Healthy Donors for Liver TransplantationNCT05040529
Comparison Between Pure Laparoscopic Donor Right Hepatectomy and Convensional Donor Right Hepatectomy
An observational study of Healthy Donors for Liver Transplantation, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
Perioperative clincal outcome between PLDRH and conventional open donor right hepatectomy (ODRH) will be compared retrospectively. Read more about this study
- Who is it for?
- Ages 17 to 65 years
- Conditions the study is for
- Healthy Donors for Liver Transplantation
- What is being tested?
- pure laparoscopic donor hepatectomy and conventional open donor hepatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2009to 28 Mar 2022
- 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 17 to 65 years
- All sexes
- Child, Adult, Older adult
Study population: A healthy person between the ages of 17 and 65 years who was willing to donate a liver was considered
Who may be able to join
- patients received right or right extended hepatectomy for liver donation at gangnam severance hospital
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcome of Living Donor Hepatectomy for Liver Transplantation: a Retrospective Study
Perioperative clincal outcome between PLDRH and conventional open donor right hepatectomy (ODRH) will be compared retrospectively.
Read the detailed description
the superiority of laparoscopic liver resection was well known in terms of reduced blood loss and minimized hospital stay compared with open liver resection. However, pure laparoscopic donor hepatectomy is a challenging procedure for beginner liver surgeons because of the major vessel preservation required during liver parenchymal transection. this study was designed to identify the superiority of laparoscopic donor hepatectomy.
- Conditions
- Healthy Donors for Liver Transplantation
- Being tested
- pure laparoscopic donor hepatectomy, conventional open donor hepatectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pure laparoscopic donor hepatectomyProcedure or surgery
pure laparoscopic donor hepatectomy: patients who underwent pure laparoscopic right or right extended hepatectomy for liver donation at gangnam severance hospital
conventional open donor hepatectomyProcedure or surgery
conventional open donor hepatectomy: patients who underwent conventional right or right extended hepatectomy for liver donation at gangnam severance hospital
| Study group | Role | What they receive |
|---|---|---|
| PLDRH | patients who underwent pure laparoscopic donor right hepatectomy Receives: Procedure: pure laparoscopic donor hepatectomy | |
| ODRH | patients who underwent conventaional open donor right hepatectomy Receives: Procedure: conventional open donor hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood loss during hepatectomy
bleeding amount during hepatectomy will be calculated in mL. based on the blood in the sucker machine and the surgical towels.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start1 Mar 2009
- Primary completion28 Feb 2021
- Study completion28 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Donors for Liver TransplantationStudies 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JinHong Lim, Gangnam Severance Hospital
- Investigators
- Jin Hong Lim, Principal investigator, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040529
- Sponsor's protocol ID
- 3-2021-0039
- Status last verified
- Sep 2021
- First submitted
- 31 Aug 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hong SK, Lee KW, Choi Y, Kim HS, Ahn SW, Yoon KC, Kim H, Yi NJ, Suh KS. Initial experience with purely laparoscopic living-donor right hepatectomy. Br J Surg. 2018 May;105(6):751-759. doi: 10.1002/bjs.10777. Epub 2018 Mar 26.
PubMed 29579333
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Living Donor Hepatectomy for Liver Transplantation: a Retrospective Study
- ClinicalTrials.gov ID
- NCT05040529
- Acronym / sponsor ID
- 3-2021-0039
- Conditions
- Healthy Donors for Liver Transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 1 Mar 2009 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Mar 2022 (estimated)
- First posted
- 10 Sep 2021 (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.
Perioperative clincal outcome between PLDRH and conventional open donor right hepatectomy (ODRH) will be compared retrospectively.
Detailed description
the superiority of laparoscopic liver resection was well known in terms of reduced blood loss and minimized hospital stay compared with open liver resection. However, pure laparoscopic donor hepatectomy is a challenging procedure for beginner liver surgeons because of the major vessel preservation required during liver parenchymal transection. this study was designed to identify the superiority of laparoscopic donor hepatectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLDRH | – | Procedure: pure laparoscopic donor hepatectomypatients who underwent pure laparoscopic donor right hepatectomy |
| ODRH | – | Procedure: conventional open donor hepatectomypatients who underwent conventaional open donor right hepatectomy |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- A healthy person between the ages of 17 and 65 years who was willing to donate a liver was considered
Key inclusion criteria (1 listed)
- patients received right or right extended hepatectomy for liver donation at gangnam severance hospital
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| pure laparoscopic donor hepatectomypure laparoscopic donor hepatectomy: patients who underwent pure laparoscopic right or right extended hepatectomy for liver donation at gangnam severance hospital | Procedure or surgery | PLDRH |
| conventional open donor hepatectomyconventional open donor hepatectomy: patients who underwent conventional right or right extended hepatectomy for liver donation at gangnam severance hospital | Procedure or surgery | ODRH |
Primary outcome
blood loss during hepatectomy
Time frame: intraoperative
bleeding amount during hepatectomy will be calculated in mL. based on the blood in the sucker machine and the surgical towels.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Background: PubMed 29579333Hong SK, Lee KW, Choi Y, Kim HS, Ahn SW, Yoon KC, Kim H, Yi NJ, Suh KS. Initial experience with purely laparoscopic living-donor right hepatectomy. Br J Surg. 2018 May;105(6):751-759. doi: 10.1002/bjs.10777. Epub 2018 Mar 26.
- Individual participant dataSharing planned: No
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.
Jin Hong Lim principal investigator
Gangnam Severance Hospital
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 Healthy Donors for Liver Transplantation, run by Gangnam Severance Hospital at 1 site in South Korea.
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 1 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 10 Sep 2021. 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 South Korea. 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?
blood loss during hepatectomy (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05040529, which also lists 1 linked publication.
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 10 Sep 2021.