Margin Intraoperative CT Feedback Feedback Study

NCT07242053 | Active Not Recruiting

• 1 other identifier: 23-5750
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer (Diagnosis)

Keywords

Surgical Margins

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Intraoperative CT of resected lung

EXPERIMENTAL

Other: Intraoperative CT of resected lung

Interventions

Intraoperative CT of resected lung OTHER

Once the wedge resection is performed, the resected specimen will brought for CT scan

Intraoperative CT of resected lung

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for wedge resection for lung malignancies (included suspected lesions).
• years of age or older.

You may not qualify if:

• Any patients with inability to give informed consent
• Wedge resection for non-therapeutic purpose, e.g. diagnostic purpose.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

UHN

Toronto, Ontario, M5G 1L7, Canada

Location

Related Publications (1)

• 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.

  PMID: 41663896 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Disease; Margins of Excision

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Morphological and Microscopic Findings

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Kazuhiro Yasufuku

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: November 21, 2025
• Study Start: March 6, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

CA (1)