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NCT Number: NCT02928718

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

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.

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Key information

Conditions

Acute Pancreatitis Digestive System Diseases Pancreatic Diseases Pancreatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Post-ERCP pancreatitis

    Time frame: 24 hours after ERCP

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

Secondary outcomes

  1. 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

  2. hyperamylasemia without symptom

    Time frame: 24 hours after ERCP

    amylase at least 3 x normal > 24h after ERCP, no abdominal pain

  3. Length of stay

    Time frame: 3mo

    Duration of hospitalization

  4. Mortality

    Time frame: 3mo

    mortality

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 10, 2016
Registry last updated
Nov 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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