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Prospective Study Comparing EUS vs ERCP Stent Insertion for Malignant Biliary Obstruction

NCT01421836 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-04-28

No results posted yet for this study

Summary

1. Purpose of the study

-To compare stent patency and complication rate between endoscopic ultrasound (EUS) guided stent insertion and endoscopic retrograde cholangiopancreatography (ERCP) guided stent insertion for malignant biliary obstruction
2. Subjects of the study

-Patients who have biliary obstruction owing to malignant tumors
3. Methods of the study

* Prospective randomized controlled study
* Patients were enrolled randomly in two groups, EUS guided stent insertion group or ERCP guided stent insertion group
* Patients will get assigned procedure (EUS guided stent insertion or ERCP guided stent insertion)for decompression of malignant biliary obstruction
* After the procedure, regular follow up, blood test,and imaging test will be done to check sufficient biliary decompression,stent patency and complications.

Conditions

  • Tumor Appearance of Biliary System Obstruction

Interventions

PROCEDURE

ERCP-guided stent insertion

ERCP guided stent insertion for malignant biliary obstruction

PROCEDURE

EUS guided stent insertion

EUS-guided stent insertion for malignant biliary obstruction

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Kwanghyuck Lee, MD, phD · Division of Gastroenterology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2015-10-31
Completion
2016-03-31

Countries

  • South Korea

Study Locations

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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 NCT01421836 on ClinicalTrials.gov