Robotic vs. Laparoscopic vs. Open Living Donor Hepatectomy

Comparison of Outcomes in Robotic vs. Laparoscopic vs. Open Living Donor Hepatectomy: A Single Center Prospective Registry Study

This will be a study to examine the outcomes of open, laparoscopic, and robotic Living Donor Liver Transplantation (LDLT) procedures. The analysis will encompass 3,448 cases (1,724 donor-recipient pairs) from January 2011 to March 2023, documenting the transition between these surgical techniques, with a noted crossover in 2018.

Study Overview

• Status: Enrolling by invitation
• Conditions: End Stage Liver Disease; Acute-On-Chronic Liver Failure; Hepatocellular Carcinoma; Acute Liver Failure
• Intervention / Treatment: Procedure: Donor hepatectomy

Detailed Description

Background: Liver transplantation is a primary treatment for end-stage liver disease, enhancing survival rates and life quality. Living donor liver transplantation (LDLT) has gained prominence due to the scarcity of deceased donor organs. Historically, the open technique dominated living donor hepatectomies. However, advances in minimally invasive surgery (MIS) led to laparoscopic and later robotic procedures. With the introduction of robotic surgery, MIS for complex surgeries improved, offering better precision and ergonomics.

Objective: To compare the short and long-term outcomes of open, laparoscopic, and robotic LDLT, focusing on both donors and recipients.

Methods: Study Design: Retrospective analysis of data from a prospective liver transplant registry, examining three LDLT techniques.

Setting: King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.

Participants: All consecutive living donor and recipient pairs undergoing LDLT between January 2011 and March 2023. Exclusions include dual or domino LDLT.

Surgical Techniques: Open, laparoscopic, and robotic techniques used for donor hepatectomies.

Variables: Primary focus on morbidity, conversion rates, and in-hospital mortality for both donors and recipients. Secondary variables will include major complications, graft, and recipient survival rates.

Data Sources and Measurement: Data sourced from a secured, encrypted transplant database, detailing patient data, operation characteristics, and post-op outcomes. Complication severity will be captured using the Clavien-Dindo classification and Comprehensive Complication Index™.

Study Size: Determined by the total number of procedures during the study duration, deemed sufficient for comparison.

Quantitative Variables: Demographics, comorbidities, operational details, post-op and long-term outcomes.

Statistical Methods: Various statistical tests will be employed for comparison, including the Student t, Mann-Whitney U, one-way ANOVA, Fischer and Chi square. Survival will be evaluated using the Kaplan-Meier method. Multivariable binary logistic regression will be employed. All statistical analyses will be conducted using R.

Ethics Approval: Obtained (ID: RAC 2121012) and in accordance with the 1964 Helsinki declaration.

• Study Type: Observational
• Enrollment (Estimated): 3448

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11563
    • Organ Transplant Center of Excellence, King Faisal Specialist Hospital & Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study cohort consists of 1,724 living donor and recipient pairs, amounting to a total of 3,448 individuals. These donors and recipients participated in living donor liver transplantation (LDLT) procedures at the King Faisal Specialist Hospital and Research Center in Riyadh, Saudi Arabia.

The donors provided a portion of their liver for transplantation. The recipient group is diverse, including both adult and pediatric patients receiving transplants from adult donors. Both laparoscopic-assisted and robotic-assisted transplant procedures will be part of the study to ensure an intention-to-treat analysis.

Description

Inclusion Criteria:

• All donor and recipient pairs that underwent LDLT at the study institution
• Between 01 January 2011 to 31 March 2023
• Both adult-to-adult and adult-to-pediatric LDLT are included.

Exclusion Criteria:

• Dual and domino LDLT are excluded.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Open; Open donor hepatectomy approach: a portion of the liver is resected from a living donor using the traditional open surgical technique, involving a large incision to access the liver directly. This method is most commonly used in living donor liver transplantation nowadays.	Procedure: Donor hepatectomy; Donor hepatectomy is a surgical procedure to resect a portion of the liver from a living donor for transplantation. This usually involved the right lobe, the left lobe or the left lateral section of the liver. Depending on the surgical method, this can be achieved through open, laparoscopic, or robotic-assisted techniques. As for the recipient, liver transplantation involves a total hepatectomy of the diseased liver from the recipient and implantation of the liver graft from the donor. This is typically performed using the open surgical approach.; Other Names: Recipient liver transplantation
Laparoscopic; Laparoscopic donor hepatectomy is a minimally invasive surgical approach where a portion of the liver is resected from a living donor using small incisions and specialized instruments.	Procedure: Donor hepatectomy; Donor hepatectomy is a surgical procedure to resect a portion of the liver from a living donor for transplantation. This usually involved the right lobe, the left lobe or the left lateral section of the liver. Depending on the surgical method, this can be achieved through open, laparoscopic, or robotic-assisted techniques. As for the recipient, liver transplantation involves a total hepatectomy of the diseased liver from the recipient and implantation of the liver graft from the donor. This is typically performed using the open surgical approach.; Other Names: Recipient liver transplantation
Robotic; Robotic donor hepatectomy is an advanced, minimally invasive surgical technique where a portion of the liver is resected from a living donor using robotic instruments. This method is known to provide enhanced precision, improved ergonomics, and superior 3D visualization.	Procedure: Donor hepatectomy; Donor hepatectomy is a surgical procedure to resect a portion of the liver from a living donor for transplantation. This usually involved the right lobe, the left lobe or the left lateral section of the liver. Depending on the surgical method, this can be achieved through open, laparoscopic, or robotic-assisted techniques. As for the recipient, liver transplantation involves a total hepatectomy of the diseased liver from the recipient and implantation of the liver graft from the donor. This is typically performed using the open surgical approach.; Other Names: Recipient liver transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Donor overall morbidity rate	Complication rate of any severity according to the Clavien-Dindo Classification	From date of donor hepatectomy until the date of first hospital discharge assessed up to 90 days postoperatively.
Recipient overall morbidity rate	Complication rate of any severity according to the Clavien-Dindo Classification	From date of liver transplantation until the date of hospital discharge assessed up to 90 days postoperatively.
Recipient in-hospital mortality rate	Recipient death up to 90 days of follow up	From date of liver transplantation until the date of death assessed up to 90 days post-transplant.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Donor minimally invasive surgery conversion to open rate	Includes conversion to open surgery for both laparoscopic and robotic approaches. This does not apply for the open surgical approach.	Time from operation start until conversion to open in minutes assessed up to 720 min
Donor hospital stay in days	Number of days the donor was hospitalised during first hospitalisation. Does not include re-hospitalizations.	From date of donor hepatectomy until the date of first hospital discharge assessed up to 90 days postoperatively.
Recipient Intensive Care Unit (ICU) stay in days	Total number of days recipient stayed in ICU. This included readmissions to ICU.	Total number of days hospitalised in ICU, from date of liver transplant until the date of discharge from ICU assessed up to 90 days postoperatively.
Recipient hospital stay in days	Number of days the recipient was hospitalised. Does not include rehospitalizations.	From date of liver transplant until the date of first hospital discharge assessed up to 90 days postoperatively.
Graft survival rates	Graft survival defined as re-transplantation or recipient death.	From date of liver transplantation until the date of re-transplantation or recipient death or last follow up assessed up to 120 months post-transplant
Recipient survival rates	Recipient survival defined as death post-transplant	From date of liver transplantation until the date of recipient death or last follow up assessed up to 120 months post-transplant

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major morbidity rates	These include complications of Grade > 2 according to the Clavien-Dindo Classification, i.e., requiring an intervention on the patient requiring organ support in the Intensive Care Unit	From date of operation until the date of hospital discharge assessed up to 90 days postoperatively.
Specific complication rates	Infection, bleeding, ascites, vascular, and biliary complications	From date of operation until the date of hospital discharge assessed up to 90 days postoperatively.

Collaborators and Investigators

• Sponsor: King Faisal Specialist Hospital & Research Center
• Investigators: Principal Investigator: Dieter C Broering, MD, PhD, Organ Transplant Center of Excellence, King Faisal Specialist Hospital & Research Centre

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2023
• Primary Completion (Estimated): October 15, 2023
• Study Completion (Estimated): October 30, 2023

Study Registration Dates

• First Submitted: September 12, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; End Stage Liver Disease; Liver Failure; Hepatic Insufficiency; Acute-On-Chronic Liver Failure; Liver Failure, Acute
• Other Study ID Numbers: RAC 2121012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No