Robot-assisted Modified Kasai Portoenterostomy Versus Open Kasai Portoenterostomy for Biliary Atresia (RKPEVSOKPE)

January 11, 2024 updated by: zebing Zheng, Zunyi Medical College

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guizhou
      • Zunyi, Guizhou, China, 563000
        • Affiliated Hospital of Zunyi Medical University
      • Zunyi, Guizhou, China, 56300
        • Affiliated Hospital of Zunyi Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: 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.
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.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Survival native liver rate(%)
Time Frame: 2 years
1- and 2-year survival with native liver (SNL) were recorded.
2 years
Jaundice clearance rate(%)
Time Frame: 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.
6 months, 1 year and 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Cholangitis (%)
Time Frame: 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].
2 years
Operative time (min)
Time Frame: 1 year
The operative time(minute) in two groups
1 year
Estimated blood loss(ml)
Time Frame: 1 year
The surgeon estimated blood loss(ml) in two groups
1 year
Bile leakage rate (%)
Time Frame: 1 year
The incidence of complication of bile leakage between two groups.
1 year
Time to enteral feeding (days)
Time Frame: 1 year
The time patients from operation to the first oral feeding
1 year
Postoperative hospital stay (days)
Time Frame: 6 months
we record the times of postoperative hospital stay
6 months
Wound infection (%)
Time Frame: 1 year
The incidence of complication of wound infection between two groups
1 year
Variceal bleeding rate(%)
Time Frame: 2 years
The incidence of complication of Variceal bleeding between two groups.
2 years
Volvulus (%)
Time Frame: 1 year
the incidence of Volvulus with adhesive bands and malrotation because of anastomotic ileus in two groups after operation 1year
1 year
Time to drain removal (days)
Time Frame: 6 months
we record the time of drain removal
6 months
Umbilical hernia rate（%）
Time Frame: 1 year
The incidence of complication of umbilical herniabetween two groups
1 year
Blood transfusion in theperioperative period (ml)
Time Frame: 6 months
the blood transfusion in theperioperative period
6 months
C-reactive protein level (mg/dl)
Time Frame: 6 months
C-reactive protein level at POD 1
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Jaundice-free survival with a native liver rate (%)
Time Frame: 2 years
Jaundice-free survival with a native liver in 6 months,1 year and 2 years
2 years
Survival with liver transplantation rate (%)
Time Frame: 2 years
Survival with liver transplantation in 6 months, 1year and 2 years.
2 years
Died (%)
Time Frame: 2 years
we record the incidence of died at 6 months, 1year and 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zunyi Medical College

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Zhu Jin, MD, Zunyi Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 21, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Robot Kasai Surgery
  • 82060100 (Other Grant/Funding Number: National Natural Science Foundation of China)
  • ZK-2021-361 (Other Grant/Funding Number: Basic Research Project of Guizhou Province China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant in this study we recruit are mainly minors, which involves privacy protection for minors, so we cannot share the personal information of participants to the other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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