Intervention and Efficacy Evaluation Study of Combined Modality Therapy in Patients with Biliary Atrisia after Kasai Operationru

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-TNRC-09000331
• Date of registration: 2009-02-11
• Prospective Registration: No
• Primary sponsor: The First Affiliated Hospital of Sun Yat Sen University
• Public title: Intervention and Efficacy Evaluation Study of Combined Modality Therapy in Patients with Biliary Atrisia after Kasai Operationru
• Scientific title: Intervention and Efficacy Evaluation Study of Combined Modality Therapy in Patients with Biliary Atrisia after Kasai Operationru
• Date of first enrolment: 2007-01-01
• Target sample size: group 1:50;group 2:50;group A:50;group B:50;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=9200
• Study type: Observational study
• Study design: Non randomized control
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Liu Juncheng

• Name: Liu Juncheng
• Affiliation: The Department of Pediatric Surgery-The First Affiliated Hospital of Sun Yat Sen University

Key inclusion & exclusion criteria

Inclusion criteria: 1. The patient be diagnosd as biliary atresia and has underwent Kasai procedure;
2. The bile drainage is well postoperation;
3. The age is less than 90 days;
4. Informed consents and willing to participant; signed the informed consent form accords with ethics principles.
Exclusion criteria: 1. The patient has little bile drainage postoperation;
2. Patient cannot tolerate the therapy for all reasons;
3. The patient and their family reject to participart the trial.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Biliary Atresia

Intervention(s)

group 1:Given Yinzhihuang with Ligustrazine from the day 3 after operation;group 2:Given Yinzhihuang with placebo from the day 3;group A:Divide two groups according different glucocorticoid, group A is given dexamethasone from the seventh day after operation;group B:Divide two groups according different glucocorticoid, group B is given methylprednisolone from the seventh day after operation;

Primary Outcome(s)

the color of faeces, skin of forehead and sclera;the size, hardness, edge of liver and the size of spleen; the evidence of portal hypertension;The degree of liver fibrosis;total bilirubin, direct bilirubin, the ratio of direct bilirubin to indirect bilirubin;

Source(s) of Monetary Support

self-financing