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Background and Aims Several ligation techniques for ulceration after endoscopic submucosal dissection (ESD) have been reported, but none have been established for clinical use because of technical complexity and the need for expensive equipment. Therefore, the technical feasibility of a new ligation method using the double-loop clips (D-L clips) technique without an adhesive agent for ulceration after ESD of the colon was assessed. Methods Among 35 patients who underwent ESD of the colon in Kushiro Rosai Hospital between April 2019 and September 2019, 26 patients who underwent ligation using the D-L clips technique for the post-ESD ulcer bed were included in this retrospective study. Continuation or cessation of antithrombotic agents was based on the Guidelines for Gastroenterological Endoscopy in Patients Undergoing Antithrombotic Treatment. Results The rate of en bloc R0 resection was 97.1%, the median length of the resected specimen was 3.2 cm (interquartile range [IQR], 2.8-3.8 cm), and the complete ligation rate was 88.5% (23 of 26). Excluding patients with lesion sites in the rectum below the peritoneal reflection, the complete ligation rate was 95.5% (21 of 22). The median duration of the ligation procedure was 20 minutes (IQR, 16-24 minutes). The only delayed procedural adverse event was post-ESD coagulation syndrome in 1 patient. Incomplete ligation was significantly more frequent in patients with lesion sites in the inferior rectal valve/anal verge area (P = .0269). Conclusions Ligation using the D-L clips technique without an adhesive agent is feasible for closing ulceration after ESD of the colon, whereas other techniques may be necessary for lesions in the rectum below the peritoneal reflection.

Several studies have demonstrated increased pericardial effusion during anti‐PD‐1 immunotherapy, and treatment in patients who have developed pericardial tamponade is controversial. In this study, we describe a 63‐year‐old woman with stage IVA lung adenocarcinoma given pembrolizumab as a first‐line therapy. After four cycles of pembrolizumab treatment, the patient suddenly developed a pericardial tamponade. Although pericardial effusion was increased, her tumor lesions were reduced. After an emergency pericardiocentesis, she continued the pembrolizumab therapy without recurrent pericardial effusions for three months until the primary tumor and lymph node metastasis progressed. Nine months after the pericardiocentesis, the patient died of progressive lung cancer, but pericardial effusion did not recur throughout the treatment course. This case study suggests that pembrolizumab therapy can be continued with a strict follow‐up in some patients with pembrolizumab‐induced pericardial tamponade. Key points • Significant findings of the study Our patient developed pericardial tamponade during pembrolizumab treatment but continued pembrolizumab treatment after emergency pericardiocentesis without recurrent pericardial effusions. • What this study adds Pembrolizumab treatments may be resumed with a strict follow‐up in some patients with treatment‐related pericardial tamponade.

Background: The incidence of post-ERCP pancreatitis (PEP) has been reported to be significantly higher in patients without main pancreatic duct (MPD) obstruction who undergo transpapillary biliary ...

Background and aims Needle tract seeding after preoperative endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) for pancreatic body and tail cancer has been reported. This study aimed to investigate the long-term outcomes, including the needle tract seeding ratio, of patients undergoing distal pancreatectomy for pancreatic body and tail cancer diagnosed preoperatively by EUS-FNA. Methods This retrospective, observational cohort study assessed patients from three university hospitals and 11 tertiary referral centers. All patients who underwent distal pancreatectomy for invasive cancer of the pancreatic body and tail between January 2006 and December 2015 were identified and reviewed. Needle tract seeding rate, recurrence-free survival (RFS), and overall survival (OS) were evaluated. Results Of the 301 total patients analyzed, 176 underwent preoperative EUS-FNA (EUS-FNA group) and 125 did not (non-EUS-FNA group). The median follow-up periods of the EUS-FNA group and non-EUS-FNA group were 32.8 and 30.1 months. Six patients (3.4%) in the EUS-FNA group were diagnosed as having needle tract seeding. The 5-year cumulative needle tract seeding rate estimated using Fine and Gray's method was 3.8% (95% CI 1.6-7.8%). The median RFS or OS was not significantly different between the EUS-FNA group and the non-EUS-FNA group (23.7 vs 16.9 months: P = 0.205; 48.0 vs 43.9 months: P = 0.392). Conclusion Although preoperative EUS-FNA for pancreatic body and tail cancer has no negative effect on RFS or OS, needle tract seeding after EUS-FNA was observed to have a non-negligible rate. (UMIN000030719).

Background and aim Data on long-term outcomes after therapeutic endoscopic retrograde cholangiopancreatography (ERCP) using balloon-assisted enteroscopy (BAE) for choledochojejunal anastomotic stenosis (CJS) or pancreaticojejunal anastomotic stenosis (PJS) remain limited. We retrospectively assessed the long-term results of patients who achieved clinical success using BAE for CJS and PJS. Methods Patients who achieved technical and clinical success for CJS or PJS by BAE-ERCP and were followed up for more than 6 months after the initial BAE-ERCP therapy were retrospectively identified at 11 Japanese institutions. The primary end-point was CJS or PJS recurrence rates. The secondary end-points were initial therapy details, initial therapy complications, and CJS or PJS recurrence treatment details. We also evaluated restenosis-associated factors. Results From September 2008 to December 2015, 67 patients (CJS, 61; PJS, six) were included. The overall CJS and PJS recurrence rates were 34.4% and 33.3%, respectively. The 1-year CJS recurrence rate was 18.5% (95% confidence interval, 10.7-31.0). Of all the patients, 88.1% underwent balloon dilation at the anastomotic stenosis site; stent placement was performed in 15 of 67 patients (22.4%). The complication rate was 8.2% in CJS and 0% in PJS. In patients who underwent balloon dilation, "remaining waist" was significantly associated with CJS recurrence after anastomotic balloon dilation (P = 0.001). Conclusions The long-term outcomes of BAE-ERCP were comparable with those of percutaneous transhepatic treatment or surgical re-anastomosis.

BACKGROUND & AIMS The efficacy of endoscopic sphincterotomy (ES) before endoscopic transpapillary biliary drainage in preventing post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) has not been established. The aim of this study was to evaluate the effect of performing ES before biliary stent/tube placement on the occurrence of PEP. METHODS Three hundred seventy patients with biliary stricture requiring endoscopic biliary stenting were enrolled and randomly allocated to the ES group (n = 185) or non-ES group (n = 185). All participants were followed up for 30 days after the procedure. The data and occurrence of adverse events were prospectively collected. The primary outcome measure of this study was the incidence of PEP within 2 days of initial transpapillary biliary drainage. Secondary outcome measures were the incidence of other adverse events related to biliary stent/tube placement. RESULTS PEP occurred in 36 patients (20.6%) in the non-ES group and in 7 patients (3.9%) in the ES group (P < .001). The difference in the incidence of PEP between the 2 groups in the per-protocol population was 16.7% (95% confidence interval, 10.1%-23.3%), which was not within the noninferiority margin of 6%. Except for bleeding, the incidences of other adverse events were not significantly different between the groups. CONCLUSION ES before endoscopic biliary stenting could have the preventive effect on the occurrence of PEP in patients with biliary stricture. University Hospital Medical Information Network Number, UMIN000025727.University Hospital Medical Information Network Clinical Trial Registry URL: https://www.umin.ac.jp/ctr/index.htm.

Background Methods have been developed for preventing delayed bleeding (DB) after gastric endoscopic submucosal dissection (GESD). However, none of the methods can completely prevent DB. We hypothesized that DB could be prevented by a modified search, coagulation, and clipping (MSCC) method for patients at low risk for DB and by combining the use of polyglycolic acid sheets and fibrin glue with the MSCC method (PMSCC method) for patients at high risk for DB (antibleeding [ABI] strategy). This study assessed the technical feasibility of this novel strategy. Method We investigated 123 lesions in 121 consecutive patients who underwent GESD in Kushiro Rosai Hospital between April 2018 and January 2020. The decision for continuation or cessation of antithrombotic agents was based on the Guidelines for Gastroenterological Endoscopy in Patients Undergoing Antithrombotic Treatment. Results Oral antithrombotic agents were administered to 28 patients (22.8%). The en bloc R0 resection rate was 98.4%. The MSCC method and the PMSCC method for preventing DB were performed in 114 and 9 lesions, respectively. The median time of the MSCC method was 16 min, and the median speed (the resection area divided by the time of method used) was 3.6 cm2/10 min. The median time of the PMSCC method was 59 min, and the median speed was 1.3 cm2/10 min. The only delayed procedural adverse event was DB in 1 (0.8%) of the 123 lesions. Conclusions The ABI strategy is feasible for preventing DB both in patients at low risk and in those at high risk for DB after GESD, whereas the PMSCC method may be necessary for reduction of time.

Background: Some methods have been developed for preventing delayed bleeding (DB) after gastric endoscopic submucosal dissection (GESD). However, none of the methods can completely prevent DB. We hypothesized that DB can be prevented by a modified the search, coagulation, and clipping (MSCC) method for patients at low risk of DB and by combining the use of PGA sheets and fibrin glue with the MSCC method (PMSCC method) for patients at high risk of DB (anti-bleeding [ABI] strategy). In this study, the technical feasibility of this novel strategy was assessed.Methods: We investigated 123 lesions in 121 consecutive patients who underwent GESD in Kushiro Rosai Hospital between April 2018 and January 2020. The decision for continuation or cessation of antithrombotic agents was based on the Guidelines for Gastroenterological Endoscopy in Patients Undergoing Antithrombotic Treatment.Results: Oral antithrombotic agents were administered to 28 patients (22.8%). En bloc R0 resection rate was 98.4%. The MSCC method and PMSCC method for preventing were performed in 114 and 9 lesions, respectively. The median time of the MSCC method was 16 min and the median speed was 3.6 cm2/10min. The median time of the PMSCC method was 59 min and the median speed was 1.3 cm2/10min. The only delayed procedural adverse event was DB in one (0.8%) of the 123 lesions. Conclusions: The ABI strategy is feasible for preventing DB in patients at low risk and high risk of DB after GESD, whereas the PMSCC method may be necessary for reduction of time.

Hemorrhage is one of the serious adverse events of endoscopic sphincterotomy (EST). However, the risk factors for delayed hemorrhage after EST have not been clarified. The aim of this study was to examine the risk factors for delayed hemorrhage after EST. Consecutive patients who underwent EST between January 2011 and December 2015 were analyzed retrospectively. The incidence, treatment outcomes, and risk factors for delayed hemorrhage were evaluated. Delayed hemorrhage was defined as symptomatic hemorrhage occurring 24 h after an endoscopic procedure. After analyzing 1113 patients who underwent EST, delayed hemorrhage was seen to occur in 30 (2.7%) patients. The median period before presentation of delayed hemorrhage was 2 days (range 1–6) after EST, and its severity was mild in four, moderate in 20, and severe in six patients. All patients with delayed hemorrhage received successful endoscopic hemostasis. Univariate analysis showed that delayed hemorrhage occurred more frequently in patients with hemodialysis (p = 0.013), heparin replacement of antithrombotic agents (p = 0.012), or early hemorrhage occurring just after EST (p

Pancreatic metastasis from colorectal cancer is rare, and there have been only a few reports of its preoperative diagnosis by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) with immunohistochemical staining. We herein describe the case of a 77-year-old woman in whom a solitary mass in the pancreatic tail was detected 11 years after rectal cancer resection. The patient also had a history of pulmonary tumor resection. We performed EUS-FNA and a histopathological examination showed adenocarcinoma with CD20+, CD7-, and CDX2+ (similar to her rectal cancer). EUS-FNA enabled a histopathological examination, including immunohistochemical staining, which helped to confirm the diagnosis of pancreatic and pulmonary metastasis from rectal cancer.

No worldwide consensus on the assessment tool for liver functional reserve is currently available. The aim of this study was to evaluate the correlation between liver elasticity of both hepatic lobes and liver functional reserve tests. This prospective observational study comprised 40 patients scheduled for hepatectomy. Liver elasticity was assessed by Virtual Touch Quantification (VTQ). The mean VTQ value for the right and left lobes was defined as the mVTQ. Liver functional reserve was measured with technetium-99m-diethylenetriaminepentaacetic acid-galactosyl-human serum albumin scintigraphy as LHL15 and HH15 and the indocyanine green (ICG) excretion test as ICG-R15 and ICG-K. All examinations were measured after biliary decompression confirmed serum a total bilirubin level

Background and study aims Short-type single-balloon enteroscope (short SBE)-assisted endoscopic retrograde cholangiopancreatography (ERCP) is a promising alternative treatment in postsurgical altered anatomy. However, it is technically demanding, and factors affecting its technical difficulty have not yet been clarified. This study aimed to examine the procedural success rate of short SBE-assisted ERCP and the potential factors affecting procedural failure. Patients and methods A total of 117 consecutive patients (203 procedures) with surgically altered anatomy underwent ERCP using prototype short SBEs. The procedural success rate of short SBE-assisted ERCP and the potential factors affecting procedural failure were examined retrospectively. Results The enteroscopy success rate and procedural success rate were 92.6 % (95 % confidence interval [CI] 88.1 % – 95.8 %) and 81.8 % (95 %CI 75.8 % – 86.8 %), respectively. Multivariate analyses indicated that pancreatic indication (odds ratio [OR] 4.35, 95 %CI 1.67 – 11.4), first ERCP attempt (OR 6.03, 95 %CI 2.17 – 16.8), and no transparent hood (OR 4.61, 95 %CI 1.48 – 14.3) were potential risk factors for procedural failure. Conclusions Short SBE-assisted ERCP was effective in postsurgical altered anatomy. This large case series suggested the potential factors affecting procedural failure.

BackgroundEndoscopic ultrasonography-guided fine-needle aspiration (EUS-FNA) has high diagnostic accuracy for pancreatic diseases. However, the effect of mass size on diagnostic accuracy has yet to be determined, especially for small pancreatic lesions. We aimed to determine the effect of pancreatic mass size on the diagnostic yield of EUS-FNA.MethodsWe searched the database in Hokkaido University Hospital between May 2008 and December 2016 and identified solid pancreatic lesions examined by EUS-FNA. All lesions were stratified into five groups based on mass sizes: groups A (

Endoscopic sphincterotomy (ES) is a standard procedure for bile duct stone removal. However, the safety of ES in patients with hemophilia remains unknown. We treated a 46-year-old man who had choledocholithiasis and severe hemophilia A with high-responding inhibitors during immune tolerance induction therapy. Since coagulation factor VIII inhibitors neutralize and inactivate endogenous and exogenous factor VIII, bleeding risk is higher in hemophilia A patients with inhibitors than in those without inhibitors. With adequate pre- and post-procedure monitoring of the clotting factor and supplemented clotting factor, the patient could safely undergo ES without bleeding complications. ES can be also an effective and safe first-line therapy for choledocholithiasis in patients with hemophilia and inhibitors under the condition of appropriate management.

Endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) is a useful and relatively safe tool for the diagnosis and staging of pancreatic cancer. However, there have recently been several reports of tumor seeding after EUS-FNA of adenocarcinomas. A 78-year-old man was admitted to our hospital due to upper gastric pain. Examinations revealed a 20 mm mass in the pancreatic body, for which EUS-FNA was performed. The cytology of the lesion was adenocarcinoma, and the stage of the cancer was T3N0M0. The patient underwent surgery with curative intent, followed by adjuvant chemotherapy with S-1. An enlarging gastric submucosal tumor was found on gastroscopy at 28 mo after surgery accompanied by a rising level of CA19-9. Biopsy result was adenocarcinoma, consistent with a pancreatic primary tumor. Tumor seeding after EUS-FNA was strongly suspected. The patient underwent surgical resection of the gastric tumor with curative intent. The pathological result of the resected gastric specimen was adenocarcinoma with a perfectly matched mucin special stain result with the previously resected pancreatic cancer. This is the first case report of tumor seeding after EUS-FNA which was surgically resected and inspected pathologically.

A 63-year-old man was admitted to our department following a secondary medical examination. Blood tests showed high levels of liver enzymes, IgG, IgG4, and antinuclear antibody. Computed tomography showed tumors in the bilateral lower lobes of the lungs and pleural thickening. After pleural and liver biopsy procedures, he was conclusively diagnosed with IgG4-related lung pseudotumor and pleural inflammation with autoimmune hepatitis. We started treatment with prednisolone 40 mg/day, and chest radiograph and blood tests showed signs of improvement. This was a rare case that suggested an association between IgG4-related disease and autoimmune hepatitis.

Background: Recently, EUS-guided fine-needle biopsy (EUS-FNB) using a Franseen needle was developed for histological tissue acquisition. However, the yield of a 25G Franseen needle when acquiring histological core tissue has been unclear. Patients and Methods: We performed a prospective, multicenter, and observational cohort study that included 100 solid lesions scheduled for EUS-FNB using a 25G Franseen needle at eight centers in Hokkaido, Japan. Only EUS-FNB specimens acquired at the first pass were evaluated without a rapid on-site evaluation. The tissue acquisition rate, acquisition rate of an adequate specimen for histological assessment, the quality of tissue sample, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), diagnostic accuracy, and adverse events were evaluated. Results: We analyzed a total of 100 solid lesions in 100 patients. The patients were 57 males and 43 females with a median age of 70 years. The technical success rate was 100%. The tissue acquisition rate was 95.0%. The acquisition rate of an adequate specimen for histological assessment was 82.0%. The sensitivity, specificity, PPV, NPV, and diagnostic accuracy were 87.0%, 100%, 100%, 40.0%, and 88.0%, respectively. The adverse event rate was 1.0%, and it was reported in only one patient who had a moderate pancreatic fistula. Conclusions: EUS-FNB using the 25G Franseen needle was feasible, and adequate histological core tissue samples were acquired with this method.

Background Adequate needle size and tissue acquisition techniques for endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) need further elucidation. Moreover, the actual negative pressure and suction forces of FNA needles remain unknown. We evaluated the suction forces of 19-gauge, 22-gauge, and 25-gauge conventional FNA needles and side hole aspiration needles using conventional negative pressure and the slow pull technique. Methods Using a manometer, we determined the mean (SD) negative pressure and suction force for needle gauge, aspiration volume, and aspiration technique. We also evaluated the time to reach the maximum negative pressure. Results Suction force was comparatively higher in the 19-gauge needle when 50 ml of negative pressure was applied. Suction force using the slow pull method was very weak at 5% of pressure found with conventional methods. With the use of a 20-ml syringe, the time to reach the maximum negative pressure was 4 s in the 19-gauge needle, 11 s in the 22-gauge needle, and 80 s in the 25-gauge needle. Conclusions Bench-top testing showed that suction force increases with a larger gauge needle and larger aspiration volume. The slow pull method produces a very weak suction force. The time to reach the maximum negative pressure was longest in the 25-gauge needle.

IntroductionThe effect of endoscopic sphincterotomy prior to endoscopic biliary stenting to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis remains to be fully elucidated. The aim of this study is to prospectively evaluate the non-inferiority of non-endoscopic sphincterotomy prior to stenting for naïve major duodenal papilla compared with endoscopic sphincterotomy prior to stenting in patients with biliary stricture.Methods and analysisWe designed a multicentre randomised controlled trial, for which we will recruit 370 patients with biliary stricture requiring endoscopic biliary stenting from 26 high-volume institutions in Japan. Patients will be randomly allocated to the endoscopic sphincterotomy group or the non-endoscopic sphincterotomy group. The main outcome measure is the incidence of pancreatitis within 2 days of initial transpapillary biliary drainage. Data will be analysed on completion of the study. We will calculate the 95%confidence intervals(CIs) of the incidence of pancreatitis in each group and analyse weather the difference in both groups with 95% CIs is within the non-inferiority margin (6%) using the Wald method.Ethics and disseminationThis study has been approved by the institutional review board of Hokkaido University Hospital (IRB: 016–0181). Results will be submitted for presentation at an international medical conference and published in a peer-reviewed journal.Trial registration numberThe University Hospital Medical Information Network ID: UMIN000025727 Pre-results.

Introduction: The presence of mural nodule (MN) is an important factor for the management of branch duct type intraductal papillary mucinous neoplasm (BD-IPMN). International consensus guidelines 2012 recommend clinical follow-up to BD-IPMN without MNs. However, it is not clear whether BD-IPMNs with MNs need surgical treatment regardless of the height of MNs. Aim: To compare the pathological and follow-up outcomes between BDIPMNs with MNs ≤6mm in height (MN+) and those without MNs (MN-). Methods: The patients who were diagnosed as BD-IPMNs with MNs ≤6mm or without MNs since April 2004 to December 2013 were retrospectively analyzed. Inclusion criteria were the obtaining of contrast enhanced CT and EUS at initial diagnosis, and surgical resection in our center or follow-up with annual/semi-annual CT/MRCP. The cyst size and main pancreatic duct (MPD) diameter were measured by CT/MRCP, while MN height was measured by EUS. Tumor progression during follow-up was defined as follows; increased cyst size ≥10mm; increased MPD diameter ≥10mm; new development of MN or increased MN height ≥2mm. Evaluation points: 1) pathological diagnosis of resected BD-IPMN, 2) follow-up outcomes Results: Among 656 patients of BD-IPMNs diagnosed in our center, MN height was evaluated as less than or equal to 6mm in 511(78%; MN+ 50, MN352). After initial diagnosis, 17(3%; MN+ 8, MN9) of them underwent immediate resection and 385(75%; MN+ 42, MN343) of them received regular follow-up, who were eligible for this analysis. The median cyst size and MPD diameter were 20(10-70) mm and 3(2-12) mm, respectively. The median height of MNs in MN+ were 3(1-6) mm. 1) The pathological diagnosis of the patients with MNwere all low/intermediate-grade dysplasia (LID), while those of the patients with MN+ were LID in 5, high-grade dysplasia (HD) in 2, and invasive carcinoma (IC) in 1. There were no significant differences in pathological diagnosis between MN+ and MN(p=0.17, chi-square test). 2) During a median follow-up period of 3.4(0.5-10.6) years, 49(13%; MN+ 9, MN40) patients exhibited tumor progression. The 5-years cumulative tumor progression rate was higher in MN+ than those in MN(MN+ 19% vs MN9%; p