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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


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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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

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