- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02928718
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
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
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
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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 |
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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).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-ERCP pancreatitis
Time Frame: 24 hours after ERCP
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Clinical pancreatitis, amylase at least 3 x normal >24h after ERCP
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24 hours after ERCP
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severe post-ERCP pancreatitis
Time Frame: 24 hours after ERCP
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Pancreatitis requiring hospitalization >10 days, intervention(percutaneous drainage or surgery), development of necrosis, or pseudocyst
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24 hours after ERCP
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hyperamylasemia without symptom
Time Frame: 24 hours after ERCP
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amylase at least 3 x normal > 24h after ERCP, no abdominal pain
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24 hours after ERCP
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Length of stay
Time Frame: 3mo
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Duration of hospitalization
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3mo
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Mortality
Time Frame: 3mo
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mortality
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3mo
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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
Keywords
Additional Relevant MeSH Terms
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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