Trial Information
Endoscopic Biliary Stenting on Demand Versus Surgical Biliary Bypass for Palliation of Patients With Advanced Cancer of the Pancreatic Head: STENTBY - A Randomized Controlled Trial
Inclusion Criteria:
- Age equal or greater than 18 years
- Diagnosis of unresectable cancer of the pancreatic head (after clinical, laboratory,
radiological assessment) requiring palliative treatment for biliary obstruction. In
unclear cases an exploratory laparotomy will be performed and resectability will be
evaluated intraoperatively
- Operability certified by anesthesiologist
- Written informed consent
Exclusion Criteria:
- Intervention technically/medically not feasible
- Expected lack of compliance
- One treatment option considered to be clearly in favor of the patient
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Quality of life
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Bruno Schmied, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of General, Visceral and Transplantation Surgery, University of Heidelberg
Authority:
Germany: Ethics Commission
Study ID:
NNR-02
NCT ID:
NCT00753441
Start Date:
September 2008
Completion Date:
January 2016
Related Keywords:
- Pancreatic Cancer
- Pancreatic cancer
- Bile duct obstruction
- Stent
- Bypass
- Cholestasis
- Pancreatic Neoplasms