Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Computer Vision-Based Recognition of Parathyroid Glands and Recurrent Laryngeal Nerves in Endoscopic Surgery (PTAIR)

1. juni 2026 oppdatert av: Bo Wang,MD, Fujian Medical University

Prospective Multicenter Model Validation Study of the PTAIR Computer Vision Model for Recognition of Parathyroid Glands and Recurrent Laryngeal Nerves During Endoscopic Thyroid Surgery

This study aims to evaluate the performance of the PTAIR computer vision model for recognizing parathyroid glands and recurrent laryngeal nerves during endoscopic thyroid surgery. Multicenter intraoperative endoscopic surgery videos will be prospectively collected. Using the video recorder timeline as the unified time reference, the first recognition time of parathyroid glands and recurrent laryngeal nerves by PTAIR, junior physicians, and senior physicians will be recorded during surgery. The continuous recognition time of parathyroid glands and recurrent laryngeal nerves by PTAIR will also be recorded.

This study focuses on the recognition performance of PTAIR in real-world multicenter endoscopic thyroid surgery settings. At this stage, PTAIR will not be used to guide intraoperative surgical decision-making, and the study will not evaluate the effect of PTAIR on clinical outcomes. The collected video data will be used to assess the performance of PTAIR under different centers, surgeons, equipment conditions, and surgical field conditions, and may provide data support for future model optimization.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Identification of the parathyroid glands and recurrent laryngeal nerves is an important component of safe thyroid surgery. Parathyroid glands are small and may resemble surrounding fat, lymph nodes, or soft tissue. The recurrent laryngeal nerve has a complex anatomical course and may be partially covered by fascia or insufficiently exposed in some cases, which may increase the difficulty of intraoperative recognition. Computer vision-based artificial intelligence models may help recognize these structures in endoscopic surgical images, but their performance in multicenter real-world surgical settings requires further validation.

Previous PTAIR studies mainly focused on parathyroid gland recognition in endoscopic thyroid surgery videos. Based on these prior studies, the present study will further evaluate the PTAIR model in a prospective multicenter setting, with a focus on recognition of parathyroid glands and recurrent laryngeal nerves. This stage of the study is designed as a model performance validation study and will not evaluate whether PTAIR changes intraoperative surgical decisions, parathyroid management, or postoperative clinical outcomes.

During endoscopic thyroid surgery, PTAIR, junior physicians, and senior physicians will identify parathyroid glands and recurrent laryngeal nerves based on the same intraoperative endoscopic visual field. All time-related outcomes will use the video recorder timeline as the unified reference. The study will record the first recognition time of the recurrent laryngeal nerve and parathyroid gland by PTAIR, junior physicians, and senior physicians, as well as the continuous recognition time of these structures by PTAIR. Expert-reviewed annotations will be used as the reference for subsequent model performance evaluation and confirmation of recognition results.

The study will also evaluate PTAIR performance under different exposure conditions, including cases with fascial coverage, incomplete exposure, or complex surgical field conditions. Multicenter video data will be used to assess model performance across different centers, surgeons, equipment settings, and operative field conditions, and may provide data for future model improvement and iteration.

Studietype

Observasjonsmessig

Registrering (Antatt)

100

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Fujian
      • Fuzhou, Fujian, Kina, 350001
        • Fujian Medical University Union Hospital
        • Ta kontakt med:

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

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

The study population includes adult patients with benign or malignant thyroid disease who are scheduled to undergo endoscopic thyroid surgery at participating centers. Eligible patients will be prospectively enrolled during the study period if they meet the inclusion and exclusion criteria, agree to intraoperative video recording and research use, and have standardized recorder-based endoscopic surgical videos available. The study will evaluate PTAIR recognition performance for parathyroid glands and recurrent laryngeal nerves and compare it with recognition by junior and senior physicians based on the same intraoperative endoscopic visual field and the same video recording timeline.

Beskrivelse

Inclusion Criteria:

  1. Age 18 years or older.
  2. Patients with benign or malignant thyroid disease who are scheduled to undergo endoscopic thyroid surgery.
  3. Standardized recorder-based intraoperative video collection is planned during surgery.
  4. Patients agree to intraoperative video recording, de-identification, and research use.
  5. Basic perioperative clinical data are available.
  6. The participating center is able to follow the standardized procedures for video collection, data upload, data security, and annotation quality control.

Exclusion Criteria:

  1. Refusal to provide informed consent.
  2. Patients scheduled to undergo conventional open thyroid surgery.
  3. Standardized recorder-based intraoperative video collection cannot be performed.
  4. Intraoperative video quality is insufficient for model analysis or expert review.
  5. Key surgical phases are missing from the video recording.
  6. Expert annotation or review of the parathyroid glands or recurrent laryngeal nerves cannot be completed.
  7. Video de-identification fails.
  8. Severe missing perioperative clinical data.
  9. Other conditions judged by the investigators to be unsuitable for study inclusion.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Multicenter Endoscopic Thyroid Surgery Video Cohort
This cohort includes adult patients with thyroid disease who are scheduled to undergo endoscopic thyroid surgery and consent to intraoperative video recording and research use. Recorder-based intraoperative videos will be collected to evaluate the recognition performance of PTAIR for parathyroid glands and recurrent laryngeal nerves. The recognition results of PTAIR will be compared with those of junior and senior physicians based on the same intraoperative endoscopic visual field and the same video recording timeline.
Annen: PTAIR Computer Vision Model Assessment
PTAIR is a computer vision model used to recognize parathyroid glands and recurrent laryngeal nerves in endoscopic thyroid surgery videos. In this observational study, PTAIR will be used to analyze recorder-based intraoperative videos and evaluate first recognition time, continuous recognition time, and recognition performance. PTAIR results will be compared with recognition by junior and senior physicians based on the same intraoperative endoscopic visual field and the same video recording timeline. At this stage, PTAIR will not be used to guide intraoperative surgical decision-making.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
First Recognition Time of the Recurrent Laryngeal Nerve
Tidsramme: Intraoperative period
Using the video recorder timeline as the unified time reference, the first recognition time of the recurrent laryngeal nerve by PTAIR, junior physicians, and senior physicians will be recorded during surgery. All recognitions will be based on the same intraoperative endoscopic visual field.
Intraoperative period
First Recognition Time of the Parathyroid Gland
Tidsramme: Intraoperative period
Using the video recorder timeline as the unified time reference, the first recognition time of the parathyroid gland by PTAIR, junior physicians, and senior physicians will be recorded during surgery. All recognitions will be based on the same intraoperative endoscopic visual field.
Intraoperative period
Continuous Recognition Time of the Recurrent Laryngeal Nerve
Tidsramme: Intraoperative period
Using the video recorder timeline as the unified time reference, the continuous recognition time of the recurrent laryngeal nerve by PTAIR will be recorded during surgery.
Intraoperative period
Continuous Recognition Time of the Parathyroid Gland
Tidsramme: Intraoperative period
Using the video recorder timeline as the unified time reference, the continuous recognition time of the parathyroid gland by PTAIR will be recorded during surgery.
Intraoperative period

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
AP50 for Recurrent Laryngeal Nerve Recognition
Tidsramme: From completion of intraoperative video collection to completion of expert annotation and model analysis
Based on expert-reviewed annotations, AP50 will be calculated for PTAIR recognition of the recurrent laryngeal nerve. AP50 refers to the average precision at an intersection-over-union threshold of 0.50.
From completion of intraoperative video collection to completion of expert annotation and model analysis
AP50 for Parathyroid Gland Recognition
Tidsramme: From completion of intraoperative video collection to completion of expert annotation and model analysis
Based on expert-reviewed annotations, AP50 will be calculated for PTAIR recognition of the parathyroid gland. AP50 refers to the average precision at an intersection-over-union threshold of 0.50.
From completion of intraoperative video collection to completion of expert annotation and model analysis
Comparison of First Recognition Time of the Recurrent Laryngeal Nerve Between PTAIR and Physicians
Tidsramme: Intraoperative period
The first recognition time of the recurrent laryngeal nerve will be compared among PTAIR, junior physicians, and senior physicians during surgery.
Intraoperative period
Comparison of First Recognition Time of the Parathyroid Gland Between PTAIR and Physicians
Tidsramme: Intraoperative period
The first recognition time of the parathyroid gland will be compared among PTAIR, junior physicians, and senior physicians during surgery.
Intraoperative period
In Situ Recognition Rate of the Parathyroid Gland
Tidsramme: From completion of intraoperative video collection to completion of expert review
Based on intraoperative videos and expert review, the in situ recognition rate of parathyroid glands by PTAIR will be recorded.
From completion of intraoperative video collection to completion of expert review
Detection Rate of Parathyroid Glands on the Surgical Specimen
Tidsramme: Intraoperative period, before removal of the surgical specimen from the body
After completion of endoscopic dissection and before removal of the surgical specimen from the body, PTAIR will be used within the endoscopic visual field to examine whether parathyroid tissue is attached to or located around the surgical specimen. The detection result will be recorded.
Intraoperative period, before removal of the surgical specimen from the body

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Fujian Medical University

Samarbeidspartnere

Peking Union Medical College Hospital
Rio de Janeiro State University
Mahidol University
The First Affiliated Hospital of Zhengzhou University
First Hospital of China Medical University
Peking University Shenzhen Hospital
Cancer Hospital of Guangxi Medical University
First Affiliated Hospital of Guangxi Medical University
Longyan First Hospital, Affiliated to Fujian Medical University
United Family Healthcare

Etterforskere

  • Hovedetterforsker: Bo Wang MD, Principal Investigator, Fujian Medical University Union Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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. juni 2026

Primær fullføring (Antatt)

31. mai 2027

Studiet fullført (Antatt)

31. mai 2028

Datoer for studieregistrering

Først innsendt

1. juni 2026

Først innsendt som oppfylte QC-kriteriene

1. juni 2026

Først lagt ut (Faktiske)

5. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PTAIR 3.0

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere