Capsule Endoscopy vs Standard of Care for Obscure Intestinal Bleeding

Study Overview
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Brief Summary
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The role of capsule endoscopy (CE) in patients with obscure / occult gastrointestinal (GI) bleeding remains unclear. This pragmatic randomized controlled trial is designed to determine the diagnostic yield and clinical outcomes of patients with obscure GI bleeding who receive CE compared to those who receive usual standard care.

Detailed Description
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Patients with iron deficiency anemia from suspected occult GI bleeding will be randomized to receive CE or usual standard care following a negative gastroscopy and colonoscopy. Our primary outcome measure (diagnostic yield) and secondary outcome measures (noted below) will be determined after one year of followup. Patients with have a minimum of one year of clinical followup. Direct health care costs in each arm of the study will be determined after a minimum of two years of followup. An economic evaluation based on the results of the clinical trial is also planned.

Official Title
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A Randomized Controlled Trial of Capsule Endoscopy vs Standard Care in Patients With Iron Deficiency Anemia With Suspected Obscure / Occult Gastrointestinal Bleeding

Conditions
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Iron Deficiency Anemia

Intervention / Treatment
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* Device: Diagnostic Test - Given Imaging Pillcam
* Other: Diagnostics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients age over 18years with iron deficiency anemia (IDA). IDA is defined as hemoglobin <137g/L in men or <120g/L in women with serum ferritin level <22ug/L in men and <10ug/L in women. Eligible patients should have a negative gastroscopy and negative colonoscopy within 1 year prior to entry into study. Negative celiac screen and /or negative small bowel biopsies Exclusion Criteria: Overt gastrointestinal bleeding Premenopausal women with menorrhagia Known or suspected small bowel obstruction Serious medical co-morbidities precluding surgery given the risk of capsule impaction Pregnancy Inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Wireless capsule endoscopy | Device: Diagnostic Test - Given Imaging Pillcam<br>* Procedure performed once only after randomization. If procedure is incomplete due to a number of variables, procedure may possibly need to be repeated. Diagnostic possibilities: normal exam, active bleeding, potential source of bleeding (angiodysplasia, ulcer, tumor)<br>* Other names: Pill camera;|
| Active Comparator: 2<br>Standard Care | Other: Diagnostics<br>* Any other diagnostic tests (if not already performed) that the referring or attending physician deems necessary aside from Wireless Capsule Endoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic yield |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of blood transfusions |  | 48 weeks | 
| number of hospitalizations for GI bleeding/anemia |  | 48 weeks | 
| number of GI-related procedures and investigations |  | 48 | 
| procedure-related complications |  | 48 | 
| quality of life | measured by 1) SF36 - 8 domains + PCS/MCS, 2) GI Quality of Life Index (GIQLI), 3) EQ-5D - index + visual analogue scale | 48 | 
| health care costs |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iron deficiency anemia, Wireless capsule endoscopy, Obscure-occult gastrointestinal bleeding