Comparison Between Two Methods of Bilateral Stenting for... | NCT01622803

Studies
Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction

NCT01622803

Sponsor

Samsung Medical Center

Status

Withdrawn

Last Update Posted

Apr 26, 2016Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Bile Duct Neoplasm
Obstructive Jaundice

Interventions

parallel stent
Y-stent (BONASTENT M-Hilar)

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Patients enrollment problem

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Aug 2013Estimated

Completion Date

Aug 2013Estimated

First Submitted Date

Jun 12, 2012

First Submission Date that Met QC Criteria

Jun 18, 2012

First Posted Date

Jun 19, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2016

Last Update Posted Date

Apr 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
parallel stent	Procedure	bilateral parallel stent insertion (right and left side)	parallel stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The time taken to insert bilateral stent		After the ERCP procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kwang hyuck Lee, MD, phD	Division of Gastroenterology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul		135-710	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001650	Bile Duct Neoplasms
D041781	Jaundice, Obstructive

Ancestor Terms

ID	Term
D001661	Biliary Tract Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided