Capsule Endoscopy vs Standard of Care for Obscure Intestinal Bleeding

University of Calgary

Status: Completed

Conditions: Iron Deficiency Anemia

Treatments: Other: Diagnostics; Device: Diagnostic Test - Given Imaging Pillcam

Study type: Interventional

Funder types: Other

Identifiers

NCT00694954

Internal tracking #1763

E20270

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

1

Experimental group

Description:

Wireless capsule endoscopy

Treatment:

Device: Diagnostic Test - Given Imaging Pillcam

2

Active Comparator group

Description:

Standard Care

Treatment:

Other: Diagnostics