Influence of Shunt Occlusion on Organ Functions in Hyperammonemic Patients With Cirrhosis Having Porto-systemic Shunt.

Not Applicable

Completed

• Conditions: Cirrhosis
• Interventions: Procedure: Shunt Occlusion; Dietary Supplement: Standard Medical Treatment (SMT)

• Registration Number: NCT03293459
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

The spontaneous Porto-systemic shunt is occluded by intervention procedures like Balloon Occluded Retrograde Transvenous Obliteration (BRTO), Plug-assisted Retrograde Transvenous Obliteration (PARTO) and shunt occlusion procedures resulting in diversion of blood flow towards the portal circulation and in turn the liver. According to this investigator hypothesized that shunt occlusion improves liver volume and function along with beneficial effect on other organ systems by decreasing ammonia and improving hepatopetal flow. All patients with cirrhosis having large shunt(\>10mm) and raised ammonia levels and will be randomized to receive standard medical treatment and those receiving shunt occlusion procedures. Investigator will assess organ functions and liver regenerative potential pre and post (after 3 to 15 months) procedure.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-03
• Study First Submitted: 2017-07-03
• Study First Submitted QC: 2017-09-25
• Study First Posted: 2017-09-26
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-13
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• 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: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shunt Occlusion +SMT	Shunt Occlusion	Shunt Occlusion +SMT
Shunt Occlusion +SMT	Standard Medical Treatment (SMT)	Shunt Occlusion +SMT
Standard Medical Treatment (SMT)	Standard Medical Treatment (SMT)	-

Primary Outcome Measures

Name	Time	Method
Increase in liver volume by CT Volumetry.	3 to 15 months

Secondary Outcome Measures

Name	Time	Method
Reduction in MELD (Model for End Stage Liver Disease) in both groups	3 to 15 months
Reduction in Plasma ammonia levels in both groups	3 to 15 months
Improvement in T Score	3 to 15 months

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India