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

Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Jejunum

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05949268
Enrollment
1300
Registered
2023-07-18
Start date
2023-09-01
Completion date
2028-07-15
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GastroIntestinal Bleeding

Keywords

Small bowel capsule endoscopy, gastrointestinal bleeding, anticaogulation

Brief 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.

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

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

Sponsors

University Hospital Freiburg
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of small bowel bleeding detected during small bowel capsule endoscopyThrough study completion, an average of 1 yearDetection of bleeding during small bowel capsule endoscopy

Secondary

MeasureTime frameDescription
Prevalence of vascular lesions as source of bleedingThrough study completion, an average of 1 yearDetection of vascular lesions angiodysplasia) as source of bleeding
Prevalence of inflammatory lesions as source of bleedingThrough study completion, an average of 1 yearDetection of inflammatory lesions as source of bleeding
Prevalence of tumor lesions as source of bleedingThrough study completion, an average of 1 yearDetection of tumor lesions as source of bleeding
Complications of small bowel capsule endoscopyThrough study completion, an average of 1 yearComplications of small bowel capsule endoscopy
Technical success of small bowel capsule endoscopyThrough study completion, an average of 1 yearTechnical success is defined as arrival of the capsule in the cecum
Time between diagnostic small bowel capsule endoscopy and small bowel enteroscopy for treatment of bleedingFrom time to the end of capsule endoscopy until beginning of small bowel enteroscopyTime between diagnostic mall bowel capsule endoscopy and small bowel enteroscopy for treatment of bleeding

Countries

Germany

Contacts

CONTACTMichael Schultheiss, MD
michael.schultheiss@uniklinik-freiburg.de+49761/270-34010
CONTACTDominik Bettinger, MD
dominik.bettinger@uniklinik-freiburg.de+49761/270-36870
PRINCIPAL_INVESTIGATORMichael Schultheiss, MD

University Medical Center Freiburg, Department of Medicine II, Freiburg, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026