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

Liver Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05677230
• Other study ID #: ILBS-Cirrhosis-52
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Tushar Madke, MD
• Phone: 01146300000
• Email: drtusharmadke[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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: 60 This is a pilot RCT, and we decided to enroll 30 patients in each arm.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Liver Cirrhosis

Intervention

Procedure:
• 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 Glue Therapy will be done till obturation every 3 weekly.

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patient having bleeding from GV at 12 months		6 months
Secondary	Proportion of patients achieving complete or partial obturation of GV		6 months
Secondary	Proportion of patients having change in grade of EV and bleeding from EV		6 months
Secondary	Proportion of patients having appearance or worsening of PHG		6 months
Secondary	Change in HVPG in those patients who bleed after BRTO/PRTO		6 months
Secondary	Change in HVPG in those patients who bleed after EVO		6 months
Secondary	Change in liver (in KPa) and splenic stiffness (in KPa) after BRTO/PRTO using transient elastography		6 months
Secondary	Change in liver (in KPa) and splenic stiffness (in KPa) after using transient elastography		6 months
Secondary	Proportion of patients having new onset decompensation with ascites, jaundice or hepatic encephalopathy		6 months
Secondary	Proportion of patient developing post procedure liver failure		6 months
Secondary	Proportion of patient developing post acute kidney injury or sepsis		6 months
Secondary	Duration of hospital stay poof procedure		12 months