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Pancreatic Neoplasms: HELP
Articles by Yukiko Ito
Based on 15 articles published since 2010
(Why 15 articles?)
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Between 2010 and 2020, Yukiko Ito wrote the following 15 articles about Pancreatic Neoplasms.
 
+ Citations + Abstracts
1 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).

2 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.).

3 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.

4 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).

5 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.

6 Article Antireflux Metal Stent as a First-Line Metal Stent for Distal Malignant Biliary Obstruction: A Pilot Study. 2017

Hamada, Tsuyoshi / Isayama, Hiroyuki / Nakai, Yousuke / Togawa, Osamu / Takahara, Naminatsu / Uchino, Rie / Mizuno, Suguru / Mohri, Dai / Yagioka, Hiroshi / Kogure, Hirofumi / Matsubara, Saburo / Yamamoto, Natsuyo / Ito, Yukiko / Tada, Minoru / Koike, Kazuhiko. ·Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. · Department of Gastroenterology, Tokyo Metropolitan Police Hospital, Tokyo, Japan. · Department of Gastroenterology, Japanese Red Cross Medical Center, Tokyo, Japan. ·Gut Liver · Pubmed #27282268.

ABSTRACT: Background/Aims: In distal malignant biliary obstruction, an antireflux metal stent (ARMS) with a funnel-shaped valve is effective as a reintervention for metal stent occlusion caused by reflux. This study sought to evaluate the feasibility of this ARMS as a first-line metal stent. Methods: Patients with nonresectable distal malignant biliary obstruction were identified between April and December 2014 at three Japanese tertiary centers. We retrospectively evaluated recurrent biliary obstruction and adverse events after ARMS placement. Results: In total, 20 consecutive patients were included. The most common cause of biliary obstruction was pancreatic cancer (75%). Overall, recurrent biliary obstruction was observed in seven patients (35%), with a median time to recurrent biliary obstruction of 246 days (range, 11 to 246 days). Stent occlusion occurred in five patients (25%), the causes of which were sludge and food impaction in three and two patients, respectively. Stent migration occurred in two patients (10%). The rate of adverse events associated with ARMS was 25%: pancreatitis occurred in three patients, cholecystitis in one and liver abscess in one. No patients experienced nonocclusion cholangitis. Conclusions: The ARMS as a first-line biliary drainage procedure was feasible. Because the ARMS did not fully prevent stent dysfunction due to reflux, further investigation is warranted.

7 Article Systematic cytological evaluation and immunocytochemistry of minichromosome maintenance protein 2 and p53 significantly improve cytological diagnosis of pancreaticobiliary adenocarcinoma. 2016

Abe, Naoya / Matsuo, Kozue / Kumasaka, Toshio / Naka, Koichi / Hashimoto, Syoichi / Takemura, Tamiko / Fujiwara, Mutsunori / Ito, Yukiko / Nakata, Ryo / Hashimoto, Takuya / Makuuchi, Masatoshi / Soejima, Yurie / Sawabe, Motoji. ·Departments of Pathology, Japanese Red Cross Medical Center, Tokyo, Japan. ·J Med Dent Sci · Pubmed #27181487.

ABSTRACT: Endoscopic retrograde cholangiopancreatography (ERCP) brushing cytology often cannot distinguish adenocarcinoma from reactive epithelial changes. We attempted to improve the diagnostic sensitivity of ERCP using the following methods: systematic cytological evaluation, immunocytochemical examination of minichromosome maintenance proteins (MCM) 2 and p53, and a combination of these methods. ERCP specimens from 53 patients (13 benign and 40 malignant cases) were studied. First, we reclassified the cases into three categories according to the systematic cytological evaluation: negative, suspicious, and positive. Secondly, immunocytochemistry was performed for MCM 2 and p53. The cut-off values were set at 25% labeling index (LI) for MCM 2 and 10% LI for p53, respectively. We evaluated the sensitivity, specificity, and diagnostic accuracy. The sensitivity of the systematic cytological evaluation alone did not improve significantly, compared with the original screening examination (77% vs. 68%). The sensitivity of immunocytochemistry for MCM 2 and p53 was 90% (P < 0.05) and 68%, respectively. Applying only the suspicious or positive categories, the sensitivity improved significantly to 93% for the combination of systematic cytological evaluation and immunocytochemistry for MCM 2 and p53 (P < 0.01). In conclusion, the combination of morphology and immunocytochemistry for MCM 2 and p53 may help to overcome the diagnostic cytological difficulties of pancreaticobiliary adenocarcinoma.

8 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.

9 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.

10 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.

11 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.

12 Article Predictive factors of solid food intake in patients with malignant gastric outlet obstruction receiving self-expandable metallic stents for palliation. 2012

Sasaki, Takashi / Isayama, Hiroyuki / Nakai, Yousuke / Togawa, Osamu / Kogure, Hirofumi / Kawakubo, Kazumichi / Mizuno, Suguru / Yashima, Yoko / Ito, Yukiko / Yamamoto, Natsuyo / Sasahira, Naoki / Hirano, Kenji / Tsujino, Takeshi / Toda, Nobuo / Tada, Minoru / Omata, Masao / Koike, Kazuhiko. ·Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo Department of Gastroenterology, Tokyo, Japan. ·Dig Endosc · Pubmed #22725106.

ABSTRACT: AIM: As for self-expandable metallic stents (SEMS) for malignant gastric outlet obstruction (GOO), some predictive factors of stent patency have been reported, although re-canalization of GOO by SEMS does not necessarily lead to favorable food intake. Therefore, we analyzed the predictive factors of oral food intake following SEMS placement. METHODS: A total of 97 consecutive patients in whom SEMS were placed for malignant GOO in five hospitals were included in this retrospective study. Clinical outcomes and predictive factors influencing solid food intake were analyzed. RESULTS: The technical and clinical success rates were 97.9% and 87.6%, respectively. The mean gastric outlet obstruction scoring system (GOOSS) improved from 0.39 to 2.24 after SEMS placement (P<0.01). The median eating period was 2.1 months (95% CI, 1.1-3.0 months), and the median survival time was 3.1 months (95% CI, 2.0-4.2 months). A Karnofsky performance status of ≤ 50 (odds ratio, 3.65; 95% CI, 1.17-13.1; P=0.03) and ascites (odds ratio, 3.28; 95% CI, 1.23-9.05; P=0.02) were identified as statistically significant independent poor predictive factors of solid food intake. CONCLUSION: SEMS is an effective treatment for patients with malignant GOO. Ascites and a poor performance status were poor predictive factors of solid food intake.

13 Article One- and two-step self-expandable metal stent placement for distal malignant biliary obstruction: a propensity analysis. 2012

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, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan. ·J Gastroenterol · Pubmed #22526271.

ABSTRACT: BACKGROUND: Although self-expandable metal stents (SEMS) are widely used for distal malignant biliary obstruction, one-step SEMS (direct placement without a prior plastic stent) and two-step SEMS (placement at second endoscopic retrograde cholangiopancreatography [ERCP] following plastic stent placement) have not been fully compared. METHODS: In this multicenter retrospective study, patients were included who underwent first-time endoscopic SEMS placement between September 1994 and December 2010. We compared the one-step and two-step strategies using a propensity analysis. RESULTS: In total, 370 patients were identified and one-step SEMS was performed in 59 patients. After adjustment using propensity scores, the median times to dysfunction were 116 and 219 days, respectively, for one-step and two-step SEMS (P = 0.058). Stent migration was more frequently observed in one-step SEMS as compared with two-step SEMS (25 vs. 11 %, P = 0.031). In one-step SEMS, the number of days of hospitalization associated with first-time SEMS placement was shorter compared with that in two-step SEMS (21 vs. 30 days, P = 0.001), and the total costs of SEMS-related interventions within 6 months were lower (6510 and 8100 USD, P = 0.004). The pathological diagnosis rates for pancreatic and biliary tract cancer at initial ERCP were 52 and 61 %. After failed diagnosis at initial ERCP, pathological diagnosis rates for pancreatic cancer were 32 versus 76 % (P = 0.005) by repeated ERCP versus endoscopic ultrasound (EUS)-guided fine-needle aspiration (FNA). CONCLUSIONS: One-step SEMS was associated with increased stent migration, despite having potential cost-effectiveness. The additional yield of pathological diagnosis at repeated ERCP was low compared with that yielded by EUS-guided FNA.

14 Article Duodenal invasion is a risk factor for the early dysfunction of biliary metal stents in unresectable pancreatic cancer. 2011

Hamada, Tsuyoshi / Isayama, Hiroyuki / Nakai, Yousuke / Togawa, Osamu / Kogure, Hirofumi / Kawakubo, Kazumichi / Tsujino, Takeshi / Sasahira, Naoki / Hirano, Kenji / Yamamoto, Natsuyo / Arizumi, Toshihiko / Ito, Yukiko / Matsubara, Saburo / Sasaki, Takashi / Yagioka, Hiroshi / Yashima, Yoko / Mohri, Dai / Miyabayashi, Kohji / Mizuno, Suguru / Nagano, Rie / Takahara, Naminatsu / Toda, Nobuo / Tada, Minoru / Omata, Masao / Koike, Kazuhiko. ·Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan. ·Gastrointest Endosc · Pubmed #21794859.

ABSTRACT: BACKGROUND: Although the placement of self-expandable metal stents (SEMSs) has been widely accepted as palliation for distal malignant biliary obstruction, the risk factors for their early dysfunction remain unclear. OBJECTIVE: To identify risk factors for early (<3 months) SEMS dysfunction in unresectable pancreatic cancer. DESIGN: A multicenter retrospective study. SETTING: Five tertiary referral centers. PATIENTS: Patients were included who underwent first-time SEMS placement for distal malignant biliary obstruction caused by pancreatic cancer between April 1994 and August 2010. MAIN OUTCOME MEASUREMENTS: Rates and causes of early dysfunction were evaluated, and risk factors were analyzed. RESULTS: In all, 317 eligible patients were identified. Covered SEMSs were placed in 82% of patients. Duodenal invasion was observed endoscopically in 37%. The median time to dysfunction was 170 days. The rates of all and early SEMS dysfunction were 55% and 31%, respectively. The major causes of SEMS dysfunction were food impaction and nonocclusion cholangitis (21% each) in early dysfunction and sludge (29%) in nonearly dysfunction. The rate of early dysfunction was 42% with duodenal invasion and 24% without duodenal invasion (P = .001). Early dysfunction caused by food impaction was more frequent in patients with duodenal invasion (10% and 4%, P = .053). Duodenal invasion was a risk factor (odds ratio 2.35; 95% CI, 1.43-3.90; P = .001) in a multiple logistic regression model. LIMITATIONS: A retrospective design. CONCLUSIONS: Duodenal invasion is a risk factor for early SEMS dysfunction in patients with pancreatic cancer.

15 Article Impact of S-1 on the survival of patients with advanced pancreatic cancer. 2010

Nakai, Yousuke / Isayama, Hiroyuki / Sasaki, Takashi / Sasahira, Naoki / Ito, Yukiko / Kogure, Hirofumi / Togawa, Osamu / Matsubara, Saburo / Arizumi, Toshihiko / Yagioka, Hiroshi / Yashima, Yoko / Kawakubo, Kazumichi / Mizuno, Suguru / Yamamoto, Keisuke / Hirano, Kenji / Tsujino, Takeshi / Ijichi, Hideaki / Tateishi, Keisuke / Toda, Nobuo / Tada, Minoru / Omata, Masao / Koike, Kazuhiko. ·Department of Gastroenterology, University of Tokyo, Bunkyo-ku, Tokyo, Japan. ·Pancreas · Pubmed #20467352.

ABSTRACT: OBJECTIVE: The aim of this study was to investigate the effect of S-1 on the prognosis of advanced pancreatic cancer. METHODS: In total, 112 patients with pancreatic cancer who received chemotherapy between April 2001 and April 2007 were divided into 2 groups: PreS-1 (53 patients who started chemotherapy before January 2005) and PostS-1 (59 patients who started chemotherapy after February 2005, the time of S-1 introduction). Patient characteristics and clinical outcomes were compared, and prognostic factors were analyzed. RESULTS: Patient characteristics did not significantly differ between the 2 groups. S-1 was administered as a second-line monotherapy in 5.7% of the PreS-1 group and combined with gemcitabine as a first-line therapy in 27.1% or as second-line monotherapy in 23.7% in the PostS-1 group. Both progression-free survival and overall survival improved after introduction of S-1 (median progression-free survival, 4.4 and 5.3 months; P = 0.043; median overall survival, 9.5 and 13.1 months; P = 0.048 in PreS-1 and PostS-1 groups, respectively). Multivariate analysis revealed that the PostS-1 group (hazards ratio, 0.52; P = 0.003), performance status, and carcinoembryonic antigen were significant prognostic factors for survival. CONCLUSIONS: Introduction of S-1 may improve the prognosis of Japanese patients with advanced pancreatic cancer.