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

NCT02928718 | Completed DMC

• 1 other identifier: 2015-1992
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Pancreatitis

Keywords

Post-ERCP pancreatitis; Genetic variation

Outcome Measures

Primary Outcomes (1)

• Post-ERCP pancreatitis

  Clinical pancreatitis, amylase at least 3 x normal \>24h after ERCP

  24 hours after ERCP

Secondary Outcomes (4)

• Severe post-ERCP pancreatitis

  24 hours after ERCP

• hyperamylasemia without symptom

  24 hours after ERCP

• Length of stay

  3mo

• Mortality

  3mo

Study Arms (1)

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).

Procedure: ERCP

Interventions

ERCP PROCEDURE

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.

High risk patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

• Choi YH, Lim Y, Jang DK, Ahn DW, Ryu JK, Paik WH, Kim YT, Kim JH, Lee SH. Genetic susceptibility to post-endoscopic retrograde cholangiopancreatography pancreatitis identified in propensity score-matched analysis. Korean J Intern Med. 2023 Nov;38(6):854-864. doi: 10.3904/kjim.2022.404. Epub 2023 Oct 23.

  PMID: 37867141 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Pancreatitis

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Sang Hyub Lee, MD. PhD.

  Department of internal medicine and liver research institute, Seoul national university hospital, Seoul, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: October 10, 2016
• Study Start: September 29, 2016
• Primary Completion: January 1, 2019
• Study Completion: July 1, 2019
• Last Updated: November 18, 2022

Record last verified: 2022-11

Locations

KR (1)