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To date, there is no established method for confirming whether sufficient margins have been obtained during surgery, only post-surgery by a pathologist. The purpose of this study is to evaluate the impact of intraoperative CT margin feedback on surgical decisions, such as additional removal. The ability to accurately evaluate surgical margins intraoperatively could reduce the risk of locoregional recurrence and eliminate the need for additional treatment after surgery. Moreover, optimal intraoperative feedback to surgeon could influence surgical decision making and contribute to the satisfactory outcome. This is a single center clinical trial. A total of 80 patients scheduled for wedge resections for lung malignancies (including suspected patients) will be enrolled in this study. Nine surgeons in the division of thoracic surgery will also be involved as participants. Once the wedge resection is performed, the resected specimen will be inflated and scanned by CT to measure surgical margin intraoperatively. Surgeons will have access to the CT data and the associated margin data immediately. They then may decide if an additional resection is required. The expected margin surveyed by questionnaire will be compared to CT measured margin, and CT measured margin will be compared to pathological margin questionnaires over course. After the total course of surgery, surgeons will be asked to complete a questionnaire as well to assess the satisfaction by intraoperative feedback.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoperative CT of resected lung | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative CT of resected lung | Other | Once the wedge resection is performed, the resected specimen will brought for CT scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| The contribution of intraoperative feedback to treatment decision, and its validity | After the total course of surgery, we will ask each surgeon individually for questionnaire 3 after feedback of the individual result of this study to assess the satisfaction by intraoperative feedback. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UHN | Toronto | Ontario | M5G 1L7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41663896 | Derived | Yanagihara T, Miura K, Bernards N, Kitazawa S, Yokote F, Nakahashi K, Fujibayashi Y, Hinokuma H, Sonoda D, Hayama N, Wakeam E, Donahoe L, Yeung J, Cypel M, De Perrot M, Pierre A, Waddell T, Keshavjee S, Cabanero M, Sato Y, Yasufuku K. Utility of Computed Tomography-Based Intraoperative Surgical Margin Evaluation in Wedge-Resected Lung Specimens. Eur J Cardiothorac Surg. 2026 Feb 5;68(2):ezag074. doi: 10.1093/ejcts/ezag074. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 26, 2024 | Sep 30, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D004194 | Disease |
| D000072662 | Margins of Excision |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065308 | Morphological and Microscopic Findings |