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Capsule Endoscopy vs. Push Enteroscopy in Occult Gastrointestinal Bleeding OGIB

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.
 
ClinicalTrials.gov Identifier: NCT00224627
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : March 26, 2007
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

Brief Summary:
Capsule endoscopy (CE) is a safe and effective tool for the assessment of obscure gastrointestinal bleeding (OGIB). However, its real efficacy and its position in the diagnostic algorithm of OGIB vs. push enteroscopy (PE) remain unknown since in previous studies both techniques were performed in all included patients The purpose of this protocol is to conduct a randomized prospective controlled trial in patients with OGIB comparing a strategy based on CE or PE followed by the alternative exploration only when the first line exploration was negative. The main outpoint of this study concerns the diagnostic yield of the two explorations. Second endpoint concerns the clinical relevance of the two strategies tested (CE ± PE vs. CE ± PE) in terms of diagnostic yield, clinical outcome, therapeutic impact and added explorations

Condition or disease Intervention/treatment Phase
Occult Gastrointestinal Bleeding Procedure: Capsule GIVEN IMAGING LTD Phase 3

Detailed Description:
This was a prospective randomized multicentric study. After the screening visit, eligible subjects were randomly assigned to be explored by CE or PE (first line exploration). The alternative exploration was only performed if no diagnosis was evidenced by the examination assigned by randomization. An independent staff member assigned subjects in 1:1 ratio between CE and PE strategies with stratification for overt and occult bleeding and centers according to consecutive number that were kept in serialized sealed opaque envelopes. After the completion of these explorations, the patients returned at month 3, 6 and 12 thereafter. At each visit, clinical evaluation and laboratory tests were performed and patients were managed according to published recommendations2 (AGA medical position). The first line exploration as well as the alternative exploration could be done during the one year follow-up period only in case of severe relapse of OGIB or necessity to perform biopsies or a therapeutic procedure.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Efficiency of Capsule Endoscopy and Push Enteroscopy in Obscure Gastrointestinal Bleeding. A Prospective Randomized Study.
Study Start Date : March 2002
Actual Study Completion Date : June 2005

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Primary Outcome Measures :
  1. The primary end point was the diagnostic yield of CE and PE (first line exploration allocated by randomization) for the identification of a definitive source of bleeding.

Secondary Outcome Measures :
  1. Secondary end points were evaluated at the end of the follow up period and concerned the clinical relevance of the two strategies (PE ± CE vs. CE ± PE). They included: (1) the diagnostic yield of the two strategies for the identification of a definitive


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients may suffer from episodes of active bleeding within the last 6 months or chronic iron-deficiency anemia (hemoglobin < 10 g/dl).
  • A gynecologic or proctologic bleeding source had to be excluded.
  • All patients had to have negative workup including upper gastrointestinal endoscopy, colonoscopy and small-bowel barium series or computed tomography enteroclysis.
  • Medical reports and/or the imaging documents were available and reviewed in all patients. Usually these investigations were repeated several times before inclusion.
  • Abdominal angiography was only performed when there were signs of active bleeding during the diagnostic work-up (n = 3). Meckel scintigraphy was usually carried out in patients under 30 years of age (n = 14).

Exclusion Criteria:

  • Patient presenting a digestive bleeding with an echo hemodynamic major and\or requiring urgent therapeutic measures
  • Wait presenting a gynaecological cause or a cause proctology of sure imputability or syndrome of malabsorption or deficiency of contribution not formally excluded
  • Patient presenting an occlusive syndrome or a hurt of stenosis hail objectivized by a radiological exploration
  • Surrounding wall(Speaker) or in age waits to procreate without effective contraception
  • The mental or physical state of the patient not allowing a maid compliance in the conditions of the try(essay) and or in the correct use of the device Patient carrier of a pacemaker or another electromechanical implant
  • Patient that must undergo an examination by MRI before having been able to eliminate the capsule
  • Enteroscopy or video capsule prerequisite technically satisfactory and in touch with same pathological episode or dating at least less than 6 months Patient participating at present in another clinical trial without direct profit which can directly or indirectly influence the results(profits) of the present study

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 ClinicalTrials.gov identifier (NCT number): NCT00224627


Locations
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France
Hopital Europeen Georges Pompidou
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Raymond JIAN, MD Assistance Publique - Hôpitaux de Paris

Publications:
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ClinicalTrials.gov Identifier: NCT00224627    
Other Study ID Numbers: P040101
CDT03002
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: March 26, 2007
Last Verified: March 2007
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Randomized study
Capsule endoscopy
Push enteroscopy
Occult gastrointestinal bleeding
Endoscopy
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases