An interventional study of Shunt Occlusion and Standard Medical Treatment (SMT) in Cirrhosis, sponsored by Institute of Liver and Biliary Sciences, India. Completed at 1 site in India. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-11-17.
Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Treatment
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.
1,270 studies on the registry are indexed under Fibrosis; 276 are open to participants now.
This study's enrollment of 40 is below the median of 63 across 840 interventional studies indexed under Fibrosis.
Browse Fibrosis studies →Institute of Liver and Biliary Sciences, India is the lead sponsor of 302 studies on the registry; 87 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Shunt Occlusion +SMT
Procedure: Shunt Occlusion · Dietary Supplement: Standard Medical Treatment (SMT)
Dietary Supplement: Standard Medical Treatment (SMT)
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.
These will include diet rich in BCAA (branch chain amino acids), laxatives and rifaximin
Increase in liver volume by CT Volumetry.
Time frame: 3 to 15 months
Reduction in MELD (Model for End Stage Liver Disease) in both groups
Time frame: 3 to 15 months
Improvement in T Score
Time frame: 3 to 15 months
Reduction in Plasma ammonia levels in both groups
Time frame: 3 to 15 months
Plan to share: No
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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