NCT03739164

Brief Summary

This is a study following the outcomes and survival of patients undergoing the TAMLAPS hepatectomy at Florida Hospital Tampa by Dr. Iswanto Sucandy

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 13, 2018

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 13, 2018

Status Verified

November 1, 2018

Enrollment Period

6 years

First QC Date

November 9, 2018

Last Update Submit

November 9, 2018

Conditions

Liver CancerLiver TumorHepatocellular CarcinomaHilar Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Growth of the Future Liver remnant

    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

    2 weeks

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults between the ages of 18 and 80 with indication for hepatectomy of \>70% liver volume

You may qualify if:

  • Patients scheduled to undergo the TAMLAPS procedure by Dr. Iswanto Sucandy.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Hospital Tampa

Tampa, Florida, 33613, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples of healthy tissue pre and post operation will be collected

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, HepatocellularKlatskin Tumor

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCholangiocarcinoma

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
100 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2018

First Posted

November 13, 2018

Study Start

July 18, 2018

Primary Completion

August 1, 2024

Study Completion

December 31, 2024

Last Updated

November 13, 2018

Record last verified: 2018-11

Locations

US(1)