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

Pancreatic Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00753441
• Other study ID #: NNR-02
• Status: Terminated
• Phase: N/A
• First received: September 15, 2008
• Last updated: October 26, 2017
• Start date: February 1, 2009
• Est. completion date: August 16, 2017

Study information

• Verified date: October 2017
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: August 16, 2017
• Est. primary completion date: August 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholestasis
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• Surgical bypass
Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary)
• Endoscopic stenting
Placement of a biliary metal stent (in combination with a duodenal metal stent in case of gastric outlet obstruction if necessary)

Locations

Country	Name	City	State
Germany	Universityhospital Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life		12 months
Primary	Serum bilirubin		12 months
Secondary	Procedure-related complications		12 months