chest wall defect
Conditions
Interventions
3D printing PEEK implant group:None
Sponsors
Department of Thoracic Surgery, Tangdu Hospital, The Fourth Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: ? Age 18-75 years old, both male and female; ? Surgical resectable chest wall malignant tumors confirmed by histology, and head, chest, and abdomen CT, positron emission tomography computed tomography (PET-CT), or whole body bone scan are performed simultaneously to exclude metastasis from other organs or parts; ? I have not undergone chest wall surgery in the past and have not used any materials to implant into the chest wall; ? No chest wall deformity, trauma, infection, etc., expected survival time = 15 weeks; ? Subject ZPS score: 0-1; ? The lung function status of the subject is at least mild to moderate obstructive/restrictive pulmonary ventilation dysfunction; ? The detection indicators of important organ functions are normal, including blood routine, liver and kidney function, coagulation series, electrocardiogram, blood gas analysis, cardiac ultrasound, etc; ? The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: ? BMI<17.5 kg/m2; ? The medical history of the subject with primary malignant tumors in other organs; ? The subject has a history of respiratory diseases (such as chronic bronchitis, asthma, COPD, interstitial pneumonia, etc.) or has previously undergone esophageal, pulmonary, mediastinal, and cardiovascular surgery; ? Have a history of active autoimmune diseases, autoimmune diseases (interstitial pneumonia, colitis, hepatitis); ? The subject has a history of allergies to metal or polymer materials; ? Has undergone major surgery within 90 days prior to this surgery; ? Patients with tumors invading the lungs, heart, large blood vessels, or with metastasis to other organs; ? Patients with active pulmonary tuberculosis infection found through medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or patients with a history of active pulmonary tuberculosis infection more than 1 year before but without formal treatment; ? Having a history of immunodeficiency, including HIV antibody testing positive, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation and allogeneic bone marrow transplantation; ? Hepatitis B (HBsAg or HBcAb test positive, and HBV-DNA = 200 IU/mL or 103 copies/mL), hepatitis C (HCV antibody positive, and HCV-RNA above the detection limit of the analysis method) ?Pregnant and lactating women ?According to the judgment of the researcher, there are other factors that may cause the subject to be forced to terminate the study midway, such as suffering from other serious diseases (such as mental illness) requiring concurrent treatment, severe abnormalities in laboratory test values, family or social factors, which may affect the safety of the subject or the collection of test data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor R0 resection rate;Tangential distance;operative time;blood loss;Imaging examination;Pulmonary function test;Disease-free survival;Overall survival;Laboratory Examination;Electrocardiogram;ECOG score;Vital signs;Physical examination;Adverse reaction incidence rate;Incidence of complications; | — |
Countries
China
Contacts
Public ContactXiaofei Li
Department of Thoracic Surgery, Tangdu Hospital, The Fourth Military Medical University
Outcome results
None listed