Acute Gastric Variceal Bleeding: Endoscopic Treatment Ver... | NCT02468167

Studies
Acute Gastric Variceal Bleeding: Endoscopic Treatment Versus BRTO

NCT02468167

Sponsor

West China Hospital

Status

Unknown status

Last Update Posted

Jan 8, 2019Actual

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Gastric Varices

Interventions

Balloon-occluded retrograde transvenous obliteration
Endoscopic cyanoacrylate injection
N-butyl-2-cyanoacrylate
Lauromacrogol

Countries

China

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

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015Actual

Primary Completion Date

Jul 2020Estimated

Completion Date

Jul 2020Estimated

First Submitted Date

Jun 3, 2015

First Submission Date that Met QC Criteria

Jun 5, 2015

First Posted Date

Jun 10, 2015Estimated

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

Jan 7, 2019

Last Update Posted Date

Jan 8, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration in the management of acute gastric bleeding.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BRTO	Active Comparator	Balloon-occluded retrograde transvenous obliteration	Procedure: Balloon-occluded retrograde transvenous obliteration Drug: Lauromacrogol
NBCA	Active Comparator	Endoscopic cyanoacrylate injection	Procedure: Endoscopic cyanoacrylate injection Drug: N-butyl-2-cyanoacrylate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Balloon-occluded retrograde transvenous obliteration	Procedure	Balloon-occluded retrograde transvenous obliteration	BRTO

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of participants with failure to control acute bleeding or failure to prevent clinically significant variceal rebleeding within 1 year after enrollment		1 year

Secondary Outcomes

Measure	Description	Time Frame
Mortality rate		3 years
Eradication rate of gastric varices		3 years
Number of participants with increase or decrease in the size of gastric varices

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cirrhosis
Active bleeding from gastric varices (GOV2 or IGV1)
Presence of gastrorenal shunt

Exclusion Criteria:

Previous pharmacologic therapy combined with endoscopic treatment to prevent rebleeding
Previous use of TIPS or surgical shunt
Non-cirrhotic portal hypertension
Contraindications to cyanoacrylate injection or BRTO
Portal cavernoma
Hepatorenal syndrome
Proven malignancy including hepatocellular carcinoma
End-stage renal disease under renal replacement therapy;
Cardiorespiratory failure
Pregnancy or patients not giving informed consent for endoscopic procedures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xufeng Luo, MD	Contact			luo_xuefeng@yeah.net

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
West China Hospital	Recruiting	Chengdu	Sichuan	610041	China

Condition Browse Module

MeSH Terms

ID	Term
D004932	Esophageal and Gastric Varices

Ancestor Terms

ID	Term
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D006975	Hypertension, Portal

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004659	Enbucrilate
D000077423	Polidocanol

Ancestor Terms

ID	Term
D003487	Cyanoacrylates
D000179	Acrylates
D000144	Acids, Acyclic
D002264	Carboxylic Acids

Browse Leaves

Not provided

Browse Branches

Not provided