Capsule Endoscopy vs Standard of Care for Obscure Intestinal Bleeding

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00694954
• Other study ID #: E20270
• Secondary ID: Internal trackin
• Status: Completed
• Phase: N/A
• First received: December 14, 2007
• Last updated: December 1, 2017
• Start date: February 2007
• Est. completion date: July 2016

Study information

• Verified date: December 2017
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Gastrointestinal Hemorrhage
• Hemorrhage
• Iron Deficiency Anemia

Intervention

Device:
• Diagnostic 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)

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

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	Alberta Heritage Foundation for Medical Research, Calgary Health Region

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic yield		48 weeks
Secondary	number of blood transfusions		48 weeks
Secondary	number of hospitalizations for GI bleeding/anemia		48 weeks
Secondary	number of GI-related procedures and investigations		48
Secondary	procedure-related complications		48
Secondary	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
Secondary	health care costs		2 years