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临床试验/NCT05949268
NCT05949268招募中不适用

Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Jejunum

University Hospital Freiburg2 个研究点 分布在 1 个国家目标入组 1,300 人开始时间: 2023年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,300
试验地点
2
主要终点
Prevalence of small bowel bleeding detected during small bowel capsule endoscopy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Patients with gastrointestinal bleeding undetected in gastroscopy and colonoscopy

Gastrointestinal bleeding in the small bowel.

干预措施: Small bowel capsule endoscopy (Device)

结局指标

主要结局

Prevalence of small bowel bleeding detected during small bowel capsule endoscopy

时间窗: Through study completion, an average of 1 year

Detection of bleeding during small bowel capsule endoscopy

次要结局

  • Prevalence of tumor lesions as source of bleeding(Through study completion, an average of 1 year)
  • Technical success of small bowel capsule endoscopy(Through study completion, an average of 1 year)
  • Prevalence of vascular lesions as source of bleeding(Through study completion, an average of 1 year)
  • Prevalence of inflammatory lesions as source of bleeding(Through study completion, an average of 1 year)
  • Complications of small bowel capsule endoscopy(Through study completion, an average of 1 year)
  • Time between diagnostic small bowel capsule endoscopy and small bowel enteroscopy for treatment of bleeding(From time to the end of capsule endoscopy until beginning of small bowel enteroscopy)

研究者

发起方
University Hospital Freiburg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Dominik Bettinger

Principal Investigator

University Hospital Freiburg

研究点 (2)

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