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OpenTrials
Completed

NCT Number: NCT02468206

Secondary Prophylaxis of Gastric Variceal Bleed

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.

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Key information

Conditions

Gastric Varices Digestive System Diseases Esophageal Diseases Esophageal and Gastric Varices Gastrointestinal Diseases Hypertension, Portal Liver Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

balloon-occluded retrograde transvenous obliteration

Procedure

Balloon-occluded retrograde transvenous obliteration

Endoscopic Cyanoacrylate injection

Procedure

Endoscopic cyanoacrylate injection

N-butyl-2-cyanoacrylate

Drug

Lauromacrogol

Drug

Primary outcomes

  1. Rebleeding rate from gastric varices

    Time frame: 3 years

Secondary outcomes

  1. Eradication rate of gastric varices

    Time frame: 3 years

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

    Time frame: 3 years

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

    Time frame: 3 years

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

    Time frame: 3 years

  5. Number of participants with appearance or worsening of ascites

    Time frame: 3 years

  6. Number of participants with complication

    Time frame: 3 years

  7. Average in-hospital stay

    Time frame: 3 years

  8. Cost of treatment

    Time frame: 3 years

  9. Mortality rate

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

Endoscopic Cyanoacrylate Injection vs. Balloon-occluded Retrograde Transvenous Obliteration in the Prevention of Gastric Variceal Rebleeding

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jun 10, 2015
Registry last updated
Jan 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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