Clinical trial NCT06994533: Comparative Study on Different Bone Reconstruction After Chest Wall Tumor Resection
Official title: Comparative Study on the Effect of New Reconstruction Methods and Traditional Reconstruction Methods on Bone Reconstruction After Chest Wall Tumor Resection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chest Wall Tumor
Lead sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: Chest wall tumors are one of the important diseases in thoracic surgery, and surgery is still the main treatment for this disease in clinical practice. Surgery for chest wall tumors requires extensive resection. However, the extensive chest wall defect formed after extensive resection can lead to the destruction of the integrity and stability of the chest wall, thus requiring chest wall reconstruction. The reconstruction of the chest wall after resection has always been a difficult point in chest wall tumor surgery, and the reconstruction of the chest wall bone is a key point in chest wall reconstruction. The goals of successful chest wall bone reconstruction include restoring chest wall rigidity, minimizing chest wall deformities, maintaining lung mechanics, and protecting thoracic organs. At present, traditional reconstruction methods are based on simulating and restoring the anatomical structure of the thoracic spine. For certain special areas of chest wall defects (such as posterior rib and paraspinal tumors), it is difficult to perform residual fixation; At the same time, traditional reconstruction methods suffer from insufficient stability after reconstruction, such as loosening, detachment, displacement, and even fracture. Therefore, it is necessary to design new chest wall reconstruction methods to meet clinical needs.

Detailed description: Chest wall tumors are one of the important diseases in thoracic surgery, and surgery is still the main treatment for this disease in clinical practice. Surgery for chest wall tumors requires the adoption of appropriate treatment plans based on the pathological results of the tumor, the location of tumor growth, the degree of local invasion of the tumor, and the presence of metastasis at the time of tumor detection. More importantly, surgical resection of primary malignant tumors of the chest wall should be carried out under careful planning, as most patients only have one chance of cure, and it becomes very difficult to undergo reoperation after tumor recurrence or surgical failure. Moreover, even if these patients undergo reoperation, their prognosis is also poor. To ensure the thoroughness of the surgery, it is usually necessary to perform an extensive resection of the chest wall tumor. However, the extensive chest wall defect formed after extensive resection can lead to the destruction of the integrity and stability of the chest wall, and if not handled properly, adverse consequences may occur. If chest wall softening, abnormal breathing, and acute respiratory failure occur early after surgery, it will affect the therapeutic effect of the surgery; In the late postoperative period, chest wall deformities, pulmonary hernias, chronic respiratory dysfunction, and even scoliosis may occur, affecting the quality of life. The reconstruction of the chest wall after resection has always been a difficult point in chest wall tumor surgery, and the reconstruction of the chest wall bone is a key point in chest wall reconstruction. The goals of successful chest wall bone reconstruction include restoring chest wall rigidity, minimizing chest wall deformities, maintaining lung mechanics, and protecting thoracic organs. In clinical treatment, it has been found that traditional reconstruction methods are unable to perform residual fixation for certain special areas of chest wall defects (such as posterior rib paravertebral tumors); There are also defects in the stability of the reconstructed implant, such as loosening, detachment, displacement, and even fracture. Therefore, it is necessary to design new chest wall reconstruction methods to meet clinical needs.

Eligibility criteria: Inclusion Criteria:

1. 18-70 years old, male or female not limited
2. Anesthesia ASA score I-II
3. Malignant tumor of soft tissue in the chest
4. Malignant tumors of ribs, rib cartilage, and sternum
5. Tumors with uncertain or unknown properties of ribs, rib cartilage, and sternum
6. Giant benign tumors of ribs, rib cartilage, and sternum
7. The preoperative examination results indicate that the tumor has not undergone distant metastasis
8. Willing to participate in the research and sign the informed consent form

Exclusion Criteria:

1. Patients with distant metastasis detected during preoperative examination
2. Inoperable tumor
3. During the examination, it was discovered that the patient had another type of malignant tumor present
4. ECOG 4
5. Suffering from active or chronic fungal/bacterial/viral infections
6. History of allergy to anesthesia related drugs
7. Heart and lung dysfunction, liver and kidney dysfunction, inability to tolerate surgery
8. Patients with mental disorders who are unable to cooperate with treatment

Primary outcomes:
measure: Stability of implants
timeFrame: 3 years
Secondary outcomes:
measure: Respiratory discomfort
timeFrame: 3 years
measure: Postoperative complications
timeFrame: 3 years
measure: Complications of implants
timeFrame: 3 years
measure: Postoperative physical function status
timeFrame: 3 years
measure: Quality of life
timeFrame: 3 years
measure: Postoperative chronic pain
timeFrame: 3 years
measure: Postoperative recovery of daily work
timeFrame: 3 years
measure: Postoperative changes in lung function
timeFrame: 3 years
measure: chest wall discomfort in patients after reconstruction surgery
timeFrame: 3 years
measure: Chest wall appearance after reconstruction surgery
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References: