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

November 17, 2022 updated by: Sang Hyub Lee, Seoul National University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are at high risk of post-ERCP pancreatitis, who have at least one of the following factors: clinically suspected sphincter of Oddi dysfunction, history of post-ERCP pancreatitis, pancreatic sphincterotomy, precut sphincterotomy, difficult cannulation, balloon dilatation of intact sphincter, endoscopic ampullectomy, and 2≥minor criteria(an age of less than 50 years and female sex, a history of recurrent pancreatitis (≥2 episodes), three or more injections of contrast agent into the pancreatic duct with at least one injection to the tail of the pancreas, excessive injection of contrast agent into the pancreatic duct resulting in opacification of pancreatic acini,the acquisition of a cytologic specimen from the pancreatic duct with the use of a brush).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High risk patients
Patients who are at high risk of post-ERCP pancreatitis, who have at least one of the following factors: clinically suspected sphincter of Oddi dysfunction, history of post-ERCP pancreatitis, pancreatic sphincterotomy, precut sphincterotomy, difficult cannulation, balloon dilatation of intact sphincter, endoscopic ampullectomy, and 2≥minor criteria(an age of less than 50 years and female sex, a history of recurrent pancreatitis (≥2 episodes), three or more injections of contrast agent into the pancreatic duct with at least one injection to the tail of the pancreas, excessive injection of contrast agent into the pancreatic duct resulting in opacification of pancreatic acini,the acquisition of a cytologic specimen from the pancreatic duct with the use of a brush).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-ERCP pancreatitis
Time Frame: 24 hours after ERCP
Clinical pancreatitis, amylase at least 3 x normal >24h after ERCP
24 hours after ERCP

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sang Hyub Lee, MD. PhD., Department of internal medicine and liver research institute, Seoul national university hospital, Seoul, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2016

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

July 21, 2016

First Submitted That Met QC Criteria

October 6, 2016

First Posted (Estimate)

October 10, 2016

Study Record Updates

Last Update Posted (Actual)

November 18, 2022

Last Update Submitted That Met QC Criteria

November 17, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2015-1992

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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