Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction

NCT01622803 | Withdrawn Phase 3 DMC

• 1 other identifier: KH0LEE
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Internal biliary drainage using stent is used for malignant hilar obstruction such as cholangiocarcinoma, hepatocellular carcinoma and other malignancy including metastasis. Bilateral drainage is more physiologic and have more long patency than unilateral drainage. There are two methods of bilateral drainage: Y-stent and side by side. However there are no clinical data about comparing the effectiveness of these two methods. Therefore the investigators want to compare the clinical outcomes of two methods: Y-stent and side by side.

Conditions

Bile Duct Neoplasm; Obstructive Jaundice

Outcome Measures

Primary Outcomes (1)

• The time taken to insert bilateral stent

  After the ERCP procedure

Study Arms (2)

parallel stent

ACTIVE COMPARATOR

parallel stent insertion group

Procedure: parallel stent

Y-stent

ACTIVE COMPARATOR

Y-stent insertion group

Device: Y-stent (BONASTENT M-Hilar)

Interventions

parallel stent PROCEDURE

bilateral parallel stent insertion (right and left side)

Also known as: bilateral pig tail plastic stent

parallel stent

Y-stent (BONASTENT M-Hilar) DEVICE

Bilateral Y-stent insertion (stent in stent type)

Also known as: BONASTENT M-Hilar, Standard Sci Tech Inc, Seoul, South Korea

Y-stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years
• patient who have obstructive jaundice (bilirubin \> 2.0mg/dl) due to hilar malignancy

You may not qualify if:

• patients with endoscopic retrograde cholangiogram is not possible
• bleeding tendency (PT INR \> 1.5, platelet \< 50,000)
• poor general condition (ECOG 3-4) or cardiopulmonary deterioration
• pregnancy

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Bile Duct Neoplasms; Jaundice, Obstructive

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Jaundice; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Kwang hyuck Lee, MD, phD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 19, 2012
• Study Start: August 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 26, 2016

Record last verified: 2016-04

Locations

KR (1)