Skip to main content
OpenTrials
Completed

NCT Number: NCT05677230

To Compare the Safety and Efficacy of Balloon Occluded/Plug Assisted Retrograde Transvenous Obliteration With Endoscopic Variceal Obturation for Primary Prophylaxis of Gastric Varices With Large Spontaneous Shunt

Study population: All the consecutive patients of cirrhosis who are diagnosed to have large gastric varices without prior history of bleeding from GV, who came to OPD or endoscopy in Hepatology department of ILBS will be evaluated for inclusion.

Study design: Prospective interventional study. The study will be conducted in the Department of Hepatology ILBS.

Study period: 1.0 years

Sample size: 42

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fibrosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-75 years
  • Cirrhotic patients, with GV (GOV2 or IGV1) with eradicated or small low risk esophageal varices with gastrorenal shunt of >10 mm size amenable for BRTO/PARTO.

Exclusion criteria

  • Non-cirrhotic portal hypertension,
  • History of bleeding from GV
  • Hepatic encephalopathy grade III/IV,
  • Acute kidney injury
  • Patients on beta blocker therapy for > 6 months prior to enrollment in study
  • Hepatocellular carcinoma
  • Portal venous thrombosis
  • Presence of jaundice (bilirubin >3 mg/dl), ascites, Child C, MELD > 18
  • Advanced cardiac or pulmonary diseases
  • Pregnancy
  • Patients not giving informed consent

Treatment and study plan

Balloon occluded/plug assisted retrograde transvenous obliteration.

Procedure

Balloon occluded/plug assisted retrograde transvenous obliteration will be done one time only.

Endoscopic Variceal Obturation

Procedure

Endoscopic Variceal Glue Therapy will be done till obturation every 3 weekly.

Primary outcomes

  1. Proportion of patient having bleeding from GV at 12 months

    Time frame: 6 months

Secondary outcomes

  1. Proportion of patients achieving complete or partial obturation of GV

    Time frame: 6 months

  2. Proportion of patients having change in grade of EV and bleeding from EV

    Time frame: 6 months

  3. Proportion of patients having appearance or worsening of PHG

    Time frame: 6 months

  4. Change in HVPG in those patients who bleed after BRTO/PRTO

    Time frame: 6 months

  5. Change in HVPG in those patients who bleed after EVO

    Time frame: 6 months

  6. Change in liver (in KPa) and splenic stiffness (in KPa) after BRTO/PRTO using transient elastography

    Time frame: 6 months

  7. Change in liver (in KPa) and splenic stiffness (in KPa) after using transient elastography

    Time frame: 6 months

  8. Proportion of patients having new onset decompensation with ascites, jaundice or hepatic encephalopathy

    Time frame: 6 months

  9. Proportion of patient developing post procedure liver failure

    Time frame: 6 months

  10. Proportion of patient developing post acute kidney injury or sepsis

    Time frame: 6 months

  11. Duration of hospital stay poof procedure

    Time frame: 12 months

  12. Evaluation of expertise of endoscopists

    Time frame: 12 months

  13. Any variceal bleed

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

To Compare the Safety and Efficacy of Balloon Occluded/Plug Assisted Retrograde Transvenous Obliteration With Endoscopic Variceal Obturation for Primary Prophylaxis of Gastric Varices With Large Spontaneous Shunt: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 10, 2023
Registry last updated
May 1, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.