Biliary Atresia Clinical Trial
— RKPEVSOKPEOfficial title:
Comparison of Robot-assisted Modified Kasai Portoenterostomy With Open Kasai Portoenterostomy for Biliary Atresia
Verified date | January 2024 |
Source | Zunyi Medical College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
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.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | December 30, 2025 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 6 Months |
Eligibility | Inclusion Criteria: - patients diagnosis type ? biliary atresia who underwent open kasai portoenterostomy or robotic-assisted Kasai portoenterostomy, aged no more than 6 months. Exclusion Criteria: - Type?biliary atresia and type?biliary atresia. biliary atresia combined with severe cardiopulmonary diseases. |
Country | Name | City | State |
---|---|---|---|
China | Affiliated Hospital of Zunyi Medical University | Zunyi | Guizhou |
China | Affiliated hospital of zunyi medical university | Zunyi | Guizhou |
Lead Sponsor | Collaborator |
---|---|
Zunyi Medical College |
China,
Murase N, Hinoki A, Shirota C, Tomita H, Shimojima N, Sasaki H, Nio M, Tahara K, Kanamori Y, Shinkai M, Yamamoto H, Sugawara Y, Hibi T, Ishimaru T, Kawashima H, Koga H, Yamataka A, Uchida H. Multicenter, retrospective, comparative study of laparoscopic an — View Citation
Zhang M, Cao G, Li X, Zhang X, Li Y, Chi S, Rong L, Tang ST. Robotic-assisted Kasai portoenterostomy for biliary atresia. Surg Endosc. 2023 May;37(5):3540-3547. doi: 10.1007/s00464-022-09855-x. Epub 2023 Jan 5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Jaundice-free survival with a native liver rate (%) | Jaundice-free survival with a native liver in 6 months,1 year and 2 years | 2 years | |
Other | Survival with liver transplantation rate (%) | Survival with liver transplantation in 6 months, 1year and 2 years. | 2 years | |
Other | Died (%) | we record the incidence of died at 6 months, 1year and 2 years | 2 years | |
Primary | Survival native liver rate(%) | 1- and 2-year survival with native liver (SNL) were recorded. | 2 years | |
Primary | Jaundice clearance rate(%) | Jaundice clearance (JC) was defined as serum total bilirubin level = 20 µmol/L (or = 1.2 mg/dL) within 6 months after the Kasai operation. JC within 6 months after surgery is widely used as the accepted measure of successful Kasai portoenterostomy. | 6 months, 1 year and 2 years | |
Secondary | Incidence of Cholangitis (%) | Cholangitis was defined as having more than two clinical presentations [fever (> 38 °C) or stool color change or increased/increasing jaundice] and two laboratory tests [elevated inflammatory parameters or increased/increasing transaminases or increased/increasing gamma-glutamyl transferase (GGT)/ bilirubin]. | 2 years | |
Secondary | Operative time (min) | The operative time(minute) in two groups | 1 year | |
Secondary | Estimated blood loss(ml) | The surgeon estimated blood loss(ml) in two groups | 1 year | |
Secondary | Bile leakage rate (%) | The incidence of complication of bile leakage between two groups. | 1 year | |
Secondary | Time to enteral feeding (days) | The time patients from operation to the first oral feeding | 1 year | |
Secondary | Postoperative hospital stay (days) | we record the times of postoperative hospital stay | 6 months | |
Secondary | Wound infection (%) | The incidence of complication of wound infection between two groups | 1 year | |
Secondary | Variceal bleeding rate(%) | The incidence of complication of Variceal bleeding between two groups. | 2 years | |
Secondary | Volvulus (%) | the incidence of Volvulus with adhesive bands and malrotation because of anastomotic ileus in two groups after operation 1year | 1 year | |
Secondary | Time to drain removal (days) | we record the time of drain removal | 6 months | |
Secondary | Umbilical hernia rate(%) | The incidence of complication of umbilical herniabetween two groups | 1 year | |
Secondary | Blood transfusion in theperioperative period (ml) | the blood transfusion in theperioperative period | 6 months | |
Secondary | C-reactive protein level (mg/dl) | C-reactive protein level at POD 1 | 6 months |
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