Liver Cirrhoses
Conditions
Brief summary
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
Interventions
PROCEDUREPlug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration
Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration
OTHERStandard Medical Treatment
Antibiotics, nutrition and supportive treatment
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in covertHepatic Encephalopathy in both groups. | 1 year | Covert HE or overt HE will be analysed using clinical examination(west haven grading), specialised tests like stroop test, CFF(critical flicker frequency) or in rare cases EEG can be done. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ascites in both groups | 1 year | Acute variceal bleed (AVB) - will be estimated by history of hematemesis, melena, and AVB will be confirm by endoscopy if these clinical history present. It can be oesophageal variceal or gastric variceal bleed as per sarin's classification, which is confirmed and managed with endoscopy procedure. AVB is defined as a bleed in a known or suspected case of PHT, with the presence of hematemesis within 24 h of presentation, and/or ongoing melena, with last melanic stool within last 24 h. The time frame for the AVB episode is 48 h. AVB is further classified as active or inactive at the time of endoscopy. BRTO/PARTO is technically feasible, safe, and effective for gastric variceal haemorrhage in patients with portal hypertension. |
| Incidence of acute variceal bleed in both groups. | 1 year | Acute variceal bleed (AVB) - will be estimated by history of hematemesis, melena, and AVB will be confirm by endoscopy if these clinical history present. It can be oesophageal variceal or gastric variceal bleed as per sarin's classification, which is confirmed and managed with endoscopy procedure. AVB is defined as a bleed in a known or suspected case of PHT, with the presence of hematemesis within 24 h of presentation, and/or ongoing melena, with last melanic stool within last 24 h. The time frame for the AVB episode is 48 h. AVB is further classified as active or inactive at the time of endoscopy. BRTO/PARTO is technically feasible, safe, and effective for gastric variceal haemorrhage in patients with portal hypertension. |
| Number of participants with Liver transplant or death in both groups. | 1 year | — |
| Change in MELD (Model for End Stage Liver Disease) by >5 point improvement in both groups. | 6 months | MELD: A disease severity scoring system for adults with liver disease, designed to improve the organ allocation in transplantation based on the severity of liver disease rather than the length of time on the waiting list.A MELD score is a number that ranges from 6 to 40, based on lab tests. |
| Change in ammonia level in both groups | 1 year | — |
| Changes in portal flow in both groups. | 1 year | Change will be measured by ICG and Doppler study tests. |
| Number of patients with prevention of Gastro-Variceal bleed in both groups. | 1 year | It is a clinical outcome and it will be assessed by history and will be confirmed and managed by endoscopic procedure. |
| Number of patients with adverse effects of PARTO/BRTO (Balloon-occluded retrograde transvenous obliteration) in both groups. | 1 year | — |
| Change in CTP (Child-Pugh score) by 2 points improvement in both groups. | 6 months | CTP- Child-Turcotte-Pugh score is ranges from 5 to 15, lowest is best and highest is worst . |
Countries
India
Contacts
Primary ContactDr Shiv Kumar Sarin, DM
Outcome results
None listed