Visszavonva1/2. fázis
Thymectomy With and Without Povidone-iodine Pleural Lavage in Stage IVA Thymic Malignancies
A legfontosabb adatok
- Ki végzi
- Yale University
- Azonosító
- Állapot
- Visszavonva
- Fázis
- 1/2. fázis
- Kezdés
- 2020. júl.
- Várható befejezés
- 2030. júl.
- A vizsgálat típusa
- Beavatkozással járó
- A vizsgált kezelések
- Intraoperative providone-iodine lavage
- A regiszteradat frissítve
- 2022. július 25.
- Miért állt le
- PI is not moving forward with study
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 16 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- 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
A vizsgálatról
Mit akar kideríteni a vizsgálat
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
A vizsgálat csoportja
- Intraoperative providone-iodine lavageA vizsgált kezelés
Intraoperative providone-iodine lavage during resection
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- The Study of Extended Thymectomy and Pleural Reductive Surgery (PRS) With Povidone-iodine Pleural Lavage in Patients With Stage IVA Thymic Malignancies
- A regiszteradat frissítve
- 2022. július 25.