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Capsule Endoscopy vs Standard of Care for Obscure Intestinal Bleeding

Primary Purpose

Iron Deficiency Anemia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Diagnostic Test - Given Imaging Pillcam
Diagnostics
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Iron Deficiency Anemia focused on measuring Iron deficiency anemia, Wireless capsule endoscopy, Obscure-occult gastrointestinal bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Calgary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Wireless capsule endoscopy

Standard Care

Outcomes

Primary Outcome Measures

diagnostic yield

Secondary Outcome Measures

number of blood transfusions
number of hospitalizations for GI bleeding/anemia
number of GI-related procedures and investigations
procedure-related complications
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
health care costs

Full Information

First Posted
December 14, 2007
Last Updated
December 1, 2017
Sponsor
University of Calgary
Collaborators
Alberta Heritage Foundation for Medical Research, Calgary Health Region
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1. Study Identification

Unique Protocol Identification Number
NCT00694954
Brief Title
Capsule Endoscopy vs Standard of Care for Obscure Intestinal Bleeding
Official Title
A Randomized Controlled Trial of Capsule Endoscopy vs Standard Care in Patients With Iron Deficiency Anemia With Suspected Obscure / Occult Gastrointestinal Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Alberta Heritage Foundation for Medical Research, Calgary Health Region

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia
Keywords
Iron deficiency anemia, Wireless capsule endoscopy, Obscure-occult gastrointestinal bleeding

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Wireless capsule endoscopy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Standard Care
Intervention Type
Device
Intervention Name(s)
Diagnostic Test - Given Imaging Pillcam
Other Intervention Name(s)
Capsule endoscopy, Given Imaging Pillcam, Pill camera
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Diagnostics
Intervention Description
Any other diagnostic tests (if not already performed) that the referring or attending physician deems necessary aside from Wireless Capsule Endoscopy.
Primary Outcome Measure Information:
Title
diagnostic yield
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
number of blood transfusions
Time Frame
48 weeks
Title
number of hospitalizations for GI bleeding/anemia
Time Frame
48 weeks
Title
number of GI-related procedures and investigations
Time Frame
48
Title
procedure-related complications
Time Frame
48
Title
quality of life
Description
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
Title
health care costs
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Eligible patients should have a negative gastroscopy and negative colonoscopy within 1 year prior to entry into study. Negative celiac screen and /or negative small bowel biopsies Exclusion Criteria: Overt gastrointestinal bleeding Premenopausal women with menorrhagia Known or suspected small bowel obstruction Serious medical co-morbidities precluding surgery given the risk of capsule impaction Pregnancy Inability to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine J. Dube, MD PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada

12. IPD Sharing Statement

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Capsule Endoscopy vs Standard of Care for Obscure Intestinal Bleeding

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