Result of Balloon Occluded Retrograde Transvenous Obliteration (Medical Device) on Organ Functions in Hyperammonemic Cirrhotics With Shunt(Liver Disease)

Not Applicable

Completed

• Conditions: Health Condition 1: null- CirrhosisHealth Condition 2: K746- Other and unspecified cirrhosis ofliver

• Registration Number: CTRI/2018/02/011891
• Lead Sponsor: Institute of Liver and Biliary Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-12-25
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Informed consent to participate in the study Age 18 to 70 years Cirrhotic patients with large shunts ( >10mm) and hyperammonemia(arterial ammonia >1.5 x N)

Exclusion Criteria

Intractable ascites Hepatocellular Carcinoma Portal Vein Thrombosis or splenic vein thrombosis High risk esophageal varices Pregnant and lactation Significant heart or respiratory failure Active gastrointestinal bleeding Refusal to participate in study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase in liver volume by CT VolumetryTimepoint: 3 Months

Secondary Outcome Measures

Name	Time	Method
Improvement in Force Expiratory Volume (FEV) in both groupsTimepoint: 3 Months;Improvement in T Score in both groupsTimepoint: 3 Months;Reduction in CTP (Child-Turcotte-Pugh) in both groupsTimepoint: 3 Months;Reduction in Fibroscan value in both groupsTimepoint: 3 Months;Reduction in Hepatic Venous Pressure Gradient in both groupsTimepoint: 3 Months;Reduction in MELD (Model for End Stage Liver Disease) in both groupsTimepoint: 3 Months;Reversal of Sarcopenia in both groupsTimepoint: 3 Months