Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Stent insertion into the main pancreatic duct

Device
Who is being recruted

Digestive System Diseases

+ Pancreatic Diseases

+ Pancreatitis

From 18 to 100 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: July 2010
See protocol details

Summary

Principal SponsorTechnical University of Munich
Last updated: October 13, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2010

Actual date on which the first participant was enrolled.

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

NCT01673763
Principal SponsorTechnical University of Munich
Last updated: October 13, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

169 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesPancreatic DiseasesPancreatitis

Criteria

3 inclusion criteria required to participate
age > 17 years
all patients undergoing ERCP with unintended cannulation or opifiacation of main pancreatic duct
signed informed consent
4 exclusion criteria prevent from participating
absent of signed informed consent
age < 18 years
intention to intervene main pancreatic duct
pregnancy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Stent insertion into the main pancreatic duct

Group II

No Intervention
No stent insertion into the main pancreatic duct

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Deptartment of Hepatobiliary Diseases Leuven University Hospitals

Leuven, BelgiumOpen Deptartment of Hepatobiliary Diseases Leuven University Hospitals in Google Maps

Klinikum rechts der Isar, Technische Universität München

Munich, Germany

P. Stradin Clinical University Hospital Gastroenterology Centere Latvijas Universitates Medicinas

Riga, Latvia

First city hospital of emergency care Northern State Medical University

Arkhangelsk, Russia
Completed4 Study Centers