Status:
COMPLETED
Capsule Endoscopy vs. Push Enteroscopy in Occult Gastrointestinal Bleeding OGIB
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Occult Gastrointestinal Bleeding
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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. ...
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 explorati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00224627
Start Date
March 1 2002
End Date
June 1 2005
Last Update
March 26 2007
Active Locations (1)
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1
Hopital Europeen Georges Pompidou
Paris, France, 75015