Capsule Endoscopy vs Standard of Care for Obscure Intestinal Bleeding

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00694954

Enrollment

160

Registered

2008-06-11

Start date

2007-02-28

Completion date

2016-07-31

Last updated

2017-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency Anemia

Keywords

Iron deficiency anemia, Wireless capsule endoscopy, Obscure-occult gastrointestinal bleeding

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.

Interventions

DEVICEDiagnostic Test - Given Imaging Pillcam

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)

OTHERDiagnostics

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
diagnostic yield	48 weeks

Secondary

Measure	Time frame	Description
number of hospitalizations for GI bleeding/anemia	48 weeks	—
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	—
procedure-related complications	48	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026