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

November 5, 2015 updated by: Tehran University of Medical Sciences

Non-inferiority Trial Comparing Pharmacological Prevention Alone Versus Pancreatic Stents Plus Pharmacological Prevention to Prevent Post-ERCP Pancreatitis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

15 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients at high risk of post-ERCP Pancreatitis undergoing ERCP are eligible to enter the study. At least one major or two minor criteria must be present for the patient to be considered at high risk for PEP:

Major

  • Sphincter of Oddi dysfunction.
  • History of previous PEP.
  • Pancreatic injection.
  • Precut sphincterotomy.
  • Balloon sphincter dilation without sphincterotomy.
  • Pancreatic guidewire passages > 1.

Minor

  • Female patients aged<60 years.
  • Nondilated common bile duct (CBD).
  • Normal serum bilirubin (<2mg/dl).
  • Failure to clear bile duct stones.
  • Failed cannulation.
  • Difficult cannulation (Time to CBD cannulation more than 10 min or more than five attempts at cannulation).

Exclusion Criteria:

  • Age younger than 15 years.
  • History of sphincterotomy.
  • Surgically altered anatomy (Billroth II gastrectomy or Roux-en-Y anastomosis).
  • Uncontrolled coagulopathy.
  • Tumor of ampulla of Vater.
  • Those undergoing routine biliary-stent exchange.
  • Acute pancreatitis at the time of ERCP.
  • Chronic pancreatitis.
  • Regular NSAID use during preceding week.
  • Unable to tolerate indomethacin (Creatinine level >1.4 mg/dL or active peptic ulcer disease).
  • Unable to tolerate nitrates (closed-angle glaucoma).
  • Unable to tolerate aggressive hydration (cardiac insufficiency: NYHA FC II or higher, renal insufficiency, electrolyte disturbances, clinical signs of fluid overload including peripheral or pulmonary edema, liver dysfunction with varix>F1, or respiratory insufficiency).
  • Patients requiring pancreatic duct drainage: to bridge dominant strictures, bypass obstructing pancreatic duct stones, drain pseudocysts, seal duct disruptions, pancreatic head cancer with main PD obstruction, IPMN or Pancreas divisum.
  • Known main pancreatic duct stricture toward the head of pancreas.
  • Pregnancy or breastfeeding.
  • Refusal to participate in the study.

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

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Pharmacological Prevention
Combination of rectal indomethacin, sublingual isosorbide dinitrate and intravenous hydration with Ringer's lactate serum without pancreatic 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.
ACTIVE_COMPARATOR: Pancreatic Stent
Pancreatic Stent PLUS Pharmacological Prevention
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.
Device: Pancreatic Stent
A 5-Fr, 4-cm-long stent (Endoflex) with a single duodenal pigtail is used for pancreatic duct stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-ERCP pancreatitis
Time Frame: 24 hours after ERCP
Pancreatitis is defined as new or worsened abdominal pain and tenderness with amylase levels at least three times above the upper limit of normal at 24 hours after the procedure, requiring hospital admission or a prolongation of planned admission.
24 hours after ERCP

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of acute pancreatitis according to revised Atlanta classification (Banks et al. GUT 2013)
Time Frame: One week after ERCP
Mild acute pancreatitis (No organ failure, No local or systemic complications) Moderately severe acute pancreatitis (transient organ failure that resolves within 48 h and/or Local or systemic complications without persistent organ failure) Severe acute pancreatitis (Persistent organ failure >48 h)
One week after ERCP

Collaborators and Investigators

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

Sponsor

Tehran University of Medical Sciences

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, 2015

Primary Completion (ANTICIPATED)

January 1, 2017

Study Registration Dates

First Submitted

February 2, 2015

First Submitted That Met QC Criteria

February 16, 2015

First Posted (ESTIMATE)

February 23, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

November 6, 2015

Last Update Submitted That Met QC Criteria

November 5, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 642416

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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