Stenting Malignant Jaundice for Quality of Life

October 25, 2011 updated by: Indiana University

Endoscopic Palliation of Malignant Biliary Tract Obstruction: Emphasis on Improvement in Quality of Life

Endoscopic stent insertion is considered the method of choice for palliation of malignant bile duct obstruction (MBDO). However, it can cause complications and requires periodic stent exchanges. While endoscopic stenting is clearly indicated for relief of cholangitis or refractory pruritus, its role in patients with jaundice alone is less clear. Endoscopic stenting for this relative indication might be justified, if there is a significant improvement in quality of life (QOL) of such patients. The aim of the investigators study was to determine whether endoscopic stenting for MBDO results in improved QOL.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Most malignant tumors causing bile duct obstruction, such as pancreatic adenocarcinoma, gallbladder carcinoma or cholangiocarcinoma, have an extremely poor prognosis. At the time of diagnosis the majority of these tumors will be unresectable with a median survival of 4-6 months. Palliation is the goal for those patients with unresectable tumors and limited survival and for those at high risk for attempts at curative resection.

Endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic stent insertion is considered the method of choice for palliative treatment of malignant bile duct obstruction (MBDO). However, it can cause complications, such as pancreatitis, bleeding, perforation, cholangitis and stent migration in a significant proportion of treated patients. Clogging of plastic stents is a predictable consequence and requires periodic stent exchanges with attendant risks and costs. While endoscopic stenting is clearly indicated for relief of cholangitis or refractory pruritus, the role of stenting in patients with jaundice alone, abdominal pain, or failure to thrive due to malignancy is less clear. Given the risk for complications and costs, endoscopic therapy might be justified in these clinical scenarios if quality of life (QOL) is significantly improved. A few available studies have demonstrated improved QOL in stented patients. However, these studies include a small number of patients and/or are retrospective in design. Therefore, more evidence to support routine palliative biliary drainage in patients with MBDO is desired.

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with suspected or proven malignant biliary obstruction who were unresectable or inoperable and were undergoing ERCP and biliary stenting for biliary depression.

Exclusion Criteria:

  • Had previously undergone biliary stenting
  • Surgery was planned
  • A guidewire could not be passed through the stricture
  • Suspected survival of < 3 months
  • Impending duodenal obstruction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 10 French Stent
10 French biliary plastic stent
Procedure: ERCP with 10 French biliary plastic stent placement
Stent placement of a 10 French biliary plastic stent
Active Comparator: 11.5 French stent
11.5 French biliary plastic stent
Procedure: ERCP with 11.5 French biliary plastic stent
biliary plastic stent placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Documented change in Quality Of Life
Time Frame: 180 days after stent insertion
Documented change in QOL over the first month and over six months after successful biliary drainage compared with that before the procedure. The FACT-G questionnaire administered at baseline, at 1 month after stent insertion and at 180 days after stent insertion was used to assess this outcome. Change from baseline was analyzed at each of these time points separately.
180 days after stent insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Documented change in symptoms and concerns specific for patients with MBDO
Time Frame: 180 days after stent placement
An additional 10 item questionnaire was administered at baseline, at 1 month after biliary stenting and at 180 days after biliary stenting.
180 days after stent placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

American College of Gastroenterology
American Society for Gastrointestinal Endoscopy

Investigators

  • Principal Investigator: Stuart Sherman, MD, Indiana University School of Medicine
  • Principal Investigator: Glen A Lehman, MD, Indiana Univesity Medical Center
  • Principal Investigator: James Frankes, MD, Rockford GE Associates
  • Principal Investigator: John Johanson, MD, Rockford GE Associates
  • Principal Investigator: Tahir Qaseem, MD, MaineHealth
  • Principal Investigator: Douglas Howell, MD, MaineHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1993

Primary Completion (Actual)

November 1, 2004

Study Completion (Actual)

November 1, 2004

Study Registration Dates

First Submitted

October 21, 2011

First Submitted That Met QC Criteria

October 25, 2011

First Posted (Estimate)

October 26, 2011

Study Record Updates

Last Update Posted (Estimate)

October 26, 2011

Last Update Submitted That Met QC Criteria

October 25, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9307-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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