Liver TransplantationNCT06331273
Impact of "No-touch" Technique on the Outcome of Liver Transplantation for Hepatocellular Carcinoma
An observational study of Liver Transplantation and No-touch Technique, run by Zhejiang University.
Trial summary
The "no-touch" technique has been one of the most important principles of oncological surgery and aimed to prevent seeding and tumor cell dissemination. Previous studies in hepatectomy have shown that no-touch technique surgery can reduce HCC recurrence and improve the survival of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation, No-touch Technique, Hepatocellular Carcinoma
- What is being tested?
- Liver transplantation with "No-touch" technique
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HCC patients who undergoing deceased donor liver transplantation for the first time.
Who may be able to join
- Diagnosis of HCC based on CT or MRI imaging or needle biopsy confirming a histologic diagnosis of HCC.
- Patients undergoing deceased donor liver transplantation for the first time.
Who cannot join
- patients who received split LT or simultaneous transplantation, (2) patients who received re-transplantation, (3) patients with macroscopic portal vein tumor thrombosis or other macrovascular invasion, (4) patients with incomplete follow-up or incomplete important parameters records.
About this study
The "no-touch" technique has been one of the most important principles of oncological surgery and aimed to prevent seeding and tumor cell dissemination. Previous studies in hepatectomy have shown that no-touch technique surgery can reduce HCC recurrence and improve the survival of patients. However, there is no consensus on whether the no-touch technique in LT for HCC improves the outcomes. This study aims to prospectively include liver transplant patients from multiple transplant centers, collecting their pre-transplant clinical information, post-transplant pathological records and exploring and clarify the correlation between "no-touch" technique and the prognosis of LT patients.
- Being tested
- Liver transplantation with "No-touch" technique
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver transplantation with "No-touch" techniqueProcedure or surgery
The core principle of "no-touch" tumor surgery revolves around avoiding direct contact with the tumor or surrounding tissues as much as possible to minimize the release of cancer cells into the bloodstream or nearby tissues.
| Study group | Role | What they receive |
|---|---|---|
| HCC patients fulfill Hangzhou criteria and receive LT with "No-touch" technique | Not described Receives: Procedure: Liver transplantation with "No-touch" technique | |
| HCC patients exceed Hangzhou criteria and receive LT with "No-touch" technique | Not described Receives: Procedure: Liver transplantation with "No-touch" technique | |
| HCC patients fulfill Hangzhou criteria and receive LT without "No-touch" technique | Not described | |
| HCC patients exceed Hangzhou criteria and receive LT without"No-touch" technique | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free surviavl rate
Measured: 2024.4.1-2028.4.1
Overall survival rate
Measured: 2024.4.1-2028.4.1
Tumor recurrence rate
Measured: 2024.4.1-2028.4.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Zhejiang 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Shulan (Hangzhou) Hospital
- Responsible party
- Principal investigator, Xiao Xu, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331273
- Sponsor's protocol ID
- CT2024-ZJU-OBS3
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of "No-touch" Technique on the Outcome of Liver Transplantation for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06331273
- Acronym / sponsor ID
- CT2024-ZJU-OBS3
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Shulan (Hangzhou) Hospital
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 26 Mar 2024 (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.
The "no-touch" technique has been one of the most important principles of oncological surgery and aimed to prevent seeding and tumor cell dissemination. Previous studies in hepatectomy have shown that no-touch technique surgery can reduce HCC recurrence and improve the survival of patients. However, there is no consensus on whether the no-touch technique in LT for HCC improves the outcomes. This study aims to prospectively include liver transplant patients from multiple transplant centers, collecting their pre-transplant clinical information, post-transplant pathological records and exploring and clarify the correlation between "no-touch" technique and the prognosis of LT patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HCC patients fulfill Hangzhou criteria and receive LT with "No-touch" technique | – | Procedure: Liver transplantation with "No-touch" technique |
| HCC patients exceed Hangzhou criteria and receive LT with "No-touch" technique | – | Procedure: Liver transplantation with "No-touch" technique |
| HCC patients fulfill Hangzhou criteria and receive LT without "No-touch" technique | – | – |
| HCC patients exceed Hangzhou criteria and receive LT without"No-touch" technique | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HCC patients who undergoing deceased donor liver transplantation for the first time.
Key inclusion criteria (2 listed)
- Diagnosis of HCC based on CT or MRI imaging or needle biopsy confirming a histologic diagnosis of HCC.
- Patients undergoing deceased donor liver transplantation for the first time.
Key exclusion criteria (1 listed)
- patients who received split LT or simultaneous transplantation, (2) patients who received re-transplantation, (3) patients with macroscopic portal vein tumor thrombosis or other macrovascular invasion, (4) patients with incomplete follow-up or incomplete important parameters records.
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 |
|---|---|---|
| Liver transplantation with "No-touch" techniqueThe core principle of "no-touch" tumor surgery revolves around avoiding direct contact with the tumor or surrounding tissues as much as possible to minimize the release of cancer cells into the bloodstream or nearby tissues. | Procedure or surgery | HCC patients exceed Hangzhou criteria and receive LT with "No-touch" technique, HCC patients fulfill Hangzhou criteria and receive LT with "No-touch" technique |
Primary outcome
Recurrence free surviavl rate
Time frame: 2024.4.1-2028.4.1
Overall survival rate
Time frame: 2024.4.1-2028.4.1
Tumor recurrence rate
Time frame: 2024.4.1-2028.4.1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation and No-touch Technique, run by Zhejiang University.
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 2 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: opening soon, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Recurrence free surviavl rate (time frame: 2024.4.1-2028.4.1). 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 26 Mar 2024.