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

NCT ID: NCT03293459

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-03

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Shunt Occlusion +SMT

Shunt Occlusion +SMT

Group Type EXPERIMENTAL

Shunt Occlusion

Intervention Type PROCEDURE

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.

Standard Medical Treatment (SMT)

Intervention Type DIETARY_SUPPLEMENT

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

Standard Medical Treatment (SMT)

Group Type ACTIVE_COMPARATOR

Standard Medical Treatment (SMT)

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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.

Intervention Type PROCEDURE

Standard Medical Treatment (SMT)

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Amar Mukund, MD

Role: STUDY_DIRECTOR

Institute of Liver & Biliary Sciences

Locations

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Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

References

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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.

Reference Type DERIVED
PMID: 36094625 (View on PubMed)

Other Identifiers

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ILBS-Cirrhosis-13

Identifier Type: -

Identifier Source: org_study_id