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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
  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
Pancreatic Cancer Procedure: Surgical bypass Procedure: Endoscopic stenting

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Nuh Rahbari, Heidelberg University:

Primary Outcome Measures:
  • Quality of life [ Time Frame: 12 months ]
  • Serum bilirubin [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Procedure-related complications [ Time Frame: 12 months ]

Enrollment: 24
Actual Study Start Date: February 1, 2009
Study Completion Date: August 16, 2017
Primary Completion Date: August 16, 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00753441


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

Responsible Party: Nuh Rahbari, MD, Heidelberg University
ClinicalTrials.gov Identifier: NCT00753441     History of Changes
Other Study ID Numbers: NNR-02
First Submitted: September 15, 2008
First Posted: September 16, 2008
Last Update Posted: October 27, 2017
Last Verified: October 2017

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

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