A Multicenter RCT Study of 3DV Technology in the Diagnosis and Treatment of PLC

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Liver Cancers
• Intervention / Treatment: Procedure: 3 d visualization technology

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 Type: Interventional
• Enrollment (Anticipated): 420
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chihua Fang, MD; Phone Number: 86 13609700805; Email: fangchihua@smu.edu.cn
• Study Contact Backup: Name: Zhenye Zhang, MM; Phone Number: 86 13570426966; Email: zhangzhenye_007@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510260
      • Recruiting
      • MI-3DVS
      • Contact: Chihua Fang, Phd; Phone Number: 86 13609700805; Email: fangchihua@smu.edu.cn
      • Contact: Wen Zhu, MD; Phone Number: 86 18664683986; Email: 281719356@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3d reconstruction visualization model to guide preoperative planning and surgery; 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.	Procedure: 3 d visualization technology; 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.
No Intervention: Based on high-quality thin slice CT images to guide preoperative planning and surgery.; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Main evaluation indicators	1 -, 3 -, 5 - year overall survival rate and tumor - free survival rate in control group and experimental group.	1 -, 3 -, 5 - year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 -, 3 -, 5 - year

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Investigators: Study Chair: Chihua Fang, MD, Zhujiang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): June 30, 2025
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 12, 2021

Study Record Updates

• Last Update Posted (Actual): February 10, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: RCT; recurrence; 3D; primary liver cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: 2020-KY-040-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No