Robotic vs. Laparoscopic vs. Open Living Donor Hepatectomy

• Conditions: Acute Liver Failure; End Stage Liver Disease; Hepatocellular Carcinoma; Acute-On-Chronic Liver Failure
• Interventions: Procedure: Donor hepatectomy

• Registration Number: NCT06062706
• Lead Sponsor: King Faisal Specialist Hospital & Research Center

Brief Summary

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.

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 Timeline

• Study Start: 2023-08-06
• Status Verified: 2023-09
• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-09-28
• Last Update Submitted: 2023-09-28
• Study First Posted: 2023-10-02
• Last Update Posted: 2023-10-02
• Primary Completion: 2023-10-15
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 3448

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Robotic	Donor hepatectomy	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.
Open	Donor hepatectomy	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.
Laparoscopic	Donor hepatectomy	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Organ Transplant Center of Excellence, King Faisal Specialist Hospital & Research Centre; 🇸🇦 Riyadh, Saudi Arabia