Clinical trial NCT06219993: Robot-assisted Modified Kasai Portoenterostomy Versus Open Kasai Portoenterostomy for Biliary Atresia
Official title: Comparison of Robot-assisted Modified Kasai Portoenterostomy With Open Kasai Portoenterostomy for Biliary Atresia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Biliary Atresia
Kasai Operation
Robotic Surgery
Open Surgery
Keywords: biliary atresia
kasai portoenterostomy
Robotic kasai
outcome
RCTs
Lead sponsor: Zunyi Medical College
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 60
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients diagnosis type Ⅲ biliary atresia who underwent open kasai portoenterostomy or robotic-assisted Kasai portoenterostomy, aged no more than 6 months.

Brief summary: 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.

Detailed description: Biliary atresia (BA) is one of the most common cholestatic childhood diseases, with an estimated incidence of 1 in 8000-18,000 live births. BA is a progressive cholangiopathy with fibro-obliterative obstruction of the bile duct. The exact pathogenesis and etiology of BA have not been fully elucidated. The hypothesis that is most widely recognized states that injury to the biliary duct is caused by an initial infection and then an autoimmune response is induced by infection, leading to progressive damage to the biliary duct. Typical clinical manifestations of BA include persistent jaundice, acholic stools, and pigmented urine in the first months after birth. Unfortunately, the presentation time of the clinical features can be delayed in BA, which may lead to misdiagnosis. The average diagnostic age of BA is 60 days in many countries. Currently, effective management for BA is the Kasai portoenterostomy (KPE), which was originally reported by Morio Kasai in 1959. open Kasai portoenterostomy (OKPE) has been introduced to restore bile drainage for patients with BA and become the gold standard. Esteves et al. reported laparoscopic Kasai portoenterostomy (LKPE) for BA in 2002, but its efficacy remains controversial compared with OKPE. Several centers have revealed positive results with modified LKPE procedures. Nonetheless, LKPE is still a complex and challenging procedure with difficulties in fiber block dissection and anastomosis, resulting in a long learning curve. With merits of articulating wrists, 3D imaging field of vision and filter tremor, robotic surgery has been gradually applied to hepatobiliary disorders in children. Theoretically, robotic-assisted Kasai portoenterostomy (RAKPE) may overcome the difficulties of LKPE in fiber block dissection and anastomosis, thereby becoming a better option for BA. Currently, reports of RAKPE in infants with BA are limited to small case series, and its effectiveness remains controversial. 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.

Eligibility criteria: Inclusion Criteria:

* patients diagnosis type Ⅲ biliary atresia who underwent open kasai portoenterostomy or robotic-assisted Kasai portoenterostomy, aged no more than 6 months.

Exclusion Criteria:

* TypeⅠbiliary atresia and typeⅡbiliary atresia. biliary atresia combined with severe cardiopulmonary diseases.

Primary outcomes:
measure: Survival native liver rate(%)
timeFrame: 2 years
measure: Jaundice clearance rate(%)
timeFrame: 6 months, 1 year and 2 years
Secondary outcomes:
measure: Incidence of Cholangitis (%)
timeFrame: 2 years
measure: Operative time (min)
timeFrame: 1 year
measure: Estimated blood loss(ml)
timeFrame: 1 year
measure: Bile leakage rate (%)
timeFrame: 1 year
measure: Time to enteral feeding (days)
timeFrame: 1 year
measure: Postoperative hospital stay (days)
timeFrame: 6 months
measure: Wound infection (%)
timeFrame: 1 year
measure: Variceal bleeding rate(%)
timeFrame: 2 years
measure: Volvulus (%)
timeFrame: 1 year
measure: Time to drain removal (days)
timeFrame: 6 months
measure: Umbilical hernia rate（%）
timeFrame: 1 year
measure: Blood transfusion in theperioperative period (ml)
timeFrame: 6 months
measure: C-reactive protein level (mg/dl)
timeFrame: 6 months
Other outcomes:
measure: Jaundice-free survival with a native liver rate (%)
timeFrame: 2 years
measure: Survival with liver transplantation rate (%)
timeFrame: 2 years
measure: Died (%)
timeFrame: 2 years
Locations:
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
state: Guizhou
city: Zunyi
country: China
facility: Affiliated hospital of zunyi medical university
state: Guizhou
Study officials:
affiliation: Zunyi Medical College
name: Zhu Jin, MD
role: STUDY_CHAIR
References:
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.
citation: 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 and open Kasai portoenterostomy in children with biliary atresia from Japanese high-volume centers. J Hepatobiliary Pancreat Sci. 2019 Jan;26(1):43-50. doi: 10.1002/jhbp.594. Epub 2019 Jan 12.