Clinical trial NCT06062706: Robotic vs. Laparoscopic vs. Open Living Donor Hepatectomy
Official title: Comparison of Outcomes in Robotic vs. Laparoscopic vs. Open Living Donor Hepatectomy: A Single Center Prospective Registry Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: End Stage Liver Disease
Acute Liver Failure
Acute-On-Chronic Liver Failure
Hepatocellular Carcinoma
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 3448
Sex: ALL
Minimum age (years): 1
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Donor overall morbidity rate
timeFrame: From date of donor hepatectomy until the date of first hospital discharge assessed up to 90 days postoperatively.
measure: Recipient overall morbidity rate
timeFrame: From date of liver transplantation until the date of hospital discharge assessed up to 90 days postoperatively.
measure: Recipient in-hospital mortality rate
timeFrame: From date of liver transplantation until the date of death assessed up to 90 days post-transplant.
Secondary outcomes:
measure: Donor minimally invasive surgery conversion to open rate
timeFrame: Time from operation start until conversion to open in minutes assessed up to 720 min
measure: Donor hospital stay in days
timeFrame: From date of donor hepatectomy until the date of first hospital discharge assessed up to 90 days postoperatively.
measure: Recipient Intensive Care Unit (ICU) stay in days
timeFrame: 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.
measure: Recipient hospital stay in days
timeFrame: From date of liver transplant until the date of first hospital discharge assessed up to 90 days postoperatively.
measure: Graft survival rates
timeFrame: 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
measure: Recipient survival rates
timeFrame: From date of liver transplantation until the date of recipient death or last follow up assessed up to 120 months post-transplant
Other outcomes:
measure: Major morbidity rates
timeFrame: From date of operation until the date of hospital discharge assessed up to 90 days postoperatively.
measure: Specific complication rates
timeFrame: From date of operation until the date of hospital discharge assessed up to 90 days postoperatively.
Locations:
city: Riyadh
country: Saudi Arabia
facility: Organ Transplant Center of Excellence, King Faisal Specialist Hospital & Research Centre
Study officials:
affiliation: Organ Transplant Center of Excellence, King Faisal Specialist Hospital & Research Centre
name: Dieter C Broering, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: