NCT00753441

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
PROCEDURE	Surgical bypass	Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy 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)

Timeline

• Start date: 2009-02-01
• Primary completion: 2017-08-16
• Completion: 2017-08-16
• First posted: 2008-09-16
• Last updated: 2017-10-27

Locations

1 site across 1 country: Germany