Robot-assisted Modified Kasai Portoenterostomy Versus Open Kasai Portoenterostomy for Biliary Atresia

Active, not recruiting

• Conditions: Kasai Operation; Biliary Atresia; Robotic Surgery; Open Surgery

• Registration Number: NCT06219993
• Lead Sponsor: Zunyi Medical College

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.

Study Timeline

• Study Start: 2023-12-21
• Study First Submitted: 2023-12-24
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-11
• Last Update Submitted: 2024-01-11
• Study First Posted: 2024-01-23
• Last Update Posted: 2024-01-23
• Primary Completion: 2024-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival native liver rate(%)	2 years	1- and 2-year survival with native liver (SNL) were recorded.
Jaundice clearance rate(%)	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.

Secondary Outcome Measures

Name	Time	Method
Volvulus (%)	1 year	the incidence of Volvulus with adhesive bands and malrotation because of anastomotic ileus in two groups after operation 1year
Estimated blood loss(ml)	1 year	The surgeon estimated blood loss(ml) in two groups
Postoperative hospital stay (days)	6 months	we record the times of postoperative hospital stay
Incidence of Cholangitis (%)	2 years	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 \[elevated inflammatory parameters or increased/increasing transaminases or increased/increasing gamma-glutamyl transferase (GGT)/ bilirubin\].
Time to drain removal (days)	6 months	we record the time of drain removal
Bile leakage rate (%)	1 year	The incidence of complication of bile leakage between two groups.
Time to enteral feeding (days)	1 year	The time patients from operation to the first oral feeding
Wound infection (%)	1 year	The incidence of complication of wound infection between two groups
Blood transfusion in theperioperative period (ml)	6 months	the blood transfusion in theperioperative period
Variceal bleeding rate(%)	2 years	The incidence of complication of Variceal bleeding between two groups.
Umbilical hernia rate（%）	1 year	The incidence of complication of umbilical herniabetween two groups
C-reactive protein level (mg/dl)	6 months	C-reactive protein level at POD 1
Operative time (min)	1 year	The operative time(minute) in two groups

Trial Locations

Locations (2)

Affiliated Hospital of Zunyi Medical University; 🇨🇳 Zunyi, Guizhou, China

Affiliated hospital of zunyi medical university; 🇨🇳 Zunyi, Guizhou, China