Primary Prophylaxis of Gastric Variceal Bleed

NCT ID: NCT02468180

Last Updated: 2021-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2022-07-31

Brief Summary

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

Detailed Description

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Conditions

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Gastric Varices

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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BRTO

Balloon-occluded retrograde transvenous obliteration

Group Type ACTIVE_COMPARATOR

Balloon-occluded retrograde transvenous obliteration

Intervention Type PROCEDURE

Balloon-occluded retrograde transvenous obliteration

Lauromacrogol

Intervention Type DRUG

NBCA

Endoscopic cyanoacrylate injection

Group Type ACTIVE_COMPARATOR

Endoscopic cyanoacrylate injection

Intervention Type PROCEDURE

Endoscopic cyanoacrylate injection

N-butyl-2-cyanoacrylate

Intervention Type DRUG

Interventions

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Balloon-occluded retrograde transvenous obliteration

Balloon-occluded retrograde transvenous obliteration

Intervention Type PROCEDURE

Endoscopic cyanoacrylate injection

Endoscopic cyanoacrylate injection

Intervention Type PROCEDURE

N-butyl-2-cyanoacrylate

Intervention Type DRUG

Lauromacrogol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Cirrhosis
2. Patients with high risk gastric varices (GOV2 or IGV1)
3. Presence of gastrorenal shunt

Exclusion Criteria

1. Acute bleed or past history of bleed from gastric varices
2. Previous treatment of gastric varices.
3. Non-cirrhotic portal hypertension
4. Contraindications to cyanoacrylate injection or BRTO
5. Portal cavernoma
6. Hepatorenal syndrome
7. Proven malignancy including hepatocellular carcinoma
8. End-stage renal disease under renal replacement therapy;
9. Cardiorespiratory failure
10. Pregnancy or patients not giving informed consent for endoscopic procedures
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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luo xuefeng

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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West China Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xufeng Luo, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Xuefeng Luo, MD

Role: primary

Other Identifiers

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BRTO-NBCA-PP

Identifier Type: -

Identifier Source: org_study_id