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

Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02928718
• Other study ID #: 2015-1992
• Status: Completed
• Start date: September 29, 2016
• Est. completion date: July 2019

Study information

• Verified date: November 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who undergo ERCP with high risk factors of post-ERCP pancreatitis

Exclusion Criteria:

• <18 years old

• current pancreatitis (<72hrs before ERCP)

• pregnant woman, breast-feeding woman

• patient refusal

• contraindication of ERCP

• patients who would only be treated of bile duct such as a change of stent with previous endoscopic sphincterotomy

• chronic pancreatitis

• patients who underwent gastrectomy (Billroth II or Roux-en Y anastomosis)

• patients who have pancreatic or distal bile duct cancer

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-ERCP pancreatitis	Clinical pancreatitis, amylase at least 3 x normal >24h after ERCP	24 hours after ERCP
Secondary	Severe post-ERCP pancreatitis	Pancreatitis requiring hospitalization >10 days, intervention(percutaneous drainage or surgery), development of necrosis, or pseudocyst	24 hours after ERCP
Secondary	hyperamylasemia without symptom	amylase at least 3 x normal > 24h after ERCP, no abdominal pain	24 hours after ERCP
Secondary	Length of stay	Duration of hospitalization	3mo
Secondary	Mortality	mortality	3mo