CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 164 enrolled
Drug / intervention
ERCP with 10 French biliary plastic stent placement +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01459965
NCT01459965N/ACompleted
CompareCT.gov

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

Indiana University·interventional·Posted Oct 26, 2011·Updated Oct 26, 2011

In Brief

A clinical study evaluating ERCP with 10 French biliary plastic stent placement and ERCP with 11.5 French biliary plastic stent for Bile Duct Neoplasms Malignant. Completed, enrolled 164 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBile Duct Neoplasms Malignant
Countries--
CollaboratorsAmerican Society for Gastrointestinal Endoscopy, American College of Gastroenterology

Timeline

N/ACompletedFinished
19931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 26, 2011
Enrollment StartJul 1, 1993
Primary CompletionNov 1, 2004
TodayJul 2, 2026
Enrollment to primary: 11.3 yearsPosted 14.7 years ago

Interventions

ERCP with 10 French biliary plastic stent placementprocedure

Stent placement of a 10 French biliary plastic stent

ERCP with 11.5 French biliary plastic stentprocedure

biliary plastic stent placement