Back to resultsEndoscopic Stenting Versus Surgical Bypass for Low Bile Duct Obstruction by Cancer of the Pancreatic Head (STENTBY)
Primary Purpose
Pancreatic Cancer
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Surgical bypass
Endoscopic stenting
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic cancer, Bile duct obstruction, Stent, Bypass
Eligibility 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
Sites / Locations
- Universityhospital Heidelberg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary)
Endoscopic biliary stenting using metal stent (completed by duodenal stent, if necessary)
Outcomes
Primary Outcome Measures
Quality of life
Serum bilirubin
Secondary Outcome Measures
Procedure-related complications
Full Information
NCT ID
NCT00753441
First Posted
September 15, 2008
Last Updated
October 26, 2017
Sponsor
Heidelberg University
1. Study Identification
Unique Protocol Identification Number
NCT00753441
Brief Title
Endoscopic Stenting Versus Surgical Bypass for Low Bile Duct Obstruction by Cancer of the Pancreatic Head
Acronym
STENTBY
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Low patient accrual
Study Start Date
February 1, 2009 (Actual)
Primary Completion Date
August 16, 2017 (Actual)
Study Completion Date
August 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreatic cancer, Bile duct obstruction, Stent, Bypass
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary)
Arm Title
B
Arm Type
Active Comparator
Arm Description
Endoscopic biliary stenting using metal stent (completed by duodenal stent, if necessary)
Intervention Type
Procedure
Intervention Name(s)
Surgical bypass
Intervention Description
Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary)
Intervention Type
Procedure
Intervention Name(s)
Endoscopic stenting
Intervention Description
Placement of a biliary metal stent (in combination with a duodenal metal stent in case of gastric outlet obstruction if necessary)
Primary Outcome Measure Information:
Title
Quality of life
Time Frame
12 months
Title
Serum bilirubin
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Procedure-related complications
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Schmied, MD
Organizational Affiliation
Department of General, Visceral and Transplantation Surgery, University of Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universityhospital Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Endoscopic Stenting Versus Surgical Bypass for Low Bile Duct Obstruction by Cancer of the Pancreatic Head
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