Preparation Regimens to Improve Capsule Endoscopy Visualization and Diagnostic Yield

Study Overview
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Brief Summary
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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)

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

Conditions
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Obscure Gastrointestinal Bleeding

Intervention / Treatment
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* Combination Product: Moviprep


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protocol 1<br>1L of Moviprep® solution the night before the procedure | Combination Product: Moviprep<br>* Bowel preparation for small bowel capsule endoscopy - same product for all groups, different administration timings<br>|
| Experimental: Protocol 2<br>1L of Moviprep® solution up to 2h before the procedure | Combination Product: Moviprep<br>* Bowel preparation for small bowel capsule endoscopy - same product for all groups, different administration timings<br>|
| Experimental: Protocol 3<br>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<br>* Bowel preparation for small bowel capsule endoscopy - same product for all groups, different administration timings<br>|
| Experimental: Protocol 4<br>1L of Moviprep® solution after the capsule had reached the duodenum | Combination Product: Moviprep<br>* Bowel preparation for small bowel capsule endoscopy - same product for all groups, different administration timings<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bowel preparation, Small bowel capsule endoscopy, Obscure gastrointestinal bleeding