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

Influence of Balloon Occluded Retrograde Transvenous Obliteration on Organ Functions in Hyperammonemic Cirrhotics With Shunt

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/02/011891
Enrollment
40
Registered
2018-02-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Cirrhosis Health Condition 2: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: Balloon Retrograde Transvenous Obliteration (BRTO): Catheterization of the gastrorenal shunt via the left renal vein will be accomplished using a catheter with a mounted occlusion ballo

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Increase in liver volume by CT VolumetryTimepoint: 3 Months—

Secondary

MeasureTime frame
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—

Countries

India

Contacts

Public ContactDr Shakti Choudhary

Institute of Liver and Biliary Sciences

shivsarin@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026