Trial record 1 of 1 for:    NCT00694954
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Capsule Endoscopy vs Standard of Care for Obscure Intestinal Bleeding

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University of Calgary.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Alberta Heritage Foundation for Medical Research
Calgary Health Region
Information provided by (Responsible Party):
Dr. Robert Hilsden, University of Calgary
ClinicalTrials.gov Identifier:
NCT00694954
First received: December 14, 2007
Last updated: December 16, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Iron Deficiency Anemia
Device: Diagnostic Test - Given Imaging Pillcam
Other: Diagnostics
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • diagnostic yield [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of blood transfusions [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • number of hospitalizations for GI bleeding/anemia [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • number of GI-related procedures and investigations [ Time Frame: 48 ] [ Designated as safety issue: No ]
  • procedure-related complications [ Time Frame: 48 ] [ Designated as safety issue: Yes ]
  • quality of life [ Time Frame: 48 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: February 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694954

Contacts
Contact: Catherine Dube, MD PhD 403-592-5020 dubec@ucalgary.ca

Locations
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 4N1
Contact: Catherine Dube, MD PhD    403-592-5020    dubec@ucalgary.ca   
Contact: Robert Hilsden, MD PhD    403-592-5100    rhilsden@ucalgary.ca   
Principal Investigator: Catherine J Dube, MD PhD, MSc         
Sub-Investigator: Steven Heitman, MD, PhD         
Sub-Investigator: Rostom Alaa, MD, PhD         
Sub-Investigator: Hilsden Robert, MD, PhD         
Sub-Investigator: Braden Manns, MD, PhD         
Sub-Investigator: Fatin Adams, Md, PhD         
Sub-Investigator: Noel Hershfield, MD, PhD         
Sub-Investigator: Jonathan Love, MD, PhD         
Sub-Investigator: Michael Ma, MD, PhD         
Sponsors and Collaborators
University of Calgary
Alberta Heritage Foundation for Medical Research
Calgary Health Region
Investigators
Principal Investigator: Catherine J. Dube, MD PhD University of Calgary
  More Information

No publications provided

Responsible Party: Dr. Robert Hilsden, Associate Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT00694954     History of Changes
Other Study ID Numbers: E20270, Internal tracking #1763
Study First Received: December 14, 2007
Last Updated: December 16, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Calgary:
Iron deficiency anemia
Wireless capsule endoscopy
Obscure-occult gastrointestinal bleeding

Additional relevant MeSH terms:
Anemia
Gastrointestinal Hemorrhage
Hemorrhage
Deficiency Diseases
Anemia, Iron-Deficiency
Hematologic Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 29, 2014