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Lactated Ringers With or Without Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

NCT02641561 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2018-02-27

Study results available
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Summary

Post-ERCP pancreatitis is a well-known and sometimes life-threatening complication of ERCP. Both LR and rectal indomethacin have shown benefit in preventing post-ERCP pancreatitis. Despite this, no study to date has evaluated both of these measures for preventing post-ERCP pancreatitis. It is our hope to evaluate the combination of these two modalities for preventing post-ERCP pancreatitis compared with either modality alone.

Conditions

  • Post-ERCP Acute Pancreatitis

Interventions

DRUG

Indomethacin

Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis

DRUG

Lactated Ringer's Solution

Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis

DRUG

Normal Saline

standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.

DRUG

Placebo

Placebo would be a suppository 50 mg x 2

Sponsors & Collaborators

  • The Cooper Health System

    lead OTHER

Principal Investigators

  • Shaffer RS Mok, MD, MBS · The Cooper Health System

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02641561 on ClinicalTrials.gov