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

Primary Purpose

Chronic Acute Pancreatitis

Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
pancreatic duct stenting
Sponsored by
University Hospital Schleswig-Holstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Acute Pancreatitis focused on measuring disrupted duct, pancreatic pseudocysts

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

No stenting

Pancreatic duct stenting

Arm Description

Control group, no stenting of the pancreatic duct in case of a disrupted duct

in case of a disrupted pancreatic duct, patients will undergo pancreatic duct stenting in this arm

Outcomes

Primary Outcome Measures

Recurrence of pancreatic pseudocyst

Secondary Outcome Measures

Full Information

First Posted
January 12, 2011
Last Updated
June 30, 2022
Sponsor
University Hospital Schleswig-Holstein
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1. Study Identification

Unique Protocol Identification Number
NCT01276002
Brief Title
Evaluation of Pancreatic Duct Stenting in Patients With Pancreatic Pseudocysts.
Acronym
Disduct
Official Title
Randomized Multicenter Study on Pancreatic Duct Stenting in Disrupted or Obstructed Ducts in Context With Endoscopic Treatment of Pancreatic Pseudocysts.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No appropriate participants
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Schleswig-Holstein

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Acute Pancreatitis
Keywords
disrupted duct, pancreatic pseudocysts

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No stenting
Arm Type
No Intervention
Arm Description
Control group, no stenting of the pancreatic duct in case of a disrupted duct
Arm Title
Pancreatic duct stenting
Arm Type
Active Comparator
Arm Description
in case of a disrupted pancreatic duct, patients will undergo pancreatic duct stenting in this arm
Intervention Type
Procedure
Intervention Name(s)
pancreatic duct stenting
Intervention Description
in case of a disrupted pancreatic duct, patients will undergo pancreatic duct stenting.
Primary Outcome Measure Information:
Title
Recurrence of pancreatic pseudocyst
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Ellrichmann, MD
Organizational Affiliation
Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Annette Fritscher-Ravens, MD, PhD
Organizational Affiliation
Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Pancreatic Duct Stenting in Patients With Pancreatic Pseudocysts.

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