Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2026-02-25 @ 8:18 AM
Study NCT ID:
NCT02928718
Status:
COMPLETED
Last Update Posted:
2022-11-18
First Post:
2016-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Association Between Post-ERCP Acute Pancreatitis and Various Genetic Mutations
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
The Association Between Post-ERCP Acute Pancreatitis and Various Genetic Mutations
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: