Robotic vs. Laparoscopic vs. Open Living Donor Hepatectomy

NCT06062706 | Unknown DMC

• 1 other identifier: RAC 2121012
• Study Type: observational
• Target: 3,448
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Liver Disease; Acute Liver Failure; Acute-On-Chronic Liver Failure; Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Donor minimally invasive surgery conversion to open rate

  Time from operation start until conversion to open in minutes assessed up to 720 min

• Donor hospital stay in days

  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 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

  From date of liver transplant until the date of first hospital discharge assessed up to 90 days postoperatively.

• 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

Other Outcomes (2)

• Major morbidity rates

  From date of operation until the date of hospital discharge assessed up to 90 days postoperatively.

• Specific complication rates

  From date of operation until the date of hospital discharge assessed up to 90 days postoperatively.

Study Arms (3)

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

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

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

Interventions

Donor hepatectomy PROCEDURE

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.

Also known as: Recipient liver transplantation

Laparoscopic; Open; Robotic

Eligibility Criteria

• Age: 1 Month - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Dual and domino LDLT are excluded.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

Organ Transplant Center of Excellence, King Faisal Specialist Hospital & Research Centre

Riyadh, 11563, Saudi Arabia

Location

MeSH Terms

Conditions

End Stage Liver Disease; Liver Failure, Acute; Acute-On-Chronic Liver Failure; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Study Officials

• Dieter C Broering, MD, PhD

  Organ Transplant Center of Excellence, King Faisal Specialist Hospital & Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: October 2, 2023
• Study Start: August 6, 2023
• Primary Completion: October 15, 2023
• Study Completion: October 30, 2023
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)