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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05140057
Other study ID # 0001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date October 31, 2023

Study information

Verified date November 2021
Source Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Recruiting
Enrollment 210
Est. completion date October 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
Moviprep
Bowel preparation for small bowel capsule endoscopy - same product for all groups, different administration timings

Locations

Country Name City State
Portugal Department of Gastroenterology, Centro Hospitalar Vila Nova de Gaia/Espinho Vila Nova De Gaia

Sponsors (1)

Lead Sponsor Collaborator
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic yield Proportion of SBCE with positive findings. findings will be classified based on the Saurin classification; the investigators will consider a positive SBCE when lesions classified as P2 or active bleeding are detected (Saurin classification, Table 2), the remaining will be classified as negative During the procedure
Primary Adequate cleansing rate A cutoff value of quantitative index = 8 points During the procedure
Secondary Proportion of SBCE with vascular lesions Vascular lesions identified in each tertile During the procedure
Secondary Proportion of SBCE with active bleeding Active bleeding in each tertile During the procedure
Secondary Diagnostic yield per tertile Positive findings in each tertile During the procedure
Secondary Transit times Time of entry in the stomach, duodenum and cecum During the procedure
Secondary Symptoms experienced during SBCE procedure Nausea, vomit, bloating, abdominal pain During the procedure
Secondary Overall patients' satisfaction with the cleansing regimen rated on a 5-point scale: 1 - very easy, 2 - easy, 3 - intermediate, 4 - difficult, 5 - very difficult During the procedure
Secondary Small bowel cleansing Mean quantitative index of the distal third of small bowel During the procedure
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