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

Not Applicable

Completed

• Conditions: Liver Cirrhosis
• Interventions: Procedure: Balloon occluded/plug assisted retrograde transvenous obliteration.; Procedure: Endoscopic Variceal Obturation

• Registration Number: NCT05677230
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-01-03
• Study First Submitted QC: 2023-01-07
• Study First Posted: 2023-01-10
• Status Verified: 2024-08
• Primary Completion: 2024-12-09
• Study Completion: 2024-12-09
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1. Age 18-75 years
2. 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balloon Occluded/plug assisted Retrograde Transvenous Obliteration.	Balloon occluded/plug assisted retrograde transvenous obliteration.	Balloon occluded/plug assisted retrograde transvenous obliteration will be done one time only.
Endoscopic Variceal Obturation	Endoscopic Variceal Obturation	endoscopic variceal glue therapy will be done till obturation every 3 weekly.

Primary Outcome Measures

Name	Time	Method
Proportion of patient having bleeding from GV at 12 months	6 months

Secondary Outcome Measures

Name	Time	Method
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
Change in liver (in KPa) and splenic stiffness (in KPa) after BRTO/PRTO using transient elastography	6 months
Change in liver (in KPa) and splenic stiffness (in KPa) after using transient elastography	6 months
Proportion of patients having new onset decompensation with ascites, jaundice or hepatic encephalopathy	6 months
Proportion of patient developing post procedure liver failure	6 months
Proportion of patient developing post acute kidney injury or sepsis	6 months
Duration of hospital stay poof procedure	12 months
Evaluation of expertise of endoscopists	12 months
Any variceal bleed	12 months

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences; 🇮🇳 New Delhi, Delhi, India