Endoscopic Stenting Versus Surgical Bypass For Low Bile Duct Obstruction By Cancer Of The Pancreatic Head

Study Overview

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

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.

N/A

Pancreatic Cancer

PROCEDURE: Surgical bypass
PROCEDURE: Endoscopic stenting

NNR-02

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2008-09-15	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-10-26
First Submitted that Met QC Criteria 2008-09-15	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-10-27
First Posted (ACTUAL) 2008-09-16	Results First Posted N/A	Last Verified 2017-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
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)

Participant Group/Arm

Intervention/Treatment

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)

Primary Outcome Measures	Measure Description	Time Frame
Quality of life		12 months
Serum bilirubin		12 months

Secondary Outcome Measures	Measure Description	Time Frame
Procedure-related complications		12 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Intervention technically/medically not feasible
Expected lack of compliance
One treatment option considered to be clearly in favor of the patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Bruno Schmied, MD, Department of General, Visceral and Transplantation Surgery, University of Heidelberg

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record