Occult Gastrointestinal Bleeding Clinical Trial
Official title:
Efficiency of Capsule Endoscopy and Push Enteroscopy in Obscure Gastrointestinal Bleeding. A Prospective Randomized Study.
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
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02727075 -
Performance Value of Research of Occult Gastrointestinal Bleeding by Immunoassay in the Diagnostic Process of Iron Deficiency Anemia in Patients Over 75 Years
|