"To Study the Impact of Balloon-occluded Retrograde Transvenous Obliteration (BRTO)/Plug Assisted Retrograde Transvenous Obliteration (PARTO) Mediated Portal Flow Modulation in Reduction of Ammonia and Improvement in Organ Volume and Functionality in Patients of Cirrhosis With LR Shunt

Institute of Liver and Biliary Sciences, India

Status: Unknown

Conditions: Liver Cirrhoses

Treatments: Procedure: Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration; Other: Standard Medical Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04089878

ILBS-Cirrhosis-25

Details and patient eligibility

About

The informed consent will be obtained from the participants in the study. The study will be conducted on indoor patients, Department of Hepatology ILBS, New Delhi. This will be a Pilot study (sample size 25 cases in each arm) with 50% chances of each patient to randomized into each arm(1:1 randomization) .

Study Population - Patients with hepatic encephalopathy with LR shunt admitted in wards/HDU (High Dependency Unit)/LC ICU(Liver Coma ICU).

Study design-Randomized controlled Trial

Study period- 1 year.

Sample Size-Single Centre prospective RCT

• Sample size- Pilot study (sample size 25 cases in each arm)
• Follow up duration-6 months

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Child A and B cirrhotic patients with Gastro/lieno-renal shunt of >8 mm.
• Covert or Overt HE
• Age 18 to 70 years

Exclusion criteria

• Intractable ascites
• PVT (with 100 % block )or PV Cavernoma and splenic vein thrombosis
• High risk esophageal varices (till eradicated)
• HVPG >16 mm Hg
• HCC
• Pregnancy and lactation
• Refusal to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

PARTO/BRTO + SMT

Experimental group

Description:

PARTO/BRTO with SMT will be given.

Treatment:

Procedure: Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration

Standard Medical Treatment

Active Comparator group

Description:

Antibiotics, nutrition and supportive treatment

Treatment:

Other: Standard Medical Treatment