Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT04371458
Status:
WITHDRAWN
Last Update Posted:
2022-07-25
First Post:
2020-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thymectomy With and Without Povidone-iodine Pleural Lavage in Stage IVA Thymic Malignancies
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
The Study of Extended Thymectomy and Pleural Reductive Surgery (PRS) With Povidone-iodine Pleural Lavage in Patients With Stage IVA Thymic Malignancies
Status:
WITHDRAWN
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI is not moving forward with study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 without providone-iodine lavage
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% povidone-iodine is mixed with sterile water with a dilution of 1/10. A total of 6-14 liters of solution will be prepared in advance of the procedure, pending the size of the patient's chest cavity. The warmed PVP-I will be instilled into the chest cavity to a volume that fills involved thoracic cavity or cavities. Once filled, the solution will be allowed to dwell for 15 minutes. At the conclusion of the 15 minutes, the PVP-I solution will be suctioned out of the chest. This process will be repeated for a total of three dwell sessions.
At the conclusion of the PVP-I lavage, chest tubes should be placed in the chest cavity to re-expand the lung adequately. Chest tube management will be at the discretion of the individual thoracic surgeons, including suction vs water seal and plan for removal.
An honest attempt to maintain the management according to the study protocol will be made. However, if it deemed inappropriate for that patient due to clinical signs, symptoms, or anticipated problems, the surgical team can make whatever changes are deemed necessary. The reason for the deviation must be documented. This patient's data will continue to be collected and analyzed on an intent-to-treat basis for the primary, secondary and tertiary endpoints.
At the conclusion of the PVP-I lavage, chest tubes should be placed in the chest cavity to re-expand the lung adequately. Chest tube management will be at the discretion of the individual thoracic surgeons, including suction vs water seal and plan for removal.
An honest attempt to maintain the management according to the study protocol will be made. However, if it deemed inappropriate for that patient due to clinical signs, symptoms, or anticipated problems, the surgical team can make whatever changes are deemed necessary. The reason for the deviation must be documented. This patient's data will continue to be collected and analyzed on an intent-to-treat basis for the primary, secondary and tertiary endpoints.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: