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

Biliary Atresia Clinical Trial

— RKPEVSOKPE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06219993
• Other study ID #: Robot Kasai Surgery
• Secondary ID: 82060100ZK-2021-
• Status: Active, not recruiting
• Start date: December 21, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: January 2024
• Source: Zunyi Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Biliary Atresia
• Kasai Operation
• Open Surgery
• Robotic Surgery

Intervention

Procedure:
• robot-assisted modified Kasai portoenterostomy
A 1.0 cm incision was made around the umblilicus for the camera port. 1.Firstly, the Exploring hepatic subcapsular spider-like telangiectasis (HSST) sign at the surface of the liver, and indocyanine green (ICG) cholangiography were observed to confirm the BA diagnosis. dissecting forceps and electric scissors were applied to dissociate the atresia bile ducts and lymph nodes in portal hepatis. Exposed the hepatic artery and portal vein. All portal vein tributaries that drain into the fibrous cone were coagulated by bipolar coagulation to expose the portal plate for resection. With electric scissors help, the fibrous plate was horizontally cut from the middle of the portal plate and transected from to the left and to the right sides which was the Glissonian systems enter the liver parenchyma until see the bile outflow by verified by ICG. The opening of microbile ducts and abundant bile outflow were clearly visible under 10× camera of Da Vinci robot.
• traditional open Kasai portoenterostomy
Dissecting forceps and electric scissors were applied to dissociate the atresia bile ducts and lymph nodes in portal hepatis. Exposed the hepatic artery and portal vein. All portal vein tributaries that drain into the fibrous cone were coagulated by bipolar coagulation to expose the portal plate for resection. With scissors help, the fibrous cone of the hilar region was transected from left to right (the level of transection depends on adequate bile outflow).

Locations

Country	Name	City	State
China	Affiliated Hospital of Zunyi Medical University	Zunyi	Guizhou
China	Affiliated hospital of zunyi medical university	Zunyi	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Zunyi Medical College

Country where clinical trial is conducted

China, 

References & Publications (2)

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

Outcome

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