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Biliary Atresia clinical trials

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NCT ID: NCT06447051 Recruiting - Biliary Atresia Clinical Trials

Efficacy of New Post Kasai ILBS Protocol in Biliary Atresia.

Start date: June 6, 2024
Phase:
Study type: Observational

Biliary atresia (BA) is a neonatal progressive fibrosing cholan- giopathy and the most frequent indication for pediatric liver trans- plantation [1]. Surgical removal of biliary remnants and Roux-en-Y hepatoportoenterostomy (HPE) aims to restore biliary drainage and suppress progression to cirrhosis. Successful HPE, defined as a serum total bilirubin level <2 mg/dL at three months after surgery, occurs in ∼50% of patients in the United States [2]. Young age seems to be the best predictor of response to HPE, with limited data on the efficacy of adjuvant therapies such as corticosteroids, antibiotics, and choleretic agents [3,4]. Potential modes of action of these therapies are to increase bile flow as well as exert an anti- inflammatory effect [5]. In 2007, a double-blind randomized trial in the United Kingdom identified a beneficial effect on corticosteroid therapy on reduction of bilirubin level at one month post HPE without sig- nificant change in the need for liver transplantation [6]. Since then there have been multiple trial most prominent being, Kings hospital trial [7] and START trial [8] which demonstrated reduction in bilirubin levels; however both failed to demonstrate any effect on native liver survival. However one study done by Bezerra et al [9] where they employed steroid in customised manner showed significant improvement in bile drainage in their subjects versus their historical cohort. Hence we propose to perform a prospective cohort study to assess the Efficacy of new post Kasai (steroid) ILBS protocol in Biliary Atresia.

NCT ID: NCT06260566 Not yet recruiting - Biliary Atresia Clinical Trials

Tolerability of Enteral NAC in Infants

Start date: May 2024
Phase: Phase 1
Study type: Interventional

Biliary atresia (BA) is a neonatal liver disease characterized by impaired bile flow and is the most common indication for pediatric liver transplantation. BA can be treated with the Kasai portoenterostomy (KP), a procedure that attempts to restore bile flow and slow disease progression. However, success of the KP procedure is quite variable, and lack of adjuvant medical therapies following KP is a major gap in pediatric hepatology. This study begins to explore oral N-acetylcysteine (NAC) as a potential medical therapy in BA by determining whether an oral formulation can be given to infants. The primary objective is to determine tolerability of the oral NAC formulation. The primary outcome is tolerating at least 3 out of 4 total doses without emesis. The Bayesian Optimal Interval Design (BOIN) trial design will be used to determine the maximum tolerated dose of oral NAC. Our secondary objective is to assess palatability of the oral NAC formulation by comparing facial expressions when taking oral NAC versus other medications commonly given to cholestatic infants.

NCT ID: NCT06219993 Active, not recruiting - Biliary Atresia Clinical Trials

Robot-assisted Modified Kasai Portoenterostomy Versus Open Kasai Portoenterostomy for Biliary Atresia

RKPEVSOKPE
Start date: December 21, 2023
Phase:
Study type: Observational [Patient Registry]

Open Kasai portoenterostomy (OKPE) is considered the standard treatment procedure for biliary atresia (BA). Robotic-assisted Kasai portoenterostomy (RAKPE) has been utilized to treat BA. However, there were no randomized controlled trials to verify its effectiveness. The objection was to compare the efficacy of Da Vinci robot-assisted with open Kasai portoenterostomy for biliary atresia.

NCT ID: NCT06184971 Recruiting - Biliary Atresia Clinical Trials

Biliary Atresia Research Network Northeast

BARNN
Start date: May 6, 2024
Phase:
Study type: Observational

This is a multi-center retrospective chart review to compile a data repository of the management and outcomes of children with biliary atresia. Overall, investigators aim to evaluate which specific factors contribute to improved patient outcomes, to help guide potential improvements in patient care and resource utilization.

NCT ID: NCT06163417 Completed - Biliary Atresia Clinical Trials

Laparoscopic Kasai Has Similar Anesthetic Outcomes to Open Kasai

Start date: January 1, 2011
Phase:
Study type: Observational

Biliary atresia (BA) is a rare biliary tree disease with a high incidence in eastern Asia. Kasai operation is a standard treatment for BA, and studies have shown that timely Kasai operation is crucial for better outcomes. The Kasai operation can be performed as either an open or laparoscopic technique. This study aimed to compare the differences in anesthetic management between the two surgical groups. Herein, we compared the outcomes of infants with BA who underwent the open and laparoscopic Kasai surgery.

NCT ID: NCT06121375 Not yet recruiting - Biliary Atresia Clinical Trials

Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Obeticholic Acid (OCA) Compared to Placebo in Pediatric Participants With Biliary Atresia, Post-hepatoportoenterostomy

Start date: March 2024
Phase: Phase 2/Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety and tolerability, as well as PK/PD of OCA in eligible pediatric participants with biliary atresia with successful hepatoportoenterostomy (HPE, also known as a Kasai portoenterostomy). The double-blind period comprises of 2 phases: dose titration phase and age expansion treatment phase.

NCT ID: NCT06017102 Recruiting - Esophageal Varices Clinical Trials

Wired Magnetically Assisted Capsule Endoscopy and Esophageal Varices

Start date: September 5, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the safeness and effectiveness of traditional esophagogastroduodenoscope (EGD) and wired magnetically assisted capsule endoscopy (MACE) in the diagnosis of esophageal varices in biliary atresia (BA) patients. The main questions it aims to answer are: - Subjects who do wired magnetically assisted capsule endoscopy do not need to open the mouths during the process, this study also want to know whether wired magnetically assisted capsule endoscopy can reduce the generation of droplets. - Diagnostic accuracy between traditional esophagogastroduodenoscope and wired magnetically assisted capsule endoscopy in biliary atresia patients with esophageal varices. Participants will do either traditional esophagogastroduodenoscope or wired magnetically assisted capsule endoscopy.

NCT ID: NCT05925543 Completed - Biliary Atresia Clinical Trials

Outcome of Kasai Portoenterostomy in Biliary Atresia in Upper Egypt

Start date: January 1, 2019
Phase:
Study type: Observational

Kasai portoenterostomy is the key standard operation for biliary atresia. The aim of the study is to evaluate the short-term outcome of Kasai portoenterostomy for biliary atresia infants in Upper Egypt.

NCT ID: NCT05925309 Recruiting - Biliary Atresia Clinical Trials

Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy

Start date: July 1, 2023
Phase: N/A
Study type: Interventional

This study is non-inferiority trial design. This study aimed to investigate the effect of prophylactic oral antibiotics on preventing cholangitis in biliary atresia (BA) patients after Kasai portoenterostomy (KP) by comparing the cholangitis rate in BA patients who received prophylactic oral antibiotics and those who did not. The patients were followed up for 2 years after KP.

NCT ID: NCT05917236 Completed - Clinical trials for BA - Biliary Atresia

Biliary Atresia With Rare Associations, a Case Report

BA
Start date: September 1, 2021
Phase:
Study type: Observational [Patient Registry]

Background: It is not often written in medical journals that preduodenal portal vein, biliary atresia, intestinal malrotation, and situs inversus totalis are all related. Case reports: A two-month-old female infant had biliary atresia type III, situs inversus totalis, midgut malrotation, and preduodenal portal vein. She had been operated on by the Kasai procedure (hepato-portoenterostomy). Discussion: It is important to carefully look into the relationship between preduodenal portal vein and biliary atresia because the patient at a risk of injury from this aberrant vein at operative intervention.