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CT-Free Electromagnetic Navigation Percutaneous Localization for Pulmonary Nodules Undergoing Sublobar Resection

29 juli 2026 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Studietyp

Observationell

Inskrivning (Faktisk)

153

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Kina
- Jiangsu
  - Nantong, Jiangsu, Kina
    - Nantong First People's Hospital
  - Nantong, Jiangsu, Kina
    - Nantong Sixth People's Hospital
  - Nantong, Jiangsu, Kina
    - Nantong University Affiliated Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Vuxen
Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Patients with pulmonary nodules requiring preoperative localization before sublobar lung resection at multiple participating centers.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Proportion of Participants With Successful Localization Based on Marker-to-Nodule Distance ≤10 mm Tidsram: 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

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Proportion of Participants Requiring Additional Localization Procedures Tidsram: 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 Tidsram: Within 30 days after surgery	Procedure-related complications including pneumothorax, pulmonary hemorrhage, and infection occurring after localization and surgery.	Within 30 days after surgery
Duration of Pulmonary Nodule Localization Procedure Tidsram: From initiation to completion of the localization procedure	The duration from initiation of localization preparation to completion of marker placement.	From initiation to completion of the localization procedure
Mean Distance Between Localization Marker and Pulmonary Nodule Center (mm) Tidsram: Immediately after surgical specimen resection	The mean distance between the localization marker and the pulmonary nodule center measured immediately after surgical specimen resection.	Immediately after surgical specimen resection
Mean Duration of Postoperative Hospital Stay Tidsram: Up to 30 days after surgical resection	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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Jianle Chen

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

24 juni 2025

Primärt slutförande (Faktisk)

28 mars 2026

Avslutad studie (Faktisk)

28 mars 2026

Studieregistreringsdatum

Först inskickad

19 juli 2026

Först inskickad som uppfyllde QC-kriterierna

29 juli 2026

Första postat (Faktisk)

4 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)