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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.