Chest Wall TumorNCT06994533
Comparative Study on Different Bone Reconstruction After Chest Wall Tumor Resection
A study testing methods on bone reconstrucion after chest wall tumor resection in people with Chest Wall Tumor, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chest Wall Tumor
- What is being tested?
- methods on bone reconstrucion after chest wall tumor resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years old, male or female not limited
- Anesthesia ASA score I-II
- Malignant tumor of soft tissue in the chest
- Malignant tumors of ribs, rib cartilage, and sternum
- Tumors with uncertain or unknown properties of ribs, rib cartilage, and sternum
- Giant benign tumors of ribs, rib cartilage, and sternum
- The preoperative examination results indicate that the tumor has not undergone distant metastasis
- Willing to participate in the research and sign the informed consent form
Who cannot join
- Patients with distant metastasis detected during preoperative examination
- Inoperable tumor
- During the examination, it was discovered that the patient had another type of malignant tumor present
- ECOG 4
- Suffering from active or chronic fungal/bacterial/viral infections
- History of allergy to anesthesia related drugs
- Heart and lung dysfunction, liver and kidney dysfunction, inability to tolerate surgery
- Patients with mental disorders who are unable to cooperate with treatment
About this study
Official title: Comparative Study on the Effect of New Reconstruction Methods and Traditional Reconstruction Methods on Bone Reconstruction After Chest Wall Tumor Resection
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.
Read the 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.
- Conditions
- Chest Wall Tumor
- Being tested
- methods on bone reconstrucion after chest wall tumor resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methods on bone reconstrucion after chest wall tumor resectionProcedure or surgery
Selecting appropriate implants for chest wall bone reconstruction
| Study group | Role | What they receive |
|---|---|---|
| new methods on bone reconstruction after chest wall tumor resection | Experimental | Using noose fixation for thoracic bone reconstruction Receives: Procedure: methods on bone reconstrucion after chest wall tumor resection |
| traditional methods on bone reconstruction after chest wall tumor resection | Active comparator | Using bridging method for thoracic bone reconstruction Receives: Procedure: methods on bone reconstrucion after chest wall tumor resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability of implants
The occurrence of detachment, displacement, and fracture of implants during follow-up in patients undergoing chest wall tumor surgery after receiving a new reconstruction method
Measured: 3 years
Secondary outcomes (10)
Respiratory discomfort
Patient's respiratory discomfort in a calm state or walking state, measured as mild, moderate, or sereve after reconstruction surgery
Measured: 3 years
Postoperative complications
Pulmonary infection, atelectasis, pleural effusion, respiratory failure, postoperative drainage tube removal time, length of hospital stay
Measured: 3 years
Complications of implants
Fracture, displacement, infection, and compatibility of implants
Measured: 3 years
Postoperative physical function status
Karnofsky scoring scale
Measured: 3 years
Quality of life
EQ-5D-5L scoring scale, postoperative chronic pain level, postoperative recovery of daily work, postoperative changes in lung function (forced vital capacity FVC, first second forced vital capacity FEV1)
Measured: 3 years
Postoperative chronic pain
NRS（Numberical rating scale）, postoperative recovery of daily work, postoperative changes in lung function (forced vital capacity FVC, first second forced vital capacity FEV1)
Measured: 3 years
Postoperative recovery of daily work
The time from the day of surgery to the resumption of normal work, postoperative changes in lung function (forced vital capacity FVC, first second forced vital capacity FEV1)
Measured: 3 years
Postoperative changes in lung function
FVC（forced vital capacity FVC） and FEV1（first second forced vital capacity）at 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, and 3 years after surgery
Measured: 3 years
chest wall discomfort in patients after reconstruction surgery
Patient chest wall discomfort in a calm or walking state, measured as mild, moderate, or severe after reconstrcution surgery
Measured: 3 years
Chest wall appearance after reconstruction surgery
The degree of recovery of chest wall appearance after surgery is evaluated based on three criteria: satisfactory, moderately satisfactory, and unsatisfactory.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest Wall TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Weiming, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994533
- Sponsor's protocol ID
- 20250418
- Status last verified
- May 2025
- First submitted
- 11 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on the Effect of New Reconstruction Methods and Traditional Reconstruction Methods on Bone Reconstruction After Chest Wall Tumor Resection
- ClinicalTrials.gov ID
- NCT06994533
- Acronym / sponsor ID
- 20250418
- Conditions
- Chest Wall Tumor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| new methods on bone reconstruction after chest wall tumor resection | Experimental | Procedure: methods on bone reconstrucion after chest wall tumor resectionUsing noose fixation for thoracic bone reconstruction |
| traditional methods on bone reconstruction after chest wall tumor resection | Active comparator | Procedure: methods on bone reconstrucion after chest wall tumor resectionUsing bridging method for thoracic bone reconstruction |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-70 years old, male or female not limited
- Anesthesia ASA score I-II
- Malignant tumor of soft tissue in the chest
- Malignant tumors of ribs, rib cartilage, and sternum
- Tumors with uncertain or unknown properties of ribs, rib cartilage, and sternum
Key exclusion criteria (8 listed)
- Patients with distant metastasis detected during preoperative examination
- Inoperable tumor
- During the examination, it was discovered that the patient had another type of malignant tumor present
- ECOG 4
- Suffering from active or chronic fungal/bacterial/viral infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methods on bone reconstrucion after chest wall tumor resectionSelecting appropriate implants for chest wall bone reconstruction | Procedure or surgery | new methods on bone reconstruction after chest wall tumor resection, traditional methods on bone reconstruction after chest wall tumor resection |
Primary outcome
Stability of implants
Time frame: 3 years
The occurrence of detachment, displacement, and fracture of implants during follow-up in patients undergoing chest wall tumor surgery after receiving a new reconstruction method
10 secondary outcomes
Respiratory discomfort
Time frame: 3 years
Postoperative complications
Time frame: 3 years
Complications of implants
Time frame: 3 years
Postoperative physical function status
Time frame: 3 years
Quality of life
Time frame: 3 years
Postoperative chronic pain
Time frame: 3 years
Postoperative recovery of daily work
Time frame: 3 years
Postoperative changes in lung function
Time frame: 3 years
chest wall discomfort in patients after reconstruction surgery
Time frame: 3 years
Chest wall appearance after reconstruction surgery
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing methods on bone reconstrucion after chest wall tumor resection in people with Chest Wall Tumor, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stability of implants (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.