Capsule Endoscopy vs Standard of Care for Obscure Intestinal Bleeding

Not Applicable

Completed

• Conditions: Iron Deficiency Anemia
• Interventions: Device: Diagnostic Test - Given Imaging Pillcam; Other: Diagnostics

• Registration Number: NCT00694954
• Lead Sponsor: University of Calgary

Brief Summary

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

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 Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-12-14
• Study First Submitted QC: 2008-06-10
• Study First Posted: 2008-06-11
• Primary Completion: 2015-12
• Study Completion: 2016-07
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-01
• Last Update Posted: 2017-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Diagnostic Test - Given Imaging Pillcam	Wireless capsule endoscopy
2	Diagnostics	Standard Care

Primary Outcome Measures

Name	Time	Method
diagnostic yield	48 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada