PDF(Pubmed)
Abstract：
UNASSIGNED: Cytoreductive surgery combined with hyperthermic intrathoracic chemotherapy (S-HITHOC) may be effective in treating thymic epithelial tumors (TETs) with pleural spread or recurrence. This study will evaluate the safety and efficacy of S-HITHOC in the treatment of TETs with pleural spread or recurrence.
UNASSIGNED: This study is an open, single-arm, prospective trial. Approximately 37 patients diagnosed with TETs with pleural spread or recurrence at the Zhongshan Hospital of Fudan University will be recruited and treated with S-HITHOC. The co-primary outcomes of the study are the length of postoperative hospital stay, complications, and overall quality of life (QoL). The secondary outcomes include drainage duration, volume, and cumulative pain scores.
UNASSIGNED: This trial was approved by the Zhongshan Hospital Research Ethics Committee. The study findings will be actively disseminated through manuscript publications and conference presentations. Information sheets will be provided to each participant, and informed written consent will be obtained for each evaluation. This prospective study will evaluate the effectiveness of a surgical resection combined with the HITHOC procedure in treating TETs with pleural spread or recurrence in China and will support the standardization of the procedure.
UNASSIGNED: This trial was registered on Clinialtrial.gov (No. NCT05446935).
UNASSIGNED: This study is an open, single-arm, prospective trial. Approximately 37 patients diagnosed with TETs with pleural spread or recurrence at the Zhongshan Hospital of Fudan University will be recruited and treated with S-HITHOC. The co-primary outcomes of the study are the length of postoperative hospital stay, complications, and overall quality of life (QoL). The secondary outcomes include drainage duration, volume, and cumulative pain scores.
UNASSIGNED: This trial was approved by the Zhongshan Hospital Research Ethics Committee. The study findings will be actively disseminated through manuscript publications and conference presentations. Information sheets will be provided to each participant, and informed written consent will be obtained for each evaluation. This prospective study will evaluate the effectiveness of a surgical resection combined with the HITHOC procedure in treating TETs with pleural spread or recurrence in China and will support the standardization of the procedure.
UNASSIGNED: This trial was registered on Clinialtrial.gov (No. NCT05446935).
摘要：
■细胞减灭术联合胸腔内热化疗（S-HITHOC）可有效治疗伴有胸膜扩散或复发的胸腺上皮肿瘤（TET）。这项研究将评估S-HITHOC治疗胸膜扩散或复发的TET的安全性和有效性。
■这项研究是一项开放的，单臂,前瞻性审判。将招募约37名在复旦大学附属中山医院诊断为胸膜扩散或复发的TET患者，并接受S-HITHOC治疗。该研究的共同主要结果是术后住院时间，并发症,和整体生活质量(QoL)。次要结果包括排水持续时间，volume,和累积疼痛评分。
■本试验经中山医院研究伦理委员会批准。研究结果将通过手稿出版物和会议演示文稿积极传播。信息表将提供给每个参与者，每次评估将获得知情的书面同意。这项前瞻性研究将评估手术切除联合HITHOC手术在中国治疗胸膜扩散或复发的TET的有效性，并将支持该程序的标准化。
■该试验已在Clinialtrial.gov上注册（编号：NCT05446935)。
■这项研究是一项开放的，单臂,前瞻性审判。将招募约37名在复旦大学附属中山医院诊断为胸膜扩散或复发的TET患者，并接受S-HITHOC治疗。该研究的共同主要结果是术后住院时间，并发症,和整体生活质量(QoL)。次要结果包括排水持续时间，volume,和累积疼痛评分。
■本试验经中山医院研究伦理委员会批准。研究结果将通过手稿出版物和会议演示文稿积极传播。信息表将提供给每个参与者，每次评估将获得知情的书面同意。这项前瞻性研究将评估手术切除联合HITHOC手术在中国治疗胸膜扩散或复发的TET的有效性，并将支持该程序的标准化。
■该试验已在Clinialtrial.gov上注册（编号：NCT05446935)。
