CT-Free Electromagnetic Navigation Percutaneous Localization for Pulmonary Nodules Undergoing Sublobar Resection
Clinical Evaluation of CT-Free Electromagnetic Navigation Percutaneous Localization System for Pulmonary Nodules Undergoing Sublobar Resection: A Multicenter Observational Cohort Study
Pulmonary nodules, particularly small and non-palpable nodules, present challenges for accurate localization during sublobar lung resection. This multicenter observational cohort study evaluated the feasibility, accuracy, and safety of CT-Free electromagnetic navigation percutaneous localization for pulmonary nodules requiring sublobar resection.
Patients who underwent CT-Free electromagnetic navigation localization were compared with patients who received conventional CT-guided localization. The primary outcome was localization success rate, defined as the distance between the localization marker and the pulmonary nodule center being within 10 mm.
Secondary outcomes included localization procedure time, conversion rate to other localization methods, surgical success rate, perioperative complications, postoperative hospitalization duration, and medical resource utilization.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Jiangsu
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Nantong、Jiangsu、中国
- Nantong First People's Hospital
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Nantong、Jiangsu、中国
- Nantong Sixth People's Hospital
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Nantong、Jiangsu、中国
- Nantong University Affiliated Hospital
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Adults aged 18 years or older.
- Patients with pulmonary nodules requiring sublobar resection.
- Non-palpable pulmonary nodules requiring preoperative localization.
- Patients undergoing CT-Free electromagnetic navigation localization or CT-guided localization.
Exclusion Criteria:
- Central pulmonary nodules unsuitable for localization.
- Patients unable to undergo sublobar resection.
- Patients with severe cardiopulmonary dysfunction or major organ dysfunction.
- Pregnancy or breastfeeding.
- Patients participating in other clinical trials.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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CT-Free Electromagnetic Navigation Localization
Patients receiving CT-Free electromagnetic navigation percutaneous localization before sublobar resection for pulmonary nodules.
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CT-Guided Localization
Patients receiving conventional CT-guided localization before sublobar resection for pulmonary nodules.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of Participants With Successful Localization Based on Marker-to-Nodule Distance ≤10 mm
時間枠：Immediately after surgical resection
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The proportion of participants with successful pulmonary nodule localization, defined as a distance between the localization marker and the pulmonary nodule center of ≤10 mm, measured by postoperative pathological specimen evaluation.
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Immediately after surgical resection
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of Participants Requiring Additional Localization Procedures
時間枠：During surgery
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The proportion of participants requiring additional localization methods because of unsuccessful or inaccurate initial localization.
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During surgery
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Number of Participants With Procedure-Related Complications
時間枠：Within 30 days after surgery
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Procedure-related complications including pneumothorax, pulmonary hemorrhage, and infection occurring after localization and surgery.
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Within 30 days after surgery
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Duration of Pulmonary Nodule Localization Procedure
時間枠：From initiation to completion of the localization procedure
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The duration from initiation of localization preparation to completion of marker placement.
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From initiation to completion of the localization procedure
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Mean Distance Between Localization Marker and Pulmonary Nodule Center (mm)
時間枠：Immediately after surgical specimen resection
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The mean distance between the localization marker and the pulmonary nodule center measured immediately after surgical specimen resection.
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Immediately after surgical specimen resection
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Mean Duration of Postoperative Hospital Stay
時間枠：Up to 30 days after surgical resection
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The mean duration of hospitalization after surgical resection, calculated from the date of surgery to the date of hospital discharge.
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Up to 30 days after surgical resection
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。