NCT03904667

Brief Summary

The aim of this study was to evaluate the surgical decisions of 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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

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

January 1, 2017

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 5, 2019

Status Verified

January 1, 2019

Enrollment Period

5 years

First QC Date

April 4, 2019

Last Update Submit

April 4, 2019

Conditions

Keywords

Watson artificial intelligencehepatocellular carcinomasurgical decisions

Outcome Measures

Primary Outcomes (1)

  • Operative outcomes

    Operative outcomes such as operative time, estimated blood loss and blood transfusion were recorded.

    intraoperative

Secondary Outcomes (1)

  • Postoperative survival

    3 years

Other Outcomes (1)

  • Disease-free survival

    3 years

Study Arms (2)

Watson on oncology recommends surgery

Other: Watson on oncology surgery decision evaluation

Watson on oncology does not recommend surgery

Other: Watson on oncology surgery decision evaluation

Interventions

Watson on oncology surgery decision evaluation. The system acquires and evaluates a large amount of structured and unstructured data from previous medical records through machine learning and natural language processing, and USES algorithms to select treatment options as the best choice for a particular patient.

Watson on oncology does not recommend surgeryWatson on oncology recommends surgery

Eligibility Criteria

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

A total of 150 hepatocellular carcinoma patients admitted to the department of hepatobiliary surgery of zhujiang hospital of southern medical university from January 2017 to December 2021 were selected and divided into experimental group and control group

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510282, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2019

First Posted

April 5, 2019

Study Start

January 1, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

April 5, 2019

Record last verified: 2019-01

Locations