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Evaluation of Pancreatic Duct Stenting in Patients With Pancreatic Pseudocysts.


2011-01


2016-12


2016-12


0

Study Overview

Evaluation of Pancreatic Duct Stenting in Patients With 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.

N/A

  • Chronic Acute Pancreatitis
  • PROCEDURE: pancreatic duct stenting
  • UKSH-122010

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 Registration Dates Results Reporting Dates Study Record Updates

2011-01-12  

N/A  

2022-06-30  

2011-01-12  

N/A  

2022-07-06  

2011-01-13  

N/A  

2022-06  

Study Plan

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

Design Details

Primary Purpose:
Treatment


Allocation:
Randomized


Interventional Model:
Parallel


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/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.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Recurrence of pancreatic pseudocysttwo years
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

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


    • PRINCIPAL_INVESTIGATOR: Mark Ellrichmann, MD, Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel, Germany

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available