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, India56 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Liver Cirrhosis

Interventions

Balloon occluded/plug assisted retrograde transvenous obliteration.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Proportion of patient having bleeding from GV at 12 months

Time frame: 6 months

Secondary Outcomes

Proportion of patients achieving complete or partial obturation of GV

Time frame: 6 months

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

Time frame: 6 months

Proportion of patients having appearance or worsening of PHG

Time frame: 6 months

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

Time frame: 6 months

Change in HVPG in those patients who bleed after EVO

Time frame: 6 months

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

Time frame: 6 months

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

Time frame: 6 months

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

Time frame: 6 months

Proportion of patient developing post procedure liver failure

Time frame: 6 months

Proportion of patient developing post acute kidney injury or sepsis

Time frame: 6 months

Duration of hospital stay poof procedure

Time frame: 12 months

Evaluation of expertise of endoscopists

Time frame: 12 months

Any variceal bleed

Time frame: 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes