Post-ERCP Pancreatitis Prevention by Stent Insertion

NCT ID: NCT01673763

Last Updated: 2017-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2017-08-31

Brief Summary

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

Detailed Description

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Conditions

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Post-ERCP Acute Pancreatitis

Keywords

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ERCP endoscopy pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Stent

Stent insertion into the main pancreatic duct

Group Type ACTIVE_COMPARATOR

Stent insertion into the main pancreatic duct

Intervention Type DEVICE

Stent insertion into the main pancreatic duct

No stent

No stent insertion into the main pancreatic duct

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Stent insertion into the main pancreatic duct

Stent insertion into the main pancreatic duct

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northern State University, Russia

UNKNOWN

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role collaborator

Latvijas Universitates Medicinas

UNKNOWN

Sponsor Role collaborator

Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Monther Bajbouj

PD Dr. med. Hana Algül

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hana Algül, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

II. Medizinische Klinik, Klinikum rechts der Isar, Ismaniger Strasse 22, 81675 Munich

Locations

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Deptartment of Hepatobiliary Diseases Leuven University Hospitals

Leuven, , Belgium

Site Status

Klinikum rechts der Isar, Technische Universität München

Munich, , Germany

Site Status

P. Stradin Clinical University Hospital Gastroenterology Centere Latvijas Universitates Medicinas

Riga, , Latvia

Site Status

First city hospital of emergency care Northern State Medical University

Arkhangelsk, , Russia

Site Status

Countries

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Belgium Germany Latvia Russia

Other Identifiers

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240179

Identifier Type: -

Identifier Source: org_study_id