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

NCT05677230 | Completed

• 1 other identifier: ILBS-Cirrhosis-52
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Proportion of patient having bleeding from GV at 12 months

  6 months

Secondary Outcomes (13)

• Proportion of patients achieving complete or partial obturation of GV

  6 months

• Proportion of patients having change in grade of EV and bleeding from EV

  6 months

• Proportion of patients having appearance or worsening of PHG

  6 months

• Change in HVPG in those patients who bleed after BRTO/PRTO

  6 months

• Change in HVPG in those patients who bleed after EVO

  6 months

Study Arms (2)

Balloon Occluded/plug assisted Retrograde Transvenous Obliteration.

EXPERIMENTAL

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

Procedure: Balloon occluded/plug assisted retrograde transvenous obliteration.

Endoscopic Variceal Obturation

ACTIVE COMPARATOR

endoscopic variceal glue therapy will be done till obturation every 3 weekly.

Procedure: Endoscopic Variceal Obturation

Interventions

Balloon occluded/plug assisted retrograde transvenous obliteration. PROCEDURE

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

Balloon Occluded/plug assisted Retrograde Transvenous Obliteration.

Endoscopic Variceal Obturation PROCEDURE

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

Endoscopic Variceal Obturation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

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

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 10, 2023
• Study Start: January 1, 2023
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: May 1, 2025

Record last verified: 2024-08

Locations

IN (1)