Laparoscopic HepatectomyNCT02131441
Surgical Specification and Efficacy Evaluation of Total Laparoscopic Left Liver Resection
A study testing laparoscopic hepatectomy and open liver resection in people with Laparoscopic Hepatectomy and Hepatocellular Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Recent clinical experience showed that laparoscopic hepatectomy has advantages of minimally invasive compared to open liver resection, however, laparoscopic liver resection is still difficult and risky. Currently it is only carried out in a few large medical centers with slow development. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Laparoscopic Hepatectomy, Hepatocellular Carcinoma
- What is being tested?
- laparoscopic hepatectomy and open liver resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Aug 2023
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Child-pugh A-B
- Primary hepatocellular carcinoma of the left liver lobe
- Tumor size ≤5cm in diameter
- KPS≥60
Who cannot join
- Significant abnormal liver function
- Significant abnormal Heart function
- Significant abnormal lung function
- Significant abnormal kidney function
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Guangzhou, Guangdong, 510120
Yan-qing Zhou, 00862081332371, ywjgbgs@163.com
About this study
Recent clinical experience showed that laparoscopic hepatectomy has advantages of minimally invasive compared to open liver resection, however, laparoscopic liver resection is still difficult and risky. Currently it is only carried out in a few large medical centers with slow development. The related research studies were retrospective analysis, there were no prospective randomized controlled multi-center study reported. Because of its relatively simple anatomical advantages, left liver seems to be as the best platform to ensure maximum safety and feasibility of prospective randomized study for laparoscopic hepatectomy .This project intends to carry out a prospective randomized controlled multi-center study to look for evidence of safety, efficacy and minimally invasive of laparoscopic left liver resection, evaluate the long-term efficacy including overall survival, disease-free survival as well as time to disease recurrence for the left liver carcinoma.
- Conditions
- Laparoscopic Hepatectomy, Hepatocellular Carcinoma
- Being tested
- laparoscopic hepatectomy, open liver resection
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic hepatectomyProcedure or surgery
open liver resectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic hepatectomy | Other | laparoscopic hepatectomy Receives: Procedure: laparoscopic hepatectomy |
| open liver resection | Other | open liver resection Receives: Procedure: open liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of bleeding
Measured: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
time of operation
Measured: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
status of the resection margins
Measured: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
bile leakage
Measured: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
abdominal adhesion
Measured: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
Secondary outcomes (3)
overall survival
Measured: Participants will be followed for 5 years.
disease-free survival
Measured: Participants will be followed for 5 years.
time to disease recurrence
Measured: Participants will be followed for 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startJul 2013
- Primary completionAug 2018 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic HepatectomyStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-jin Chen, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131441
- Sponsor's protocol ID
- TLLLR-001
- Other IDs
- 2013005
- Status last verified
- May 2014
- First submitted
- 29 Apr 2014
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Specification and Efficacy Evaluation of Total Laparoscopic Left Liver Resection
- ClinicalTrials.gov ID
- NCT02131441
- Acronym / sponsor ID
- TLLLR-001
- Conditions
- Laparoscopic Hepatectomy, Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 6 May 2014 (estimated)
- 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.
Recent clinical experience showed that laparoscopic hepatectomy has advantages of minimally invasive compared to open liver resection, however, laparoscopic liver resection is still difficult and risky. Currently it is only carried out in a few large medical centers with slow development. The related research studies were retrospective analysis, there were no prospective randomized controlled multi-center study reported. Because of its relatively simple anatomical advantages, left liver seems to be as the best platform to ensure maximum safety and feasibility of prospective randomized study for laparoscopic hepatectomy .This project intends to carry out a prospective randomized controlled multi-center study to look for evidence of safety, efficacy and minimally invasive of laparoscopic left liver resection, evaluate the long-term efficacy including overall survival, disease-free survival as well as time to disease recurrence for the left liver carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic hepatectomy | Other | Procedure: laparoscopic hepatectomylaparoscopic hepatectomy |
| open liver resection | Other | Procedure: open liver resectionopen liver resection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Child-pugh A-B
- Primary hepatocellular carcinoma of the left liver lobe
- Tumor size ≤5cm in diameter
- KPS≥60
Key exclusion criteria (4 listed)
- Significant abnormal liver function
- Significant abnormal Heart function
- Significant abnormal lung function
- Significant abnormal kidney function
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 |
|---|---|---|
| laparoscopic hepatectomy | Procedure or surgery | laparoscopic hepatectomy |
| open liver resection | Procedure or surgery | open liver resection |
Primary outcome
amount of bleeding
Time frame: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
time of operation
Time frame: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
status of the resection margins
Time frame: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
bile leakage
Time frame: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
abdominal adhesion
Time frame: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
3 secondary outcomes
overall survival
Time frame: Participants will be followed for 5 years.
disease-free survival
Time frame: Participants will be followed for 5 years.
time to disease recurrence
Time frame: Participants will be followed for 5 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic hepatectomy and open liver resection in people with Laparoscopic Hepatectomy and Hepatocellular Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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 4 inclusion and 4 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 6 May 2014. 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 China. 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?
Contact Ya-Jin Chen, M.D. (00862034071169, drcaojun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of bleeding (time frame: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.). The study lists 5 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 6 May 2014.