Liver CancerTAMLAPSNCT03739164
Tampa Associating Microwave Liver Ablation With Portal Vein Ligation for Staged Hepatectomy (TAMLAPS)
An observational study of Liver Cancer and Liver Tumor, run by Florida Hospital Tampa Bay Division at 1 site in United States.
Trial summary
This is a study following the outcomes and survival of patients undergoing the TAMLAPS hepatectomy at Florida Hospital Tampa by Dr. Iswanto Sucandy Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cancer, Liver Tumor, Hepatocellular Carcinoma
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2018to 31 Dec 2024
- How long will I take part?
- 100 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults between the ages of 18 and 80 with indication for hepatectomy of >70% liver volume
Who may be able to join
- Patients scheduled to undergo the TAMLAPS procedure by Dr. Iswanto Sucandy.
Who cannot join
- Subjects with history of noncompliance.
- Subjects with physical health, substance abuse, or mental health problems that will limit the subject's ability to meet study requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Complete Robotic Tampa Associating Microwave Liver Ablation With Portal Vein Ligation
This is a study following the outcomes and survival of patients undergoing the TAMLAPS hepatectomy at Florida Hospital Tampa by Dr. Iswanto Sucandy
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular, Klatskin Tumor
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth of the Future Liver remnant
- Liver growth determined by measuring the kinetic growth rate obtained from pre-operative and post-op stage one CT evaluations of the FLR volume
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start18 Jul 2018
- Primary completion1 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
- Target duration
- 100 Years
Sponsor and investigators
- Lead sponsor
- Florida Hospital Tampa Bay Division
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739164
- Sponsor's protocol ID
- TAMLAPS
- Acronym
- TAMLAPS
- Status last verified
- Nov 2018
- First submitted
- 9 Nov 2018
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Robotic Tampa Associating Microwave Liver Ablation With Portal Vein Ligation
- ClinicalTrials.gov ID
- NCT03739164
- Acronym / sponsor ID
- TAMLAPS / TAMLAPS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Florida Hospital Tampa Bay DivisionUniversity, hospital or other
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Nov 2018 (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 is a study following the outcomes and survival of patients undergoing the TAMLAPS hepatectomy at Florida Hospital Tampa by Dr. Iswanto Sucandy
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 100 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults between the ages of 18 and 80 with indication for hepatectomy of >70% liver volume
Key inclusion criteria (1 listed)
- Patients scheduled to undergo the TAMLAPS procedure by Dr. Iswanto Sucandy.
Key exclusion criteria (2 listed)
- Subjects with history of noncompliance.
- Subjects with physical health, substance abuse, or mental health problems that will limit the subject's ability to meet study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Growth of the Future Liver remnant
Time frame: 2 weeks
1. Liver growth determined by measuring the kinetic growth rate obtained from pre-operative and post-op stage one CT evaluations of the FLR volume
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Liver Cancer and Liver Tumor, run by Florida Hospital Tampa Bay Division at 1 site in United States.
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 2 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 13 Nov 2018. 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 United States. 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?
Growth of the Future Liver remnant (time frame: 2 weeks). 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 13 Nov 2018.