Status:
WITHDRAWN
Thymectomy With and Without Povidone-iodine Pleural Lavage in Stage IVA Thymic Malignancies
Lead Sponsor:
Yale University
Conditions:
Stage IVA Thymoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 wit...
Detailed Description
Following the surgical portion of the procedure, assuming frozen section confirms the suspected diagnosis, pleural lavage using 10% povidone-iodine (warmed to normothermic 37°C) will begin. The 10% po...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2030
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04371458
Start Date
July 1 2020
End Date
July 1 2030
Last Update
July 25 2022
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