Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Small Bowel
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Small bowel capsule endoscopy.
- Who it may be relevant to
- Registry conditions: GastroIntestinal Bleeding. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Jejunum
Overview
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.
Detailed description
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.
Interventions
- Device Small bowel capsule endoscopy
Patients with gastrointestinal bleeding receive small bowel capsule endoscopy after bleeding could not be located in gastroscopy or colonoscopy.
Primary outcome measures
- Prevalence of small bowel bleeding detected during small bowel capsule endoscopy [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (6)
- Prevalence of vascular lesions as source of bleeding [Time frame: Through study completion, an average of 1 year]
- Prevalence of inflammatory lesions as source of bleeding [Time frame: Through study completion, an average of 1 year]
- Prevalence of tumor lesions as source of bleeding [Time frame: Through study completion, an average of 1 year]
- Complications of small bowel capsule endoscopy [Time frame: Through study completion, an average of 1 year]
- Technical success of small bowel capsule endoscopy [Time frame: Through study completion, an average of 1 year]
- Time between diagnostic small bowel capsule endoscopy and small bowel enteroscopy for treatment of bleeding [Time frame: From time to the end of capsule endoscopy until beginning of small bowel enteroscopy]
Eligibility criteria
Inclusion criteria
- suspicion of gastrointestinal bleeding in the small bowel undetected by gastroscopy and colonoscopy
- informed consent
Exclusion criteria
- contraindications for small bowel capsule endoscopy (e.g. stenosis)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- University Medical Center Freiburg, Department of Medicine II — Freiburg im Breisgau
Publications
- 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
Identifiers
NCT: NCT05949268 · Capsule endoscopy_FR