Application of Electromagnetic Navigation System in Pulmonary Nodule Localization
16. mai 2026 oppdatert av: Haifeng Wang, Shanghai Pulmonary Hospital, Shanghai, China
Electromagnetic Navigation-Guided Versus CT-Guided Localization of Pulmonary Nodules: A Multicenter, Prospective, Randomized Controlled Trial
This study aims to design and conduct a multicenter, prospective, randomized controlled post-market clinical trial to validate the clinical efficacy of high-precision electromagnetic navigation technology.
Studieoversikt
Status
Har ikke rekruttert ennå
Studietype
Intervensjonell
Registrering (Antatt)
400
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Shenghao Huang
- Telefonnummer: +86 153 5656 1656
- E-post: huangshplus5@163.com
Studiesteder
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Shanghai, Kina
- Shanghai Pulmonary Hospital
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Ta kontakt med:
- Haifeng Wang
- Telefonnummer: +8602156561656
- E-post: huangshplus5@163.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Age 18-80 years, regardless of gender;
- Solitary single nodule, scheduled for lung nodule puncture and localization;
- Chest CT (lung window mode) showing a maximum nodule diameter ≤ 2 cm;
- Eastern Cooperative Oncology Group (ECOG) performance status score 0-2;
- Voluntary participation, with signed informed consent.
Exclusion Criteria:
- Not suitable for video-assisted thoracoscopic surgery;
- The distance between the center of the lesion and the dome of the diaphragm is < 3 cm;
- History of thoracic adhesion due to previous thoracotomy or pleural infection;
- Patients judged by the investigator to be unsuitable for preoperative transthoracic or transbronchial localization;
- Inability to complete follow-up or poor compliance.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Electromagnetic Navigation Localization Group
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Performed by an experienced thoracic surgeon or interventional radiologist under general or local anesthesia, the procedure is guided by an electromagnetic navigation system.
The procedural steps include: 1) preoperative import of the patient's CT data into the navigation system for path planning; 2) intraoperative coupling of the positioning sensor with the puncture instrument; 3) under real-time three-dimensional imaging guidance of the electromagnetic navigation system, performing percutaneous puncture to accurately place a positioning guidewire / microcoil / dye near the target pulmonary nodule; 4) postoperative CT scan to confirm the localization.
This is a single-session procedure.
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Aktiv komparator: CT-Guided Localization Group
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Performed by an experienced thoracic surgeon or interventional radiologist under local anesthesia, the procedure is guided using a CT scanner.
The steps include: 1) positioning the patient appropriately and performing a CT scan to determine the puncture site and path; 2) employing CT fluoroscopy or intermittent CT scanning for real-time guidance; 3) under CT image guidance, performing a percutaneous puncture to place a localization guidewire / microcoil / dye near the target pulmonary nodule; 4) performing a repeat CT scan post-procedure to confirm the localization position.
This is a single-session procedure.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Success rate of intraoperative localization of lung nodules
Tidsramme: Day 0 (Intraoperative)
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Thoracoscopic exploration enables accurate identification and localization of markers (e.g., contrast dye, microcoils, etc.), with the distance between the center of the marker or the main imaging area and the center of the target nodule being ≤20 mm, and ultimately successfully guides the resection of the target lesion.
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Day 0 (Intraoperative)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Localization Accuracy
Tidsramme: Day 0 (Intraoperative)
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The shortest physical distance (unit: mm) between the actual localization marker point (e.g., the center of the dye) and the outer edge of the nodular lesion in the resected specimen.
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Day 0 (Intraoperative)
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Location Procedure Time
Tidsramme: Day 0 (Intraoperative)
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CT-guided group: Time from the start of the initial localization planning CT scan to the completion of marker/needle deployment and withdrawal of instruments from the body surface. Electromagnetic navigation group: Time from when the bronchoscope passes the vocal cords to the completion of marker deployment and withdrawal of the guiding instrument (unit: min). |
Day 0 (Intraoperative)
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Conversion Rate
Tidsramme: Day 0 (Intraoperative)
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The proportion of subjects in whom conversion from complete thoracoscopy to thoracotomy, or from the planned sublobar resection (wedge/segment) to an extended resection (e.g., lobectomy), was necessitated due to failure to locate the lesion, insufficient surgical margin resulting from excessive localization error, or severe complications related to localization (such as major hemorrhage).
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Day 0 (Intraoperative)
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Complication Rate
Tidsramme: Day 0 through hospital discharge or Day 7 postoperatively, whichever comes first
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Record the incidence of all complications related to the localization procedure.
In addition to complications common to percutaneous approaches, such as pneumothorax and intrathoracic hemorrhage, airway-related complications, including airway mucosal injury/bleeding, bronchospasm, and severe hypoxemia, should be systematically documented.
Assessment should be performed based on the adverse event grading criteria.
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Day 0 through hospital discharge or Day 7 postoperatively, whichever comes first
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Radiation Exposure
Tidsramme: Day 0 (Intraoperative)
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Dose-length product (DLP) value of radiation received by the patient, as recorded by the CT scanner (unit: mGy·cm).
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Day 0 (Intraoperative)
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Operative Time
Tidsramme: Day 0 (Intraoperative)
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Time from the initiation of the skin incision for thoracoscopy to the completion of wound closure (unit: min).
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Day 0 (Intraoperative)
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Early Postoperative Pain Score
Tidsramme: Day 0 (immediately after localization); 24 hours postoperatively
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Visual Analog Scale (VAS) or Numeric Rating Scale (NRS), scored from 0 to 10 points (with 0 representing no pain and 10 representing the most severe pain).
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Day 0 (immediately after localization); 24 hours postoperatively
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Haifeng Wang, Shanghai Pulmonary Hospital, Shanghai, China
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. mai 2026
Primær fullføring (Antatt)
1. januar 2027
Studiet fullført (Antatt)
1. april 2027
Datoer for studieregistrering
Først innsendt
5. mai 2026
Først innsendt som oppfylte QC-kriteriene
16. mai 2026
Først lagt ut (Faktiske)
19. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB-K26-427
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