NCT02468206

Brief Summary

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 rebleeding and improvement in survival.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 10, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2019

Completed
Last Updated

January 8, 2019

Status Verified

January 1, 2019

Enrollment Period

2.7 years

First QC Date

June 3, 2015

Last Update Submit

January 7, 2019

Conditions

Gastric Varices

Outcome Measures

Primary Outcomes (1)

  • Rebleeding rate from gastric varices

    3 years

Secondary Outcomes (9)

  • Eradication rate of gastric varices

    3 years

  • Number of participants with increase or decrease in the size of gastric varices

    3 years

  • Number of participants with appearance or worsening of new oesophageal varices

    3 years

  • Number of participants with appearance or worsening of portal hypertensive gastropathy

    3 years

  • Number of participants with appearance or worsening of ascites

    3 years

  • +4 more secondary outcomes

Study Arms (2)

BRTO

ACTIVE COMPARATOR

Balloon-occluded retrograde transvenous obliteration

Procedure: Balloon-occluded retrograde transvenous obliterationDrug: Lauromacrogol

NBCA

ACTIVE COMPARATOR

Endoscopic Cyanoacrylate injection in the gastric varix

Procedure: Endoscopic cyanoacrylate injectionDrug: N-butyl-2-cyanoacrylate

Interventions

Balloon-occluded retrograde transvenous obliterationPROCEDURE

Balloon-occluded retrograde transvenous obliteration

BRTO
Endoscopic cyanoacrylate injectionPROCEDURE

Endoscopic cyanoacrylate injection

NBCA
N-butyl-2-cyanoacrylateDRUG
NBCA
LauromacrogolDRUG
BRTO

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cirrhosis
  • Patients who had bled from GOV2 or IGV1（≥5 days and ≤ 28days）
  • Presence of gastrorenal shunt

You may not qualify if:

  • Previous treatment of gastric varices, including endoscopic therapy, NSBB, TIPS, or surgery
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Esophageal and Gastric Varices

Interventions

EnbucrilatePolidocanol

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHypertension, PortalLiver Diseases

Intervention Hierarchy (Ancestors)

CyanoacrylatesAcrylatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsNitrilesPolymersMacromolecular SubstancesBiomedical and Dental MaterialsTissue AdhesivesManufactured MaterialsTechnology, Industry, and AgriculturePolyethylene GlycolsEthylene GlycolsGlycolsAlcohols

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 10, 2015

Study Start

June 1, 2015

Primary Completion

February 28, 2018

Study Completion

January 7, 2019

Last Updated

January 8, 2019

Record last verified: 2019-01

Locations

CN(1)