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

Study Overview
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Brief Summary
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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.

Official Title
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Influence of Shunt Occlusion on Organ Functions in Hyperammonemic Patients With Cirrhosis Having Porto-systemic Shunt. A Randomized Controlled Trial.

Conditions
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Cirrhosis

Intervention / Treatment
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* Procedure: Shunt Occlusion
* Dietary Supplement: Standard Medical Treatment (SMT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shunt Occlusion +SMT<br>Shunt Occlusion +SMT | Procedure: Shunt Occlusion<br>* Catheterization of the Porto-systemic shunt (via the left renal vein for gastro-lienorenal shunt) will be accomplished using a catheter and occlusion will be performed with balloon catheter/vascular plug. Occlusion venography is then performed to define the type of varix/varices and the anatomy of the venous drainage followed by infusion of sclerosant. The occluded balloon were inflated and remained in place for a maximum of 24 hours deflated under fluoroscopy the next day/plug is deployed and sclerosant is injected to obliterate the shunt and follow up CT is done to look for completion on the next day. Follow up CT abdomen is done periodically to look for effect on shunt and organ.<br>Dietary Supplement: Standard Medical Treatment (SMT)<br>* These will include diet rich in BCAA (branch chain amino acids), laxatives and rifaximin<br>|
| Active Comparator: Standard Medical Treatment (SMT)<br> | Dietary Supplement: Standard Medical Treatment (SMT)<br>* These will include diet rich in BCAA (branch chain amino acids), laxatives and rifaximin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in liver volume by CT Volumetry. |  | 3 to 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in MELD (Model for End Stage Liver Disease) in both groups |  | 3 to 15 months | 
| Improvement in T Score |  | 3 to 15 months | 
| Reduction in Plasma ammonia levels in both groups |  | 3 to 15 months |