NCT03293459

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

July 3, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 26, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

2.1 years

First QC Date

July 3, 2017

Last Update Submit

November 13, 2020

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Increase in liver volume by CT Volumetry.

    3 to 15 months

Secondary Outcomes (3)

  • 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

Study Arms (2)

Shunt Occlusion +SMT

EXPERIMENTAL

Shunt Occlusion +SMT

Procedure: Shunt OcclusionDietary Supplement: Standard Medical Treatment (SMT)

Standard Medical Treatment (SMT)

ACTIVE COMPARATOR
Dietary Supplement: Standard Medical Treatment (SMT)

Interventions

Shunt OcclusionPROCEDURE

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.

Shunt Occlusion +SMT
Standard Medical Treatment (SMT)DIETARY_SUPPLEMENT

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

Shunt Occlusion +SMTStandard Medical Treatment (SMT)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Related Publications (1)

  • 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.

    PMID: 36094625DERIVED

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dr Amar Mukund, MD

    Institute of Liver & Biliary Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2017

First Posted

September 26, 2017

Study Start

July 3, 2017

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

November 17, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)