideaki / Tateishi, Keisuke / Tada, Minoru / Koike, Kazuhiko. ·From the Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. ·Pancreas · Pubmed #25636085.

ABSTRACT: OBJECTIVES: Malignant ascites (MA) caused by peritoneal carcinomatosis is not uncommon in patients with pancreatic cancer. However, the clinical features and outcomes in these patients remain to be elucidated. METHODS: Baseline characteristics and overall survival (OS) of consecutive patients with advanced pancreatic cancer who presented with MA were retrospectively evaluated. RESULTS: Of 494 patients with advanced pancreatic cancer, 73 (15%) presented with MA. Patients with synchronous MA (n = 21), compared with those with metachronous MA (n = 52), had better performance status (P = 0.02), smaller amount of ascites (P < 0.01), and higher chance of receiving chemotherapy (57% vs 17%, P < 0.01), and resulted in longer OS (115 vs 42 days, P < 0.01). Overall survival was significantly longer in patients receiving chemotherapy than in those with best supportive care alone (124 vs 50 days, P < 0.01). In a multivariate analysis, chemotherapy was prognostic in addition to performance status, CRP, and small amount of MA; the hazard ratio of chemotherapy was 0.46, compared with best supportive care alone (P = 0.02). CONCLUSIONS: Although the prognosis of pancreatic cancer patients with MA remains poor, selected patients may be candidate for chemotherapy, regardless of the timing of appearance of MA.

17 Article Risk factors for post-ERCP pancreatitis in wire-guided cannulation for therapeutic biliary ERCP. 2015

Nakai, Yousuke / Isayama, Hiroyuki / Sasahira, Naoki / Kogure, Hirofumi / Sasaki, Takashi / Yamamoto, Natsuyo / Saito, Kei / Umefune, Gyotane / Akiyama, Dai / Kawahata, Shuhei / Matsukawa, Miho / Saito, Tomotaka / Hamada, Tsuyoshi / Takahara, Naminatsu / Mizuno, Suguru / Miyabayashi, Koji / Mohri, Dai / Hirano, Kenji / Tada, Minoru / Koike, Kazuhiko. ·Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. ·Gastrointest Endosc · Pubmed #25442080.

ABSTRACT: BACKGROUND: Wire-guided cannulation (WGC) was reported to decrease post-ERCP pancreatitis (PEP), but risk factors for PEP in WGC are not fully elucidated. OBJECTIVE: To evaluate the incidence and risk factors of PEP in WGC. DESIGN: Single-center retrospective study. SETTING: Academic center. PATIENTS: A total of 800 consecutive patients with a native papilla. INTERVENTIONS: Biliary therapeutic ERCP by using WGC. MAIN OUTCOME MEASUREMENTS: The rate of PEP and its risk factors. RESULTS: Biliary cannulation was successful by using WGC alone in 70.5%, and the final cannulation rate was 96.1%. Unintentional guidewire insertion and contrast material injection into the pancreatic duct (PD) during cannulation occurred in 55.3% and 21.8%, respectively. The incidence of PEP was 9.5% (mild 5.6%, moderate 2.9%, severe 1.0%). Multivariate analysis revealed a common bile duct (CBD) diameter of <9 mm (odds ratio [OR] 2.03; P = .006) and unintentional guidewire insertion into the PD (OR 2.25; P = .014) as risk factors for PEP. PD opacification was not a risk factor for PEP (OR 1.15; P = .642), but the incremental increase of the PEP rate was seen in patients with CBDs <9 mm: 4.6% without any PD manipulation, 8.3% with contrast material alone, 16.9% with guidewire alone, and 22.1% with both contrast material and guidewire. LIMITATIONS: Retrospective design in a single center. CONCLUSION: Unintentional PD manipulation was not uncommon in WGC. Guidewire insertion into the PD and a small CBD were risk factors for PEP in biliary therapeutic ERCP with the use of WGC.

18 Article Association between autoimmune pancreatitis and malignancy. 2014

Hirano, Kenji / Isayama, Hiroyuki / Tada, Minoru / Koike, Kazuhiko. ·Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan, khirano-tky@umin.ac.jp. ·Clin J Gastroenterol · Pubmed #26183737.

ABSTRACT: Chronic inflammatory diseases are often associated with malignancy, and this phenomenon occurs even in the field of gastroenterology. For example, chronic pancreatitis has been reported to be highly associated with the occurrence of pancreatic cancer. However, the association between autoimmune pancreatitis (AIP) and pancreatic cancer is still an unsolved problem. As AIP is associated with immunoglobulin G4-related disease, which causes a variety of inflammatory and fibrotic lesions, the association between AIP and total malignancies is also a matter of interest. Here, we discuss the association between AIP and malignancy. As for the association between AIP and pancreatic cancer, there is no conclusive evidence, although several reports have suggested that the relative risk of pancreatic cancer is high in AIP. Concerning the association between AIP and total malignancies, there are two reports from Japan. Neither report supported the idea that chronic inflammation in AIP caused the increased risk of total malignancies. However, one report proposed the possibility that AIP might develop as a paraneoplastic syndrome in some patients because many cancers occurred within 1 year of AIP diagnosis, and thereby concluded that patients with AIP were at high risk of having various cancers. The paraneoplastic syndrome hypothesis should be tested in future studies.

19 Article Smoking, family history of cancer, and diabetes mellitus are associated with the age of onset of pancreatic cancer in Japanese patients. 2014

Mizuno, Suguru / Nakai, Yousuke / Isayama, Hiroyuki / Kawahata, Shuhei / Saito, Tomotaka / Takagi, Kaoru / Watanabe, Takeo / Uchino, Rie / Hamada, Tsuyoshi / Miyabayashi, Koji / Kogure, Hirofumi / Sasaki, Takashi / Yamamoto, Natsuyo / Sasahira, Naoki / Hirano, Kenji / Tsujino, Takeshi / Ijichi, Hideaki / Tateishi, Keisuke / Tada, Minoru / Koike, Kazuhiko. ·From the Department of Gastroenterology, Graduate School of Medicine, University of Tokyo, Tokyo, Japan. ·Pancreas · Pubmed #24979618.

ABSTRACT: OBJECTIVES: The aim of this study was to examine the association of risk factors including diabetes mellitus (DM) with the age of onset in Japanese pancreatic cancer (PC) patients. METHODS: We retrospectively reviewed 688 PC patients diagnosed at our institute. We analyzed the association between the age of onset of PC and the following variables: sex, smoking, alcohol, DM, and a family history of cancer especially PC. RESULTS: The mean age of PC diagnosis was 67.6 years. The onset of PC occurred earlier in current smokers (63.6 years old, P < 0.001) compared with past smokers (69.5 years old) and never smokers (68.6 years old). Patients with long-standing DM (>2 years) were older (70.5 years, P < 0.001) when diagnosed with PC than patients with new-onset DM (within 2 years) (66.9 years old) and patients without DM (66.7 years old). In the multivariate analysis, current smokers and a family history of cancer other than PC were associated with earlier onset. Conversely, long-standing DM was associated with later onset. CONCLUSIONS: In Japanese PC patients, current smokers and a family history of cancer other than PC were associated with a younger age of onset. Conversely, long-standing DM was associated with a later onset.

20 Article Transmural biliary drainage can be an alternative to transpapillary drainage in patients with an indwelling duodenal stent. 2014

Hamada, Tsuyoshi / Isayama, Hiroyuki / Nakai, Yousuke / Kogure, Hirofumi / Yamamoto, Natsuyo / Kawakubo, Kazumichi / Takahara, Naminatsu / Uchino, Rie / Mizuno, Suguru / Sasaki, Takashi / Togawa, Osamu / Matsubara, Saburo / Ito, Yukiko / Hirano, Kenji / Tsujino, Takeshi / Tada, Minoru / Koike, Kazuhiko. ·Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan, hamada-tky@umin.ac.jp. ·Dig Dis Sci · Pubmed #24839917.

ABSTRACT: BACKGROUND: Self-expandable metal stents (SEMS) are widely utilized to relieve symptoms of malignant gastric outlet obstruction (GOO), but GOO is frequently complicated by nonresectable distal biliary obstruction. The optimal endoscopic approach to biliary drainage in this setting remains controversial and has yet to be resolved. AIMS: To compare the safety and efficacy of endoscopic ultrasound-guided transmural biliary drainage (EUS-BD) and transpapillary drainage in patients with an indwelling duodenal SEMS. METHODS: Patients who underwent EUS-BD or transpapillary drainage for distal malignant biliary obstruction with an indwelling duodenal SEMS between June 2007 and August 2012 at three Japanese tertiary referral centers were identified retrospectively. We compared times to stent dysfunction, causes of dysfunction, and procedural related complications between these two groups. RESULTS: Twenty patients were included in the study (7 EUS-BD and 13 transpapillary drainage). EUS-BD was performed via hepaticogastrostomy using a SEMS in three patients and via choledochoduodenostomy using a SEMS or a plastic stent in two patients each. Transpapillary drainage was performed using a SEMS in all patients. The stent patency rate in the EUS-BD group was higher than that in the transpapillary drainage group (100 vs. 71% at 1 month and 83 vs. 29% at 3 months, respectively). The rate of stent dysfunction in the EUS-BD group tended to be lower than that in the transpapillary group (14 vs. 54%; P = 0.157). Complication rates were similar between the groups (P = 1.000), with moderate bleeding in one patient in the EUS-BD group and mild pancreatitis in one patient in the transpapillary group. CONCLUSION: Endoscopic ultrasound-guided transmural biliary drainage is an alternative to transpapillary drainage in patients with an indwelling duodenal SEMS.

21 Article Risk factors for covered metallic stent migration in patients with distal malignant biliary obstruction due to pancreatic cancer. 2014

Nakai, Yousuke / Isayama, Hiroyuki / Kogure, Hirofumi / Hamada, Tsuyoshi / Togawa, Osamu / Ito, Yukiko / Matsubara, Saburo / Arizumi, Toshihiko / Yagioka, Hiroshi / Mizuno, Suguru / Sasaki, Takashi / Yamamoto, Natsuyo / Hirano, Kenji / Tada, Minoru / Koike, Kazuhiko. ·Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. ·J Gastroenterol Hepatol · Pubmed #24720610.

ABSTRACT: BACKGROUND AND AIM: Covered metallic stents (CMSs) were developed to overcome tumor ingrowth in uncovered metallic stents (UMSs) for malignant biliary obstruction, but superiority of CMSs over UMSs is still controversial due to the high migration rate in CMS. Therefore, we conducted this retrospective analysis to clarify risk factors for stent migration, including mechanical properties of CMSs. METHODS: Patients with unresectable pancreatic cancer, receiving CMS for distal malignant biliary obstruction in five tertiary care centers, were retrospectively studied. Univariate and multivariate analyses to identify prognostic factors for early (< 6 months) stent migration were performed using a proportional hazards model with death or stent occlusion without stent migration as a competing risk. Two mechanical properties were included in the analysis: axial force, the recovery force that leads to a CMS straightening, and radial force (RF), the expansion force against the stricture. RESULTS: Among 290 patients who received CMS placement for distal malignant biliary obstruction, stent migration rate was 15.2%. CMS migrated early (< 6 months) in 10.0% and distally in 11.7%, respectively. In the multivariate analysis, significant risk factors for early stent migration were chemotherapy (subdistribution hazard ratios [SHR] 4.46, P = 0.01), CMS with low RF (SHR 2.23, P = 0.03), and duodenal invasion (SHR 2.25, P = 0.02). CONCLUSION: CMS with low RF, chemotherapy, and duodenal invasion were associated with CMS migration from our study.

22 Article Metallic stent with high axial force as a risk factor for cholecystitis in distal malignant biliary obstruction. 2014

Nakai, Yousuke / Isayama, Hiroyuki / Kawakubo, Kazumichi / Kogure, Hirofumi / Hamada, Tsuyoshi / Togawa, Osamu / Ito, Yukiko / Matsubara, Saburo / Arizumi, Toshihiko / Yagioka, Hiroshi / Takahara, Naminatsu / Uchino, Rie / Mizuno, Suguru / Miyabayashi, Koji / Yamamoto, Keisuke / Sasaki, Takashi / Yamamoto, Natsuyo / Hirano, Kenji / Tada, Minoru / Koike, Kazuhiko. ·Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. ·J Gastroenterol Hepatol · Pubmed #24628054.

ABSTRACT: BACKGROUND AND AIM: Tumor involvement to the orifice of cystic duct (OCD) is a risk factor for cholecystitis after self-expandable metallic stent (SEMS) placement, but its prevention is still difficult. We conducted this multicenter analysis to clarify a type of SEMS or a method to place SEMS which would decrease the incidence of cholecystitis after SEMS placement. METHODS: The incidence of cholecystitis was studied in consecutive patients receiving SEMS for distal malignant biliary obstruction in five tertiary care centers. Multiple logistic regression analysis was performed to evaluate risk factors for cholecystitis. RESULTS: A total of 376 patients who received SEMS placement for distal malignant biliary obstruction were analyzed. Tumor involvement to OCD was diagnosed in 25.3%. Overall incidence of cholecystitis was 6.9%. Cholecystitis was observed in 8.0% of 300 patients with covered SEMS, 16.8% of 95 patients with tumor involvement to OCD, 10.8% of 234 patients with SEMS of high axial force (AF), and 12.0% of 158 patients with SEMS length ≤ 60 mm. In the multivariate analysis, tumor involvement to OCD (odds ratio [OR] 5.40, P < 0.001), SEMSs with high AF (OR 5.33, P = 0.002), and SEMS length ≤ 60 mm (OR 3.19, P = 0.010) are risk factors. Among patients with tumor involvement to OCD, the incidence of cholecystitis in SEMS with high and low AF was 25.0% and 5.0%, respectively. CONCLUSION: This study with an expanded cohort reconfirmed tumor involvement to OCD as a risk factor for cholecystitis after SEMS placement. SEMS with low AF might decrease cholecystitis.

23 Article Slow pull versus suction in endoscopic ultrasound-guided fine-needle aspiration of pancreatic solid masses. 2014

Nakai, Yousuke / Isayama, Hiroyuki / Chang, Kenneth J / Yamamoto, Natsuyo / Hamada, Tsuyoshi / Uchino, Rie / Mizuno, Suguru / Miyabayashi, Koji / Yamamoto, Keisuke / Kawakubo, Kazumichi / Kogure, Hirofumi / Sasaki, Takashi / Hirano, Kenji / Tanaka, Mariko / Tada, Minoru / Fukayama, Masashi / Koike, Kazuhiko. ·Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. ·Dig Dis Sci · Pubmed #24429514.

ABSTRACT: BACKGROUND: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) of pancreatic masses is an established procedure for obtaining a pathological specimen. However, application of suction during EUS-FNA is still controversial and the efficacy of the slow-pull technique was recently reported for new core biopsy needles. AIM: The purpose of this study was to compare the suction and slow-pull techniques using regular FNA needles. METHODS: The diagnostic yield of the suction and slow-pull techniques was retrospectively studied for patients who underwent EUS-FNA for pancreatic solid lesions. RESULTS: A total of 367 passes (181 by suction and 186 by the slow-pull technique) were performed during 97 EUS-FNA procedures for 93 patients with pancreatic solid lesions. The slow-pull technique resulted in lower scores for cellularity (≥2 for 37.5 % vs. 76.7 %) but scores for contamination with blood were lower (≥2 for 25.0 % vs. 66.7 %) and sensitivity of diagnosis of malignancy was higher (90.0 % vs. 67.9 %) when a 25-gauge FNA needle was used. There were no significant differences between the two techniques when a 22-gauge needle was used. In multivariate analysis of 82 cases with malignancy, the slow-pull technique (odds ratio (OR) 1.92, P = 0.028), tumor size ≥25 mm (OR 4.64, P < 0.001), and tumor location in the body or tail (OR 2.82, P < 0.001) were associated with greater sensitivity. CONCLUSION: The slow-pull technique was associated with less contamination with blood and can potentially increase the diagnostic yield compared with the suction technique in EUS-FNA of pancreatic solid masses, especially with a 25-gauge FNA needle.

24 Article Disease-specific mortality among patients with intraductal papillary mucinous neoplasm of the pancreas. 2014

Kawakubo, Kazumichi / Tada, Minoru / Isayama, Hiroyuki / Sasahira, Naoki / Nakai, Yousuke / Takahara, Naminatsu / Uchino, Rie / Hamada, Tsuyoshi / Miyabayashi, Koji / Yamamoto, Keisuke / Mizuno, Suguru / Mohri, Dai / Kogure, Hirofumi / Sasaki, Takashi / Yamamoto, Natsuyo / Hirano, Kenji / Ijichi, Hideaki / Tateishi, Keisuke / Koike, Kazuhiko. ·Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. · Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. Electronic address: mtada-tky@umin.ac.jp. ·Clin Gastroenterol Hepatol · Pubmed #23892276.

ABSTRACT: BACKGROUND & AIMS: Intraductal papillary mucinous neoplasm (IPMN) of the pancreas is associated with synchronous and metachronous pancreatic cancer. However, the risk factors for pancreatic cancer-specific mortality have not been determined. We evaluated disease-specific mortality among patients with IPMNs harboring high-risk stigmata. METHODS: We analyzed data from 243 patients diagnosed with IPMN, with indications for surgery according to the consensus criteria, at the University of Tokyo Hospital from 1995 to January 2011. By using optimal matching and propensity scores based on 16 characteristics, we matched patients who underwent surgery at diagnosis with those who did not undergo surgery. A competing risk analysis was used to assess the risk of pancreatic cancer-specific mortality. RESULTS: Fifty-nine patients underwent surgery after diagnosis and 184 did not. After adjustment with propensity scores, detection of a hypo-attenuating area by computed tomography, which indicates invasive carcinoma, was associated significantly with pancreatic cancer-specific mortality (adjusted hazard ratio, 16.75; 95% confidence interval, 2.72-103.3; P = .002). Cyst diameter, main pancreatic duct diameter, and the presence of a mural nodule were not associated significantly with pancreatic cancer-specific mortality. Surgical management was found to reduce pancreatic cancer-specific mortality, especially in patients with hypo-attenuating areas (P = .038). CONCLUSIONS: Detection of a hypo-attenuating area by computed tomography significantly increases the risk for pancreatic cancer-specific mortality among IPMN patients with consensus indications for surgery. Surgical resection significantly reduces this risk.

25 Article Estimation and comparison of cumulative incidences of biliary self-expandable metallic stent dysfunction accounting for competing risks. 2014

Hamada, Tsuyoshi / Nakai, Yousuke / Isayama, Hiroyuki / Togawa, Osamu / Kogure, Hirofumi / Kawakubo, Kazumichi / Tsujino, Takeshi / Sasahira, Naoki / Hirano, Kenji / Yamamoto, Natsuyo / Ito, Yukiko / Sasaki, Takashi / Mizuno, Suguru / Toda, Nobuo / Tada, Minoru / Koike, Kazuhiko. ·Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. ·Dig Endosc · Pubmed #23650933.

ABSTRACT: BACKGROUND: Self-expandable metallic stent (SEMS) placement is widely carried out for distal malignant biliary obstruction, and survival analysis is used to evaluate the cumulative incidences of SEMS dysfunction (e.g. the Kaplan-Meier [KM] method and the log-rank test). However, these statistical methods might be inappropriate in the presence of 'competing risks' (here, death without SEMS dysfunction), which affects the probability of experiencing the event of interest (SEMS dysfunction); that is, SEMS dysfunction can no longer be observed after death. A competing risk analysis has rarely been done in studies on SEMS. PATIENTS AND METHODS: We introduced the concept of a competing risk analysis and illustrated its impact on the evaluation of SEMS outcomes using hypothetical and actual data. Our illustrative study included 476 consecutive patients who underwent SEMS placement for unresectable distal malignant biliary obstruction. RESULTS: A significant difference between cumulative incidences of SEMS dysfunction in male and female patients via theKM method (P = 0.044 by the log-rank test) disappeared after applying a competing risk analysis (P = 0.115 by Gray's test). In contrast, although cumulative incidences of SEMS dysfunction via the KM method were similar with and without chemotherapy (P = 0.647 by the log-rank test), cumulative incidence of SEMS dysfunction in the non-chemotherapy group was shown to be significantly lower (P = 0.031 by Gray's test) in a competing risk analysis. CONCLUSION: Death as a competing risk event needs to be appropriately considered in estimating a cumulative incidence of SEMS dysfunction, otherwise analytical results may be biased.

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