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

NCT ID: NCT06219993

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-21
• Study Completion Date: 2025-12-30

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.

Conditions

Biliary Atresia; Kasai Operation; Robotic Surgery; Open Surgery

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

RKPE group

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 by Da Vinci robot.

2. The Roux-en-Y jejunojejunostomy reconstruction was fashioned extracorporeally through the umbilical incision.

3. With Da Vinci robotic 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.

4. Last, an end-to-side hepaticojejunostomy was conducted with one-layer continuous 5-0 PDS sutures posteriorly and anteriorly. A drainage tube was left under the liver, and the incision was closed.

robot-assisted modified Kasai portoenterostomy

Intervention Type: PROCEDURE

1. 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.

2. 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.

OKPE group

1. The Exploring hepatic subcapsular spider-like telangiectasis (HSST) sign at the surface of the liver, cholangiography were observed to confirm the BA diagnosis by conventional open surgery.

2. The Roux-en-Y jejunojejunostomy reconstruction by hand-sewn anastomosis.

3. 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).

4. Last, an end-to-side hepaticojejunostomy was conducted with one-layer interrupt 5-0 PDS sutures posteriorly and anteriorly. A drainage tube was left under the liver, and the incision was closed.

traditional open Kasai portoenterostomy

Intervention Type: PROCEDURE

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).

Interventions

robot-assisted modified Kasai portoenterostomy

1. 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.

2. 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.

Intervention Type: PROCEDURE

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).

Intervention Type: PROCEDURE

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.

• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zunyi Medical College

OTHER

Sponsor Role: lead

Responsible Party

zebing Zheng

prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhu Jin, MD

Role: STUDY_CHAIR

Zunyi Medical College

Locations

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Affiliated hospital of zunyi medical university

Zunyi, Guizhou, China

Countries

China

References

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.

Reference Type: RESULT

PMID: 36602550 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30488647 (View on PubMed)

Other Identifiers

82060100

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ZK-2021-361

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Robot Kasai Surgery

Identifier Type: -

Identifier Source: org_study_id