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

NCT ID: NCT00753441

Last Updated: 2017-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-01

Study Completion Date

2017-08-16

Brief Summary

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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

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Conditions

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Pancreatic Cancer

Keywords

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Pancreatic cancer Bile duct obstruction Stent Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

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

Group Type EXPERIMENTAL

Surgical bypass

Intervention Type PROCEDURE

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

B

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

Group Type ACTIVE_COMPARATOR

Endoscopic stenting

Intervention Type PROCEDURE

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

Interventions

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Surgical bypass

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

Intervention Type PROCEDURE

Endoscopic stenting

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Nuh Rahbari

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruno Schmied, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Universityhospital Heidelberg

Heidelberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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NNR-02

Identifier Type: -

Identifier Source: org_study_id