Pan-intestinal Capsule Endoscopy Versus Colonoscopy in Iron Deficiency Anemia or Overt GI Bleeding

Study Overview
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Brief Summary
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The authors hypothesize that in patients with iron deficiency anemia or gastrointestinal bleeding, pan-intestinal capsule endoscopy is a safe and well tolerated procedure that may improve diagnostic yield comparatively to the current standard invasive colonoscopy.

Detailed Description
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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.

Official Title
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Pan-intestinal Capsule Endoscopy Versus Conventional Colonoscopy in Iron Deficiency Anemia or Overt GI Bleeding: a Prospective Cohort Study

Conditions
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Iron Deficiency Anemia, GastroIntestinal Bleeding

Intervention / Treatment
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* Diagnostic Test: Pan-intestinal capsule endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients from external consultation, hospital ward or urgency department, with suspected GI bleeding presenting in the occult form as IDA (Hb <12.0 g/dL in female gender or <13.0 g/dL in male gender) and/or overt GI bleeding presenting as melaena and/or haematochezia, and with prior non-diagnostic upper GI endoscopy (esophagogastroduodenoscopy, EGD) Exclusion Criteria: Lack of informed consent Suspected lesions at index EGD that could justify the anemia or digestive bleeding Known history of gastroparesis or bowel dysmotility Known or suspected intestinal stricture Female patients with potential gynaecological source of bleeding causative of the clinical condition Patients with severe malnutrition Patients unable to walk at least for short periods and/or with neurological and/or psychiatric condition potentially favouring protocol deviations Allergy or contra-indications to any of the drugs or products used in the study Pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pan-intestinal capsule endoscopy<br>PillCam Crohn's capsule protocol | Diagnostic Test: Pan-intestinal capsule endoscopy<br>* Patients with iron deficiency anemia or overt GI bleeding with non-diagnostic upper GI endoscopy will be submitted to same-day pan-intestinal capsule endoscopy using PillCam Crohn's Capsule (Medtronic) followed by conventional colonoscopy under propofol sedation<br>* Other names: Conventional colonoscopy;|
| Active Comparator: Conventional colonoscopy<br>Same-day colonoscopy under propofol sedation | Diagnostic Test: Pan-intestinal capsule endoscopy<br>* Patients with iron deficiency anemia or overt GI bleeding with non-diagnostic upper GI endoscopy will be submitted to same-day pan-intestinal capsule endoscopy using PillCam Crohn's Capsule (Medtronic) followed by conventional colonoscopy under propofol sedation<br>* Other names: Conventional colonoscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with at least one potentially bleeding lesion detected in small bowel and/or colon | Potentially bleeding lesions include tumors, angiectasias, erosions, ulcers, diverticula or active bleeding | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: number of participants with any procedure-related adverse events | Adverse events include capsule retention, bowel preparation-related (nausea, vomiting, dizziness, seizures, abdominal pain or bloating), bleeding, perforation or cardiopulmonary complications | 2 weeks | 
| Patient's preference: number of participants preferring capsule endoscopy or colonoscopy | Questionnaire regarding preference based on overall experience and perception of the strengths and limitations of each procedure | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iron deficiency anemia, gastrointestinal bleeding, pan-intestinal capsule endoscopy