NCT01622803

WithdrawnPhase 3

Comparison Between Two Methods of Bilateral Stenting for Mal...

Samsung Medical Center Source

Samsung Medical Center

ClinicalTrials.gov

Compare

Other study identifiers

Sponsor study identifier

KH0LEE

Study Type

interventional

Actual enrollment (reported)

0

Locations

1 country

Sites

1

Timeline

Study Start

August 2011

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2013

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

August 2013

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: withdrawn
Actual enrollment (reported): 0 participants
Study completion date: August 2013
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2011
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
June 12, 2012
Actual (reported)
First Posted
June 19, 2012
Actual (reported)
Primary Completion
August 2013
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2013
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: April 26, 2016
Status Verified: April 2016
Last Update Submitted: April 24, 2016

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 stentProcedure

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:

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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:

Sponsors & Collaborators

Samsung Medical Center
Otherlead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

MeSH Terms

Conditions

Bile Duct NeoplasmsJaundice, Obstructive

Condition Hierarchy (Ancestors)

Biliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesJaundiceHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns 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

Enrollment

0 participants (actual enrollment reported by the registry).

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 2011

Date type not reported

This date has not been verified as actual or estimated.

NCT01321203

Outcome of Carbon Dioxide Versus Air Insufflations During Endoscopic Retrograde Cholangiopancreatography (ERCP)

Completed

NCT01688375

The Effect of Ursodeoxycholic Acid in Liver Functional Restoration of Patients With Obstructive Jaundice

Phase 2Unknown

NCT03510754

Endoscopic Ultrasound-guided Biliary Drainage for Malignant Biliary Obstruction After Failed ERCP

Completed

NCT05246176

Ultrasonography as a Single Tool for Guided Percutaneous Transhepatic Biliary Drainage in Obstructive Jaundice

Not ApplicableUnknown

NCT02477228

Biliary Cannulation During Endoscopic Retrograde Cholangiopancreatography: Precut Versus Conventional Cannulation

Not ApplicableCompleted

NCT03491254

Investigating the Efficacy and Safety of the Combination Treatment of Huaier Granule and Biliary Drainage for MOJ

Unknown

BONASTENT M-Hilar, Standard Sci Tech Inc, Seoul, South Korea

Y-stent

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Contact the study team to confirm eligibility.

Primary Completion

August 2013

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

August 2013

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

April 26, 2016

Record last verified: 2016-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01622803
Data provider: ClinicalTrials.gov
Source updated: 2016-04-26
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:15 UTC

Locations

KR(1)

Study Stopped

Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

parallel stent

Y-stent

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

parallel stent

Y-stent

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations