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

Last updated: December 4, 2024
Sponsor: University Hospital Freiburg
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastric Ulcers

Hemorrhage

Ulcers

Treatment

Small bowel capsule endoscopy

Clinical Study ID

NCT05949268
Capsule endoscopy_FR
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • suspicion of gastrointestinal bleeding in the small bowel undetected by gastroscopyand colonoscopy

  • informed consent

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 1300
Treatment Group(s): 1
Primary Treatment: Small bowel capsule endoscopy
Phase:
Study Start date:
September 01, 2023
Estimated Completion Date:
July 15, 2028

Study 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.

Connect with a study center

  • University Medical Center Freiburg, Department of Medicine II

    Freiburg, 79106
    Germany

    Active - Recruiting

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