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

University Hospital Schleswig-Holstein (UKSH)

Status: Withdrawn

Conditions: Chronic Acute Pancreatitis

Treatments: Procedure: pancreatic duct stenting

Study type: Interventional

Funder types: Other

Identifiers

NCT01276002

UKSH-122010

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

No stenting

No Intervention group

Description:

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

Pancreatic duct stenting

Active Comparator group

Description:

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

Treatment:

Procedure: pancreatic duct stenting