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Post-ERCP Pancreatitis Prevention by Stent Insertion (PEPSI)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Technische Universität München.
Recruitment status was:  Recruiting
Sponsor:
Collaborators:
Northern State University, Russia
Katholieke Universiteit Leuven
Latvijas Universitates Medicinas
Information provided by (Responsible Party):
Monther Bajbouj, Technische Universität München
ClinicalTrials.gov Identifier:
NCT01673763
First received: October 17, 2011
Last updated: August 27, 2012
Last verified: August 2012
  Purpose
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 Intervention
Post-ERCP Acute Pancreatitis
Device: Stent insertion into the main pancreatic duct

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Incidence of post-ERCP pancreatitis [ Time Frame: up to 1 week ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 603
Study Start Date: July 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 
Study First Received: October 17, 2011
Last Updated: August 27, 2012
Health Authority: Germany: Ethics Commission
Russia: Ethics Committee
Belgium: Ethics Committee
Latvia: State Agency of Medicines

Keywords provided by Technische Universität München:
ERCP
endoscopy
pancreatitis

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on December 09, 2016