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Post-ERCP Pancreatitis Prevention by Stent Insertion (PEPSI)

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ClinicalTrials.gov Identifier: NCT01673763
Recruitment Status : Completed
First Posted : August 28, 2012
Last Update Posted : October 13, 2017
Sponsor:
Collaborators:
Northern State University, Russia
Katholieke Universiteit Leuven
Latvijas Universitates Medicinas
Information provided by (Responsible Party):
Monther Bajbouj, Technische Universität München

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.

Condition or disease Intervention/treatment Phase
Post-ERCP Acute Pancreatitis Device: Stent insertion into the main pancreatic duct Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
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
Actual Study Start Date : July 2010
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Incidence of post-ERCP pancreatitis [ Time Frame: up to 1 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673763


Locations
Belgium
Deptartment of Hepatobiliary Diseases Leuven University Hospitals
Leuven, Belgium, 3000
Germany
Klinikum rechts der Isar, Technische Universität München
Munich, Germany, 81675
Latvia
P. Stradin Clinical University Hospital Gastroenterology Centere Latvijas Universitates Medicinas
Riga, Latvia, 1002
Russian Federation
First city hospital of emergency care Northern State Medical University
Arkhangelsk, Russian Federation, 163045
Sponsors and Collaborators
Technische Universität München
Northern State University, Russia
Katholieke Universiteit Leuven
Latvijas Universitates Medicinas
Investigators
Principal Investigator: Hana Algül, MD, MPH II. Medizinische Klinik, Klinikum rechts der Isar, Ismaniger Strasse 22, 81675 Munich

Additional Information:
Responsible Party: Monther Bajbouj, PD Dr. med. Hana Algül, Technische Universität München
ClinicalTrials.gov Identifier: NCT01673763     History of Changes
Other Study ID Numbers: 240179
First Posted: August 28, 2012    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017

Keywords provided by Monther Bajbouj, Technische Universität München:
ERCP
endoscopy
pancreatitis

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases