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Идёт набор NCT05949268

Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Small Bowel

Наблюдательное GastroIntestinal Bleeding

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: Small bowel capsule endoscopy.
Кому может быть актуально
Состояния в реестре: GastroIntestinal Bleeding. Базовые параметры: от 18 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
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Jejunum

Обзор

Small bowel capsule endoscopy is the main diagnostic standard for small bowel bleeding. This study investigates the detection rate of small bowel bleeding in capsule endoscopy and further endoscopic treatment in a prospective and retrospective cohort.

Подробное описание

Small bowel capsule endoscopy is considered the diagnostic gold standard in the diagnosis of diseases of the small bowel. Most indications for capsule endoscopy are overt small bowel bleedings - defined as gastrointestinal bleeding after negative gastroscopy and colonoscopy - or occult iron deficiency anemia. Timing of small bowel capsule endoscopy seems to be decisive for the diagnosis of small bowel bleeding: corresponding to the actual guidelines the detection of small bowel bleeding can be up to \> 70% if the intervention is performed within 2 days. Treatment of small bowel bleedings can be performed with small bowel enteroscopy such as balloon or motorized spiral enteroscopy. Against this background this study investigates the rate of small bowel bleeding diagnosed in capsule endoscopy. The aim of the study is to report tumorous, vascular and inflammatory findings as well as complications and cecal accessibility. One focus of the study is the time between small bowel bleeding and small bowel capsule endoscopy and small bowel enteroscopy, respectively. Endoscopic therapies and further bleeding episodes are recorded. In order to determine the improved clinical outcome after the introduction of the shortened timing for recommendation published in 2022, a retrospective cohort should be included in addition to a prospective cohort.

Вмешательства

  • Устройство Small bowel capsule endoscopy
    Patients with gastrointestinal bleeding receive small bowel capsule endoscopy after bleeding could not be located in gastroscopy or colonoscopy.

Первичные конечные точки

  • Prevalence of small bowel bleeding detected during small bowel capsule endoscopy [Срок оценки: Through study completion, an average of 1 year]
Вторичные конечные точки (6)
  • Prevalence of vascular lesions as source of bleeding [Срок оценки: Through study completion, an average of 1 year]
  • Prevalence of inflammatory lesions as source of bleeding [Срок оценки: Through study completion, an average of 1 year]
  • Prevalence of tumor lesions as source of bleeding [Срок оценки: Through study completion, an average of 1 year]
  • Complications of small bowel capsule endoscopy [Срок оценки: Through study completion, an average of 1 year]
  • Technical success of small bowel capsule endoscopy [Срок оценки: Through study completion, an average of 1 year]
  • Time between diagnostic small bowel capsule endoscopy and small bowel enteroscopy for treatment of bleeding [Срок оценки: From time to the end of capsule endoscopy until beginning of small bowel enteroscopy]

Критерии участия

Критерии включения

  • suspicion of gastrointestinal bleeding in the small bowel undetected by gastroscopy and colonoscopy
  • informed consent

Критерии исключения

  • contraindications for small bowel capsule endoscopy (e.g. stenosis)

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Германия · 1 центр
  • University Medical Center Freiburg, Department of Medicine II — Freiburg im Breisgau

Публикации

  • Rondonotti E, Spada C, Adler S, May A, Despott EJ, Koulaouzidis A, Panter S, Domagk D, Fernandez-Urien I, Rahmi G, Riccioni ME, van Hooft JE, Hassan C, Pennazio M. Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review. Endoscopy. 2018 Apr;50(4):423-446. doi: 10.1055/ PMID 29539652

Идентификаторы

NCT: NCT05949268 · Capsule endoscopy_FR

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗