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

GastroIntestinal Bleeding Clinical Trial

Official title:

Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Jejunum

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05949268
• Other study ID #: Capsule endoscopy_FR
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: July 15, 2028

Study information

• Verified date: November 2023
• Source: University Hospital Freiburg
• Contact: Michael Schultheiss, MD
• Phone: +49761/270-34010
• Email: michael.schultheiss[@]uniklinik-freiburg.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Est. completion date: July 15, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• GastroIntestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Germany	University Medical Center Freiburg, Department of Medicine II	Freiburg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Freiburg

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of small bowel bleeding detected during small bowel capsule endoscopy	Detection of bleeding during small bowel capsule endoscopy	Through study completion, an average of 1 year
Secondary	Prevalence of vascular lesions as source of bleeding	Detection of vascular lesions angiodysplasia) as source of bleeding	Through study completion, an average of 1 year
Secondary	Prevalence of inflammatory lesions as source of bleeding	Detection of inflammatory lesions as source of bleeding	Through study completion, an average of 1 year
Secondary	Prevalence of tumor lesions as source of bleeding	Detection of tumor lesions as source of bleeding	Through study completion, an average of 1 year
Secondary	Complications of small bowel capsule endoscopy	Complications of small bowel capsule endoscopy	Through study completion, an average of 1 year
Secondary	Technical success of small bowel capsule endoscopy	Technical success is defined as arrival of the capsule in the cecum	Through study completion, an average of 1 year
Secondary	Time between diagnostic small bowel capsule endoscopy and small bowel enteroscopy for treatment of bleeding	Time between diagnostic mall 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