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

NCT ID: NCT05949268

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2028-07-15

Brief Summary

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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

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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.

Conditions

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GastroIntestinal Bleeding

Keywords

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Small bowel capsule endoscopy gastrointestinal bleeding anticaogulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with gastrointestinal bleeding undetected in gastroscopy and colonoscopy

Gastrointestinal bleeding in the small bowel.

Small bowel capsule endoscopy

Intervention Type DEVICE

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

Interventions

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Small bowel capsule endoscopy

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

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Freiburg

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Dominik Bettinger

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Schultheiss, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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University Medical Center Freiburg, Department of Medicine II

Freiburg im Breisgau, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Michael Schultheiss, MD

Role: CONTACT

Phone: +49761/270-34010

Email: [email protected]

Dominik Bettinger, MD

Role: CONTACT

Phone: +49761/270-36870

Email: [email protected]

Facility Contacts

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Michael Schultheiss, MD

Role: primary

References

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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/a-0576-0566. Epub 2018 Mar 14.

Reference Type BACKGROUND
PMID: 29539652 (View on PubMed)

Other Identifiers

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Capsule endoscopy_FR

Identifier Type: -

Identifier Source: org_study_id