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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Cirrhosis

Treatments: Procedure: Shunt Occlusion; Dietary Supplement: Standard Medical Treatment (SMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03293459

ILBS-Cirrhosis-13

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Shunt Occlusion +SMT

Experimental group

Description:

Shunt Occlusion +SMT

Treatment:

Dietary Supplement: Standard Medical Treatment (SMT)

Procedure: Shunt Occlusion

Standard Medical Treatment (SMT)

Active Comparator group

Treatment:

Dietary Supplement: Standard Medical Treatment (SMT)