Liver ResectionNCT03917017
The Evaluation of Surgical Decisions and Prognosis of the Radiomics and Watson Artificial Intelligence in Patients With Hepatocellular Carcinoma
A study testing Radiomics and Watson artificial intelligence in people with Liver Resection, run by Zhujiang Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Resection
- What is being tested?
- Radiomics and Watson artificial intelligence
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510282
Chihua Fang, M.D, (+86)2062782568, fangch_dr@163.com
Shuo Qi, M.D, (+86)2062782568, qishuousc@163.com
About this study
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.
Read the 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.
- Conditions
- Liver Resection
- Being tested
- Radiomics and Watson artificial intelligence
- Keywords
- radiomics, Watson artificial intelligence, hepatocellular carcinoma, surgical decisions, prognosis
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Radiomics and Watson artificial intelligence | Experimental | Not described Receives: Device: Radiomics and Watson artificial intelligence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative survival
Survival after hepatectomy
Measured: 5 years
Secondary outcomes (1)
Disease-free survival
Survival time without tumor after HCC resection
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver ResectionStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chihua Fang, M.D;Ph.D, Study director, China, Guangdong Zhujiang Hospital of The Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917017
- Sponsor's protocol ID
- 201901
- Status last verified
- Feb 2022
- First submitted
- 4 Apr 2019
- Last updated
- 15 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Surgical Decisions and Prognosis of the Radiomics and Watson Artificial Intelligence in Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03917017
- Acronym / sponsor ID
- 201901
- Conditions
- Liver Resection
- Keywords
- radiomics, Watson artificial intelligence, hepatocellular carcinoma, surgical decisions, prognosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiomics and Watson artificial intelligence | Experimental | Device: Radiomics and Watson artificial intelligence |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiomics and Watson artificial intelligenceThe 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. | Device | Radiomics and Watson artificial intelligence |
Primary outcome
Postoperative survival
Time frame: 5 years
Survival after hepatectomy
1 secondary outcome
Disease-free survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chihua Fang, M.D;Ph.D study director
China, Guangdong Zhujiang Hospital of The Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiomics and Watson artificial intelligence in people with Liver Resection, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chihua Fang, M.D;Ph.D (+8613609700805, fangch_dr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.