UnknownNot Applicable

Preparation Regimens to Improve Capsule Endoscopy Visualization and Diagnostic Yield

Portugal210 participantsStarted 2021-12-01

Plain-language 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)

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Diagnostic yield

Timeframe: During the procedure

Adequate cleansing rate

Timeframe: During the procedure

Trial details

NCT IDNCT05140057

SponsorCentro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2023-10-31

View on ClinicalTrials.gov More Obscure Gastrointestinal Bleeding trials