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The goal of this observational study is to explore the effectiveness of electrocautery resection combined with hyperthermic intrathoracic chemotherapy (HITHOC) in patients with thymic epithelial tumors with pleural metastasis or recurrence. The study aims to:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrocautery Resection + HITHOC | Patients with thymic epithelial tumors with pleural metastasis or recurrence who undergo extended thymectomy with electrocautery resection of pleural metastases followed by two cycles of hyperthermic intrathoracic chemotherapy (HITHOC) with cisplatin and doxorubicin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients with thymic epithelial tumors with pleural metastasis or recurrence who undergo extended thymectomy with electrocautery resection of pleural metastases followed by two cycles of hyperthermic | Procedure | Extended thymectomy with electrocautery ablation and resection of pleural metastases. Larger lesions (>1cm) are thoroughly ablated with electrocautery followed by complete resection. Smaller lesions (≤1cm) that are difficult to resect are thoroughly ablated with electrocautery. |
| Measure | Description | Time Frame |
|---|---|---|
| Event-Free Survival (EFS) | Time from treatment start to first occurrence of local recurrence, distant metastasis, or death from any cause. Events are assessed through regular imaging and clinical follow-up. | From treatment initiation to first event (local recurrence, distant metastasis, or death), assessed up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Grade ≥3 Treatment-Related Adverse Events | Rate of grade ≥3 adverse events according to Clavien-Dindo classification related to surgery or chemotherapy. This includes surgical complications and chemotherapy-related toxicities. | From treatment initiation through 30 days post-treatment |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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Adults aged 16-80 years with pathologically confirmed thymic epithelial tumors (thymoma or thymic carcinoma) with pleural dissemination or recurrence, suitable for electrocautery resection and hyperthermic intrathoracic chemotherapy as determined by multidisciplinary team.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital, Department of Thoracic Surgery | Shanghai | Shanghai Municipality | 200080 | China |
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| Hyperthermic Intrathoracic Chemotherapy (HITHOC) | Procedure | Two cycles of hyperthermic intrathoracic chemotherapy performed 2-4 days apart using BR-TRG-I device. Chemotherapy solution containing cisplatin (50 mg/m²) and doxorubicin (25 mg/m²) is circulated at 400 mL/min with inflow temperature maintained at 42-43°C for 60 minutes per cycle. |
|
Time from disease grouping to death from any cause. |
| From enrollment to death from any cause, assessed up to 36 months |
| Quality of Life Assessed by EQ-5D | Quality of life assessed using the EuroQol 5 Dimensions (EQ-5D) questionnaire. The EQ-5D visual analog scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate better quality of life. | Baseline, post-treatment, and at 3, 6, 12, 24, and 36 months |
| ID | Term |
|---|---|
| C536905 | Thymic epithelial tumor |
| D013945 | Thymoma |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013953 | Thymus Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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