ICG Fluorescence Versus CO₂ Inflation-Deflation for Intersegmental Plane Identification During Thoracoscopic Segmentectomy
2. august 2026 oppdatert av: Zhang Ni, Tongji Hospital
Comparison of Indocyanine Green Fluorescence and Carbon Dioxide Inflation-Deflation for Intersegmental Plane Identification During Thoracoscopic Segmentectomy: A Prospective Paired Study
Intersegmental plane identification is a critical step in thoracoscopic anatomical segmentectomy because it helps ensure adequate surgical margins while preserving healthy lung tissue. Indocyanine green (ICG) fluorescence imaging and carbon dioxide (CO₂) inflation-deflation are two techniques used to identify the intersegmental plane, but their agreement and clinical applicability have not been adequately evaluated.
This prospective paired study aims to compare the intersegmental planes identified by ICG fluorescence imaging and the CO₂ inflation-deflation method during thoracoscopic anatomical segmentectomy. In each participant, both techniques will be performed during the same operation, and the identified intersegmental planes will be compared. The findings of this study may provide evidence regarding the agreement and clinical applicability of the two methods for intersegmental plane identification.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
50
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: Zhang Ni Zhang Ni
- Telefonnummer: +8613006315393
- E-post: zhangnidoc@163.com
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:
- Adults aged 18 to 80 years.
- Scheduled to undergo elective thoracoscopic anatomical segmentectomy.
- Preoperative thin-section chest CT with three-dimensional reconstruction available for surgical planning.
- Lesion considered suitable for anatomical segmentectomy by the thoracic surgery team.
- Able and willing to provide written informed consent.
Exclusion Criteria:
- Known allergy or contraindication to indocyanine green (ICG).
- Pregnant or breastfeeding women.
- Severe hepatic dysfunction or other conditions contraindicating the use of ICG.
- Severe emphysema, bullous lung disease, diffuse pulmonary fibrosis, or other severe pulmonary parenchymal disease expected to interfere with intersegmental plane identification.
- Conversion to thoracotomy before completion of both intersegmental plane identification methods.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Single Group
Participants undergoing thoracoscopic anatomical segmentectomy will undergo intersegmental plane identification using indocyanine green (ICG) fluorescence imaging and carbon dioxide (CO₂) inflation-deflation during the same surgical procedure.
The intersegmental planes identified by the two techniques will be compared to evaluate their clinical concordance and intraoperative performance.
The final parenchymal transection line will be determined by the operating surgeon according to intraoperative clinical judgment.
|
Intravenous indocyanine green (ICG) fluorescence imaging is used intraoperatively to identify the intersegmental plane during thoracoscopic anatomical segmentectomy.
Carbon dioxide (CO₂) inflation-deflation is used intraoperatively to identify the intersegmental plane during thoracoscopic anatomical segmentectomy.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical concordance of the intersegmental planes identified by indocyanine green fluorescence imaging and carbon dioxide inflation-deflation
Tidsramme: Intraoperative, after both intersegmental boundaries have been identified and marked and immediately before pulmonary parenchymal division during thoracoscopic segmentectomy.
|
Clinical concordance between the intersegmental planes identified by the two techniques, determined by blinded assessment of de-identified intraoperative videos.
Concordance is defined as Grade A or Grade B agreement; discordance is defined as Grade C.
|
Intraoperative, after both intersegmental boundaries have been identified and marked and immediately before pulmonary parenchymal division during thoracoscopic segmentectomy.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Difference in tumor-to-plane distance (Δ margin)
Tidsramme: Immediately after removal of the resected specimen during the surgical procedure and before formalin fixation
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Difference in the shortest distance from the tumor to the intersegmental plane identified by carbon dioxide (CO₂) inflation-deflation and indocyanine green (ICG) fluorescence imaging, measured on the resected specimen (Δ margin = CO₂ - ICG).
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Immediately after removal of the resected specimen during the surgical procedure and before formalin fixation
|
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Time to intersegmental plane visualization
Tidsramme: Intraoperative, from completion of ICG injection or complete CO₂ reinflation to first visualization of the respective intersegmental boundary, before pulmonary parenchymal division during thoracoscopic segmentectomy.
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Time from completion of the identification procedure to visualization of a clearly identifiable intersegmental plane for each technique.
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Intraoperative, from completion of ICG injection or complete CO₂ reinflation to first visualization of the respective intersegmental boundary, before pulmonary parenchymal division during thoracoscopic segmentectomy.
|
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Technical success rate
Tidsramme: Intraoperative, at completion of each intersegmental plane identification technique and before pulmonary parenchymal division during thoracoscopic segmentectomy.
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Proportion of procedures in which a clearly identifiable intersegmental plane is successfully visualized using each technique.
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Intraoperative, at completion of each intersegmental plane identification technique and before pulmonary parenchymal division during thoracoscopic segmentectomy.
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Perioperative safety
Tidsramme: From surgery until hospital discharge
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Perioperative adverse events related to indocyanine green (ICG) fluorescence imaging or carbon dioxide (CO₂) inflation-deflation, including allergic reactions, physiological changes, and intraoperative complications.
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From surgery until hospital discharge
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Samarbeidspartnere og etterforskere
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Studierekorddatoer
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Studer hoveddatoer
Studiestart (Antatt)
15. juli 2026
Primær fullføring (Antatt)
15. september 2026
Studiet fullført (Antatt)
30. september 2026
Datoer for studieregistrering
Først innsendt
11. juli 2026
Først innsendt som oppfylte QC-kriteriene
2. august 2026
Først lagt ut (Faktiske)
4. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. august 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TJ-IRB202606104
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