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

NCT ID: NCT01421836

Last Updated: 2016-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2016-03-31

Brief 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.

Detailed Description

1. Inclusion criteria 1) age: 18 - 80 2) a patients who had common bile duct dilatation because of malignant distal common bile duct obstruction in radiologically 3) Hyperbilirubinemia (total bilirubin >= 1.5 mg/dl) 4) inoperable state 5) a patients who agree to join this study

2. Exclusion criteria 1) a patients who can not endure sedation 2) a patients with bleeding tendency (PT > 1.5 INR, PLT < 50,000) 3) a patients with systemic infection 4) a patients who had hilar obstruction

Conditions

Tumor Appearance of Biliary System Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ERCP guided stent insertion

Group Type: ACTIVE_COMPARATOR

ERCP-guided stent insertion

Intervention Type: PROCEDURE

ERCP guided stent insertion for malignant biliary obstruction

EUS guided stent insertion

Group Type: ACTIVE_COMPARATOR

EUS guided stent insertion

Intervention Type: PROCEDURE

EUS-guided stent insertion for malignant biliary obstruction

Interventions

ERCP-guided stent insertion

ERCP guided stent insertion for malignant biliary obstruction

Intervention Type: PROCEDURE

EUS guided stent insertion

EUS-guided stent insertion for malignant biliary obstruction

Intervention Type: PROCEDURE

Other Intervention Names

ERCP-guided metal stent insertion; EUS-guided metal stent insertion

Eligibility Criteria

Inclusion Criteria

• distal biliary obstruction due to malignant tumor
• unresectable tumor
• Jaundice

Exclusion Criteria

• Children
• Hilar obstruction
• Active infection
• Bleeding tendency

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kwang Hyuck Lee

Professor of Department of Medicine,Samsung Medical Center,Sungkyunkwan University School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kwanghyuck Lee, MD, phD

Role: STUDY_DIRECTOR

Division of Gastroenterology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

Locations

Samsung Medical Center

Seoul, Irwon-dong, Gangnam-gu, South Korea

Countries

South Korea

References

Park JK, Woo YS, Noh DH, Yang JI, Bae SY, Yun HS, Lee JK, Lee KT, Lee KH. Efficacy of EUS-guided and ERCP-guided biliary drainage for malignant biliary obstruction: prospective randomized controlled study. Gastrointest Endosc. 2018 Aug;88(2):277-282. doi: 10.1016/j.gie.2018.03.015. Epub 2018 Mar 30.

Reference Type: DERIVED

PMID: 29605722 (View on PubMed)

Other Identifiers

2011-03-101-001

Identifier Type: -

Identifier Source: org_study_id