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
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

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: January 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary)
Procedure: Surgical bypass
Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary)
Active Comparator: B
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Recruiting
Heidelberg, Germany, 69120
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   
Principal Investigator: Bruno Schmied, MD         
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Bruno Schmied, MD Department of General, Visceral and Transplantation Surgery, University of Heidelberg
  More Information

No publications provided

Responsible Party: Nuh Rahbari, MD, University of Heidelberg
ClinicalTrials.gov Identifier: NCT00753441     History of Changes
Other Study ID Numbers: NNR-02
Study First Received: September 15, 2008
Last Updated: May 20, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Heidelberg University:
Pancreatic cancer
Bile duct obstruction
Stent
Bypass

Additional relevant MeSH terms:
Cholestasis
Pancreatic Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014