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Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction

This study is currently recruiting participants.
Verified June 2012 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Kwang Hyuck Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01622803
First received: June 12, 2012
Last updated: June 18, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Bile Duct Neoplasm
Obstructive Jaundice
 Procedure: parallel stent
Device: Y-stent (BONASTENT M-Hilar)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • The time taken to insert bilateral stent [ Time Frame: After the ERCP procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: August 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: parallel stent
parallel stent insertion group
 Procedure: parallel stent
bilateral parallel stent insertion (right and left side)
Other Name: bilateral pig tail plastic stent
Active Comparator: Y-stent
Y-stent insertion group
 Device: Y-stent (BONASTENT M-Hilar)
Bilateral Y-stent insertion (stent in stent type)
Other Name: BONASTENT M-Hilar, Standard Sci Tech Inc, Seoul, South Korea

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01622803

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Kwang hyuck Lee, MD, PhD     82-10-9933-1628     lkhyuck@gmail.com    
Contact: Woo ik Chang, MD     82-10-4706-1118     iatersnake@naver.com    
Sponsors and Collaborators
Samsung Medical Center
Investigators
Study Director: Kwang hyuck Lee, MD, phD Division of Gastroenterology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
  More Information

No publications provided

Responsible Party: Kwang Hyuck Lee, Assistant Professor of Medicine, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01622803     History of Changes
Other Study ID Numbers: KH0LEE
Study First Received: June 12, 2012
Last Updated: June 18, 2012
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Bile Duct Diseases
Bile Duct Neoplasms
Neoplasms
Jaundice
Jaundice, Obstructive
Biliary Tract Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013