CT-Free Electromagnetic Navigation Percutaneous Localization for Pulmonary Nodules Undergoing Sublobar Resection
29. juli 2026 opdateret af: Jianle Chen
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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
153
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Jiangsu
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Nantong, Jiangsu, Kina
- Nantong First People's Hospital
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Nantong, Jiangsu, Kina
- Nantong Sixth People's Hospital
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Nantong, Jiangsu, Kina
- Nantong University Affiliated Hospital
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with pulmonary nodules requiring preoperative localization before sublobar lung resection at multiple participating centers.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
CT-Free Electromagnetic Navigation Localization
Patients receiving CT-Free electromagnetic navigation percutaneous localization before sublobar resection for pulmonary nodules.
|
|
CT-Guided Localization
Patients receiving conventional CT-guided localization before sublobar resection for pulmonary nodules.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of Participants With Successful Localization Based on Marker-to-Nodule Distance ≤10 mm
Tidsramme: Immediately after surgical resection
|
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.
|
Immediately after surgical resection
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of Participants Requiring Additional Localization Procedures
Tidsramme: During surgery
|
The proportion of participants requiring additional localization methods because of unsuccessful or inaccurate initial localization.
|
During surgery
|
|
Number of Participants With Procedure-Related Complications
Tidsramme: Within 30 days after surgery
|
Procedure-related complications including pneumothorax, pulmonary hemorrhage, and infection occurring after localization and surgery.
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Within 30 days after surgery
|
|
Duration of Pulmonary Nodule Localization Procedure
Tidsramme: From initiation to completion of the localization procedure
|
The duration from initiation of localization preparation to completion of marker placement.
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From initiation to completion of the localization procedure
|
|
Mean Distance Between Localization Marker and Pulmonary Nodule Center (mm)
Tidsramme: Immediately after surgical specimen resection
|
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
Tidsramme: 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.
|
Up to 30 days after surgical resection
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Samarbejdspartnere og efterforskere
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Sponsor
Datoer for undersøgelser
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Studer store datoer
Studiestart (Faktiske)
24. juni 2025
Primær færdiggørelse (Faktiske)
28. marts 2026
Studieafslutning (Faktiske)
28. marts 2026
Datoer for studieregistrering
Først indsendt
19. juli 2026
Først indsendt, der opfyldte QC-kriterier
29. juli 2026
Først opslået (Faktiske)
4. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2025-K079
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