Portal Hypertension, Biliary Atresia Clinical Trial
— BA-BBOfficial title:
Propanolol for Primary Prophylaxis for Variceal Bleed in Biliary Atresia - An Open Label Randomized Controlled Study
Biliary atresia is the commonest etiology of neonatal cholestasis and is the most common indication for pediatric liver transplantation world-wide. Kasai-portoenterostomy (KPE) is the operative procedure of choice which helps in restoration of biliary flow and preventing rapid progression of fibrosis. Only 50-60% of infants have a successful surgery in terms of normalization of bilirubin (<2 mg/dL) after 3 months. Remaining 40-50% have rapid progression of PHT and eventual decompensation. Additionally, around 50-70% of infants with successful KPE have 1 or more episodes of cholangitis, and the severe ones if left untreated lead to progressive portal hypertension. Moreover in Indian setting a significant number of infants with biliary atresia reach late when the KPE is not feasible, and this group develops very rapid PHT and decompensation. Hence, overall around 70-80% of infants and children develop PHT within 5 years of age. Variceal bleed has been shown to be an important determinant of survival in infants with high bilirubin. Usage of beta-blockers in adult cirrhotics has been shown to reduce the progression of varices and incidence of variceal bleed. Although many pediatric hepatology centers worldwide use beta-blockers, there has been no controlled trial specifically to address this issue in children with biliary atresia. So, we planned this study to evaluate the efficacy of beta-blockers as primary prophylaxis for prevention of variceal bleed in biliary atresia children.
| Status | Recruiting |
| Enrollment | 92 |
| Est. completion date | June 15, 2022 |
| Est. primary completion date | June 13, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Months to 5 Years |
| Eligibility | Inclusion Criteria: Infants and children with biliary atresia from 6 months to 5 years of age fulfilling either of the following conditions: i. With unsuccessful Kasai portoenterostomy procedure with a bilirubin >2 mg/dL, or ii. Who did not underwent Kasai portoenterostomy, or iii. With successful Kasai portoenterostomy procedure with a bilirubin <2 mg/dL, but with features of portal hypertension i.e. clinical splenomegaly and/or thrombocytopenia (platelets < 1,00,000/mm3). Exclusion Criteria: i. History suggestive of hyper-reactive airway disease. ii. Congestive heart failure iii. Any degree of heart block (I,, II, III) iv. Infants and children already on beta-blockers in last 4 weeks. v. Portal vein atresia or thrombosis. vi. History of variceal bleed. vii. Infants and children on prophylactic or therapeutic endotherapy (band ligation or sclerotherapy). viii. Potential liver transplant within 1 month. |
| Country | Name | City | State |
|---|---|---|---|
| India | Institute of Liver and Biliary Sciences | New Delhi | Delhi |
| Lead Sponsor | Collaborator |
|---|---|
| Institute of Liver and Biliary Sciences, India |
India,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Bleeding free survival over 18 months follow-up | 18 months | ||
| Secondary | Progression, persistence or regression of esophageal varices | 3 months | ||
| Secondary | Progression, persistence or regression of gastric varices | 3 months | ||
| Secondary | Progression, persistence or regression of portal hypertensive gastropathy | 3 months | ||
| Secondary | Progression, persistence or regression of esophageal varices | 6 months | ||
| Secondary | Progression, persistence or regression of gastric varices | 6 months | ||
| Secondary | Progression, persistence or regression of portal hypertensive gastropathy | 6 months | ||
| Secondary | Progression, persistence or regression of esophageal varices | 12 months | ||
| Secondary | Progression, persistence or regression of gastric varices | 12 months | ||
| Secondary | Progression, persistence or regression of portal hypertensive gastropathy | 12 months | ||
| Secondary | Progression, persistence or regression of esophageal varices | 18 months | ||
| Secondary | Progression, persistence or regression of gastric varices | 18 months | ||
| Secondary | Progression, persistence or regression of portal hypertensive gastropathy | 18 months | ||
| Secondary | Overall survival | 6 months | ||
| Secondary | Overall survival | 12 months | ||
| Secondary | Overall survival | 18 months |