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

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ClinicalTrials.gov Identifier: NCT03917017
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Zhujiang Hospital

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.

Condition or disease Intervention/treatment Phase
Liver Resection Device: Radiomics and Watson artificial intelligence Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Evaluation of Surgical Decisions and Prognosis of the Radiomics and Watson Artificial Intelligence in Patients With Hepatocellular Carcinoma
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Arm Intervention/treatment
Experimental: Radiomics and Watson artificial intelligence Device: Radiomics and Watson artificial intelligence

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 Measures :
  1. Postoperative survival [ Time Frame: 5 years ]
    Survival after hepatectomy


Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: 5 years ]
    Survival time without tumor after HCC resection


Other Outcome Measures:
  1. Intraoperative blood loss [ Time Frame: intraoperative ]
    Operative outcome



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917017


Contacts
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Contact: Chihua Fang, M.D;Ph.D +8613609700805 fangch_dr@163.com

Locations
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China, Guangdong
Zhujiang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510282
Contact: Chihua Fang, M.D    (+86)2062782568    fangch_dr@163.com   
Contact: Shuo Qi, M.D    (+86)2062782568    qishuousc@163.com   
Sponsors and Collaborators
Zhujiang Hospital
Investigators
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Study Director: Chihua Fang, M.D;Ph.D China, Guangdong Zhujiang Hospital of The Southern Medical University

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Responsible Party: Zhujiang Hospital
ClinicalTrials.gov Identifier: NCT03917017     History of Changes
Other Study ID Numbers: 201901
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: January 2019

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

Keywords provided by Zhujiang Hospital:
radiomics
Watson artificial intelligence
hepatocellular carcinoma
surgical decisions
prognosis

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases