An Economic Evaluation of Capsule Endoscopy for Obscure-Occult Gastrointestinal (GI) Bleeding - Full Text View

Sponsors and Collaborators:	University of Calgary Alberta Heritage Foundation for Medical Research Calgary Health Region
Information provided by:	University of Calgary
ClinicalTrials.gov Identifier:	NCT00694954

Purpose

The purpose of this study is to conduct a cost-effectiveness analysis of wireless capsule endoscopy in the investigation of patients with obscure-occult gastrointestinal bleeding. To perform this analysis, a randomized controlled trial of capsule endoscopy compared with standard care will be conducted.

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

MedlinePlus related topics: Anemia Endoscopy Gastrointestinal Bleeding

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Uncontrolled, Parallel Assignment
Official Title:	A Randomized Prospective Study Comparing the Diagnostic Yield and Cost Analysis of Wireless Capsule Endoscopy and Standard Care in Evaluating Patients With Obscure-Occult Gastrointestinal Bleeding Presenting as Iron Deficiency Anemia.

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 lesions diagnosed [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	February 2007
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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)
2: Active Comparator 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:

We propose a full scale economic evaluation of wireless capsule endoscopy (WCE) for patients with obscure-occult gastrointestinal bleeding in an Alberta Health Care setting using the perspective of the health care purchaser. Given that a randomized trial comparing WCE to standard care for obscure-occult GI bleeding has not been performed, we are also proposing such a trial to inform this economic evaluation.

This study follows our successful trial of WCE versus standard care in patients with obscure-overt gastrointestinal bleeding. Obscure-occult bleeding is a much more common clinical problem and thus represents an important patient population to study.

Eligibility

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

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

Contacts and Locations

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

Responsible Party:	University of Calgary ( Dr. Catherine Dube Associate Professor of Medicine, Division of Gastroenterology )
Study ID Numbers:	E20270, Internal tracking #1763
Study First Received:	December 14, 2007
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00694954
Health Authority:	Canada: Health Canada

Keywords provided by University of Calgary:

Iron deficiency anemia
Wireless capsule endoscopy
Obscure-occult gastrointestinal bleeding

Study placed in the following topic categories:

Metabolic Diseases
Hematologic Diseases
Gastrointestinal Diseases
Gastrointestinal Hemorrhage
Anemia
Iron Metabolism Disorders
Hemorrhage

Anemia, Iron-Deficiency
Digestive System Diseases
Malnutrition
Nutrition Disorders
Metabolic disorder
Iron
Deficiency Diseases

Additional relevant MeSH terms:

Pathologic Processes
Anemia, Hypochromic

ClinicalTrials.gov processed this record on January 16, 2009