Primary Liver CancersNCT05118451
A Multicenter RCT Study of 3DV Technology in the Diagnosis and Treatment of PLC
A study testing 3 d visualization technology in people with Primary Liver Cancers, run by Zhujiang Hospital at 1 site in China.
Trial summary
Primary liver cancer is the most common malignant tumor of the liver. Radical surgery is the preferred treatment, but its 5-year recurrence rate is as high as 70%, which is often associated with incomplete surgical resection and residual tumor. Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Primary Liver Cancers
- What is being tested?
- 3 d visualization technology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 30 Jun 2025
- 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 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary liver cancer clinically diagnosed preoperatively (tumor ≥3cm to ≤10cm, diagnostic criteria: Primary liver cancer Diagnosis and Treatment Code 2019 edition);
- No tumor thrombi formation and distant metastasis were found in the imaging data;
- Child-Pugh grading standard of liver function was GRADE A or B;
- 18-66 years old;
- Complete clinical case data;
- all patients underwent surgical treatment;
- Voluntarily participate in the study and sign the informed consent.
Who cannot join
- There are basic diseases that cannot tolerate surgery (such as severe cardiopulmonary cerebral renal insufficiency);
- Preoperative imaging examination found cancer thrombus in main portal vein and branches, common hepatic vein and branches, main hepatic vein and branches and inferior vena cava;
- planned pregnancy, unplanned pregnancy and pregnancy;
- Preoperative child-Pugh grading standard of liver function was Grade C.
- Disease researchers that the investigator considers inappropriate to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
MI-3DVS
Guangzhou, Guangdong, 510260
Chihua Fang, Phd, 13609700805 ext. 86, fangchihua@smu.edu.cn
Wen Zhu, MD, 18664683986 ext. 86, 281719356@qq.com
About this study
Official title: A Multicenter Randomized Controlled Clinical Study of 3d Visualization Technology in the Diagnosis and Treatment of Primary Liver Cancer
Primary liver cancer is the most common malignant tumor of the liver. Radical surgery is the preferred treatment, but its 5-year recurrence rate is as high as 70%, which is often associated with incomplete surgical resection and residual tumor. Since the 21st century, with the rapid development of surgery and new science and technology, the diagnosis and treatment of liver diseases have been closely linked with imaging diagnostics, biomedical engineering, molecular imaging technology, computer science and other interdisciplinary subjects. Three-dimensional (3D) visualization technology is one of the emerging auxiliary diagnosis and treatment methods. It plays an important role in accurate diagnosis, surgical planning and surgical navigation of primary liver cancer, and can effectively improve the success rate of surgery and reduce the incidence of postoperative complications. Its diagnostic and treatment value in primary liver cancer is mainly reflected in :(1) to clarify the spatial location relationship of abdominal space occupying lesions, understand the relationship between space occupying lesions and surrounding tissues, important blood vessels and cavities, judge tumor resectable, and make preoperative planning for tumor classification and surgical resection scope. (2) Calculation of individual liver segmentation and liver volume based on the topological relationship of blood flow 4. 3D simulation software was used to automatically calculate the resectioned liver volume and residual liver volume with statistical correlation, which was helpful to judge the probability of liver failure after liver cancer. (3) Variation of hepatic artery, portal vein and bile duct can be found, and the variation of duct can be evaluated by three-dimensional model, including whether there is contact, length of contact, whether there is stenosis in lumen, etc., especially the resectable ability of tumor patients can be evaluated by 3D and real-time dynamic navigation during surgery.
Read the detailed description
Intervention of the experimental group: based on high-quality thin-slice CT image reconstruction 3d visualization model to guide preoperative planning and surgery. The surgical process and perioperative management are as follows: All patients in this study were operated by the medical team whose main member was the medical team leader, and all patients were treated with anatomic hepatectomy. The main points of anatomic hepatectomy are summarized as follows :(1) determine and mark the boundary of liver segment according to ischemia line or staining. (2) The postoperative liver section should fully expose the iconic veins and vessels. (3) The initial part of Glisson's pedicle of the target liver segment was severed. Tissue was taken from the surgical margins of all patients and sent to frozen sections for examination. Routine pathological examinations were performed on all resected liver after surgery. Postoperative patients were treated with relevant perioperative symptomatic treatment, and blood routine examination, liver function and coagulation function were detected on the 1st, 3rd and 5th day after surgery.
Intervention in the control group: preoperative planning and operation were guided based on high-quality thin-slice CT images. Perioperative management same as above.
- Conditions
- Primary Liver Cancers
- Being tested
- 3 d visualization technology
- Keywords
- primary liver cancer, RCT, recurrence, 3D
- Medical subject headings
- Carcinoma, Hepatocellular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 d visualization technologyProcedure or surgery
3D visualization technology refers to the conversion of 2d imaging data such as CT and MR into 3D stereoscopic images through computer calculation, analysis and reconstruction, visually separating the shapes and spatial distribution features of targets such as liver, blood vessels and tumors directly, accurately and quickly to present three-dimensional views. Combined with transparency, rotation, scaling and measurement techniques, real-time and interactive 3D dynamic analysis of 3d visual model is carried out. In addition, the computer was used to simulate the operation, and the feasible surgical plan was discussed. The best surgical plan was selected based on the patient's individual data.
| Study group | Role | What they receive |
|---|---|---|
| 3d reconstruction visualization model to guide preoperative planning and surgery | Experimental | All patients in this study were operated by the medical team whose main members were the medical team leader, and all patients underwent anatomic hepatectomy. The main points of anatomic hepatectomy are summarized as follows :(1) determine and mark the boundary of liver segment according to ischemia line or staining. (2) The postoperative liver section should fully expose the iconic veins and vessels. (3) The initial part of Glisson's pedicle of the target liver segment was severed. Tissue was taken from the surgical margins of all patients and sent to frozen sections for examination. Routine pathological examinations were performed on all resected liver after surgery. Postoperative patients were treated with relevant perioperative symptomatic treatment, and blood routine examination, liver function and coagulation function were detected on the 1st, 3rd and 5th day after surgery. Receives: Procedure: 3 d visualization technology |
| Based on high-quality thin slice CT images to guide preoperative planning and surgery. | No intervention | All patients in this study were operated by the medical team whose main members were the medical team leader, and all patients underwent anatomic hepatectomy. The main points of anatomic hepatectomy are summarized as follows :(1) determine and mark the boundary of liver segment according to ischemia line or staining. (2) The postoperative liver section should fully expose the iconic veins and vessels. (3) The initial part of Glisson's pedicle of the target liver segment was severed. Tissue was taken from the surgical margins of all patients and sent to frozen sections for examination. Routine pathological examinations were performed on all resected liver after surgery. Postoperative patients were treated with relevant perioperative symptomatic treatment, and blood routine examination, liver function and coagulation function were detected on the 1st, 3rd and 5th day after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main evaluation indicators
1 -, 3 -, 5 - year overall survival rate and tumor - free survival rate in control group and experimental group.
Measured: 1 -, 3 -, 5 - year
Secondary outcomes (1)
Secondary evaluation index
① The consistency of preoperative evaluation and actual situation between the experimental group and the control group; ② To evaluate the influence of 3d visualization on surgical strategy, changes of perioperative liver function indexes and postoperative complications.
Measured: 1 -, 3 -, 5 - year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start1 Jul 2020
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Liver CancersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention of the experimental group: based on high-quality thin-slice CT image reconstruction 3d visualization model to guide preoperative planning and surgery. The surgical process and perioperative management are as follows: All patients in this study were operated by the medical team whose main member was the medical team leader, and all patients were treated with anatomic hepatectomy. Intervention in the control group: preoperative planning and operation were guided based on high-quality thin-slice CT images.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chihua Fang,MD, Zhujiang Hospital
- Investigators
- Chihua Fang, MD, Study chair, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118451
- Sponsor's protocol ID
- 2020-KY-040-02
- Status last verified
- Feb 2022
- First submitted
- 22 Sep 2021
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zeng X, Tao H, Dong Y, Zhang Y, Yang J, Xuan F, Zhou J, Jia W, Liu J, Dai C, Hu H, Xiang N, Zeng N, Zhou W, Lau W, Yang J, Fang C. Impact of three-dimensional reconstruction visualization technology on short-term and long-term outcomes after hepatectomy in patients with hepatocellular carcinoma: a propensity-score-matched and inverse probability of treatment-weighted multicenter study. Int J Surg. 2024 Mar 1;110(3):1663-1676. doi: 10.1097/JS9.0000000000001047.
PubMed 38241321
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Clinical Study of 3d Visualization Technology in the Diagnosis and Treatment of Primary Liver Cancer
- ClinicalTrials.gov ID
- NCT05118451
- Acronym / sponsor ID
- 2020-KY-040-02
- Conditions
- Primary Liver Cancers
- Keywords
- primary liver cancer, RCT, recurrence, 3D
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 12 Nov 2021 (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.
Primary liver cancer is the most common malignant tumor of the liver. Radical surgery is the preferred treatment, but its 5-year recurrence rate is as high as 70%, which is often associated with incomplete surgical resection and residual tumor. Since the 21st century, with the rapid development of surgery and new science and technology, the diagnosis and treatment of liver diseases have been closely linked with imaging diagnostics, biomedical engineering, molecular imaging technology, computer science and other interdisciplinary subjects. Three-dimensional (3D) visualization technology is one of the emerging auxiliary diagnosis and treatment methods. It plays an important role in accurate diagnosis, surgical planning and surgical navigation of primary liver cancer, and can effectively improve the success rate of surgery and reduce the incidence of postoperative complications. Its diagnostic and treatment value in primary liver cancer is mainly reflected in :(1) to clarify the spatial location relationship of abdominal space occupying lesions, understand the relationship between space occupying lesions and surrounding tissues, important blood vessels and cavities, judge tumor resectable, and make preoperative planning for tumor classification and surgical resection scope. (2) Calculation of individual liver segmentation and liver volume based on the topological relationship of blood flow 4. 3D simulation software was used to automatically calculate the resectioned liver volume and residual liver volume with statistical correlation, which was helpful to judge the probability of liver failure after liver cancer. (3) Variation of hepatic artery, portal vein and bile duct can be found, and the variation of duct can be evaluated by three-dimensional model, including whether there is contact, length of contact, whether there is stenosis in lumen, etc., especially the resectable ability of tumor patients can be evaluated by 3D and real-time dynamic navigation during surgery.
Detailed description
Intervention of the experimental group: based on high-quality thin-slice CT image reconstruction 3d visualization model to guide preoperative planning and surgery. The surgical process and perioperative management are as follows: All patients in this study were operated by the medical team whose main member was the medical team leader, and all patients were treated with anatomic hepatectomy. The main points of anatomic hepatectomy are summarized as follows :(1) determine and mark the boundary of liver segment according to ischemia line or staining. (2) The postoperative liver section should fully expose the iconic veins and vessels. (3) The initial part of Glisson's pedicle of the target liver segment was severed. Tissue was taken from the surgical margins of all patients and sent to frozen sections for examination. Routine pathological examinations were performed on all resected liver after surgery. Postoperative patients were treated with relevant perioperative symptomatic treatment, and blood routine examination, liver function and coagulation function were detected on the 1st, 3rd and 5th day after surgery.
Intervention in the control group: preoperative planning and operation were guided based on high-quality thin-slice CT images. Perioperative management same as above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Intervention of the experimental group: based on high-quality thin-slice CT image reconstruction 3d visualization model to guide preoperative planning and surgery. The surgical process and perioperative management are as follows: All patients in this study were operated by the medical team whose main member was the medical team leader, and all patients were treated with anatomic hepatectomy. Intervention in the control group: preoperative planning and operation were guided based on high-quality thin-slice CT images.
| Arm | Type | Receives |
|---|---|---|
| 3d reconstruction visualization model to guide preoperative planning and surgery | Experimental | Procedure: 3 d visualization technologyAll patients in this study were operated by the medical team whose main members were the medical team leader, and all patients underwent anatomic hepatectomy. The main points of anatomic hepatectomy are summarized as follows :(1) determine and mark the boundary of liver segment according to ischemia line or staining. (2) The postoperative liver section should fully expose the iconic veins and vessels. (3) The initial part of Glisson's pedicle of the target liver segment was severed. Tissue was taken from the surgical margins of all patients and sent to frozen sections for examination. Routine pathological examinations were performed on all resected liver after surgery. Postoperative patients were treated with relevant perioperative symptomatic treatment, and blood routine examination, liver function and coagulation function were detected on the 1st, 3rd and 5th day after surgery. |
| Based on high-quality thin slice CT images to guide preoperative planning and surgery. | No intervention | –All patients in this study were operated by the medical team whose main members were the medical team leader, and all patients underwent anatomic hepatectomy. The main points of anatomic hepatectomy are summarized as follows :(1) determine and mark the boundary of liver segment according to ischemia line or staining. (2) The postoperative liver section should fully expose the iconic veins and vessels. (3) The initial part of Glisson's pedicle of the target liver segment was severed. Tissue was taken from the surgical margins of all patients and sent to frozen sections for examination. Routine pathological examinations were performed on all resected liver after surgery. Postoperative patients were treated with relevant perioperative symptomatic treatment, and blood routine examination, liver function and coagulation function were detected on the 1st, 3rd and 5th day after surgery. |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with primary liver cancer clinically diagnosed preoperatively (tumor ≥3cm to ≤10cm, diagnostic criteria: Primary liver cancer Diagnosis and Treatment Code 2019 edition);
- No tumor thrombi formation and distant metastasis were found in the imaging data;
- Child-Pugh grading standard of liver function was GRADE A or B;
- 18-66 years old;
- Complete clinical case data;
Key exclusion criteria (5 listed)
- There are basic diseases that cannot tolerate surgery (such as severe cardiopulmonary cerebral renal insufficiency);
- Preoperative imaging examination found cancer thrombus in main portal vein and branches, common hepatic vein and branches, main hepatic vein and branches and inferior vena cava;
- planned pregnancy, unplanned pregnancy and pregnancy;
- Preoperative child-Pugh grading standard of liver function was Grade C.
- Disease researchers that the investigator considers inappropriate to participate in this clinical trial.
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 |
|---|---|---|
| 3 d visualization technology3D visualization technology refers to the conversion of 2d imaging data such as CT and MR into 3D stereoscopic images through computer calculation, analysis and reconstruction, visually separating the shapes and spatial distribution features of targets such as liver, blood vessels and tumors directly, accurately and quickly to present three-dimensional views. Combined with transparency, rotation, scaling and measurement techniques, real-time and interactive 3D dynamic analysis of 3d visual model is carried out. In addition, the computer was used to simulate the operation, and the feasible surgical plan was discussed. The best surgical plan was selected based on the patient's individual data. | Procedure or surgery | 3d reconstruction visualization model to guide preoperative planning and surgery |
Primary outcome
Main evaluation indicators
Time frame: 1 -, 3 -, 5 - year
1 -, 3 -, 5 - year overall survival rate and tumor - free survival rate in control group and experimental group.
1 secondary outcome
Secondary evaluation index
Time frame: 1 -, 3 -, 5 - year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Derived from this study: PubMed 38241321Zeng X, Tao H, Dong Y, Zhang Y, Yang J, Xuan F, Zhou J, Jia W, Liu J, Dai C, Hu H, Xiang N, Zeng N, Zhou W, Lau W, Yang J, Fang C. Impact of three-dimensional reconstruction visualization technology on short-term and long-term outcomes after hepatectomy in patients with hepatocellular carcinoma: a propensity-score-matched and inverse probability of treatment-weighted multicenter study. Int J Surg. 2024 Mar 1;110(3):1663-1676. doi: 10.1097/JS9.0000000000001047.
- Individual participant dataSharing planned: No
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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, MD study chair
Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 d visualization technology in people with Primary Liver Cancers, 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 7 inclusion and 5 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 10 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, MD (13609700805 ext. 86, fangchihua@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main evaluation indicators (time frame: 1 -, 3 -, 5 - year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05118451, which also lists 1 linked publication.
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 10 Feb 2022.