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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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12 June 2017 |
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Main ID: |
ChiCTR-IPR-16008609 |
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Date of registration:
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2016-06-07 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Therapeutic effect of prophylactic intravenous antibiotics after Kasai procedure in biliary atresia
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Scientific title:
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A clinical randomized controlled study to investigate the preventive effect of prophylactic intravenous antibiotics against cholangitis after Kasai procedure in biliary atresia |
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Date of first enrolment:
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2016-07-01 |
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Target sample size:
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Short-term Group:86;Long-term Group:86; |
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Recruitment status: |
Completed |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=14568 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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Post-market
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Countries of recruitment
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China
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Contacts
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Name:
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Shan Zheng
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Address:
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399 Wanyuan Road, Shanghai, China
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Telephone:
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+86 15900898826 |
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Email:
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szheng@shmu.edu.cn |
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Affiliation:
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Children's Hospital of Fudan University |
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Name:
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Jia Liu
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Address:
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399 Wanyuan Road, Shanghai, China
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Telephone:
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+86 18801970501 |
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Email:
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357590782@qq.com |
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Affiliation:
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Children's Hospital of Fudan University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Perform Kasai portoenterostomy for Type 3 Biliary Atresia in Children's Hospital of Fudan University;
2. Post-conception age older than 36 weeks, both genders;
3. No history of drug allergies to the medications used during the trial;
4. No preoperation use of antibiotics or probiotics;
5. Written informed consent to participate in the clinical trial obtained prior to completion of Kasai procedure.
Exclusion criteria: 1. Kasai portoenterostomy performed in other institutions;
2. Known allergy to the medication used during the trial or other adjuvant therapies;
3. Preoperation use of antibiotics or probiotics;
4. With other severe concurrent illnesses that will interfere with the conduct and results of the study.
Age minimum:
0
Age maximum:
1
Gender:
Both
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Health Condition(s) or Problem(s) studied
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biliary atresia
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Intervention(s)
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Short-term Group:Cefoperazone 5 days;Long-term Group:Cefoperazone 14 days;
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Primary Outcome(s)
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Percentage of cholangitis at 6 months after Kasai procedure;
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Secondary Outcome(s)
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The first occurrence, frequency and duration of cholangitis;Survival with native liver at 6 months after Kasai procedure;Serum total bilirubin concentration and liver function prior and at 1 month, 3 months, 6 months after Kasai procedure;Percentage of cholangitis at 3 months after Kasai procedure;Percentage of jaundice clearance (serum total bilirubin less than 20 umol/L) at 3 months, 6 months after Kasai procedure;Percentage of adverse events at 1, 3, 6 months after Kasai procedure;
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Source(s) of Monetary Support
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self-supported
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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