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

Sponsor

Institute of Liver and Biliary Sciences, India (Other)

Overall Status

Completed

CT.gov ID

NCT03293459

Collaborator

(none)

Enrollment

Location

Arms

24.9

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis	Procedure: Shunt Occlusion Dietary Supplement: Standard Medical Treatment (SMT)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 3, 2017

Actual Primary Completion Date :

Jul 31, 2019

Actual Study Completion Date :

Jul 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Shunt Occlusion +SMT Shunt Occlusion +SMT	Procedure: Shunt Occlusion 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. Dietary Supplement: Standard Medical Treatment (SMT) These will include diet rich in BCAA (branch chain amino acids), laxatives and rifaximin
Active Comparator: Standard Medical Treatment (SMT)	Dietary Supplement: Standard Medical Treatment (SMT) These will include diet rich in BCAA (branch chain amino acids), laxatives and rifaximin

Arm

Intervention/Treatment

Experimental: Shunt Occlusion +SMT

Shunt Occlusion +SMT

Procedure: Shunt Occlusion

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.

Dietary Supplement: Standard Medical Treatment (SMT)

These will include diet rich in BCAA (branch chain amino acids), laxatives and rifaximin

Active Comparator: Standard Medical Treatment (SMT)

Dietary Supplement: Standard Medical Treatment (SMT)

These will include diet rich in BCAA (branch chain amino acids), laxatives and rifaximin

Outcome Measures

Primary Outcome Measures

Increase in liver volume by CT Volumetry. [3 to 15 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Liver and Biliary Sciences	New Delhi	Delhi	India	110070

Sponsors and Collaborators

Institute of Liver and Biliary Sciences, India

Investigators

Study Director: Dr Amar Mukund, MD, Institute of Liver & Biliary Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institute of Liver and Biliary Sciences, India

ClinicalTrials.gov Identifier:

NCT03293459

Other Study ID Numbers:

ILBS-Cirrhosis-13

First Posted:

Sep 26, 2017

Last Update Posted:

Nov 17, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Liver Cirrhosis

Fibrosis

Study Results

No Results Posted as of Nov 17, 2020