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临床试验/NCT06219993
NCT06219993进行中(未招募)不适用

Comparison of Robot-assisted Modified Kasai Portoenterostomy With Open Kasai Portoenterostomy for Biliary Atresia

Zunyi Medical College2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年12月21日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
2
主要终点
Survival native liver rate(%)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
— 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Survival native liver rate(%)

时间窗: 2 years

1- and 2-year survival with native liver (SNL) were recorded.

Jaundice clearance rate(%)

时间窗: 6 months, 1 year and 2 years

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.

次要结局

  • Operative time (min)(1 year)
  • Volvulus (%)(1 year)
  • Estimated blood loss(ml)(1 year)
  • Postoperative hospital stay (days)(6 months)
  • Incidence of Cholangitis (%)(2 years)
  • Time to drain removal (days)(6 months)
  • Bile leakage rate (%)(1 year)
  • Time to enteral feeding (days)(1 year)
  • Wound infection (%)(1 year)
  • Blood transfusion in theperioperative period (ml)(6 months)
  • Variceal bleeding rate(%)(2 years)
  • Umbilical hernia rate(%)(1 year)
  • C-reactive protein level (mg/dl)(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

zebing Zheng

prof.

Zunyi Medical College

研究点 (2)

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