Capsule Endoscopy vs Standard of Care for Obscure Intestinal Bleeding

University of Calgary160 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

160

Conditions

Iron Deficiency Anemia

Interventions

Diagnostic Test - Given Imaging PillcamDEVICE

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)

DiagnosticsOTHER

Any other diagnostic tests (if not already performed) that the referring or attending physician deems necessary aside from Wireless Capsule Endoscopy.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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. 2. Eligible patients should have a negative gastroscopy and negative colonoscopy within 1 year prior to entry into study. 3. Negative celiac screen and /or negative small bowel biopsies Exclusion Criteria: 1. Overt gastrointestinal bleeding 2. Premenopausal women with menorrhagia 3. Known or suspected small bowel obstruction 4. Serious medical co-morbidities precluding surgery given the risk of capsule impaction 5. Pregnancy 6. Inability to provide informed consent

Locations (1)

University of Calgary

Calgary, Alberta, Canada

Outcomes

Primary Outcomes

diagnostic yield

Time frame: 48 weeks

Secondary Outcomes

number of blood transfusions

Time frame: 48 weeks

number of hospitalizations for GI bleeding/anemia

Time frame: 48 weeks

number of GI-related procedures and investigations

Time frame: 48

procedure-related complications

Time frame: 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

Time frame: 48

health care costs

Time frame: 2 years

Data from ClinicalTrials.gov

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