Preparation Regimens to Improve Capsule Endoscopy Visualization and Diagnostic Yield

Obscure Gastrointestinal Bleeding Clinical Trial

— PrepRICE  

Official title:

Preparation Regimens to Improve Capsule Endoscopy Visualization and Diagnostic Yield: a Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05140057
• Other study ID #: 0001
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Obscure Gastrointestinal Bleeding

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