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Идёт набор NCT06678477

Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Positive Fecal Immunochemical Test Group

Без фазы С лечением Adenoma Detection Rate Colonoscopy Three Dimensional Fecal Immunochemical Test

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 3D device.
Кому может быть актуально
Состояния в реестре: Adenoma Detection Rate, Colonoscopy, Three Dimensional, Fecal Immunochemical Test. Базовые параметры: от 40 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Тайвань
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Positive Fecal Immunochemical Test Group: a Multi-center, Randomized Controlled Trial

Обзор

Background: Adenoma detection rate is one of the most quality indicator: an accumulating body of evidence has shown that detection and resection of pre-cancerous adenoma by colonoscopy could effectively prevent colorectal cancer (CRC) and its related mortality1,2. Among various colonoscopy quality indicators, such as cecal intubation rate, withdrawal time, and adenoma detection rate (ADR), ADR is the most important one and most closely associated with the subsequent risk of CRC3,4. A recent study further demonstrated the improvement of ADR could reduce subsequent risk of CRC5. Equipment and technique to improve ADR: To be noted, among all colorectal neoplasm, non-polypoid lesions, such as flat or depressed lesions, carries higher likelihood to be overlooked during conventional colonoscopy and these overlooked lesions were the main etiology of post-colonoscopy colorectal cancer (PCCRC)6. Nowadays, several colonoscopy technologies had been developed to enhance the detection of colorectal adenoma such as using digital or dye-spray chromoendoscopy7 or add-on device such as Cap/Endocuff/third eye/FUSE-assisted endoscopy8. Among them, some had showed the potential to enhance the detection of non-polypoid lesion, for example, the next-generation NBI9 or iSCAN10. Application of 3D endoscopy on GI disease: 3D endoscopy is a new technology that using image processing technique to offer more information on tissue depth in comparison with conventional 2D endoscopy. The utility of 3D endoscopy on GI tract was mainly from upper GI tract and it was proved to enhance the diagnostic accuracy on superficial gastric tumors11 and shortened the procedure time during performing gastric endoscopic submucosal dissection (ESD)12. However, few is known that whether 3D colonoscopy could enhance the ADR, especially for non-polypoid lesion detection, during colonoscopy examination. Positive fecal immunochemical test(FIT) group Among subjects who receive colonoscopy examination, higher advanced adenoma or invasive caners were found in FIT positive group. However, still about half of positive FIT subjects who received colonoscopy exam, have negative colonoscopy result. Non polypoid lesions could be overlooked during the colonoscopy. Therefore, we tried to use this prospective, multicenter, randomized control study to demonstrate the efficacy of 3D colonoscopy on adenoma detection in comparison with conventional 2D colonoscopy in this kind of high risk group.

Вмешательства

  • Устройство 3D device
    Use 3D machine to generate the 3D image

Первичные конечные точки

  • Adenoma detection rate [Срок оценки: 30 minutes]
Вторичные конечные точки (7)
  • Flat-ADR [Срок оценки: 30 minutes]
  • Proximal ADR [Срок оценки: 30 minutes]
  • SSLDR [Срок оценки: 30 minutes]
  • AADR [Срок оценки: 30 minutes]
  • Polyp detection rate [Срок оценки: 30 minutes]
  • adenoma number per colonoscopy, [Срок оценки: 30 minutes]
  • polyp number per colonoscopy, [Срок оценки: 30 minutes]

Критерии участия

Критерии включения

  • Subjects who are 40 years of older
  • Subjects who have positive fecal immunochemical test

Критерии исключения

  • Contraindication for colonoscopy
  • Subjects with familiar or hereditary polyposis
  • Subjects with history of colectomy
  • Inadequate bowel cleansing level
  • Subjects with inflammatory bowel disease

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Диагностика

Центры проведения

Тайвань · 3 центра
  • National Taiwan University Hospital, Hsinchu Branch — Hsinchu
  • National Taiwan University Cancer Center — Taipei
  • National Taiwan University Hospital — Taipei

Идентификаторы

NCT: NCT06678477 · 202311028DIPA

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗