Influence of Shunt Occlusion on Organ Functions in Hyperammonemic Patients With Cirrhosis Having Porto-systemic Shunt.
Primary Purpose
Cirrhosis
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Shunt Occlusion
Standard Medical Treatment (SMT)
Sponsored by
About this trial
This is an interventional treatment trial for Cirrhosis
Eligibility Criteria
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
Sites / Locations
- Institute of Liver and Biliary Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Shunt Occlusion +SMT
Standard Medical Treatment (SMT)
Arm Description
Shunt Occlusion +SMT
Outcomes
Primary Outcome Measures
Increase in liver volume by CT Volumetry.
Secondary Outcome Measures
Reduction in MELD (Model for End Stage Liver Disease) in both groups
Improvement in T Score
Reduction in Plasma ammonia levels in both groups
Full Information
NCT ID
NCT03293459
First Posted
July 3, 2017
Last Updated
November 13, 2020
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT03293459
Brief Title
Influence of Shunt Occlusion on Organ Functions in Hyperammonemic Patients With Cirrhosis Having Porto-systemic Shunt.
Official Title
Influence of Shunt Occlusion on Organ Functions in Hyperammonemic Patients With Cirrhosis Having Porto-systemic Shunt. A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 3, 2017 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Shunt Occlusion +SMT
Arm Type
Experimental
Arm Description
Shunt Occlusion +SMT
Arm Title
Standard Medical Treatment (SMT)
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Shunt Occlusion
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard Medical Treatment (SMT)
Intervention Description
These will include diet rich in BCAA (branch chain amino acids), laxatives and rifaximin
Primary Outcome Measure Information:
Title
Increase in liver volume by CT Volumetry.
Time Frame
3 to 15 months
Secondary Outcome Measure Information:
Title
Reduction in MELD (Model for End Stage Liver Disease) in both groups
Time Frame
3 to 15 months
Title
Improvement in T Score
Time Frame
3 to 15 months
Title
Reduction in Plasma ammonia levels in both groups
Time Frame
3 to 15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Amar Mukund, MD
Organizational Affiliation
Institute of Liver & Biliary Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36094625
Citation
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. 2023 Feb;17(1):150-158. doi: 10.1007/s12072-022-10418-4. Epub 2022 Sep 12. Erratum In: Hepatol Int. 2022 Dec;16(6):1496-1498.
Results Reference
derived
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Influence of Shunt Occlusion on Organ Functions in Hyperammonemic Patients With Cirrhosis Having Porto-systemic Shunt.
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