To Study the Impact of Balloon-occluded Retrograde Transvenous Obliteration (BRTO)/Plug Assisted Retrograde Transvenous Obliteration (PARTO) Mediated Portal Flow Modulation in Reduction of Ammonia and Improvement in Organ Volume and Functionality in Patients of Cirrhosis With LR Shunt

Study Overview
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Brief Summary
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The informed consent will be obtained from the participants in the study. The study will be conducted on indoor patients, Department of Hepatology ILBS, New Delhi. This will be a Pilot study (sample size 25 cases in each arm) with 50% chances of each patient to randomized into each arm(1:1 randomization) . Study Population - Patients with hepatic encephalopathy with LR shunt admitted in wards/HDU (High Dependency Unit)/LC ICU(Liver Coma ICU). Study design-Randomized controlled Trial Study period- 1 year. Sample Size-Single Centre prospective RCT Sample size- Pilot study (sample size 25 cases in each arm) Follow up duration-6 months

Official Title
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To Study the Impact of Balloon-occluded Retrograde Transvenous Obliteration (BRTO)/Plug Assisted Retrograde Transvenous Obliteration (PARTO) Mediated Portal Flow Modulation in Reduction of Ammonia and Improvement in Organ Volume and Functionality in Patients of Cirrhosis With LR Shunt - A Randomized Trial.ImPARTO Trial

Conditions
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Liver Cirrhoses

Intervention / Treatment
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* Procedure: Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration
* Other: Standard Medical Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child A and B cirrhotic patients with Gastro/lieno-renal shunt of >8 mm. Covert or Overt HE Age 18 to 70 years Exclusion Criteria: Intractable ascites PVT (with 100 % block )or PV Cavernoma and splenic vein thrombosis High risk esophageal varices (till eradicated) HVPG >16 mm Hg HCC Pregnancy and lactation Refusal to participate in the 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: PARTO/BRTO + SMT<br>PARTO/BRTO with SMT will be given. | Procedure: Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration<br>* Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration<br>|
| Active Comparator: Standard Medical Treatment<br>Antibiotics, nutrition and supportive treatment | Other: Standard Medical Treatment<br>* Antibiotics, nutrition and supportive treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in covertHepatic Encephalopathy in both groups. | Covert HE or overt HE will be analysed using clinical examination(west haven grading), specialised tests like stroop test, CFF(critical flicker frequency) or in rare cases EEG can be done. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ammonia level in both groups |  | 1 year | 
| Incidence of ascites in both groups | Acute variceal bleed (AVB) - will be estimated by history of hematemesis, melena, and AVB will be confirm by endoscopy if these clinical history present. It can be oesophageal variceal or gastric variceal bleed as per sarin's classification, which is confirmed and managed with endoscopy procedure. AVB is defined as a bleed in a known or suspected case of PHT, with the presence of hematemesis within 24 h of presentation, and/or ongoing melena, with last melanic stool within last 24 h. The time frame for the AVB episode is 48 h. AVB is further classified as active or inactive at the time of endoscopy. BRTO/PARTO is technically feasible, safe, and effective for gastric variceal haemorrhage in patients with portal hypertension. | 1 year | 
| Incidence of acute variceal bleed in both groups. | Acute variceal bleed (AVB) - will be estimated by history of hematemesis, melena, and AVB will be confirm by endoscopy if these clinical history present. It can be oesophageal variceal or gastric variceal bleed as per sarin's classification, which is confirmed and managed with endoscopy procedure. AVB is defined as a bleed in a known or suspected case of PHT, with the presence of hematemesis within 24 h of presentation, and/or ongoing melena, with last melanic stool within last 24 h. The time frame for the AVB episode is 48 h. AVB is further classified as active or inactive at the time of endoscopy. BRTO/PARTO is technically feasible, safe, and effective for gastric variceal haemorrhage in patients with portal hypertension. | 1 year | 
| Number of participants with Liver transplant or death in both groups. |  | 1 year | 
| Change in MELD (Model for End Stage Liver Disease) by >5 point improvement in both groups. | MELD: A disease severity scoring system for adults with liver disease, designed to improve the organ allocation in transplantation based on the severity of liver disease rather than the length of time on the waiting list.A MELD score is a number that ranges from 6 to 40, based on lab tests. | 6 months | 
| Change in CTP (Child-Pugh score) by 2 points improvement in both groups. | CTP- Child-Turcotte-Pugh score is ranges from 5 to 15, lowest is best and highest is worst . | 6 months | 
| Changes in portal flow in both groups. | Change will be measured by ICG and Doppler study tests. | 1 year | 
| Number of patients with prevention of Gastro-Variceal bleed in both groups. | It is a clinical outcome and it will be assessed by history and will be confirmed and managed by endoscopic procedure. | 1 year | 
| Number of patients with adverse effects of PARTO/BRTO (Balloon-occluded retrograde transvenous obliteration) in both groups. |  | 1 year |