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

Not Applicable

Terminated

• Conditions: Pancreatic Cancer
• Interventions: Procedure: Surgical bypass; Procedure: Endoscopic stenting

• Registration Number: NCT00753441
• Lead Sponsor: Heidelberg University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-15
• Study First Submitted QC: 2008-09-15
• Study First Posted: 2008-09-16
• Study Start: 2009-02-01
• Primary Completion: 2017-08-16
• Study Completion: 2017-08-16
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-26
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Surgical bypass	Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary)
B	Endoscopic stenting	Endoscopic biliary stenting using metal stent (completed by duodenal stent, if necessary)

Primary Outcome Measures

Name	Time	Method
Quality of life	12 months
Serum bilirubin	12 months

Secondary Outcome Measures

Name	Time	Method
Procedure-related complications	12 months

Trial Locations

Locations (1)

Universityhospital Heidelberg; 🇩🇪 Heidelberg, Germany