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Intramuscular Diclofenac in the Prevention of Post-ERCP Pancreatitis

NCT01717599 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 343

Last updated 2021-05-04

No results posted yet for this study

Summary

Pancreatitis is one of the major complications of ERCP. It has been shown that NSAIDs are potent inhibitors of phospholipase A2, activity which is increased in pancreatitis. The only one study with IM diclofenac showed reduction of post-ERCP pancreatitis without SOD (sphincter of Oddi dysfunction) by subgroup analysis in small study population. Therefore the investigators must need large scaled randomized control study including of SOD.

Conditions

  • Post ERCP Pancreatitis

Interventions

DRUG

Diclofenac

Diclofenac 90mg, 2ml/A, IM(intramuscular) injection immediately after procedure of ERCP

DRUG

normal saline

normal saline 2ml/A, IM(intramuscular) injection immediately after procedure of ERCP

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-29
Primary Completion
2013-08-28
Completion
2013-08-28

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01717599 on ClinicalTrials.gov