Robotic vs. Laparoscopic vs. Open Living Donor Hepatectomy

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06062706
• Other study ID #: RAC 2121012
• Status: Enrolling by invitation
• Start date: August 6, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: September 2023
• Source: King Faisal Specialist Hospital & Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3448
• Est. completion date: October 30, 2023
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Liver Failure
• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Hepatic Insufficiency
• Hepatocellular Carcinoma
• Liver Diseases
• Liver Failure
• Liver Failure, Acute

Intervention

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.

Locations

Country	Name	City	State
Saudi Arabia	Organ Transplant Center of Excellence, King Faisal Specialist Hospital & Research Centre	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Faisal Specialist Hospital & Research Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Primary	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.
Primary	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.
Primary	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	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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