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NCT Number: NCT05949268

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Freiburg, Department of Medicine II

Freiburg im Breisgau, 79106, Germany

Location status: Recruiting

Location contact

Dominik Bettinger, MD

SUB_INVESTIGATOR

Michael Schultheiss, MD

CONTACT

[email protected]

49761270-34010

Paul-Christoph Zeisler, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Small bowel capsule endoscopy

Device

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

Primary outcomes

  1. Prevalence of small bowel bleeding detected during small bowel capsule endoscopy

    Time frame: Through study completion, an average of 1 year

    Detection of bleeding during small bowel capsule endoscopy

Secondary outcomes

  1. Prevalence of vascular lesions as source of bleeding

    Time frame: Through study completion, an average of 1 year

    Detection of vascular lesions angiodysplasia) as source of bleeding

  2. Prevalence of inflammatory lesions as source of bleeding

    Time frame: Through study completion, an average of 1 year

    Detection of inflammatory lesions as source of bleeding

  3. Prevalence of tumor lesions as source of bleeding

    Time frame: Through study completion, an average of 1 year

    Detection of tumor lesions as source of bleeding

  4. Complications of small bowel capsule endoscopy

    Time frame: Through study completion, an average of 1 year

    Complications of small bowel capsule endoscopy

  5. Technical success of small bowel capsule endoscopy

    Time frame: Through study completion, an average of 1 year

    Technical success is defined as arrival of the capsule in the cecum

  6. 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

    Time between diagnostic mall bowel capsule endoscopy and small bowel enteroscopy for treatment of bleeding

Study contacts

Contact information is provided by the study sponsor or research team.

Dominik Bettinger, MD

CONTACT

[email protected]

+49761/270-36870

Michael Schultheiss, MD

CONTACT

[email protected]

+49761/270-34010

Sponsors and collaborators

Lead sponsor

University Hospital Freiburg

Other

Registry information

Official study title

Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Jejunum

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jul 18, 2023
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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