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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Withdrawn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