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

Recruiting

• Conditions: GastroIntestinal Bleeding
• Interventions: Device: Small bowel capsule endoscopy

• Registration Number: NCT05949268
• Lead Sponsor: University Hospital Freiburg

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.

Study Timeline

• Study First Submitted: 2023-06-29
• Study First Submitted QC: 2023-07-07
• Study First Posted: 2023-07-18
• Study Start: 2023-09-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2027-12-31
• Study Completion: 2028-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1300

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with gastrointestinal bleeding undetected in gastroscopy and colonoscopy	Small bowel capsule endoscopy	Gastrointestinal bleeding in the small bowel.

Primary Outcome Measures

Name	Time	Method
Prevalence of small bowel bleeding detected during small bowel capsule endoscopy	Through study completion, an average of 1 year	Detection of bleeding during small bowel capsule endoscopy

Secondary Outcome Measures

Name	Time	Method
Prevalence of tumor lesions as source of bleeding	Through study completion, an average of 1 year	Detection of tumor lesions as source of bleeding
Technical success of small bowel capsule endoscopy	Through study completion, an average of 1 year	Technical success is defined as arrival of the capsule in the cecum
Prevalence of vascular lesions as source of bleeding	Through study completion, an average of 1 year	Detection of vascular lesions angiodysplasia) as source of bleeding
Prevalence of inflammatory lesions as source of bleeding	Through study completion, an average of 1 year	Detection of inflammatory lesions as source of bleeding
Complications of small bowel capsule endoscopy	Through study completion, an average of 1 year	Complications of small bowel capsule endoscopy
Time between diagnostic small bowel capsule endoscopy and small bowel enteroscopy for treatment of bleeding	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

Trial Locations

Locations (1)

University Medical Center Freiburg, Department of Medicine II; 🇩🇪 Freiburg, Germany