Chest wall reconstruction: Extended resection of chest wall tumors with subsequent biodegradable polycaprolactone (PCL) 3D-printed rib prosthetic reconstruction
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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
Primary outcome measure(s)
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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