Effect of endoscopic transpapillary biliary drainage with/without endoscopic sphincterotomy on post-endoscopic retrograde cholangiopancreatography pancreatitis in patients with biliary stricture (E-BEST) : a protocol for a multicentre randomised controlled trial

Introduction: The 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 naive major duodenal papilla compared with endoscopic sphincterotomy prior to stenting in patients with biliary stricture. Methods and analysis: We 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 dissemination: This 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 number: The University Hospital Medical Information Network ID: UMIN000025727 Pre-results

Successful endoscopic sphincterotomy for choledocholithiasis in a patient with severe hemophilia A and inhibitors

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

Effect of Pancreatic Mass Size on Clinical Outcomes of Endoscopic Ultrasound-Guided Fine-Needle Aspiration

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 (<10mm), B (10-20mm), C (20-30mm), D (30-40mm) and E (40mm). The sensitivity, specificity, diagnostic accuracy and adverse event rate were retrospectively evaluated.ResultsWe analyzed a total of 788 solid pancreatic lesions in 761 patients. The patients included 440 males (57.8%) with a mean age of 65.7years. The sensitivities in groups A (n=36), B (n=223), C (n=304), D (n=147) and E (n=78) were 89.3%, 95.0%, 97.4%, 98.5% and 98.7%, respectively, and they significantly increased as the mass size increased (P<0.01, chi-squared test for trend). The diagnostic accuracies were 91.7%, 96.4%, 97.7%, 98.6% and 98.7%, respectively, and they also significantly increased as the mass size increased (P=0.03). Multivariate analysis showed that pancreatic mass size was associated with diagnostic accuracy. The adverse event rates were not significantly different among the five groups.ConclusionsThe sensitivities and diagnostic accuracies of EUS-FNA for solid pancreatic lesions are higher for lesions 10mm in size, and they are strongly correlated with mass size

CORRELATION BETWEEN LIVER ELASTICITY BY ULTRASOUND ELASTOGRAPHY AND LIVER FUNCTIONAL RESERVE

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 <= 2 mg/dL. Mean VTQ values were moderately correlated with LHL15 (r = -0.42, p < 0.01), HH15 (r = 0.48,p < 0.01), ICG-R15 (r = 0.53,p < 0.01) and ICG-K (r = -0.61,p < 0.01) values. In conclusion, the liver elasticity determined by VTQ would be a useful predictor of liver functional reserve in patients scheduled for hepatectomy. (C) 2019 World Federation for Ultrasound in Medicine & Biology. All rights reserved

Resected tumor seeding in stomach wall due to endoscopic ultrasonography-guided fine needle aspiration of pancreatic adenocarcinoma

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