Thymectomy With and Without Povidone-iodine Pleural Lavage in Stage IVA Thymic Malignancies (NCT04371458) | Clinical Trial Compass
WithdrawnPhase 1/2
Thymectomy With and Without Povidone-iodine Pleural Lavage in Stage IVA Thymic Malignancies
Stopped: PI is not moving forward with study
0Started 2020-07
Plain-language summary
To evaluate whether intraoperative pleural lavage with providone-iodine following complete resection and pleural reductive surgery for stage IVA thymoma reduces recurrent rates compared to surgery without providone-iodine lavage
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Eastern Cooperative Oncology Group - PS 0 or 1
* Patients with a histologic diagnosis of thymic epithelial tumor (thymoma WHO type A, AB, B1, B2, B3; or thymic carcinoma) who in the opinion of the attending thoracic surgeon can technically receive a macroscopic complete resection of pleural nodules. This histologic diagnosis can be obtained either preoperatively, or based on frozen section intra-operatively.
* Signed informed consent form
* Completely resectable burden of disease
* No evidence of distant organ metastasis except resectable pulmonary parenchymal nodules and intrathoracic lymph node metastasis as evidenced by CT chest, physical examination, and any other indicated studies
* Medically suitability for resection as determined by the operating surgeon
* Women of childbearing potential (WOCBP) must have a negative urinary pregnancy test pre-operatively
Exclusion Criteria:
* Patients with active invasive cancers, other than thymoma, that requires treatment, except non-melanomatous skin cancer, superficial bladder cancer or cervical cancer and early stage prostate cancer.
* If frozen section reveals a diagnosis other than thymoma or thymic carcinoma, the patient will be removed from protocol and the providone-iodine lavage will not be performed.
* Hyperthyroidism or Radioisotope treatment for thyroid disease.
* Radiographic evidence of disease beyond the primary site and pleural space
* History of pulmonary resection more than lobectomy. (regar…