Preparation Regimens to Improve Capsule Endoscopy Visualization and Diagnostic Yield

NCT05140057 | Unknown

• 1 other identifier: 0001
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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)

Conditions

Obscure Gastrointestinal Bleeding

Keywords

Small bowel capsule endoscopy; Obscure gastrointestinal bleeding; Bowel preparation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Proportion of SBCE with vascular lesions

  During the procedure

• Proportion of SBCE with active bleeding

  During the procedure

• Diagnostic yield per tertile

  During the procedure

• Transit times

  During the procedure

• Symptoms experienced during SBCE procedure

  During the procedure

Study Arms (4)

Protocol 1

EXPERIMENTAL

1L of Moviprep® solution the night before the procedure

Combination Product: Moviprep

Protocol 2

EXPERIMENTAL

1L of Moviprep® solution up to 2h before the procedure

Combination Product: Moviprep

Protocol 3

EXPERIMENTAL

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

Protocol 4

EXPERIMENTAL

1L of Moviprep® solution after the capsule had reached the duodenum

Combination Product: Moviprep

Interventions

Moviprep COMBINATION_PRODUCT

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

Protocol 1; Protocol 2; Protocol 3; Protocol 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Department of Gastroenterology, Centro Hospitalar Vila Nova de Gaia/Espinho

Vila Nova de Gaia, Portugal

RECRUITING

MeSH Terms

Interventions

MoviPrep

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Principal Investigator

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: December 1, 2021
• Study Start: December 1, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: December 1, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)