Study Stopped
No appropriate participants
Evaluation of Pancreatic Duct Stenting in Patients With Pancreatic Pseudocysts.
Disduct
Randomized Multicenter Study on Pancreatic Duct Stenting in Disrupted or Obstructed Ducts in Context With Endoscopic Treatment of Pancreatic Pseudocysts.
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 12, 2011
CompletedFirst Posted
Study publicly available on registry
January 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJuly 6, 2022
June 1, 2022
5.9 years
January 12, 2011
June 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence of pancreatic pseudocyst
two years
Study Arms (2)
No stenting
NO INTERVENTIONControl group, no stenting of the pancreatic duct in case of a disrupted duct
Pancreatic duct stenting
ACTIVE COMPARATORin case of a disrupted pancreatic duct, patients will undergo pancreatic duct stenting in this arm
Interventions
in case of a disrupted pancreatic duct, patients will undergo pancreatic duct stenting.
Eligibility Criteria
You may qualify if:
- pancreatic pseudocyst, at least 6 cm in diameter
- symptomatic pancreatic pseudocyst
- increasing size of pancreatic pseudocyst within 6 weeks
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel
Kiel, 24105, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head Interdisciplinary Endoscopy
Study Record Dates
First Submitted
January 12, 2011
First Posted
January 13, 2011
Study Start
January 1, 2011
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
July 6, 2022
Record last verified: 2022-06