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Spots Global Cancer Trial Database for Prospective Study Comparing EUS vs ERCP Stent Insertion for Malignant Biliary Obstruction

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Trial Identification

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

Official Title: Prospective Study Comparing EUS Guided Biliary Drainage and ERCP With Stent Placement for Malignant Biliary Obstruction

Study ID: NCT01421836

Study Description

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

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Samsung Medical Center, Seoul, Irwon-dong, Gangnam-gu, Korea, Republic of

Contact Details

Name: Kwanghyuck Lee, MD, phD

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

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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