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The Evaluation of Surgical Decisions and Prognosis of the Radiomics and Watson Artificial Intelligence in Patients With Hepatocellular Carcinoma

Primary Purpose

Liver Resection

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Radiomics and Watson artificial intelligence
Sponsored by
Zhujiang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Resection focused on measuring radiomics, Watson artificial intelligence, hepatocellular carcinoma, surgical decisions, prognosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 years≤ Age ≤80 years
  2. Compling with the diagnosis criteria of complex hepatic carcinoma.
  3. Primary hepatic carcinoma without intrahepatic or extrahepatic extensive cancer metastasis, the metastatic hepatic carcinoma whose primary focal has been controlled
  4. Preoperative liver function is Child - Pugh grade A or B.
  5. The patients are volunteered for the study.

Exclusion Criteria:

  1. Patients with mental illness.
  2. 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.)
  3. The patients refused to take part in the study.
  4. There are other co-existed malignant tumors.
  5. Benign liver diseases.
  6. Indocyanine green allergy

Sites / Locations

  • Zhujiang Hospital of Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiomics and Watson artificial intelligence

Arm Description

Outcomes

Primary Outcome Measures

Postoperative survival
Survival after hepatectomy

Secondary Outcome Measures

Disease-free survival
Survival time without tumor after HCC resection

Full Information

First Posted
April 4, 2019
Last Updated
February 13, 2022
Sponsor
Zhujiang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03917017
Brief Title
The Evaluation of Surgical Decisions and Prognosis of the Radiomics and Watson Artificial Intelligence in Patients With Hepatocellular Carcinoma
Official Title
The Evaluation of Surgical Decisions and Prognosis of the Radiomics and Watson Artificial Intelligence in Patients With Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhujiang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.Imaging omics is a newly emerging research method in recent years, which has great potential in cancer diagnosis and treatment, and can monitor treatment and predict the prognosis of patients, so as to better realize accurate diagnosis and treatment of diseases.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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Resection
Keywords
radiomics, Watson artificial intelligence, hepatocellular carcinoma, surgical decisions, prognosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiomics and Watson artificial intelligence
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Radiomics and Watson artificial intelligence
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative survival
Description
Survival after hepatectomy
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Disease-free survival
Description
Survival time without tumor after HCC resection
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Intraoperative blood loss
Description
Operative outcome
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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. Indocyanine green allergy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chihua Fang, M.D;Ph.D
Phone
+8613609700805
Email
fangch_dr@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chihua Fang, M.D;Ph.D
Organizational Affiliation
China, Guangdong Zhujiang Hospital of The Southern Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510282
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chihua Fang, M.D
Phone
(+86)2062782568
Email
fangch_dr@163.com
First Name & Middle Initial & Last Name & Degree
Shuo Qi, M.D
Phone
(+86)2062782568
Email
qishuousc@163.com

12. IPD Sharing Statement

Learn more about this trial

The Evaluation of Surgical Decisions and Prognosis of the Radiomics and Watson Artificial Intelligence in Patients With Hepatocellular Carcinoma

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