Chest Wall Tumor
Conditions
Keywords
PCL Implant, Chest Wall Reconstruction, 3D Printing Technology
Brief summary
This project focuses on patients with chest wall tumors who are expected to have a maximum intraoperative anterolateral chest wall defect diameter of 5-10 cm and require chest wall reconstruction with rib implants. It aims to evaluate the efficacy and safety of biodegradable 3D-printed implants in chest wall reconstruction surgery, providing a superior reconstruction strategy for patients with tumor-induced chest wall defects.
Interventions
Extended resection of chest wall tumors with subsequent biodegradable polycaprolactone (PCL) 3D-printed rib prosthetic reconstruction
Sponsors
Tang-Du Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients who meet all of the following criteria are eligible to participate in the study: 1. Aged 18-70 years; 2. No gender restriction; 3. ECOG Performance Status 0-1; 4. Chest CT-confirmed chest wall-originating tumor; 5. Histologically/cytologically confirmed primary or metastatic chest wall tumor; 6. Anticipated intraoperative anterolateral chest wall defect diameter 5-10 cm (maximum) or costal arch reconstruction required (investigator-assessed); 7. Scheduled for prosthetic chest wall reconstruction; 8. No prior chest wall reconstruction surgery; 9. Willing to provide written informed consent and comply with follow-up visits and protocol requirements.
Exclusion criteria
* Patients who meet any of the following criteria are ineligible for this study: 1. Patients with posterior chest wall defects; 2. Uncontrolled underlying medical conditions or contraindications to general anesthesia; 3. Pregnant or lactating women; 4. Concurrent severe comorbidities that may interfere with study evaluations, including: Severe hepatic, cardiac, or renal diseases; Active malignancies (other than the indicated chest wall tumor); Alcohol use disorder 5. lnability to provide reliable symptom reporting due to:P sychiatric disorders, Severe neurosis, Non-compliance with trial requirements 6. Women of childbearing potential\* and their partners unwilling to use effective contraception; 7. Prior history of chest wall reconstruction surgery; 8. Active uncontrolled bacterial, fungal, or viral infections; 9. Participation in other clinical trials within 3 months prior to enrollment; 10. Any other conditions deemedunsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abnormal breathing | Postoperative 1 month, 3 months, 6 months, and 12 months | Observe the integrity of the chest wall shape and the presence of abnormal breathing |
| Implant Degradation Performance Monitoring | Postoperative 1 month, 3 months, 6 months, and 12 months | Thin-section chest CT + 3D imaging (DICOM format data) * Implant volume changes: Precise measurement of volumetric changes through 3D reconstruction; * Implant density changes: Quantification of density changes using Hounsfield Units (HU values), including adjacent bone tissue changes; ③ Bone resorption/formation: Observation of potential bone loss or new bone formation; ④ Implant structural integrity: Assessment for cracks, voids, or other structural compromises. |
| Peri-implant Soft Tissue Evaluation | Postoperative 1 month, 3 months, 6 months, and 12 months | Chest MRI to evaluate thickening of the pleural fibrous layer surrounding the implant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in respiratory function--Pulmonary Function Test | Postoperative 1 month, 3 months, 6 months, and 12 months | The assessment of changes in respiratory function through pulmonary function tests includes indicators such as Forced Vital Capacity (FVC), Forced Expiratory Volume in the First Second (FEV₁), Total Lung Capacity (TLC), Residual Volume (RV), and Maximum Voluntary Ventilation (MVV). |
| Adverse events | form date of enrollment until the end of the study, assessed up to 12 months | — |
Countries
China
Contacts
Primary ContactXiaolong Yan
Backup ContactLei Wang
Outcome results
None listed