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

NCT00753441 | Terminated DMC

• 1 other identifier: NNR-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

Pancreatic cancer; Bile duct obstruction; Stent; Bypass

Outcome Measures

Primary Outcomes (2)

• Quality of life

  12 months

• Serum bilirubin

  12 months

Secondary Outcomes (1)

• Procedure-related complications

  12 months

Study Arms (2)

A

EXPERIMENTAL

Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary)

Procedure: Surgical bypass

B

ACTIVE COMPARATOR

Endoscopic biliary stenting using metal stent (completed by duodenal stent, if necessary)

Procedure: Endoscopic stenting

Interventions

Surgical bypass PROCEDURE

Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary)

A

Endoscopic stenting PROCEDURE

Placement of a biliary metal stent (in combination with a duodenal metal stent in case of gastric outlet obstruction if necessary)

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Universityhospital Heidelberg

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Cholestasis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Bile Duct Diseases; Biliary Tract Diseases

Study Officials

• Bruno Schmied, MD

  Department of General, Visceral and Transplantation Surgery, University of Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 15, 2008
• First Posted: September 16, 2008
• Study Start: February 1, 2009
• Primary Completion: August 16, 2017
• Study Completion: August 16, 2017
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

DE (1)