D0097 - Low Volume Preparation Regimen for Colon Capsule Endoscopy – Clinical Study

Tuesday, October 25, 2022

10:00 AM – 12:00 PM ET

Location: Crown Ballroom

Presenting Author(s)

Ignacio Fernandez-Urien Sainz, MD, PhD

University Hospital of Navarra
Pamplona, Navarra, Spain

Award: Presidential Poster Award

Ignacio Fernandez-Urien Sainz, MD, PhD¹, Inbal Eyal, ², Naama Schwartz, ², Ari Bergwerk, MD³
¹University Hospital of Navarra, Pamplona, Navarra, Spain; ²Medtronic, Yokneam, HaZafon, Israel; ³Medtronic, Nof Ayalon, Yerushalayim, Israel

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 1). 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 1). 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).

Discussion: 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.

References: Rex et al. Accuracy of capsule colonoscopy in detecting colorectal polyps in a screening population. Gastroenterology 2015; 148: 948-957

Figure: Figure 1: Study endpoints rate by regimens

Low Volume Preparation Regimen					High Volume Preparation Regimen
Time			Group A	Group B	Time			Historical Control (HC) Group
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
Day -2	Evening	Senna tablets	40mg (2x20mg)	40mg (2x20mg)	Day -2	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	0.5L Plenvu	0.5L SuPrep		19:00 - 21:00	Evening prep	2 liters of PEG (SF-ELS) solution
	20:30 - 22:00	Water	1L water	1L water		19:00 - 21:00	Evening prep	2 liters of PEG (SF-ELS) solution
Day 0	07:00 - 07:30	Morning prep	0.5L Plenvu	0.5L SuPrep	Day 0	07:00 - 08:30	Morning prep	2 liters of PEG (SF-ELS) solution
	07:30 - 08:30	Water	1L water	1L water
	08:30	Tablet	Resolor**, 2mg	Resolor**, 2mg
	09:15 (up to 09:45)	PillCam	PillCam	PillCam		09:15	PillCam	PillCam
	10:00 - 10:30 *	Boost 1 (G2SB)	0.5L SuPrep	0.15L Pico-Salax		10:00 - 10:30*	Boost 1 (G2SB)	0.5L SuPrep
	10:30 - 11:30	Water	1L water	1L water		10:30 - 11:30	Water	1L Water
	12:00 - 12:15	Boost 2 (2 hours after Boost 1)	0.25L SuPrep	0.075L Pico-Salax		13:00 - 13:15	Boost 2 (3 hours after Boost 1)	0.25L SuPrep
	12:15 - 12:45	Water	0.5L water	0.5L water		13:15 - 13:45	Water	1L Water
	14:00 - 14:15	Boost 3 (2 hours after Boost 2)	0.25L SuPrep	0.075L Pico-Salax		15:00 - 15:15	Suppository (2 hours after Boost 2)	10 mg bisacodyl
	14:15 - 14:45	Water	0.5L water	0.5L water		15:00 - 15:15	Suppository (2 hours after Boost 2)	10 mg bisacodyl
	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		17:00	Light meal (2 hours after Suppository)
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.

Table: Table 1. Description of the preparation regimens

Disclosures:

Ignacio Fernandez-Urien Sainz: Medtronic – Advisory Committee/Board Member.

Inbal Eyal: Medtronic – Employee.

Naama Schwartz: Medtronic – Employee.

Ari Bergwerk: Medtronic – Employee.

Ignacio Fernandez-Urien Sainz, MD, PhD¹, Inbal Eyal, ², Naama Schwartz, ², Ari Bergwerk, MD³. D0097 - Low Volume Preparation Regimen for Colon Capsule Endoscopy – Clinical Study, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.