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Endoscopic Stenting Versus Surgical Bypass for Low Bile Duct Obstruction by Cancer of the Pancreatic Head (STENTBY)

This study has been terminated.
(Low patient accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00753441
First Posted: September 16, 2008
Last Update Posted: October 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nuh Rahbari, Heidelberg University
September 15, 2008
September 16, 2008
October 27, 2017
February 1, 2009
August 16, 2017   (Final data collection date for primary outcome measure)
  • Quality of life [ Time Frame: 12 months ]
  • Serum bilirubin [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT00753441 on ClinicalTrials.gov Archive Site
Procedure-related complications [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
 
Endoscopic Stenting Versus Surgical Bypass for Low Bile Duct Obstruction by Cancer of the Pancreatic Head
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
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pancreatic Cancer
  • Procedure: Surgical bypass
    Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy 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)
  • Experimental: A
    Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary)
    Intervention: Procedure: Surgical bypass
  • Active Comparator: B
    Endoscopic biliary stenting using metal stent (completed by duodenal stent, if necessary)
    Intervention: Procedure: Endoscopic stenting
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
August 16, 2017
August 16, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00753441
NNR-02
Yes
Not Provided
Not Provided
Nuh Rahbari, Heidelberg University
Heidelberg University
Not Provided
Principal Investigator: Bruno Schmied, MD Department of General, Visceral and Transplantation Surgery, University of Heidelberg
Heidelberg University
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP