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Status unknownNCT02468167Updated Jan 8, 2019

Acute Gastric Variceal Bleeding: Endoscopic Treatment Versus BRTO

An interventional study of Balloon-occluded retrograde transvenous obliteration and Endoscopic cyanoacrylate injection in Gastric Varices, sponsored by West China Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-01-08.

Sponsored by West China Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gastric Varices
03

In context

Esophageal and Gastric Varices

169 studies on the registry are indexed under Esophageal and Gastric Varices; 41 are open to participants now.

This study's planned enrollment of 70 is below the median of 104 across 109 interventional studies indexed under Esophageal and Gastric Varices.

Browse Esophageal and Gastric Varices studies →

Lead sponsor

West China Hospital is the lead sponsor of 483 studies on the registry; 240 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Cirrhosis
  2. Active bleeding from gastric varices (GOV2 or IGV1)
  3. Presence of gastrorenal shunt

Exclusion criteria

Exclusion Criteria:

  1. Previous pharmacologic therapy combined with endoscopic treatment to prevent rebleeding
  2. Previous use of TIPS or surgical shunt
  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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Active comparator
    BRTO

    Balloon-occluded retrograde transvenous obliteration

    Procedure: Balloon-occluded retrograde transvenous obliteration · Drug: Lauromacrogol

  • Active comparator
    NBCA

    Endoscopic cyanoacrylate injection

    Procedure: Endoscopic cyanoacrylate injection · Drug: N-butyl-2-cyanoacrylate

Interventions

  • ProcedureBalloon-occluded retrograde transvenous obliteration

    Balloon-occluded retrograde transvenous obliteration

  • ProcedureEndoscopic cyanoacrylate injection

    Endoscopic cyanoacrylate injection

  • DrugN-butyl-2-cyanoacrylate
  • DrugLauromacrogol
06

What researchers measure

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. Mortality rate

    Time frame: 3 years

  2. Eradication rate of gastric varices

    Time frame: 3 years

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

    Time frame: 3 years

  4. Number of participants with appearance or worsening of new oesophageal varices

    Time frame: 3 years

  5. Number of participants with appearance or worsening of portal hypertensive gastropathy

    Time frame: 3 years

  6. Number of participants with appearance or worsening of ascites

    Time frame: 3 years

  7. Number of participants with complication

    Time frame: 3 years

  8. Average in-hospital stay

    Time frame: 3 years

  9. Cost of treatment

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • West China Hospital
    Chengdu, Sichuan 610041, China
    • Xuefeng Luo, MD · Contact · 862885422389
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02468167
Lead sponsor
West China Hospital
Responsible party
luo xuefeng (MD, West China Hospital) — Principal investigator
First posted
Jun 10, 2015
Start date
Jun 2015
Primary completion
Jul 2020 (estimated)
Completion
Jul 2020 (estimated)
Last update
Jan 8, 2019

Study contacts

Xufeng Luo, MD
Contact
luo_xuefeng@yeah.net

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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