NCT03917017

Brief Summary

The aim of this study was to evaluate the surgical decisions and prognosis of the radiomics and Watson artificial intelligence in patients with hepatocellular carcinoma.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

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

January 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

6 years

First QC Date

April 4, 2019

Last Update Submit

February 13, 2022

Conditions

Liver Resection

Keywords

radiomicsWatson artificial intelligencehepatocellular carcinomasurgical decisionsprognosis

Outcome Measures

Primary Outcomes (1)

  • Postoperative survival

    Survival after hepatectomy

    5 years

Secondary Outcomes (1)

  • Disease-free survival

    5 years

Other Outcomes (1)

  • Intraoperative blood loss

    intraoperative

Study Arms (1)

Radiomics and Watson artificial intelligence

EXPERIMENTAL
Device: Radiomics and Watson artificial intelligence

Interventions

Radiomics and Watson artificial intelligenceDEVICE

The artificial intelligence platform developed by IBM Watson can provide treatment decisions and corresponding theoretical basis to guide surgical decisions based on the key clinical data of liver cancer patients. The imaging histology can be used to conduct intraoperative navigation surgical resection and treatment monitoring, and established a prognosis model to predict the prognosis of patients by grading the results of postoperative follow-up and microvascular invasion of pathological liver cancer, so as to better achieve accurate diagnosis and treatment of the disease.

Radiomics and Watson artificial intelligence

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years≤ Age ≤80 years
  • Compling with the diagnosis criteria of complex hepatic carcinoma.
  • Primary hepatic carcinoma without intrahepatic or extrahepatic extensive cancer metastasis, the metastatic hepatic carcinoma whose primary focal has been controlled
  • Preoperative liver function is Child - Pugh grade A or B.
  • The patients are volunteered for the study.

You may not qualify if:

  • Patients with mental illness.
  • Patients can't tolerate the operation owe to a variety of basic diseases (such as severe cardiopulmonary insufficiency, renal insufficiency, cachexia and blood system diseases, etc.)
  • The patients refused to take part in the study.
  • There are other co-existed malignant tumors.
  • Benign liver diseases.
  • Indocyanine green allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510282, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiomics

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Chihua Fang, M.D;Ph.D

    China, Guangdong Zhujiang Hospital of The Southern Medical University

    STUDY DIRECTOR

Central Study Contacts

Chihua Fang, M.D;Ph.D

CONTACT

+8613609700805fangch_dr@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2019

First Posted

April 16, 2019

Study Start

January 1, 2019

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 15, 2022

Record last verified: 2022-02

Locations

CN(1)