Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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

1 de junho de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Descrição detalhada

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 estudo

Observacional

Inscrição (Estimado)

100

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Bo Wang Professor, MD
  • Número de telefone: 86+13959123550
  • E-mail: wangbo@fjmu.edu.cn

Locais de estudo

    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
First Recognition Time of the Recurrent Laryngeal Nerve
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
AP50 for Recurrent Laryngeal Nerve Recognition
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de junho de 2026

Conclusão Primária (Estimado)

31 de maio de 2027

Conclusão do estudo (Estimado)

31 de maio de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

1 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de junho de 2026

Primeira postagem (Real)

5 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever