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Effective preoperative planning and real-time intraoperative guidance are crucial for performing accurate liver resections. To address this need, the researchers have designed advanced 3D-printed liver models using a self-healing elastomer, created through the copolymerization of 4-acryloylmorpholine (ACMO) and methoxy poly(ethylene glycol) acrylate (mPEGA). These models demonstrate outstanding healing properties, swiftly restoring their structure within minutes at room temperature, and quickly recovering after incisions.
In previous studies, Professor Yuhua Zhang, the project applicant, collaborated with a team from Zhejiang University to develop a 3D-printed liver model that is self-healing and reusable for repeated cutting. They preliminarily explored the feasibility of applying this model for preoperative planning and surgical training for liver surgeries. The results were published in Nature Communications (Lu et al., Nat Commun. Dec 19;14(1):8447). Building on this, the applicant intends to establish a personalized liver surgery planning system (Personalized Liver Surgery Planning System Based on High-Fidelity 3D Printed Self-Healing Liver Models, SH-LPS), which will assess, through a randomized controlled trial, the value of SH-LPS in improving liver surgery efficiency and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D group | Experimental | A three-dimensional digital model is constructed based on the patient's CT/MRI data and a physical model is printed. Using the model's self-healing property after cutting, multiple simulated surgeries are performed to help plan the optimal surgical approach. The best surgical path derived from the model is combined with traditional CT/MRI data to determine the final surgical path, and the surgery is then performed according to this finalized path. |
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| CT/MRI group | Sham Comparator | The surgical approach is planned based on traditional two-dimensional CT/MRI images, and the surgery is performed according to this planned path. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D printed models | Device | A three-dimensional digital model is constructed based on the patient's preoperative CT/MRI images, and a personalized physical model is created using 3D printing. This model has the ability to self-heal after being cut. Surgeons can perform multiple simulated surgeries on the model to plan the optimal surgical path before the authetic surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Opertation duration | The duration from the start to the end of the surgery. | Until the end of the surgey |
| Blood loss | Blood loss during the operation | Until the end of the surgey |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | The percentage of surgical cases in which the tumor is completely removed with no microscopic residual cancer cells left at the margins of the resected tissue | Until the day the official pathology report comes out, an average of two weeks |
| Surgical complications |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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|
| CT or MRI image | Other | Obtain the patient's CT/MRI images and determine the definitive surgical path based on the two-dimensional images. |
|
The incidence rate of surgical complications |
| Until three months after the surgery |
| Postoperative hospital stay. | Postoperative hospital stay refers to the period of time a patient remains in the hospital after undergoing surgery, until they are medically stable and deemed fit for discharge. | Until the day the patient is discharged, an average of one week. |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |