Ignite Creation Date:
2024-05-06 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05925309
Status:
RECRUITING
Last Update Posted:
2023-12-07
First Post:
2023-06-14
Brief Title:
Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy
Sponsor:
Childrens Hospital of Fudan University
Organization:
Childrens Hospital of Fudan University
Study Overview
Official Title:
Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy in Biliary Atresia a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Biliary atresia BA is a devastating inflammatory obstructive neonatal disease affecting intrahepatic and extrahepatic bile ducts Kasai portoenterostomy KP is the mainstay of treatment for BA Cholangitis is a common complication after KP with an overall incidence of 22-93 and an incidence of 30-70 within 6 months after KP The mechanism of cholangitis may be intestinal bacteria ascending into the intrahepatic biliary system or bacterial colonization etc Common causative organisms include Klebsiella Escherichia coli Pseudomonas aeruginosa Enterobacter cloacae Acinetobacter baumannii Streptococcus and Salmonella typhi There is some controversy about prophylactic antibiotics after KP and the type dosage and course of antibiotics in medical institutions around the world vary greatly After years of improvement although the postoperative management and short-term prognosis of BA have improved the overall incidence of cholangitis has not changed much High-quality evidence for antibiotic prophylaxis after KP remains lacking It still remains unknown that whether long-term prophylactic oral antibiotics could benefit the patients Long-term use of antibiotics may not only increase the burden of liver dysfunction in patients but also lead to antibiotic resistance intestinal flora disturbance and increase the risk of allergies and autoimmune diseases It is of great significance to use evidence-based medicine to find a relatively reasonable cholangitis prevention program
This study is non-inferiority trial design This study aimed to investigate the effect of prophylactic oral antibiotics on preventing cholangitis by comparing the cholangitis rate in BA patients who received prophylactic oral antibiotics after KP and those who did not Patients diagnosed with type III BA and receiving KP at Childrens Hospital of Fudan University will be assigned to 2 groups Both groups received the same basic treatment then the patients in the antibiotics group received prophylactic oral antibiotics until the 6th month after KP while the non-antibiotics group no longer used prophylactic antibiotics until cholangitis occurred The cholangitis rate within 6 months after KP were measured to evaluate the preventive effect of prophylactic oral antibiotics on cholangitis The patients were followed up for 2 years after KP
This study is non-inferiority trial design This study aimed to investigate the effect of prophylactic oral antibiotics on preventing cholangitis by comparing the cholangitis rate in BA patients who received prophylactic oral antibiotics after KP and those who did not Patients diagnosed with type III BA and receiving KP at Childrens Hospital of Fudan University will be assigned to 2 groups Both groups received the same basic treatment then the patients in the antibiotics group received prophylactic oral antibiotics until the 6th month after KP while the non-antibiotics group no longer used prophylactic antibiotics until cholangitis occurred The cholangitis rate within 6 months after KP were measured to evaluate the preventive effect of prophylactic oral antibiotics on cholangitis The patients were followed up for 2 years after KP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None