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

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

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.

Study Overview

• Status: Completed
• Conditions: Cirrhosis
• Intervention / Treatment: Procedure: Shunt Occlusion; Dietary supplement: Standard Medical Treatment (SMT)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver and Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Study Director: Dr Amar Mukund, MD, Institute of Liver & Biliary Sciences

Publications and helpful links

General Publications

• Mukund A, Choudhury SP, Tripathy TP, Ananthashayana VH, Jagdish RK, Arora V, Singh SP, Mishra AK, Sarin SK. Influence of shunt occlusion on liver volume and functions in hyperammonemic cirrhosis patients having large porto-systemic shunts: a randomized control trial. Hepatol Int. 2022 Sep 12. doi: 10.1007/s12072-022-10418-4. Online ahead of print. Erratum In: Hepatol Int. 2022 Dec;16(6):1496-1498.

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2017
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: July 3, 2017
• First Submitted That Met QC Criteria: September 25, 2017
• First Posted (Actual): September 26, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 13, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: ILBS-Cirrhosis-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No