Comparison of the Sensitivity of pCLE and Pathological Biopsy for Gastric Mucosal Lesions

Официальное название

Comparison of the Sensitivity of Probe-Based Confocal Laser Endomicroscopy and Pathological Biopsy for Gastric Mucosal Lesions

Обзор

The pathological biopsy of gastric lesions, performed prior to endoscopic submucosal dissection (ESD), is crucial for differentiating the pathological nature of the lesions and guiding treatment decisions. However, due to the impact of biopsy sampling, the sensitivity of the pathological biopsy is not optimal. The probe - based confocal laser endomicroscopy (pCLE) technique enables the real - time display of high-resolution microscopic images of the mucosal layer (with an amplification factor of up to 1000 times) through a slender optical fiber probe that can pass through the standard endoscope's working channel. It is an optical biopsy technique and has unique value in determining the pathological nature of gastric lesions. As the Digestive Endoscopy Center of Shanghai Changhai Hospital is a national-level pCLE application demonstration center, it has prospectively collected numerous cases of pCLE examinations of gastric mucosal lesions. The main purpose of this study is to retrospectively analyze these cases and compare the sensitivity and specificity of pathological biopsy and pCLE in differentiating the pathological nature of gastric mucosal lesions.

Подробное описание

In this study, the pathological results of ESD or surgical resection of large specimens were used as the gold standard. The sensitivity of preoperative confocal endomicroscopy examination and pathological biopsy for gastric mucosal cancerous lesions was compared. The study adopted a retrospective approach and invited three experts to conduct offline blind diagnoses of the confocal endoscopy images respectively. First, two experts independently diagnosed all the cases. For those cases with inconsistent diagnosis results, a third expert was then consulted for a final determination. Although it was a retrospective study, the cases included in the research were all prospectively and continuously included in a demonstration project.

Вмешательства

• Диагностический тест Probe-based Confocal Laser Endomicroscopy
  Description: 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
• 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 (4)

• Specificity [Срок оценки: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for specific calculations.]
• 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.]
• Positive Predictive Value (PPV) [Срок оценки: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for sensitivity calculation.]
• Nnegative predictive value (NPV) [Срок оценки: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for sensitivity calculation.]

Критерии участия

Критерии включения

• All patients aged 18-75 who underwent pCLE examination and received ESD treatmen.

Критерии исключения

• lack of pre-ESD pathological biopsy results, and ESD pathology indicated advanced gastric cancer.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-кроссовер

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Naval Medical University — Шанхай

Идентификаторы

NCT: NCT07507071 · pCLE vs. Pathological Biopsy

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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