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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01276002
Other study ID # UKSH-122010
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 2011
Est. completion date December 2016

Study information

Verified date June 2022
Source University Hospital Schleswig-Holstein
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Procedure:
pancreatic duct stenting
in case of a disrupted pancreatic duct, patients will undergo pancreatic duct stenting.

Locations

Country Name City State
Germany Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel Kiel

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrence of pancreatic pseudocyst two years