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Capsule Endoscopy vs Standard of Care for Obscure Intestinal Bleeding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00694954
Recruitment Status : Completed
First Posted : June 11, 2008
Last Update Posted : December 5, 2017
Alberta Heritage Foundation for Medical Research
Calgary Health Region
Information provided by (Responsible Party):
Dr. Robert Hilsden, 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.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Device: Diagnostic Test - Given Imaging Pillcam Other: Diagnostics Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : February 2007
Actual Primary Completion Date : December 2015
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Wireless capsule endoscopy
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 Names:
  • Capsule endoscopy
  • Given Imaging Pillcam
  • Pill camera

Active Comparator: 2
Standard Care
Other: Diagnostics
Any other diagnostic tests (if not already performed) that the referring or attending physician deems necessary aside from Wireless Capsule Endoscopy.

Primary Outcome Measures :
  1. diagnostic yield [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. number of blood transfusions [ Time Frame: 48 weeks ]
  2. number of hospitalizations for GI bleeding/anemia [ Time Frame: 48 weeks ]
  3. number of GI-related procedures and investigations [ Time Frame: 48 ]
  4. procedure-related complications [ Time Frame: 48 ]
  5. quality of life [ Time Frame: 48 ]
    measured by 1) SF36 - 8 domains + PCS/MCS, 2) GI Quality of Life Index (GIQLI), 3) EQ-5D - index + visual analogue scale

  6. health care costs [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00694954

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Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4N1
Sponsors and Collaborators
University of Calgary
Alberta Heritage Foundation for Medical Research
Calgary Health Region
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Principal Investigator: Catherine J. Dube, MD PhD University of Calgary

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Responsible Party: Dr. Robert Hilsden, Associate Professor, University of Calgary Identifier: NCT00694954    
Other Study ID Numbers: E20270
Internal tracking #1763
First Posted: June 11, 2008    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017
Keywords provided by Dr. Robert Hilsden, University of Calgary:
Iron deficiency anemia
Wireless capsule endoscopy
Obscure-occult gastrointestinal bleeding
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Pathologic Processes
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Nutrition Disorders