Clinical trial NCT05677230: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patient having bleeding from GV at 12 months
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of patients achieving complete or partial obturation of GV
timeFrame: 6 months
measure: Proportion of patients having change in grade of EV and bleeding from EV
timeFrame: 6 months
measure: Proportion of patients having appearance or worsening of PHG
timeFrame: 6 months
measure: Change in HVPG in those patients who bleed after BRTO/PRTO
timeFrame: 6 months
measure: Change in HVPG in those patients who bleed after EVO
timeFrame: 6 months
measure: Change in liver (in KPa) and splenic stiffness (in KPa) after BRTO/PRTO using transient elastography
timeFrame: 6 months
measure: Change in liver (in KPa) and splenic stiffness (in KPa) after using transient elastography
timeFrame: 6 months
measure: Proportion of patients having new onset decompensation with ascites, jaundice or hepatic encephalopathy
timeFrame: 6 months
measure: Proportion of patient developing post procedure liver failure
timeFrame: 6 months
measure: Proportion of patient developing post acute kidney injury or sepsis
timeFrame: 6 months
measure: Duration of hospital stay poof procedure
timeFrame: 12 months
measure: Evaluation of expertise of endoscopists
timeFrame: 12 months
measure: Any variceal bleed
timeFrame: 12 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References: