NCT02928718

The Association Between Post-ERCP Acute Pancreatitis and Various Genetic Mutations

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 75 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pancreatitis remains the most common complication of ERCP, with the reported incidence ranging from 2% to 9%. Although 80% of cases are mild, a significant number of patients may develop severe pancreatitis, that means additional morbidity and risk for death. ERCP, despite the development of new diagnostic tools, remains a widely used procedure, so post-ERCP pancreatitis is a problem with significant impact. Several studies and meta-analyses helped us to recognize special factors that put an individual in high risk for the development of post-ERCP pancreatitis. Among these factors special interest presents the history of post-ERCP pancreatitis as an independent risk factor for a new episode of post-ERCP pancreatitis. It seems that some individuals have a genetically predisposed susceptibility in this particular complication. The aim of the present study is to investigate the possible genetic variation associated with post-ERCP pancreatitis using whole genome sequencing.

Detailed description

This study includes patients who are at high risk of post-ERCP pancreatitis. Blood samples will be gathered to investigate the possible genetic variation associated with post-ERCP pancreatitis using whole genome sequencing. DNA for whole genome sequencing will be extracted using DNA extraction kit (Qiagen Inc., Hinden, Germany) and the concentration \& purity of DNA will be measured using Nanodrop (Nano Drop Technologies, Wilmington, DE, USA) or fluorometric quantitation(Qubit fluorometer). Genetic variations which are associated with acute pancreatitis will be searched using whole genome sequencing. Post-ERCP pancreatitis is the primary outcome. Medical records and data of genetic variations will be reviewed for identifying possible risk factors and genetic variations associated with post-ERCP pancreatitis.

Conditions

• Acute Pancreatitis

Interventions

Type	Name	Description
PROCEDURE	ERCP	Two expert endoscopists will perform ERCP. Patients will be sedated with midazolam(2-5mg) and pethidine(25-50mg) with careful monitoring. Duodenoscope (TJF-240 or TJF-260; Olympus Corp., Tokyo, Japan) will be used. Cholangiography or pancreatography will be gathered after selective bile duct or pancreatic duct cannulation. Therapy such as endoscopic sphincterotomy, stent insertion, and etc., will be done.

Timeline

• Start date: 2016-09-29
• Primary completion: 2019-01-01
• Completion: 2019-07-01
• First posted: 2016-10-10
• Last updated: 2022-11-18

Locations

1 site across 1 country: South Korea