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Robot-Assisted Versus Free-Hand CT-Guided Flexible Guidewire Localization of Pulmonary Nodules

2026. november 7. frissítette: Peking University Third Hospital

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.

A tanulmány áttekintése

Állapot

Toborzás

Körülmények

Beavatkozás / kezelés

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

60

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

  • Kína
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kína, 100191
        • Toborzás
        • Peking University Third Hospital
        • Kapcsolatba lépni:

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Egyéb
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Egyetlen

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: 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.
Eszköz: Robotic puncture navigation and positioning system

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.

Más nevek:
  • uInterv C550-A
Aktív összehasonlító: 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.
Eljárás: Free-Hand CT-Guided Flexible Guidewire Localization

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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Total Dose-Length Product
Időkeret: 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

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
First-Attempt Puncture Success Rate
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: During the localization procedure

Number of needle punctures through the pleura during CT-guided localization.
During the localization procedure
Localization Procedure Duration
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Peking University Third Hospital

Nyomozók

  • Kutatásvezető: Fuxin Guo, Peking University Third Hospital

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2026. október 28.

Elsődleges befejezés (Becsült)

2027. február 1.

A tanulmány befejezése (Becsült)

2027. április 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. november 7.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. november 7.

Első közzététel (Tényleges)

2026. november 13.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. november 13.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. november 7.

Utolsó ellenőrzés

2026. november 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Egyéb vizsgálati azonosító számok

  • M20260645

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

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Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

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Nem

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