Application of Watson for Oncology in Hepatocellular Carc... | NCT03904667

Studies
Application of Watson for Oncology in Hepatocellular Carcinoma Surgery

NCT03904667

Sponsor

Zhujiang Hospital

Status

Unknown status

Last Update Posted

Apr 5, 2019Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Liver Resection

Interventions

Watson on oncology surgery decision evaluation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Apr 4, 2019

First Submission Date that Met QC Criteria

Apr 4, 2019

First Posted Date

Apr 5, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2019

Last Update Posted Date

Apr 5, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Hepatectomy is an effective treatment for patients with hepatocellular carcinoma, but liver failure after hepatectomy may lead to increased postoperative mortality. Therefore, it is very important to make preoperative surgical decisions, evaluate the safety of the operation and identify which patients are likely to suffer from liver failure. The artificial intelligence platform developed by IBM Watson for Watson tumor treatment decisions can provide treatment decisions and corresponding theoretical basis to guide surgical decisions based on the key clinical data of liver cancer patients.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Watson on oncology surgery decision evaluation	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Operative outcomes	Operative outcomes such as operative time, estimated blood loss and blood transfusion were recorded.	intraoperative

Secondary Outcomes

Measure	Description	Time Frame
Postoperative survival	Survival after hepatectomy	3 years

Other Outcomes

Measure	Description	Time Frame
Disease-free survival	Survival time without tumor after hepatectomy	3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhujiang Hospital of Southern Medical University		Guangzhou	Guangdong	510282	China

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided