Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05949268
Other study ID # Capsule endoscopy_FR
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05060731 - Iron Supplementation in Upper Non-variceal Gastrointestinal Bleeding Phase 4
Not yet recruiting NCT03243240 - Computed Tomography in Gastrointestinal Bleeding N/A
Completed NCT02595853 - Efficacy of a Novel Hemostatic Powder in GI Bleeding
Terminated NCT01756690 - Predicting Lung Injury From Transfusion in Patients With Liver Disease N/A
Completed NCT01434108 - Effects of the Administration of Ornithine Phenylacetate in Patients With Cirrhosis and Upper Gastrointestinal Bleeding Phase 2/Phase 3
Completed NCT01424254 - The Effectiveness of Video-capsule Endoscopy in Gastrointestinal Bleeding of Obscure Origin Phase 3
Completed NCT05884931 - Effectiveness and Safety of Nexpowder as an Endoscopic Hemostatic Treatment N/A
Completed NCT01335516 - Follow-up of Glypressin (Terlipressin) Clinical Efficacy in the Treatment of Bleeding Oesophageal Varices N/A
Withdrawn NCT00401908 - Factors Contributing To Cardiovascular Morbidity and Mortality in Patients With Gastrointestinal Bleeding N/A
Recruiting NCT05024864 - HELicobacter Pylori Screening to Prevent Gastrointestinal Bleeding in MI Patients N/A
Completed NCT05008640 - Creation of an E-toileting Log Through Classification of the Physical Properties of Stool and Urine Using TrueLoo™
Recruiting NCT06259292 - Comprehensive HHT Outcomes Registry of the United States (CHORUS)
Completed NCT03716466 - Evaluation of Prophylactic Endotracheal Intubation
Completed NCT05362227 - High-Volume Vs Low-Volume Preparation in Emergency Department N/A
Completed NCT02405286 - Prospective Assessment of the Rockall Risk ScoringSystem in Patients With Upper Gastrointestinal Hemorrhage N/A
Recruiting NCT00562445 - Adrenal Insufficiency in Critical Emergencies in Digestive Diseases N/A
Recruiting NCT05290857 - Anticoagulation After GI Bleeding Pilot Study and Registry N/A
Recruiting NCT02863250 - Australian and New Zealand Massive Transfusion Registry
Completed NCT01415869 - Occult Gastrointestinal Bleeding in Non-pulsatile Left Ventricular Assist Device(VAD)Patients
Completed NCT01821326 - Risk Factors for Rebleeding in Patients With Obscure Gastrointestinal Bleeding N/A