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Stenting Malignant Jaundice for Quality of Life

NCT01459965 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2011-10-26

No results posted yet for this study

Summary

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.

Conditions

  • Bile Duct Neoplasms Malignant

Interventions

PROCEDURE

ERCP with 10 French biliary plastic stent placement

Stent placement of a 10 French biliary plastic stent

PROCEDURE

ERCP with 11.5 French biliary plastic stent

biliary plastic stent placement

Sponsors & Collaborators

  • American Society for Gastrointestinal Endoscopy

    collaborator OTHER

  • American College of Gastroenterology

    collaborator OTHER

  • Indiana University

    lead OTHER

Principal Investigators

  • Stuart Sherman, MD · Indiana University School of Medicine

  • Glen A Lehman, MD · Indiana Univesity Medical Center

  • James Frankes, MD · Rockford GE Associates

  • John Johanson, MD · Rockford GE Associates

  • Tahir Qaseem, MD · MaineHealth

  • Douglas Howell, MD · MaineHealth

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1993-07-31
Primary Completion
2004-11-30
Completion
2004-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01459965 on ClinicalTrials.gov