End Stage Liver DiseaseNCT06062706
Robotic vs. Laparoscopic vs. Open Living Donor Hepatectomy
An observational study of End Stage Liver Disease and Acute Liver Failure, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
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… Read more about this study
- Who is it for?
- Ages 1 month to 75 years
- Conditions the study is for
- End Stage Liver Disease, Acute Liver Failure, Acute-On-Chronic Liver Failure
- What is being tested?
- Donor hepatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 3,448 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 6 Aug 2023to 30 Oct 2023
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Dual and domino LDLT are excluded.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Organ Transplant Center of Excellence, King Faisal Specialist Hospital & Research Centre
Riyadh, 11563
About this study
Official title: 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.
Read the 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.
- Conditions
- End Stage Liver Disease, Acute Liver Failure, Acute-On-Chronic Liver Failure, Hepatocellular Carcinoma
- Being tested
- Donor hepatectomy
- Medical subject headings
- End Stage Liver Disease, Liver Failure, Acute, Acute-On-Chronic Liver Failure, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donor hepatectomyProcedure or surgery
Also called Recipient liver transplantation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Donor hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Donor overall morbidity rate
Complication rate of any severity according to the Clavien-Dindo Classification
Measured: 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
Measured: 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
Measured: 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
Includes conversion to open surgery for both laparoscopic and robotic approaches. This does not apply for the open surgical approach.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: From date of liver transplantation until the date of recipient death or last follow up assessed up to 120 months post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start6 Aug 2023
- Primary completion15 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,448 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dieter C Broering, MD, PhD, Principal investigator, Organ Transplant Center of Excellence, King Faisal Specialist Hospital & Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062706
- Sponsor's protocol ID
- RAC 2121012
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes in Robotic vs. Laparoscopic vs. Open Living Donor Hepatectomy: A Single Center Prospective Registry Study
- ClinicalTrials.gov ID
- NCT06062706
- Acronym / sponsor ID
- RAC 2121012
- Conditions
- End Stage Liver Disease, Acute Liver Failure, Acute-On-Chronic Liver Failure, Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,448 participants (estimated)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- 6 Aug 2023 (actual)
- Primary completion
- 15 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open | – | Procedure: Donor hepatectomyOpen 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 | – | Procedure: Donor hepatectomyLaparoscopic 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. |
| Robotic | – | Procedure: Donor hepatectomyRobotic 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. |
Who may qualify
- Ages
- 1 month to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Dual and domino LDLT are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donor hepatectomyAlso: Recipient liver transplantationDonor 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. | Procedure or surgery | Laparoscopic, Open, Robotic |
Primary outcome
Donor overall morbidity rate
Time frame: 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 overall morbidity rate
Time frame: 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
Recipient in-hospital mortality rate
Time frame: 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
6 secondary outcomes
Donor minimally invasive surgery conversion to open rate
Time frame: Time from operation start until conversion to open in minutes assessed up to 720 min
Donor hospital stay in days
Time frame: 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
Time frame: 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
Time frame: From date of liver transplant until the date of first hospital discharge assessed up to 90 days postoperatively.
Graft survival rates
Time frame: 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
Time frame: From date of liver transplantation until the date of recipient death or last follow up assessed up to 120 months post-transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dieter C Broering, MD, PhD principal investigator
Organ Transplant Center of Excellence, King Faisal Specialist Hospital & Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Liver Disease and Acute Liver Failure, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Donor overall morbidity rate (time frame: From date of donor hepatectomy until the date of first hospital discharge assessed up to 90 days postoperatively.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023; AzTrials last refreshed its copy on 3 Nov 2026.