Pan-intestinal Capsule Endoscopy Versus Colonoscopy in Iron Deficiency Anemia or Overt GI Bleeding
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- GastroIntestinal Bleeding
- Iron Deficiency Anemia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Factorial AssignmentIntervention Model Description: Prospective, single-blinded, single center cohort study. All patients will undergo pan-intestinal capsule endoscopy followed by conventional colonoscopy with deep sedation in the same day, with no need for further bowel preparation.Masking: Double (Care Provider, Investigator)Masking Description: The capsule endoscopy reader will be independent from the physicians performing the conventional colonoscopies, and all investigators will be blinded to each other's findings and reports. Capsule endoscopy and colonoscopy findings will be compared and in case of disagreement it will be discussed until a consensus is reached, if necessary, with the intervention of an independent third reader, experienced in both techniques and not involved in the primary reading of any of the examinations.Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 8 years and 100 years
- Gender
- Both males and females
Description
Patients presenting with iron deficiency anemia (IDA) or overt GI bleeding are often submitted to conventional upper GI endoscopy and colonoscopy, followed by small bowel capsule endoscopy if diagnosis remains elusive. Recently, however, the possibility of performing pan-intestinal endoscopy using a...
Patients presenting with iron deficiency anemia (IDA) or overt GI bleeding are often submitted to conventional upper GI endoscopy and colonoscopy, followed by small bowel capsule endoscopy if diagnosis remains elusive. Recently, however, the possibility of performing pan-intestinal endoscopy using a video capsule that evaluates both the small bowel and the colon in a single non-invasive examination, opens new perspectives for the management of those conditions, particularly when the initial upper GI endoscopy has been non-diagnostic. The authors hypothesize that performing early pan-intestinal capsule endoscopy strategy may allow, in a safe and well tolerated manner, to identify which patients would benefit of further interventions, such as colonoscopy or invasive enteroscopy, guided by findings pre-identified at capsule examination. The study aims to evaluate whether pan-intestinal capsule endoscopy is superior to the current standard strategy of conventional colonoscopy after non-diagnostic upper endoscopy in patients with IDA or overt GI bleeding, regarding diagnostic yield, safety and tolerability.
Tracking Information
- NCT #
- NCT04782986
- Collaborators
- Medtronic
- Investigators
- Principal Investigator: Bruno Rosa, MD Gastroenterology Department, Hospital da Senhora da Oliveira - Guimarães, Portugal
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