S139 Low Volume Preparation Regimen for Colon Capsule Endoscopy – Clinical Study

Abstract

Introduction: Colon Capsule Endoscopy (CCE) procedure requires a preparation regimen (PR) to provide a clean visualization of the colon and promote capsule propulsion throughout the colon. Unfortunately, PR remains a significant barrier for patients, who must consume high volume preparation materials. The aim of this study was to demonstrate non-inferiority of a low-volume PR compared to a high-volume PR. Methods: Two new PRs were selected for this study (Table). Healthy participants (age 50+) were assigned to receive either Plenvu/SuPrep/prucalopride (Group A, n=101) or SuPrep/Pico-Salax/prucalopride (Group B, n=99), prior to CCE. The endpoints for this study were overall adequate cleansing, capsule excretion rate in 10 hours, completion and adverse events (AEs). For the historical control (HC) group, a subset of 142 subjects (age 50+) from a previously published diagnostic study which included high volume PR was utilized (1). The new PR groups and HC group were reviewed by the same experienced CCE reader. Sample size estimation and analysis assumed 15% margin for P< 0.025 one-sided non-inferiority Farrington-Manning test. Results: Group A demonstrated superior results as compared to the HC with regards to colon cleansing and completion (P< 0.0001) and was non-inferior with regards to capsule excretion in 10 hours (P< 0.0001) (Figure). Non-inferiority was not established for AEs (P=0.045) as Group A demonstrated a higher rate of AEs, which were mostly mild vomiting. Group B demonstrated non-inferior results as compared to the HC with regards to capsule excretion in 10 hours (P=0.0002), cleansing (P=0.028) and AE (P=0.027). Non-inferiority for completion was not established (P=0.07). Conclusion: A new low volume PR (Group A) achieved superior completion when compared to HC; however, the AE results were not inferior. AEs were mostly mild vomiting and the increase may be due to regulation changes in the past decade which led to more events being classified as AEs. Plenvu/SuPrep/prucalopride may be an alternative low volume PR for CCE procedure.Figure 1.: Study endpoints rate by regimens Table 1. - Description of the preparation regimens Low Volume Preparation Regimen High Volume Preparation Regimen Time Group A Group B Time Historical Control (HC) Group Day -2 All day Water At least 10 glasses At least 10 glasses Day -2 All day Water At least 10 glasses Evening Senna Tablets 40 mg (2 × 20 mg) 40 mg (2 × 20 mg) Bedtime Senna Tablets 4 Tablets (12 mg) Day -1 All day Clear liquid diet Day -1 All day Clear liquid diet 20:30 - 22:00 Evening prep 0.5 L Plenvu 0.5 L SuPrep 19:00 - 21:00 Evening prep 2 liters of PEG (SF-ELS) solution Water 1 L water 1 L water Day 0 07:00 - 07:30 Morning prep 0.5 L Plenvu 0.5 L SuPrep Day 0 07:00 - 08:30 Morning prep 2 liters of PEG (SF-ELS) solution 07:30 - 08:30 Water 1 L water 1 L water 08:30 Tablet Resolor**, 2 mg Resolor**, 2 mg 09:15 (up to 09:45) PillCam PillCam PillCam 09:15 PillCam PillCam 10:00 - 10:30 * Boost 1 (G2SB) 0.5 L SuPrep 0.15 L Pico-Salax 10:00 - 10:30* Boost 1 (G2SB) 0.5 L SuPrep 10:30 - 11:30 Water 1 L water 1 L water 10:30 - 11:30 Water 1 L Water 12:00 - 12:15 Boost 2 (2 hours after Boost 1) 0.25 L SuPrep 0.075 L Pico-Salax 13:00 - 13:15 Boost 2 (3 hours after Boost 1) 0.25 L SuPrep 12:15 - 12:45 Water 0.5 L water 0.5 L water 13:15 - 13:45 Water 1 L Water 14:00 - 14:15 Boost 3 (2 hours after Boost 2) 0.25 L SuPrep 0.075 L Pico-Salax 15:00 - 15:15 Suppository (2 hours after Boost 2) 10 mg bisacodyl 14:15 - 14:45 Water 0.5 L water 0.5 L water 15:00 Light meal (1 hour after Boost 3) 17:00 Light meal (2 hours after Suppository) 16:00 Suppository (1 hour after the meal) 10 mg bisacodyl 10 mg bisacodyl Maximum Solution Volume 2L 1.3L Maximum Solution Volume 4.75L *Time of capsule passage into small bowel (G2SB( is estimated. 10mg Reglan is administrated in case the capsule fails to enter SB within 1h from ingestion (alert 0).**Resolor is the specific brand of prucalopride that was used.