Endoscopic Stenting Versus Surgical Bypass for Low Bile Duct Obstruction by Cancer of the Pancreatic Head - Full Text View

Sponsored by:	University of Heidelberg
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00753441

Purpose

The prognosis of patients with unresectable pancreatic cancer is dismal. Hence, palliation of tumor-associated symptoms, in particular jaundice due to low bile duct obstruction and gastric outlet obstruction, is the primary aim of these patients' care. Endoscopic stenting and surgical bypass are currently the two competing treatment options. There is currently no randomized trial comparing the recently developed metal stents to surgical bypass. Furthermore, there is very limited data on quality of life of these patients receiving either therapy. While endoscopic stenting represents the less invasive treatment, surgery may provide better long-term control requiring one-time treatment. Due to the incomplete evidence the present randomized controlled trial is designed to compare quality of life of patients undergoing endoscopic stenting on demand or surgical bypass for palliation of symptoms caused by cancer of the pancreatic head requiring with low bile duct obstruction.

Condition	Intervention	Phase
Pancreatic Cancer	Procedure: Surgical bypass Procedure: Endoscopic stenting	Phase II Phase III

MedlinePlus related topics: Cancer Endoscopy Pancreatic Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	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

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Serum bilirubin [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Procedure-related complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary)	Procedure: Surgical bypass Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary)
B: Active Comparator Endoscopic biliary stenting using metal stent (completed by duodenal stent, if necessary)	Procedure: Endoscopic stenting Placement of a biliary metal stent (in combination with a duodenal metal stent in case of gastric outlet obstruction if necessary)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753441

Contacts

Contact: Nuh N Rahbari, MD	+49 6221 56 ext 39448	nuh.rahbari@med.uni-heidelberg.de
Contact: Bruno Schmied, MD	+49 6221 56 ext 36540	bruno.schmied@med.uni-heidelberg.de

Locations

Germany
Universityhospital Heidelberg
Heidelberg, Germany, 69120

Sponsors and Collaborators

University of Heidelberg

Investigators

Principal Investigator:

Bruno Schmied, MD

Department of General, Visceral and Transplantation Surgery, University of Heidelberg

More Information

Responsible Party:	Department of General, Visceral and Transplantation Surgery, University of Heidelberg ( Dr. Bruno Schmied )
Study ID Numbers:	NNR-02
Study First Received:	September 15, 2008
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00753441
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Heidelberg:

Pancreatic cancer
Bile duct obstruction
Stent
Bypass

Study placed in the following topic categories:

Digestive System Neoplasms
Digestive System Diseases
Bile Duct Diseases
Cholestasis
Biliary Tract Diseases
Pancreatic Neoplasms

Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009