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

1 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

100

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Bo Wang Professor, MD
  • Número de teléfono: 86+13959123550
  • Correo electrónico: wangbo@fjmu.edu.cn

Ubicaciones de estudio

    • Fujian
      • Fuzhou, Fujian, Porcelana, 350001
        • Fujian Medical University Union Hospital
        • Contacto:
          • Bo Wang Porfessor, MD
          • Número de teléfono: 86+13959123550
          • Correo electrónico: wangbo@fjmu.edu.cn

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
First Recognition Time of the Recurrent Laryngeal Nerve
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
AP50 for Recurrent Laryngeal Nerve Recognition
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

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Publicaciones y enlaces útiles

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Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

31 de mayo de 2027

Finalización del estudio (Estimado)

31 de mayo de 2028

Fechas de registro del estudio

Enviado por primera vez

1 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

1 de junio de 2026

Publicado por primera vez (Actual)

5 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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