Evaluation of a new pan-enteric video capsule endoscopy system in patients with suspected or established inflammatory bowel disease – feasibility study

Background and study aims Inflammatory bowel disease (IBD) affects the small bowel and colon. Endoscopic evaluation of these organs is essential. The new pan-enteric Crohn’s capsule (PCC) system is customized for complete coverage of IBD lesions in the entire bowel, allowing assessment and follow-up...

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Main Authors: Rami Eliakim, Cristiano Spada, Alon Lapidus, Inbal Eyal, Silvia Pecere, Ignacio Fernández-Urién, Adi Lahat, Guido Costamagna, Avraham Schwartz, Yulia Ron, Henit Yanai, Samuel Adler
Format: Article
Language:English
Published: Georg Thieme Verlag KG 2018-10-01
Series:Endoscopy International Open
Online Access:http://www.thieme-connect.de/DOI/DOI?10.1055/a-0677-170
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author Rami Eliakim
Cristiano Spada
Alon Lapidus
Inbal Eyal
Silvia Pecere
Ignacio Fernández-Urién
Adi Lahat
Guido Costamagna
Avraham Schwartz
Yulia Ron
Henit Yanai
Samuel Adler
author_facet Rami Eliakim
Cristiano Spada
Alon Lapidus
Inbal Eyal
Silvia Pecere
Ignacio Fernández-Urién
Adi Lahat
Guido Costamagna
Avraham Schwartz
Yulia Ron
Henit Yanai
Samuel Adler
author_sort Rami Eliakim
collection DOAJ
description Background and study aims Inflammatory bowel disease (IBD) affects the small bowel and colon. Endoscopic evaluation of these organs is essential. The new pan-enteric Crohn’s capsule (PCC) system is customized for complete coverage of IBD lesions in the entire bowel, allowing assessment and follow-up of disease severity and extent. The aim of this study was to evaluate the functionality of the PCC system in patients with suspected or established IBD. Patients and methods This was a prospective five-center feasibility study assessing the performance of PCC. Subjects ingested PCC after patency assurance with standard bowel preparation plus boosts. The primary endpoint was successful procedure, that is, video creation and report generation in accordance with methodology. Secondary endpoints were subjective coverage of the entire bowel, duration of reading time, video quality and occurrence of adverse events. Results Forty-one patients were included in the study with a mean age of 40.8 years ± 15.5, 46 % of whom were males. Seventy-one percent of patients had established Crohn’s disease (CD) and 53 % had active disease. Cleansing was graded good/excellent in 95 %. All 41 videos met the primary endpoint. There was no retention, 83 % reached the toilet while still recording. Thirty-one percent of patients with CD had proximal disease. Bowel coverage was graded 6.7 ± 0.6 and 6.1 ± 1.3 (1 – 7, unconfident – confident), image quality 6.1 ± 0.8 (1 – 7, poor – excellent), and reading time 3.7 ± 1.4 (1 – 7, very short to very long). Conclusions The PCC system is a minimally invasive system allowing extensive evaluation of the entire bowel in patients with IBD.
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spelling doaj.art-f13986d32f304ac99bbf157d08b40bcd2022-12-22T01:26:26ZengGeorg Thieme Verlag KGEndoscopy International Open2364-37222196-97362018-10-010610E1235E124610.1055/a-0677-170Evaluation of a new pan-enteric video capsule endoscopy system in patients with suspected or established inflammatory bowel disease – feasibility studyRami Eliakim0Cristiano Spada1Alon Lapidus2Inbal Eyal3Silvia Pecere4Ignacio Fernández-Urién5Adi Lahat6Guido Costamagna7Avraham Schwartz8Yulia Ron9Henit Yanai10Samuel Adler11Sheba Medical Center, Gastroenterology, Ramat Gan, IsraelCatholic University – Digestive Endoscopy Unit, Rome, Italy Medtronic Inc, Yoqneam, IsraelMedtronic Inc, Yoqneam, IsraelPoliclinico Universitario Agostino Gemelli – Digestive Endoscopy Unit, Rome, ItalyComplejo Hospitalario de Navarra – Servicio de Digestivom Pamplona, SpainSheba Medical Center, Gastroenterology, Ramat Gan, IsraelCatholic University – Digestive Endoscopy Unit, Rome, Italy Shaare Zedek Medical Center – Gastroenterology, Jerusalem, IsraelTel Aviv Sourasky Medical Ceneter – Gastroenterology, Tel Aviv, IraelTel Aviv Sourasky Medical Ceneter – Gastroenterology, Tel Aviv, IraelShaare Zedek Medical Center – Gastroenterology, Jerusalem, IsraelBackground and study aims Inflammatory bowel disease (IBD) affects the small bowel and colon. Endoscopic evaluation of these organs is essential. The new pan-enteric Crohn’s capsule (PCC) system is customized for complete coverage of IBD lesions in the entire bowel, allowing assessment and follow-up of disease severity and extent. The aim of this study was to evaluate the functionality of the PCC system in patients with suspected or established IBD. Patients and methods This was a prospective five-center feasibility study assessing the performance of PCC. Subjects ingested PCC after patency assurance with standard bowel preparation plus boosts. The primary endpoint was successful procedure, that is, video creation and report generation in accordance with methodology. Secondary endpoints were subjective coverage of the entire bowel, duration of reading time, video quality and occurrence of adverse events. Results Forty-one patients were included in the study with a mean age of 40.8 years ± 15.5, 46 % of whom were males. Seventy-one percent of patients had established Crohn’s disease (CD) and 53 % had active disease. Cleansing was graded good/excellent in 95 %. All 41 videos met the primary endpoint. There was no retention, 83 % reached the toilet while still recording. Thirty-one percent of patients with CD had proximal disease. Bowel coverage was graded 6.7 ± 0.6 and 6.1 ± 1.3 (1 – 7, unconfident – confident), image quality 6.1 ± 0.8 (1 – 7, poor – excellent), and reading time 3.7 ± 1.4 (1 – 7, very short to very long). Conclusions The PCC system is a minimally invasive system allowing extensive evaluation of the entire bowel in patients with IBD.http://www.thieme-connect.de/DOI/DOI?10.1055/a-0677-170
spellingShingle Rami Eliakim
Cristiano Spada
Alon Lapidus
Inbal Eyal
Silvia Pecere
Ignacio Fernández-Urién
Adi Lahat
Guido Costamagna
Avraham Schwartz
Yulia Ron
Henit Yanai
Samuel Adler
Evaluation of a new pan-enteric video capsule endoscopy system in patients with suspected or established inflammatory bowel disease – feasibility study
Endoscopy International Open
title Evaluation of a new pan-enteric video capsule endoscopy system in patients with suspected or established inflammatory bowel disease – feasibility study
title_full Evaluation of a new pan-enteric video capsule endoscopy system in patients with suspected or established inflammatory bowel disease – feasibility study
title_fullStr Evaluation of a new pan-enteric video capsule endoscopy system in patients with suspected or established inflammatory bowel disease – feasibility study
title_full_unstemmed Evaluation of a new pan-enteric video capsule endoscopy system in patients with suspected or established inflammatory bowel disease – feasibility study
title_short Evaluation of a new pan-enteric video capsule endoscopy system in patients with suspected or established inflammatory bowel disease – feasibility study
title_sort evaluation of a new pan enteric video capsule endoscopy system in patients with suspected or established inflammatory bowel disease feasibility study
url http://www.thieme-connect.de/DOI/DOI?10.1055/a-0677-170
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