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| Name | Class |
|---|---|
| Shanghai Children's Hospital | OTHER |
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Application of multi-center, prospective study on the severity of postoperative cholangitis biliary atresia classification, according to the degree of cholangitis targeted therapy, to improve the therapeutic effect of postoperative cholangitis biliary atresia, decrease the overuse of antibiotics related complications.
Cholangitis patients post-kasai Portoenterostomy were grouped by cholangitis severity score, according to the severity was divided into mild, moderate, severe cholangitis, all levels of cholangitis patients were divided into subgroups by age and post-kasai Portoenterostomy jaundice matching design of experiment, then they were randomly divided into control group and experimental group, and all the control group unified antibiotic treatment, the experimental group was graded antibiotic treatment according to the severity cholangitis, after three days treatment,evaluate each treatment effect, average hospitalization days, the average hospitalization expenses, antimicrobial drug use strength to evaluate the therapeutic effect of postoperative cholangitis biliary atresia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| moderate cholangitis | Experimental | Meropenem injection, iv. drip,20mg/Kg,Q12h; Tinidazole injection, iv. drip,20mg/Kg,Qd. |
|
| severe cholangitis | Experimental | Meropenem injection, iv. drip,20mg/Kg,Q8h; Teicoplanin injection, iv. drip,10mg/Kg,Qd; Tinidazole injection, iv. drip,20mg/Kg,Qd. |
|
| control group | Active Comparator | Sulperazon, iv.,drip,100mg/Kg,Bid; Tinidazole injection, iv. drip,20mg/Kg,Qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulperazon | Drug | moderate cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recovery rate | The cure indicator including:1.Temperature:T≤37.5℃; 2. Infection index:WBC<10x109/L, CRP<10mg/L. After 7days treatment, we calculate the cure number and recovery rate of each group to evaluate the efficiency. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate | To collect recurrent episode of cholangitis and recurrent rate of each group. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Feng Jiexiong, Postdoctoral | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji hospital affiliated to tongji medical college of huazhong university of science and technology | Wuhan | Hubei | 430030 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37678274 | Derived | Wang P, Zhang HY, Yang J, Zhu T, Wu X, Yi B, Sun X, Wang B, Wang T, Tang W, Xie H, Tou J, Han Y, Liu X, Zhan J, Liu Y, Li Y, Lv Z, Lu L, Zhao B, Fu T, Wu D, Bai J, Li W, Yang H, Zhang G, Ren H, Feng J. Severity assessment to guide empiric antibiotic therapy for cholangitis in children after Kasai portoenterostomy: a multicenter prospective randomized control trial in China. Int J Surg. 2023 Dec 1;109(12):4009-4017. doi: 10.1097/JS9.0000000000000682. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 30, 2022 | |
| Reset | Sep 6, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 30, 2022 | Sep 6, 2023 |
| ID | Term |
|---|---|
| D008105 | Liver Cirrhosis, Biliary |
| D010349 | Patient Compliance |
| D002761 | Cholangitis |
| D001656 | Biliary Atresia |
| ID | Term |
|---|---|
| D002780 | Cholestasis, Intrahepatic |
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
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| ID | Term |
|---|---|
| C057923 | sulperazone |
| D014011 | Tinidazole |
| D017334 | Teicoplanin |
| D000077731 | Meropenem |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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Cholangitis patients post-kasai Portoenterostomy were grouped by cholangitis severity score, according to the severity was divided into mild, moderate, severe cholangitis, all levels of cholangitis patients were divided into subgroups by age and post-kasai Portoenterostomy jaundice matching design of experiment, then they were randomly divided into control group and experimental group.
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|
| Teicoplanin | Drug | severe cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic. |
|
|
| Meropenem Injection | Drug | cholangitis in control group were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic. |
|
|
| TongjiHospital |
| Wuhan |
| Hubei |
| 430030 |
| China |
| D004066 |
| Digestive System Diseases |
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D004065 | Digestive System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000077427 | Lipoglycopeptides |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |