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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05677230

Enrollment

Registered

2023-01-10

Start date

2023-01-01

Completion date

2024-12-09

Last updated

2025-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis

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

Interventions

PROCEDUREBalloon occluded/plug assisted retrograde transvenous obliteration.

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

PROCEDUREEndoscopic Variceal Obturation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Proportion of patient having bleeding from GV at 12 months	6 months

Secondary

Measure	Time frame
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 achieving complete or partial obturation of GV	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
Proportion of patients having new onset decompensation with ascites, jaundice or hepatic encephalopathy	6 months

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026