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减瘤手术联合胸腔内热化疗治疗伴有胸膜播散或复发的胸腺上皮性恶性肿瘤(CHOICE):一项前瞻性、开放性、单臂研究的研究方案

Cytoreductive surgery combined with hyperthermic intrathoracic chemotherapy for the treatment of thymic epithelial malignancies with pleural spread or recurrence (CHOICE): a study protocol for a prospective, open, single-arm study.

作者信息

Yang Xinyu, Wang Shuai, Jiang Jiahao, Lin Miao, Gao Jian, Ding Jianyong, Tan Lijie

机构信息

Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.

Cancer Center, Zhongshan Hospital, Fudan University, Shanghai, China.

出版信息

J Thorac Dis. 2024 Jan 30;16(1):760-767. doi: 10.21037/jtd-23-759. Epub 2023 Dec 25.

Abstract

BACKGROUND

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.

METHODS

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.

DISCUSSION

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.

REGISTRATION

This trial was registered on Clinialtrial.gov (No. NCT05446935).

摘要

背景

减瘤手术联合胸腔内热化疗(S-HITHOC)可能对治疗伴有胸膜播散或复发的胸腺上皮肿瘤(TETs)有效。本研究将评估S-HITHOC治疗伴有胸膜播散或复发的TETs的安全性和有效性。

方法

本研究是一项开放、单臂、前瞻性试验。复旦大学附属中山医院将招募约37例诊断为伴有胸膜播散或复发的TETs患者,并采用S-HITHOC进行治疗。该研究的共同主要结局指标为术后住院时间、并发症及总体生活质量(QoL)。次要结局指标包括引流持续时间、引流量及累积疼痛评分。

讨论

本试验已获中山医院研究伦理委员会批准。研究结果将通过发表论文和在会议上报告的方式积极传播。将向每位参与者提供信息表,并针对每次评估获取知情书面同意书。这项前瞻性研究将评估手术切除联合HITHOC程序在中国治疗伴有胸膜播散或复发的TETs的有效性,并将支持该程序的标准化。

注册

本试验已在Clinicaltrial.gov上注册(编号:NCT05446935)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c044/10894403/9f85ed6e8d90/jtd-16-01-760-f1.jpg

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