Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01622803
Recruitment Status : Withdrawn (Patients enrollment problem)
First Posted : June 19, 2012
Last Update Posted : April 26, 2016
Information provided by (Responsible Party):
Kwang Hyuck Lee, Samsung Medical Center

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction
Study Start Date : August 2011
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. The time taken to insert bilateral stent [ Time Frame: After the ERCP procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01622803

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Study Director: Kwang hyuck Lee, MD, phD Division of Gastroenterology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

Responsible Party: Kwang Hyuck Lee, Assistant Professor of Medicine, Samsung Medical Center Identifier: NCT01622803     History of Changes
Other Study ID Numbers: KH0LEE
First Posted: June 19, 2012    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: April 2016

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