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Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction

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ClinicalTrials.gov Identifier: NCT01622803
Recruitment Status : Withdrawn (Patients enrollment problem)
First Posted : June 19, 2012
Last Update Posted : April 26, 2016
Sponsor:
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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT01622803


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
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

Responsible Party: Kwang Hyuck Lee, Assistant Professor of Medicine, Samsung Medical Center
ClinicalTrials.gov 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
Jaundice, Obstructive
Bile Duct Neoplasms
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases