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©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
PillCamColon2 after incomplete colonoscopy - A prospective multicenter study
Peter Baltes, Marc Bota, Jörg Albert, Michael Philipper, Hans-Georg Hörster, Friedrich Hagenmüller, Ingo Steinbrück, Ralf Jakobs, Matthias Bechtler, Dirk Hartmann, Horst Neuhaus, Jean-Pierre Charton, Rupert Mayershofer, Horst Hohn, Thomas Rösch, Stefan Groth, Tanja Nowak, Peter Wohlmuth, Martin Keuchel
Peter Baltes, Marc Bota, Martin Keuchel, Clinic for Internal Medicine, Bethesda Krankenhaus Bergedorf, Hamburg 21029, Germany
Jörg Albert, Department of Internal Medicine I, Klinikum der JW. Goethe Universität, Frankfurt 60590, Germany
Michael Philipper, Gastroenterologische Schwerpunktpraxis, Düsseldorf 40227, Germany
Hans-Georg Hörster, Gastropraxis Rheydt, Mönchengladbach 41236, Germany
Friedrich Hagenmüller, Ingo Steinbrück, 1st Medical Department, Asklepios Klinikum Altona, Hamburg 22763, Germany
Ralf Jakobs, Matthias Bechtler, Medical Clinic C, Klinikum der Stadt Ludwigshafen, Ludwigshafen 67063, Germany
Dirk Hartmann, Clinic for Internal Medicine, Sana Klinikum Lichtenberg, Berlin 10365, Germany
Horst Neuhaus, Jean-Pierre Charton, Clinic for Internal Medicine, Evangelisches Krankenhaus, Düsseldorf 40217, Germany
Rupert Mayershofer, Gastroenterologie am Burgweiher, Bonn 53123, Germany
Horst Hohn, Schwerpunktpraxis Gastroenterologie, Koblenz 56068, Germany
Thomas Rösch, Stefan Groth, Clinic for Interdisciplinary Endoscopy, University Hospital Eppendorf, Hamburg 20251, Germany
Tanja Nowak, CorporateHealth International, Hamburg 20149, Germany
Peter Wohlmuth, Biometry and Data Management, Asklepios Proresearch, Hamburg 20099, Germany
Author contributions: Albert J, Hagenmüller F, Jakobs R, Hartmann D, Neuhaus H, Wohlmuth P and Keuchel M designed the study; Baltes P, Bota M, Albert J, Philipper M, Hörster HG, Steinbrück I, Bechtler M, Hartmann D, Charton JP, Mayershofer R, Hohn H and Keuchel M collected, analysed and reviewed the data; Baltes P, Bota M and Keuchel M managed the study; Baltes P, Bota M, Nowak T and Keuchel M wrote the manuscript; Rösch T and Groth S revised the manuscript; all authors read and approved the final version of the manuscript.
Institutional review board statement: The research was approved by the Ethics Committee of Hamburg Chamber of Physicians.
Informed consent statement: All study participants provided informed written consent prior to study enrollment.
Conflict-of-interest statement: Peter Baltes, Michael Philliper, Ingo Steinbrück, and Horst Hohn received lecture fees from Given Imaging, Jörg Albert, Martin Keuchel received study support and lecture fees from Given Imaging, Tanja Nowak was an employee of Given Imaging, the other authors have nothing to declare. The study was supported by Given Imaging, Hamburg, Germany by providing the capsules and an unrestricted grant.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Peter Baltes, MD, Doctor, Senior Consultant, Clinic for Internal Medicine, Bethesda Krankenhaus Bergedorf, Akademisches Lehrkrankenhaus der Universität Hamburg, Glindersweg 80, Hamburg 21029, Germany. baltes@bkb.info
Telephone: +49-40-725541201 Fax: +49-40-725541202
Received: June 9, 2018
Peer-review started: June 9, 2018
First decision: July 4, 2018
Revised: July 18, 2018
Accepted: July 21, 2018
Article in press: July 21, 2018
Published online: August 21, 2018
ARTICLE HIGHLIGHTS
Research background
Optical colonoscopy (OC) is the gold standard for visualization of the colon. However, it may be incomplete e.g. due to unfavorable anatomy. Colon capsule endoscopy (CCE) is cleared by the US Food and Drug Administration for patients with previously incomplete OC. Second generation CCE has been shown to have a higher sensitivity for detection of colon polyps than first generation. Low volume bowel prep with Moviprep has been shown to be feasible for CCE.
Research motivation
Bowel preparation for CCE is more extensive than for OC. Thus, we aimed to evaluate, if second generation CCE is feasible using either repeated low volume bowel prep or staying on clear liquids following an incomplete OC.
Research objectives
Main research objective was the ability of CCE to visualize those colon segments not reached by incomplete OC. Secondary objectives were additional diagnostic yield of CCE, rate of complete colon visualization by CCE, cleansing levels, and safety.
Research methods
In this prospective multicenter study 81 patients underwent second generation colon capsule endoscopy with PillCamColon2 after incomplete OC. CCE was performed either the following day (protocol A) after staying on clear liquids and 0.75 L Moviprep in the morning or within 30 d after new split-dose Moviprep (protocol B). Boosts consisted of 0.75 L and 0.25 L Moviprep, and phospho-soda as rescue if the capsule was not excreted after 7 hours.
Research results
Seventy-four patients were finally analyzed per protocol. Of those, cleansing was adequate in 67% of cases and CCE could visualize the colonic segments missed by incomplete colonoscopy in 90% (protocol A) and 97% (protocol B, P = 0.35, n.s.) of the patients. Detection rates were similar with both protocols: Significant polyps and one adenocarcinoma were detected in 24% of cases. Polyps were found predominantly in the right colon (86%) in segments not reached by OC. Extra-colonic findings as reflux esophagitis, suspected Barrett esophagus, upper GI-bleeding, gastric polyps, gastric erosions, and angiectasia were detected in 8 patients. One capsule (1.4%) was retained in the ileum without symptoms and removed during uneventful resection for unknown Crohn`s disease diagnosed as cause of unclear anemia. CCE was well tolerated. One patient suffered from self-limiting vomiting after phospho-soda.
Research conclusions
Second generation CCE using low volume prep is useful to complement incomplete OC, detects additional relevant findings including extra-colonic lesions, and is well tolerated. CCE is feasible the following day after staying on clear liquids or after new prep within 30 d. Potential risk of capsule retention must be considered.
Research perspectives
Future studies should address improvement of colon cleansing levels and completeness of CCE after incomplete OC. Cost-effectiveness of CCE after incomplete OC should be addressed by future research in comparison with other methods as CT colonoscopy, MR colonoscopy, and device assisted colonoscopy.
