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Post-ERCP Pancreatitis Prevention by Stent Insertion (PEPSI)

Primary Purpose

Post-ERCP Acute Pancreatitis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Stent insertion into the main pancreatic duct
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-ERCP Acute Pancreatitis focused on measuring ERCP, endoscopy, pancreatitis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Deptartment of Hepatobiliary Diseases Leuven University Hospitals
  • Klinikum rechts der Isar, Technische Universität München
  • P. Stradin Clinical University Hospital Gastroenterology Centere Latvijas Universitates Medicinas
  • First city hospital of emergency care Northern State Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Stent

No stent

Arm Description

Stent insertion into the main pancreatic duct

No stent insertion into the main pancreatic duct

Outcomes

Primary Outcome Measures

Incidence of post-ERCP pancreatitis

Secondary Outcome Measures

Full Information

First Posted
October 17, 2011
Last Updated
October 11, 2017
Sponsor
Technical University of Munich
Collaborators
Northern State University, Russia, KU Leuven, Latvijas Universitates Medicinas
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1. Study Identification

Unique Protocol Identification Number
NCT01673763
Brief Title
Post-ERCP Pancreatitis Prevention by Stent Insertion
Acronym
PEPSI
Official Title
Study to Reduce Incidence of Post-ERCP Pancreatitis by Stent Insertion in the Main Pancreatic Duct After Unintended Cannulation of the Main Pancreatic Duct
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2010 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technical University of Munich
Collaborators
Northern State University, Russia, KU Leuven, Latvijas Universitates Medicinas

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-ERCP Acute Pancreatitis
Keywords
ERCP, endoscopy, pancreatitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stent
Arm Type
Active Comparator
Arm Description
Stent insertion into the main pancreatic duct
Arm Title
No stent
Arm Type
No Intervention
Arm Description
No stent insertion into the main pancreatic duct
Intervention Type
Device
Intervention Name(s)
Stent insertion into the main pancreatic duct
Intervention Description
Stent insertion into the main pancreatic duct
Primary Outcome Measure Information:
Title
Incidence of post-ERCP pancreatitis
Time Frame
up to 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hana Algül, MD, MPH
Organizational Affiliation
II. Medizinische Klinik, Klinikum rechts der Isar, Ismaniger Strasse 22, 81675 Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deptartment of Hepatobiliary Diseases Leuven University Hospitals
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Klinikum rechts der Isar, Technische Universität München
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
P. Stradin Clinical University Hospital Gastroenterology Centere Latvijas Universitates Medicinas
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
First city hospital of emergency care Northern State Medical University
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

Post-ERCP Pancreatitis Prevention by Stent Insertion

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