Evaluation of Pancreatic Duct Stenting in Patients With Pancreatic Pseudocysts.

Not Applicable

Withdrawn

• Conditions: Chronic Acute Pancreatitis
• Interventions: Procedure: pancreatic duct stenting

• Registration Number: NCT01276002
• Lead Sponsor: University Hospital Schleswig-Holstein

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-12
• Study First Submitted QC: 2011-01-12
• Study First Posted: 2011-01-13
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pancreatic duct stenting	pancreatic duct stenting	in case of a disrupted pancreatic duct, patients will undergo pancreatic duct stenting in this arm

Primary Outcome Measures

Name	Time	Method
Recurrence of pancreatic pseudocyst	two years

Trial Locations

Locations (1)

Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel; 🇩🇪 Kiel, Germany