Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00224627
Status:
COMPLETED
Last Update Posted:
2007-03-26
First Post:
2005-09-16
Brief Title:
Capsule Endoscopy vs Push Enteroscopy in Occult Gastrointestinal Bleeding OGIB
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Efficiency of Capsule Endoscopy and Push Enteroscopy in Obscure Gastrointestinal Bleeding A Prospective Randomized Study
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDT03002 | None | None | None |