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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Liver Cirrhosis

Treatments: Procedure: Endoscopic Variceal Obturation; Procedure: Balloon occluded/plug assisted retrograde transvenous obliteration.

Study type: Interventional

Funder types: Other

Identifiers

NCT05677230

ILBS-Cirrhosis-52

Details and patient eligibility

About

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

Enrollment: 56 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Balloon Occluded/plug assisted Retrograde Transvenous Obliteration.

Experimental group

Description:

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

Treatment:

Procedure: Balloon occluded/plug assisted retrograde transvenous obliteration.

Endoscopic Variceal Obturation

Active Comparator group

Description:

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

Treatment:

Procedure: Endoscopic Variceal Obturation