Evaluation of Pancreatic Duct Stenting in Patients With Pancreatic Pseudocysts.

Chronic Acute Pancreatitis Clinical Trial

— Disduct  

Official title:

Randomized Multicenter Study on Pancreatic Duct Stenting in Disrupted or Obstructed Ducts in Context With Endoscopic Treatment of Pancreatic Pseudocysts.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01276002
• Other study ID #: UKSH-122010
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Chronic Acute Pancreatitis
• Pancreatic Pseudocyst
• Pancreatitis

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