Risk Factors of Post-ERCP Pancreatitis in Patients Receiving Rectal Indomethacin

September 1, 2016 updated by: Yanglin Pan, Air Force Military Medical University, China

Risk Factors Related to Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis in High-risk Patients Who Underwent ERCP and Received Prophylactic Rectal Indomethacin

Post-endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis (PEP)remains the most frequent adverse event of ERCP. Rectal indomethacin, as one kind of classic NSAIDs, has been proved to be effective in reducing the incidence of PEP. It has been widely used to prevent PEP in patients, especially those with potentially high risks of PEP. However, rectal indomethacin can not completely eradicate the occurrence of PEP. The rate of PEP in patients receiving indomethacin ranges from 3.2% to 9.2%. The risk factors of PEP in patients receiving rectal indomethacin remains unclear. The aim of the study was to identify potential risk factors in high-risk patients whose received administration of prophylactic rectal indomethacin after ERCP.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

790

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

  • China
    • Fujian
      • Xiamen, Fujian, China
        • Department of gastroenterology,Chinese PLA 174 Hospital
    • Shaanxi
      • Xi'an, Shaanxi, China
        • The First Affiliated Hospital of Xi'an Jiaotong University
      • Xi'an, Shaanxi, China
        • Xijing Hospital of Digestive Diseases

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent ERCP and received administration of rectal indomethacin.

Description

Inclusion Criteria:

  • Undergoing diagnostic or interventional ERCP
  • Receiving administration of rectal indomethacin(100mg) after ERCP
  • High risk patients determined at the discretions of endoscopists

Exclusion Criteria:

  • Dose other than 100mg
  • Acute pancreatitis within 3 days before ERCP
  • Average risk patients at the discretions of endoscopists
  • Using NSAIDs within 7 days before ERCP
  • Without cannulation attempts
  • Administration of rectal indomethacin before or during ERCP

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
Indomethacin Group

All the patients with high risks of PEP received administration of one single dose of 100mg rectal indomethacin after ERCP.

Patients were considered high risk of PEP if they met one of the following criteria: clinical suspicion of sphincter of Oddi dysfunction, a history of PEP, pancreatic sphincterotomy, precut sphincterotomy, ≥8 cannulation attempts, cannulation time≥10 minutes; pneumatic dilatation of an intact biliary sphincter, ≥3 inadvertent pancreatic duct cannulation, opacification of pancreatic acini, or the acquisition of a cytologic specimen from the pancreatic duct with the use of a brush or forceps.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall PEP rate
Time Frame: 1 year
PEP was defined if patients experienced abdominal pain for more than 24h after procedure, accompanying with amylase or lipase ≥ 3 times equal to the upper limit of normal value.
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
The rate of moderate-severe pancreatitis
Time Frame: 1 year
1 year
Overall ERCP-related complication rate
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Air Force Military Medical University, China

Investigators

  • Principal Investigator: Yanglin Pan, Xijing Hospital of Disgestive Diseases.The Fourth Military University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

February 29, 2016

First Submitted That Met QC Criteria

March 15, 2016

First Posted (Estimate)

March 16, 2016

Study Record Updates

Last Update Posted (Estimate)

September 5, 2016

Last Update Submitted That Met QC Criteria

September 1, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20160224-2

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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