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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.
Yang, Xinyu; Wang, Shuai; Jiang, Jiahao; Lin, Miao; Gao, Jian; Ding, Jianyong; Tan, Lijie.
Afiliación
  • Yang X; Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
  • Wang S; Cancer Center, Zhongshan Hospital, Fudan University, Shanghai, China.
  • Jiang J; Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
  • Lin M; Cancer Center, Zhongshan Hospital, Fudan University, Shanghai, China.
  • Gao J; Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
  • Ding J; Cancer Center, Zhongshan Hospital, Fudan University, Shanghai, China.
  • Tan L; Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
J Thorac Dis ; 16(1): 760-767, 2024 Jan 30.
Article en En | MEDLINE | ID: mdl-38410567
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).
Palabras clave

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Thorac Dis Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: China

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Thorac Dis Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: China