Comparison of the Sensitivity of pCLE and Pathological Biopsy Before ESD

Официальное название

Comparison of the Sensitivity of Probe-based Confocal Laser Endomicroscopy and Pathological Biopsy Before Endoscopic Submucosal Dissection

Обзор

Pathological biopsy before endoscopic submucosal dissection (ESD) the gastric lesion plays an important role in differentiating the pathological nature of the lesion and guiding treatment decisions. However, due to the influence of the materials used, the sensitivity of pathological biopsy is not satisfactory. Confocal Laser Endomicroscopy (CLE) is a technology that integrates a confocal microscope into an endoscope. It enables the acquisition of high-resolution microscopic images of the mucosal layer in real-time (with a magnification of up to 1000 times), and it is an optical biopsy technique. It has unique value in the determination of the pathological nature of gastric lesions. The main purpose of this study is to compare the sensitivity of pathological biopsy and CLE in differentiating the pathological nature of gastric lesions.

Вмешательства

• Диагностический тест Probe-based Confocal Laser Endomicroscopy
  Confocal Laser Endomicroscopy (CLE) is an advanced in vivo imaging technique that combines confocal microscopy with endoscopy, enabling real-time, microscopic visualization of tissues at a cellular level during endoscopic procedures. Probe-based CLE (pCLE) can enter the stomach cavity through the biopsy channel of the endoscope and observe the gastric mucosa. All patients scheduled for endoscopic submucosal dissection (ESD) of gastric lesions must undergo probe-based confocal laser endomicroscop
• Диагностический тест Pathological biopsy
  A pathological biopsy is a medical procedure that involves the removal of a small sample of tissue or cells from the body for microscopic examination. It is a crucial diagnostic tool used to identify diseases, particularly cancer, infections, inflammatory conditions, and other abnormalities.

Первичные конечные точки

• Sensitivity [Срок оценки: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for sensitivity calculation.]

Вторичные конечные точки (2)

• Accuracy [Срок оценки: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for the calculation of accuracy.]
• Specificity [Срок оценки: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for specific calculations.]

Критерии участия

Критерии включения

• patients aged 18 to 85 years who were scheduled for endoscopic submucosal dissection due to early-stage gastric cancer were consecutively enrolled.

Критерии исключения

• Severe cardiac or pulmonary dysfunction, impaired renal function, coagulopathy, pregnancy or lactation, allergy to fluorescein, and inability to provide informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Китай · 4 центра

• Guangxi Zhuang Autonomous Region People's Hospital — Nanning
• Northern Theater Command Hospital — Шэньян
• West China Hospital of Sichuan University — Чэнду
• The First Affiliated Hospital of Naval Medical University — Шанхай

Идентификаторы

NCT: NCT07088744 · Optical biopsy-CLE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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