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Completed

NCT Number: NCT03293459

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

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.

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Key information

Conditions

Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver and Biliary Sciences

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shunt Occlusion

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)

Dietary Supplement

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

Primary outcomes

  1. Increase in liver volume by CT Volumetry.

    Time frame: 3 to 15 months

Secondary outcomes

  1. Reduction in MELD (Model for End Stage Liver Disease) in both groups

    Time frame: 3 to 15 months

  2. Improvement in T Score

    Time frame: 3 to 15 months

  3. Reduction in Plasma ammonia levels in both groups

    Time frame: 3 to 15 months

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 26, 2017
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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