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

Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Jejunum

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.

Study Overview

• Status: Recruiting
• Conditions: GastroIntestinal Bleeding
• Intervention / Treatment: Device: Small bowel capsule endoscopy

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 Type: Observational
• Enrollment (Estimated): 1300

Contacts and Locations

• Study Contact: Name: Michael Schultheiss, MD; Phone Number: +49761/270-34010; Email: michael.schultheiss@uniklinik-freiburg.de
• Study Contact Backup: Name: Dominik Bettinger, MD; Phone Number: +49761/270-36870; Email: dominik.bettinger@uniklinik-freiburg.de

Study Locations

• Germany
  • Freiburg im Breisgau, Germany, 79106
    • Recruiting
    • University Medical Center Freiburg, Department of Medicine II
    • Contact: Michael Schultheiss, MD; Phone Number: 49761270-34010; Email: michael.schultheiss@uniklinik-freiburg.de
    • Sub-Investigator: Dominik Bettinger, MD
    • Sub-Investigator: Paul-Christoph Zeisler, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with gastrointestinal bleeding undetected in gastroscopy and colonoscopy; Gastrointestinal bleeding in the small bowel.	Device: Small bowel capsule endoscopy; Patients with gastrointestinal bleeding receive small bowel capsule endoscopy after bleeding could not be located in gastroscopy or colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Prevalence of inflammatory lesions as source of bleeding	Detection of inflammatory lesions as source of bleeding	Through study completion, an average of 1 year
Prevalence of tumor lesions as source of bleeding	Detection of tumor lesions as source of bleeding	Through study completion, an average of 1 year
Complications of small bowel capsule endoscopy	Complications of small bowel capsule endoscopy	Through study completion, an average of 1 year
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
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

Collaborators and Investigators

• Sponsor: University Hospital Freiburg
• Investigators: Principal Investigator: Michael Schultheiss, MD, University Medical Center Freiburg, Department of Medicine II, Freiburg, Germany

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 15, 2028

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: July 7, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: gastrointestinal bleeding; Small bowel capsule endoscopy; anticaogulation
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Gastrointestinal Diseases; Hemorrhage; Pathological Conditions, Signs and Symptoms; Gastrointestinal Hemorrhage; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy
• Other Study ID Numbers: Capsule endoscopy_FR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD are shared on reasonable request to the Principal Investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No