Stenting Malignant Jaundice for Quality of Life

This study has been completed.
Sponsor:
Collaborators:
American Society for Gastrointestinal Endoscopy
American College of Gastroenterology
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01459965
First received: October 21, 2011
Last updated: October 25, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Bile Duct Neoplasms Malignant
Procedure: ERCP with 10 French biliary plastic stent placement
Procedure: ERCP with 11.5 French biliary plastic stent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Endoscopic Palliation of Malignant Biliary Tract Obstruction: Emphasis on Improvement in Quality of Life

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Documented change in Quality Of Life [ Time Frame: 180 days after stent insertion ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Documented change in symptoms and concerns specific for patients with MBDO [ Time Frame: 180 days after stent placement ] [ Designated as safety issue: No ]
    An additional 10 item questionnaire was administered at baseline, at 1 month after biliary stenting and at 180 days after biliary stenting.


Enrollment: 164
Study Start Date: July 1993
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459965

Sponsors and Collaborators
Indiana University
American Society for Gastrointestinal Endoscopy
American College of Gastroenterology
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 Maine Medical Center
Principal Investigator: Douglas Howell, MD Maine Medical Center
  More Information

Publications:
Sherman S, Lehman G, Earle D, Lazaridis E, Frankes J, Johanson J, Qaseem T, Howell D (1996) Multicenter randomized trial of 10 French versus 11.5 French plastic stents for malignant bile duct obstruction. Gastrointest Endosc 43:A421
Hahn EA, Cella D, (1997) Unbiased quality of life measurement across literacy levels and mode of administration. Qual Life Res 6:654.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01459965     History of Changes
Other Study ID Numbers: 9307-04
Study First Received: October 21, 2011
Last Updated: October 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Jaundice
Biliary stents
Palliation
Quality of Life
Endoscopic Retrograde Cholangiography

Additional relevant MeSH terms:
Bile Duct Neoplasms
Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 14, 2014