Preparation Regimens to Improve Capsule Endoscopy Visualization and Diagnostic Yield

  • STATUS
    Recruiting
  • End date
    Oct 31, 2023
  • participants needed
    210
  • sponsor
    Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Updated on 10 December 2021

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)

Details
Condition obscure gastrointestinal bleeding
Treatment MoviPrep
Clinical Study IdentifierNCT05140057
SponsorCentro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Last Modified on10 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Be 18 years old or older
Present OGIB (either occult or overt)
Agree with study's procedures and have signed the informed consent for the study and SBCE, prior to SBCE procedure

Exclusion Criteria

Patients performing capsule endoscopy in urgent setting for overt obscure GI bleeding
Inpatients or bedridden
History of surgery of the esophagus, stomach, small bowel, or colon
History of abdominal or pelvic radiation therapy
Suspected or confirmed stenosis or occlusion
Suspected or confirmed bowel perforation
Severe comorbidities, as defined by grade 3 "severe decompensation" in the Adult Comorbidity Evaluation-27 index (ACE-27)
Pregnant women
Patients using narcotics or prokinetics in the week before the SBCE
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