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Non-inferiority of Pharmacological Prevention Alone Versus Pancreatic Stents to Prevent Post-ERCP Pancreatitis

NCT02368795 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2015-11-06

No results posted yet for this study

Summary

Pancreatitis is the most important complication of ERCP. The severity of this condition varies from mild to severe and can lead to prolonged hospitalization, surgical interventions, and even death. Several patient-related and procedure related factors have been identified that are associated with a higher risk of post-ERCP pancreatitis. So far, several methods have been proposed to avoid pancreatitis in patients at higher risk of this complication.

Several studies have shown that different drug therapies (indomethacin suppository, a sublingual nitrate tablet and the administration of intravenous Ringer's solution) each may reduce the incidence of post-ERCP pancreatitis. All these drug therapies are safe, cheap and easy to administer.

Several other studies have shown that pancreatic duct stenting (placement of a plastic tube in the pancreatic duct) is an effective intervention in preventing and reducing the severity of post-ERCP pancreatitis, especially in high-risk groups. However, there are still a few drawbacks to consider with pancreatic duct stenting: there are some difficulties with insertion of a PD stent, it is associated with a need for radiological follow-up and/or repeat endoscopy for removal, higher cost and a small but important risk of complications (e.g. stent migration).

Most of the clinical trials of pancreatic duct stenting were performed, before the results of trials of drug therapies were available. Moreover, no RCT (to the investigators knowledge) has compared the efficacy of pancreatic duct stenting in patients who already received a combination of drug therapies to prevent post-ERCP pancreatitis in high-risk patients. The purpose of this study is to determine the noninferiority of a combination of drug therapies in relation to pancreatic duct stenting to prevent post-ERCP pancreatitis in high-risk patients.

Conditions

Interventions

DEVICE

Pancreatic Stent

A 5-Fr, 4-cm-long stent (Endoflex) with a single duodenal pigtail is used for pancreatic duct stenting

DRUG

Indomethacin

Indomethacin 100 mg suppository ten minutes before ERCP

DRUG

Isosorbide Dinitrate

Sublingual Isosorbide dinitrate 5 mg before ERCP

DRUG

Ringer's lactate

IV Ringer's lactate serum with a dose of 6 cc/kg/h during the procedure and 20 cc/kg after ERCP as a bolus dose and 3 cc/kg/h for the next 8 hours.

Sponsors & Collaborators

  • Tehran University of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2017-01-31

Countries

  • Iran

Study Locations

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Entities

Diseases

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 NCT02368795 on ClinicalTrials.gov