Evaluation of Pancreatic Duct Stenting in Patients With Pancreatic Pseudocysts. (Disduct)

June 30, 2022 updated by: Mark Ellrichmann, University Hospital Schleswig-Holstein

Randomized Multicenter Study on Pancreatic Duct Stenting in Disrupted or Obstructed Ducts in Context With Endoscopic Treatment of Pancreatic Pseudocysts.

The disruption of the pancreatic duct seems to be a major cause pseudocyst formation and persistence in patients suffering from acute/chronic pancreatitis. No prospective randomized studies have been conducted on the influence of pancreatic duct stenting for the patients' benefits and recurrence rates. The aim fo this study is therefore to evaluate prospectively in a randomized, controlled fashion in patients wit pancreatic pseudocysts, wether pancreatic duct stenting of a disrupted pancreatic duct is beneficial in terms of quicker clinical recovery and avoidance of recurrence of pancreatic pseudocysts.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Kiel, Germany, 24105
        • Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • pancreatic pseudocyst, at least 6 cm in diameter
  • symptomatic pancreatic pseudocyst
  • increasing size of pancreatic pseudocyst within 6 weeks

Exclusion Criteria:

  • Pregnancy
  • Age less than 18 years
  • Postoperative status preventing access to papilla
  • Allergy to contrast preventing from ERP
  • Missing informed consent to study
  • PTT above 1.5 times of normal, unless substituted
  • Platelet count less than 50.000/µl, unless substituted
  • Pancreatic ascites or fistula
  • Life expectancy less than 2 years
  • Percutaneously drained cysts are not part of the study

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: No stenting
Control group, no stenting of the pancreatic duct in case of a disrupted duct
ACTIVE_COMPARATOR: Pancreatic duct stenting
in case of a disrupted pancreatic duct, patients will undergo pancreatic duct stenting in this arm
Procedure: pancreatic duct stenting
in case of a disrupted pancreatic duct, patients will undergo pancreatic duct stenting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence of pancreatic pseudocyst
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Schleswig-Holstein

Investigators

  • Principal Investigator: Mark Ellrichmann, MD, Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel, Germany
  • Study Director: Annette Fritscher-Ravens, MD, PhD, Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

January 12, 2011

First Submitted That Met QC Criteria

January 12, 2011

First Posted (ESTIMATE)

January 13, 2011

Study Record Updates

Last Update Posted (ACTUAL)

July 6, 2022

Last Update Submitted That Met QC Criteria

June 30, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKSH-122010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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