Preparation Regimens to Improve Capsule Endoscopy Visualization and Diagnostic Yield (PrepRICE)

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

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)

Study Overview

• Status: Recruiting
• Conditions: Obscure Gastrointestinal Bleeding
• Intervention / Treatment: Combination product: Moviprep

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Vila Nova De Gaia, Portugal
    • Recruiting
    • Department of Gastroenterology, Centro Hospitalar Vila Nova de Gaia/Espinho
    • Contact: Manuela Estevinho; Phone Number: +351 227865100; Email: mmestevinho@gmail.com
    • Contact: Rolando Pinho
    • Sub-Investigator: Rolando Pinho
    • Sub-Investigator: Ana Catarina Gomes
    • Sub-Investigator: Ana Ponte
    • Sub-Investigator: Adélia Rodrigues
    • Principal Investigator: Manuela Estevinho

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Protocol 1; 1L of Moviprep® solution the night before the procedure	Combination product: Moviprep; Bowel preparation for small bowel capsule endoscopy - same product for all groups, different administration timings
Experimental: Protocol 2; 1L of Moviprep® solution up to 2h before the procedure	Combination product: Moviprep; Bowel preparation for small bowel capsule endoscopy - same product for all groups, different administration timings
Experimental: 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	Combination product: Moviprep; Bowel preparation for small bowel capsule endoscopy - same product for all groups, different administration timings
Experimental: Protocol 4; 1L of Moviprep® solution after the capsule had reached the duodenum	Combination product: Moviprep; Bowel preparation for small bowel capsule endoscopy - same product for all groups, different administration timings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Adequate cleansing rate	A cutoff value of quantitative index ≥ 8 points	During the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of SBCE with vascular lesions	Vascular lesions identified in each tertile	During the procedure
Proportion of SBCE with active bleeding	Active bleeding in each tertile	During the procedure
Diagnostic yield per tertile	Positive findings in each tertile	During the procedure
Transit times	Time of entry in the stomach, duodenum and cecum	During the procedure
Symptoms experienced during SBCE procedure	Nausea, vomit, bloating, abdominal pain	During the procedure
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
Small bowel cleansing	Mean quantitative index of the distal third of small bowel	During the procedure

Collaborators and Investigators

• Sponsor: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): October 31, 2023
• Study Completion (Anticipated): October 31, 2023

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 17, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Bowel preparation; Obscure gastrointestinal bleeding; Small bowel capsule endoscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: 0001 (Researcher)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No