Clinical trial NCT05140057: Preparation Regimens to Improve Capsule Endoscopy Visualization and Diagnostic Yield
Official title: Preparation Regimens to Improve Capsule Endoscopy Visualization and Diagnostic Yield: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obscure Gastrointestinal Bleeding
Keywords: Small bowel capsule endoscopy
Obscure gastrointestinal bleeding
Bowel preparation
Lead sponsor: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Sponsor class: OTHER_GOV
First posted: 2021-12-01
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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)


Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic yield
timeFrame: During the procedure
measure: Adequate cleansing rate
timeFrame: During the procedure
Secondary outcomes:
measure: Proportion of SBCE with vascular lesions
timeFrame: During the procedure
measure: Proportion of SBCE with active bleeding
timeFrame: During the procedure
measure: Diagnostic yield per tertile
timeFrame: During the procedure
measure: Transit times
timeFrame: During the procedure
measure: Symptoms experienced during SBCE procedure
timeFrame: During the procedure
measure: Overall patients' satisfaction with the cleansing regimen
timeFrame: During the procedure
measure: Small bowel cleansing
timeFrame: During the procedure
Other outcomes:
Locations:
city: Vila Nova De Gaia
country: Portugal
facility: Department of Gastroenterology, Centro Hospitalar Vila Nova de Gaia/Espinho
Study officials:
References: