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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Heidelberg University
Sponsor:
Information provided by (Responsible Party):
Nuh Rahbari, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00753441
First received: September 15, 2008
Last updated: May 20, 2013
Last verified: May 2013

September 15, 2008
May 20, 2013
September 2008
September 2015   (final data collection date for primary outcome measure)
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Serum bilirubin [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00753441 on ClinicalTrials.gov Archive Site
Procedure-related complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Recruiting
100
January 2016
September 2015   (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
Both
18 Years and older
No
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
Germany
 
NCT00753441
NNR-02
Yes
Nuh Rahbari, University of Heidelberg
Heidelberg University
Not Provided
Principal Investigator: Bruno Schmied, MD Department of General, Visceral and Transplantation Surgery, University of Heidelberg
Heidelberg University
May 2013

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