Detachable String Magnetically Controlled Capsule Endoscopy for Patients with AUGIB

Официальное название

Detachable String Magnetically Controlled Capsule Endoscopy for Patients with Acute Upper Gastrointestinal Bleeding: a Prospective Study

Обзор

Use CE for pre-examination of patients with AUGIB symptoms in emergency centers may reduce the need for emergency electronic gastroscopy and have certain advantages in clinical work. Patients with low-risk lesions can be discharged without the need for EGD and hospitalization, greatly improving the utilization of medical resources.

Подробное описание

The investigators plan to conduct exploratory research by sequentially performing DS-MCE and EGD examinations on AUGIB patients with stable hemodynamics, using EGD as the gold standard to evaluate the sensitivity of DS-MCE in diagnosing upper gastrointestinal bleeding lesions and active bleeding.

Вмешательства

• Другое DS-MCE and EGD examinations
  sequentially performing DS-MCE and EGD examinations on AUGIB patients with stable hemodynamics

Первичные конечные точки

• The sensitivity of DS-MCE in detection active bleeding and bleeding lesions, using the detection of EGD as the gold standard, [Срок оценки: From enrollment to the end of end of follow-up at 4 weeks]

Вторичные конечные точки (12)

• The specificity of ds MCE in detecting active bleeding and bleeding lesions using EGD as the gold standard [Срок оценки: From enrollment to the end of end of follow-up at 4 weeks]
• The number of observed signs of bleeding [Срок оценки: From enrollment to the end of end of follow-up at 4 weeks]
• Detection rate of bleeding lesions in enrolled subjects [Срок оценки: From enrollment to the end of end of follow-up at 4 weeks]
• Detection rate of lesions in enrolled subjects [Срок оценки: From enrollment to the end of end of follow-up at 4 weeks]
• The time from the admission of subjects to the detection of bleeding lesions [Срок оценки: From enrollment to the end of end of follow-up at 4 weeks]
• Number of therapeutic interventions (endoscopy, DSA, surgery) for enrolled subjects [Срок оценки: From enrollment to the end of end of follow-up at 4 weeks]
• The time from the admission of subjects to the start of therapeutic interventions (endoscopy, DSA, surgery) [Срок оценки: From enrollment to the end of end of follow-up at 4 weeks]
• Detection rate of esophageal, gastric, and small intestinal lesions in enrolled subjects [Срок оценки: From enrollment to the end of end of follow-up at 4 weeks]
• Time of traditional electronic gastroscopy examination [Срок оценки: From enrollment to the end of end of follow-up at 4 weeks]
• Time of DS-MCE examination [Срок оценки: From enrollment to the end of end of follow-up at 4 weeks]
• Incidence of rebleeding in enrolled subjects 30 days after discharge [Срок оценки: From enrollment to the end of end of follow-up at 4 weeks]
• Rate of all-cause mortality among enrolled subjects within 30 days of discharge [Срок оценки: From enrollment to the end of end of follow-up at 4 weeks]

Критерии участия

Критерии включения

• No gender limit, age ≥ 18 years
• Presenting to the emergency department with melena or hematemesis
• Hemodynamically stable at presentation
• No endoscopic examination has been performed due to this bleeding
• Agree to participate in this clinical trial and sign an informed consent form

Критерии исключения

• Patients with acute active massive bleeding or hemodynamic instability (blood pressure < 90 mmHg and heart rate > 120 beats per minute)
• Patients with Hematochezia
• Hemodynamics remained unstable after fluid resuscitation
• Known or suspected intestinal obstruction, stenosis, or fistula
• Severe motor disorders such as asthma, swallowing disorders, or gastric paralysis
• History of abdominal surgery that affects the normal structure of the digestive tract in the past
• When capsule retention occurs, the problem cannot be solved through surgery due to subjective or objective reasons
• Implantable medical devices such as pacemakers, electronic cochlear implants, drug infusion pumps, and neural stimulators are installed inside the body, except for MRI compatible products
• Pregnant women
• Those who require MRI examination before capsule endoscopy discharge
• Suffering from severe cardiovascular and pulmonary diseases (such as severe myocardial infarction, arrhythmia, heart failure, and respiratory failure)
• Refuse MCE or gastroscopy examination
• The researchers believe that the subjects have any other factors that are not suitable for participation in the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• Changhai hospital — Шанхай

Идентификаторы

NCT: NCT06725056 · DS-MCE for patients with AUGIB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗