Robot-Assisted Versus Manual Puncture for Pulmonary Nodule Ablation
Comparison of Robot-Assisted Versus Manual Puncture for Ablation of Pulmonary Nodules: A Prospective Cohort Study
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Pulmonary nodule ablation has become an important minimally invasive treatment option for patients who are unsuitable for surgical resection or who prefer image-guided local therapy. Successful CT-guided ablation depends on accurate needle placement, which may require repeated CT scans and multiple needle adjustments when conventional manual puncture is used. Robotic navigation systems have the potential to improve puncture precision and procedural efficiency while maintaining procedural safety.
This prospective observational cohort study compares robot-assisted puncture using the TH-S1 robotic navigation system with conventional manual CT-guided puncture in patients undergoing pulmonary nodule ablation. Participants are assigned to treatment groups according to routine clinical practice without randomization.
The primary outcomes are the number of intraoperative CT scans and needle adjustments. Secondary outcomes include puncture success, puncture deviation distance, radiation exposure measured by dose-length product (DLP), and procedure-related complications. Baseline characteristics will be adjusted using propensity score-based weighting methods before comparative analyses.
The study aims to evaluate whether robot-assisted puncture improves procedural efficiency while maintaining comparable safety and technical success relative to conventional manual puncture.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Guangdong
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Guangzhou, Guangdong, Kina
- The First Affiliated Hospital of Guangzhou Medical University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Age ≥18 years.
- Patients with peripheral pulmonary nodules scheduled for CT-guided thermal ablation.
- Eligible for either robot-assisted or conventional manual puncture according to routine clinical practice.
- Written informed consent provided.
Exclusion Criteria:
- Pulmonary nodules unsuitable for percutaneous ablation because of proximity to major vessels, bronchi, or other critical structures.
- Previous thoracic surgery or local treatment affecting puncture planning.
- Severe cardiopulmonary dysfunction or other contraindications to CT-guided ablation.
- Pregnancy.
- Inability or unwillingness to provide informed consent.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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Robot-Assisted Puncture
Patients undergoing CT-guided pulmonary nodule ablation using the TH-S1 robotic navigation system.
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Manual Puncture
Patients undergoing conventional manual CT-guided pulmonary nodule ablation.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Needle Adjustments
Tidsramme: During the procedure
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Total number of needle adjustments required to achieve the planned puncture trajectory.
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During the procedure
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Number of Intraoperative CT Scans
Tidsramme: During the procedure
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Total number of CT scans performed during the puncture procedure.
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During the procedure
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Technical Success Rate
Tidsramme: During the procedure
|
Technical success was defined as successful completion of the planned CT-guided puncture and ablation procedure.
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During the procedure
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Puncture Deviation
Tidsramme: During the procedure
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Puncture deviation was measured as the distance (mm) between the planned target point and the actual needle tip position after puncture.
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During the procedure
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Radiation Exposure
Tidsramme: During the procedure
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Radiation exposure was assessed using the cumulative dose-length product (DLP, mGy·cm) recorded during the procedure.
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During the procedure
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Procedure-Related Complications
Tidsramme: Within 48 hours after the procedure
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Procedure-related complications were evaluated and graded according to the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) classification system.
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Within 48 hours after the procedure
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ES-2024-129-02A
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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