Post-ERCP Pancreatitis Prevention by Stent Insertion (PEPSI)

October 11, 2017 updated by: Monther Bajbouj, Technical University of Munich

Study to Reduce Incidence of Post-ERCP Pancreatitis by Stent Insertion in the Main Pancreatic Duct After Unintended Cannulation of the Main Pancreatic Duct

The presented study is designed to analyze the efficacy of pancreatic stent insertion in patients undergoing ERCP with accidental cannulation of the pancreatic duct.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

169

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 Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Deptartment of Hepatobiliary Diseases Leuven University Hospitals
  • Germany
      • Munich, Germany, 81675
        • Klinikum rechts der Isar, Technische Universität München
  • Latvia
      • Riga, Latvia, 1002
        • P. Stradin Clinical University Hospital Gastroenterology Centere Latvijas Universitates Medicinas
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • First city hospital of emergency care Northern State Medical University

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

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all patients undergoing ERCP with unintended cannulation or opifiacation of main pancreatic duct
  • age > 17 years
  • signed informed consent

Exclusion Criteria:

  • intention to intervene main pancreatic duct
  • age < 18 years
  • pregnancy
  • absent of signed informed consent

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Stent
Stent insertion into the main pancreatic duct
Device: Stent insertion into the main pancreatic duct
Stent insertion into the main pancreatic duct
No Intervention: No stent
No stent insertion into the main pancreatic duct

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of post-ERCP pancreatitis
Time Frame: up to 1 week
up to 1 week

Collaborators and Investigators

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

Sponsor

Technical University of Munich

Collaborators

KU Leuven
Northern State University, Russia
Latvijas Universitates Medicinas

Investigators

  • Principal Investigator: Hana Algül, MD, MPH, II. Medizinische Klinik, Klinikum rechts der Isar, Ismaniger Strasse 22, 81675 Munich

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 (Actual)

July 1, 2010

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

October 17, 2011

First Submitted That Met QC Criteria

August 27, 2012

First Posted (Estimate)

August 28, 2012

Study Record Updates

Last Update Posted (Actual)

October 13, 2017

Last Update Submitted That Met QC Criteria

October 11, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 240179

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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