Thymectomy With and Without Povidone-iodine Pleural Lavage in Stage IVA Thymic Malignancies

• Status: Not yet recruiting
• Trial end date: 2030-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University

Criteria

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. (regardless of laterality)

• Pregnant or lactating patients

• Patients with iodine allergy

• Patients who have severe liver disease including cirrhosis, grade III-IV elevations in liver function studies, or bilirubin in excess of 1.5 mg/decilitre

• Pulmonary nodules or visceral nodules requiring pulmonary resection sacrificing more than half of ipsilateral lung parenchyma.