Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-26 @ 2:00 PM
Study NCT ID:
NCT05140057
Status:
UNKNOWN
Last Update Posted:
2021-12-01
First Post:
2021-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preparation Regimens to Improve Capsule Endoscopy Visualization and Diagnostic Yield
Sponsor:
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Organization:
Study Overview
Official Title:
Preparation Regimens to Improve Capsule Endoscopy Visualization and Diagnostic Yield: a Randomized Trial
Status:
UNKNOWN
Status Verified Date:
2021-11
Last Known Status:
RECRUITING
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:
PrepRICE
Brief Summary:
Small bowel capsule endoscopy (SBCE) has become an important tool in clinical practice since its introduction in 2000. This non-invasive method allows the visualization of small bowel mucosa, being essential in the management of many conditions, such as suspected small bowel bleeding, inflammatory bowel diseases and intestinal polyposis syndromes. Despite recommendations concerning SBCE in different pathologies, there are still some technical concerns to be addressed. The optimal preparation for SBCE has been one of these controversial issues.
Currently, the European Society of Gastrointestinal Endoscopy (ESGE) recommends that patients ingest a purgative agent (2L of polyethylene glycol, PEG) and antifoaming agents for SBCE, because it was associated with a better visualization. However, it remains unclear which is the optimal timing for purgative use. Furthermore, the use of a booster agent after capsule ingestion is already performed in colon capsule endoscopy, but less is known about its application in SBCE. Also, it remains to be clarified whether a better visualization results in higher diagnostic yield and impacts patients' outcomes.
Therefore, the global aim of this prospective, randomized, multi-centric study is to determine the optimal timing and preparation for small-bowel capsule endoscopy (regardless of the equipment used), comparing four groups of different preparation protocols:
* Protocol 1) 1L of Moviprep® solution the night before the procedure
* Protocol 2) 1L of Moviprep® solution up to 2h before the procedure
* Protocol 3) 0.5L of Moviprep® solution up to 2h before the procedure plus 0.5L of Moviprep® solution after the capsule had reached the duodenum (assessed with real-time viewer)
* Protocol 4) 1L of Moviprep® solution after the capsule had reached the duodenum (assessed using real-time viewer)
Currently, the European Society of Gastrointestinal Endoscopy (ESGE) recommends that patients ingest a purgative agent (2L of polyethylene glycol, PEG) and antifoaming agents for SBCE, because it was associated with a better visualization. However, it remains unclear which is the optimal timing for purgative use. Furthermore, the use of a booster agent after capsule ingestion is already performed in colon capsule endoscopy, but less is known about its application in SBCE. Also, it remains to be clarified whether a better visualization results in higher diagnostic yield and impacts patients' outcomes.
Therefore, the global aim of this prospective, randomized, multi-centric study is to determine the optimal timing and preparation for small-bowel capsule endoscopy (regardless of the equipment used), comparing four groups of different preparation protocols:
* Protocol 1) 1L of Moviprep® solution the night before the procedure
* Protocol 2) 1L of Moviprep® solution up to 2h before the procedure
* Protocol 3) 0.5L of Moviprep® solution up to 2h before the procedure plus 0.5L of Moviprep® solution after the capsule had reached the duodenum (assessed with real-time viewer)
* Protocol 4) 1L of Moviprep® solution after the capsule had reached the duodenum (assessed using real-time viewer)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: