Frontlight ResearchEarly access
WithdrawnPhase 1/2
Thymectomy With and Without Povidone-iodine Pleural Lavage in Stage IVA Thymic Malignancies
Key facts
- Who runs it
- Yale University
- Trial code
- Status
- Withdrawn
- Phase
- Phase 1/2
- Started
- Jul 2020
- Expected to end
- Jul 2030
- Type of study
- Interventional
- Treatments tested
- Intraoperative providone-iodine lavage
- Record updated
- 25 July 2022
- Why it stopped
- PI is not moving forward with study
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- Pulmonary nodules or visceral nodules requiring pulmonary resection sacrificing more than half of ipsilateral lung parenchyma
- 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
- 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)
- 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
- 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
- Pregnant or lactating patients
About the trial
What the trial wants to find out
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
The group in the trial
- Intraoperative providone-iodine lavageTreatment being tested
Intraoperative providone-iodine lavage during resection
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Study of Extended Thymectomy and Pleural Reductive Surgery (PRS) With Povidone-iodine Pleural Lavage in Patients With Stage IVA Thymic Malignancies
- Record updated
- 25 July 2022