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

1 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

100

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Chiny
    • Fujian
      • Fuzhou, Fujian, Chiny, 350001
        • Fujian Medical University Union Hospital
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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.
Inny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
First Recognition Time of the Recurrent Laryngeal Nerve
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
AP50 for Recurrent Laryngeal Nerve Recognition
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Fujian Medical University

Współpracownicy

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

Śledczy

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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

31 maja 2027

Ukończenie studiów (Szacowany)

31 maja 2028

Daty rejestracji na studia

Pierwszy przesłany

1 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

1 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

5 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

5 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • PTAIR 3.0

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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