Robot-Assisted Versus Free-Hand CT-Guided Flexible Guidewire Localization of Pulmonary Nodules
A Prospective Randomized Controlled Study of Robot-Assisted Versus Conventional Free-Hand CT-Guided Preoperative Flexible Guidewire Localization of Pulmonary Nodules
Small pulmonary nodules can be difficult to identify during thoracoscopic surgery. CT-guided flexible guidewire localization helps surgeons locate these nodules before resection. This study compares robot-assisted and conventional free-hand localization at Peking University Third Hospital. Sixty adults who require preoperative localization will be randomly assigned to one of two groups, with 30 participants in each group. Both groups will use the same type of flexible guidewire localization needle. The primary objective is to compare radiation exposure measured by dose-length product. The study will also assess puncture performance, localization accuracy, procedure duration, CT scan count, and procedure-related complications.
調査の概要
状態
条件
詳細な説明
This investigator-initiated, prospective, single-center, randomized, parallel-group study compares robot-assisted and conventional free-hand CT-guided flexible guidewire localization before thoracoscopic pulmonary nodule resection. Written informed consent is obtained before enrollment.
Participants undergo a localization difficulty assessment. A computer-generated sequence assigns participants in a 1:1 ratio within low- and high-difficulty strata using block randomization. Both groups use the same type of flexible guidewire localization needle. In the robot-assisted group, CT images are used for three-dimensional reconstruction and trajectory planning. The physician confirms the target, entry point, angle, and depth, and inserts the needle with robotic trajectory guidance. Repeat CT confirms the needle position, and the guidewire is deployed after the planned target region has been reached. Post-localization CT assesses guidewire position and complications.
The procedure is open-label. The protocol specifies blinded assessment of post-localization CT images by two independent imaging physicians. Planned and actual puncture angles and depths, and the distance between the planned target and actual needle tip, are also recorded in the robot-assisted group. Conversion to free-hand localization is permitted when required for participant safety because of robotic system failure or failed registration, and the reason is recorded.
Continuous variables are summarized as means and standard deviations or medians and interquartile ranges, as appropriate. Between-group comparisons use the independent-samples t test or Mann-Whitney U test. Categorical variables are compared using the chi-square test or Fisher exact test.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Fuxin Guo
- 電話番号：+86 15269757106
- メール：15269757106@163.com
研究場所
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100191
- 募集
- Peking University Third Hospital
-
コンタクト：
- Fuxin Guo
- 電話番号：+86 15269757106
- メール：15269757106@163.com
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age 18 to 80 years.
- A pulmonary nodule identified on preoperative high-resolution chest CT, with planned thoracoscopic wedge resection or segmentectomy.
- Maximum target nodule diameter of 20 mm or less.
- A pure ground-glass, part-solid (mixed ground-glass), or small solid nodule.
- A nodule considered difficult to identify by intraoperative inspection or palpation and requiring preoperative CT-guided localization.
- Ability to tolerate percutaneous pulmonary localization and subsequent video-assisted thoracoscopic surgery.
- Voluntary participation and written informed consent from the participant or a legally authorized representative.
Exclusion Criteria:
- Maximum target nodule diameter greater than 20 mm, or no need for preoperative localization in the investigator's judgment.
- No safe puncture trajectory that avoids major vessels, the heart, mediastinum, severe bullous disease, or other important structures.
- Severe pulmonary dysfunction that precludes percutaneous pulmonary puncture or thoracoscopic surgery.
- Coagulation dysfunction or inability to interrupt anticoagulant or antiplatelet treatment according to clinical standards.
- Clinically significant pneumothorax, pleural effusion, active infection, or another condition affecting safety assessment before localization.
- Pregnancy or breastfeeding.
- Inability to cooperate with positioning, breath-holding, or CT scanning.
- Severe ipsilateral pleural adhesions, previous thoracic surgery, or previous radiotherapy considered to compromise localization safety.
- Any other condition making participation unsuitable in the investigator's judgment.
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
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Robot-Assisted CT-Guided Localization
Participants undergo robot-assisted CT-guided flexible guidewire localization before thoracoscopic resection. The uInterv C550-A system is used for CT-based reconstruction and trajectory planning. The physician confirms the target, entry point, angle, and depth and inserts the needle with robotic trajectory guidance. CT confirms satisfactory needle-tip placement before guidewire deployment. Final CT assesses guidewire position and complications. Both arms use the same type of flexible guidewire localization needle. |
The uInterv C550-A robotic puncture navigation and positioning system is used for CT-guided preoperative flexible guidewire localization of pulmonary nodules. CT images are used for three-dimensional reconstruction and trajectory planning. The physician confirms the target, skin entry point, puncture angle, and depth, and inserts the needle with robotic trajectory guidance. CT confirms satisfactory needle-tip placement before the flexible guidewire is deployed. A final CT scan assesses guidewire position and procedure-related complications. The same type of flexible guidewire localization needle is used in both groups.
他の名前：
|
|
アクティブコンパレータ：Conventional Free-Hand CT-Guided Localization
Participants undergo conventional free-hand CT-guided flexible guidewire localization before thoracoscopic resection. The physician selects the skin entry point and trajectory on CT images, inserts the localization needle under local anesthesia, and adjusts the needle as needed. CT confirms satisfactory needle-tip placement before guidewire deployment. Final CT assesses guidewire position and complications. Both arms use the same type of flexible guidewire localization needle. |
Percutaneous placement of a flexible guidewire localization needle using conventional manual trajectory planning and CT guidance before thoracoscopic resection. The physician inserts and adjusts the needle as needed. CT confirms satisfactory needle-tip placement before guidewire deployment, followed by final CT assessment. |
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 |
|---|---|---|
|
Total Dose-Length Product
時間枠：During the localization procedure, from the first CT scan to completion of the final CT scan after guidewire deployment
|
Total dose-length product (DLP), measured in mGy·cm, summed across all localization-related CT acquisitions, including the initial planning CT, CT acquisitions during needle placement, and the final post-deployment CT. |
During the localization procedure, from the first CT scan to completion of the final CT scan after guidewire deployment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
First-Attempt Puncture Success Rate
時間枠：During the localization procedure
|
Percentage of participants with satisfactory needle-tip placement on the first puncture attempt without subsequent needle adjustment. |
During the localization procedure
|
|
Technical Localization Success Rate
時間枠：From guidewire localization through completion of the subsequent thoracoscopic resection
|
Percentage of participants in whom flexible guidewire localization enables intraoperative identification and resection of the target pulmonary nodule during thoracoscopic surgery. |
From guidewire localization through completion of the subsequent thoracoscopic resection
|
|
Localization Deviation
時間枠：During localization, on the CT scan confirming final needle-tip position before guidewire deployment
|
Distance in millimeters between the planned target point and the actual needle-tip position, measured on CT after needle placement. |
During localization, on the CT scan confirming final needle-tip position before guidewire deployment
|
|
Number of Needle Adjustments
時間枠：During the localization procedure
|
Number of adjustments to needle position after the initial needle insertion during CT-guided localization. |
During the localization procedure
|
|
Number of Pleural Punctures
時間枠：During the localization procedure
|
Number of needle punctures through the pleura during CT-guided localization. |
During the localization procedure
|
|
Localization Procedure Duration
時間枠：During the localization procedure, from the first CT scan through completion of the final post-deployment CT scan
|
Elapsed time in minutes from the start of the first localization-related CT scan to completion of the final CT scan after flexible guidewire deployment. |
During the localization procedure, from the first CT scan through completion of the final post-deployment CT scan
|
|
Number of CT Acquisitions
時間枠：During the localization procedure
|
Total number of CT acquisitions performed for localization, including the initial planning CT, scans during needle placement, and the final CT after guidewire deployment. |
During the localization procedure
|
|
Pneumothorax Rate
時間枠：From localization through 2 months after localization
|
Percentage of participants with localization-related pneumothorax, assessed on post-localization CT and during follow-up. |
From localization through 2 months after localization
|
|
Intrapulmonary Hemorrhage Rate
時間枠：From localization through 2 months after localization
|
Percentage of participants with localization-related intrapulmonary hemorrhage, assessed on post-localization CT and during follow-up. |
From localization through 2 months after localization
|
|
Guidewire Dislodgement or Migration Rate
時間枠：From guidewire deployment through the subsequent thoracoscopic surgery; safety follow-up through 2 months after localization
|
Percentage of participants with dislodgement or migration of the localization guidewire after deployment, assessed on CT and during subsequent thoracoscopic surgery. Events are recorded during the 2-month safety follow-up; the guidewire is used for preoperative localization and is not intended to remain in place throughout follow-up. |
From guidewire deployment through the subsequent thoracoscopic surgery; safety follow-up through 2 months after localization
|
協力者と研究者
捜査官
- 主任研究者：Fuxin Guo、Peking University Third Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
本研究に関する用語
その他の研究ID番号
- M20260645
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。