Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-11-30

Brief Summary

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Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to 30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in high risk patients was considered a "standard" method to prevent PEP. However, the risk factors of PEP is not fully clear. Rectal indomethacin before ERCP for all patients, not just for selected high-risk patients, may preventing PEP maximum. The purpose of this study is to determine whether routine using of rectal indomethacin is more effective than the conditional strategy.

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Detailed Description

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Conditions

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Post-ERCP Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Pre-ERCP group

Pre-ERCP rectal Indomethacin in all patients.

Group Type EXPERIMENTAL

Pre-ERCP rectal Indomethacin

Intervention Type DRUG

Rectal Indomethacin was administrated within 30min before ERCP in all patients.

Post-ERCP group

Post-ERCP rectal Indomethacin in high-risk patients.

Group Type ACTIVE_COMPARATOR

Post-operational Rectal Indomethacin

Intervention Type DRUG

Rectal Indomethacin was administrated immediately after ERCP in high-risk patients, while average risk patients did not.

Interventions

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Pre-ERCP rectal Indomethacin

Rectal Indomethacin was administrated within 30min before ERCP in all patients.

Intervention Type DRUG

Post-operational Rectal Indomethacin

Rectal Indomethacin was administrated immediately after ERCP in high-risk patients, while average risk patients did not.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing diagnostic or therapeutic ERCP.

Exclusion Criteria

* Unwillingness or inability to consent for the study;
* Age \< 18 years old;
* Intrauterine pregnancy;
* Breastfeeding mother;
* Standard contraindications to ERCP;
* Allergy to NSAIDs;
* Received NSAIDs in prior 7 days;
* Renal failure (Cr \>1.4mg/dl=120umol/l);
* Active or recurrent (within 4 weeks) gastrointestinal hemorrhage;
* Acute pancreatitis within 72 hours;
* Known pancreatic head mass;
* Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram;
* ERCP for biliary stent removal or exchange without anticipated pancreatogram;
* Known active cardiovascular or cerebrovascular disease.
* Presence of coagulopathy before the procedure or received anticoagulation therapy within three days before the procedure;

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No