Clinical trial NCT05949268: Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Small Bowel
Official title: Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Jejunum
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: GastroIntestinal Bleeding
Keywords: Small bowel capsule endoscopy
gastrointestinal bleeding
anticaogulation
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present with gastrointestinal bleeding undetected in gastroscopy or colonoscopy will be included in this cohort study. In these patients bleeding in the small bowel is suspected and they are allocated to a diagnostic assessment with small bowel capsule endoscopy.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Prevalence of small bowel bleeding detected during small bowel capsule endoscopy
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Prevalence of vascular lesions as source of bleeding
timeFrame: Through study completion, an average of 1 year
measure: Prevalence of inflammatory lesions as source of bleeding
timeFrame: Through study completion, an average of 1 year
measure: Prevalence of tumor lesions as source of bleeding
timeFrame: Through study completion, an average of 1 year
measure: Complications of small bowel capsule endoscopy
timeFrame: Through study completion, an average of 1 year
measure: Technical success of small bowel capsule endoscopy
timeFrame: Through study completion, an average of 1 year
measure: Time between diagnostic small bowel capsule endoscopy and small bowel enteroscopy for treatment of bleeding
timeFrame: From time to the end of capsule endoscopy until beginning of small bowel enteroscopy
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: University Medical Center Freiburg, Department of Medicine II
Study officials:
affiliation: University Medical Center Freiburg, Department of Medicine II, Freiburg, Germany
name: Michael Schultheiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.