Thymectomy With and Without Povidone-iodine Pleural Lavage in Stage IVA Thymic Malignancies

Stage IVA Thymoma Clinical Trial

Official title:

The Study of Extended Thymectomy and Pleural Reductive Surgery (PRS) With Povidone-iodine Pleural Lavage in Patients With Stage IVA Thymic Malignancies

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04371458
• Other study ID #: 2000026157
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: July 2020
• Est. completion date: July 2030

Study information

• Verified date: July 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2030
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

• 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.

• 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)

• Pregnant or lactating patients

• 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

• Pulmonary nodules or visceral nodules requiring pulmonary resection sacrificing more than half of ipsilateral lung parenchyma.

Related Conditions & MeSH terms

• Stage IVA Thymoma
• Thymoma

Intervention

Drug:
• Intraoperative providone-iodine lavage
Intraoperative providone-iodine lavage during resection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	Progression free survival as compared to that of matched patients in a prospectively enrolled international database of thymic malignancies (ITMIG)	5 years
Secondary	Pleural recurrence	Pleural recurrence will be assessed with CT scans of the chest every 6 months starting 6 months after the index operation and continuing for 3 years. After 3 years, if no recurrence has been identified yet, patients will get CT scans of the chest on an annual basis.	5 years
Secondary	Overall survival	Overall survival will be assessed by regular patient evaluations, which will correspond with the CT scans of the chest. If a patient expires, date and cause of death will be recorded. Causes related to thymic malignancy will be differentiated from other causes of mortality to arrive at disease-specific survival and all-cause overall survival.	5 years
Secondary	Patient and disease characteristics	Identification of patient and disease characteristics associated with improved responses to providone-iodine lavage.; Variables examined will include demographic data such as age, sex and comorbidities. Additional data evaluated will include specific aspects of the primary thymic tumor such as burden of thoracic disease (confined to mediastinum, extension into ipsilateral pleura, burden of disease in pleura), and pathology characteristics (WHO Type, level of differentiation).	5 years