Prospective Study
Copyright ©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Aug 21, 2018; 24(31): 3556-3566
Published online Aug 21, 2018. doi: 10.3748/wjg.v24.i31.3556
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
Processing time: 69 Days and 21.5 Hours
Abstract
AIM

To evaluate the ability of PillCamColon2 to visualize colonic segments missed by incomplete optical colonoscopy (OC) and to assess the diagnostic yield.

METHODS

This prospective multicentre study included 81 patients from nine centres who underwent second-generation colon capsule endoscopy (CCE) following incomplete OC performed by an experienced gastroenterologist (> 1000 colonoscopies). Patients with stenosis were excluded. According to patient preferences, CCE was performed 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 was given as a rescue if the capsule was not excreted after seven hours.

RESULTS

Seventy-four patients were analysed (51% of them in group A; 49% in group B). Bowel cleansing was adequate in 67% of cases, and CCE could visualize colonic segments missed by incomplete colonoscopy in 90% of patients under protocol A and 97% of patients under protocol B (P = 0.35, n.s.). Significant polyps including adenocarcinoma were detected in 24% of cases. Detection rates for all polyps and significant polyps per patient were similar in both protocols. Polyps were found predominantly in the right colon (86%) in segments that were not reached by OC. Extracolonic findings - such as reflux esophagitis, suspected Barrett esophagus, upper GI-bleeding, gastric polyps, gastric erosions and angiectasia - were detected in eight patients. PillCamColon2 capsule was retained in the ileum of one patient (1.4%) without symptoms and removed during an uneventful resection for unknown Crohn’s disease that was diagnosed as the cause of anemia, which was the indication for colonoscopy. CCE was well tolerated. One patient suffered from self-limiting vomiting after consuming the phospho-soda.

CONCLUSION

Second-generation CCE using a low-volume preparation is useful after incomplete OC, and it allows for the detection of additional relevant findings, but cleansing efficiency could be improved.

Keywords: Colon capsule endoscopy; PillCamColon2; Incomplete colonoscopy; Low volume prep; Moviprep; Phospho-soda; Cleanliness level; Complementation rate; Polyps

Core tip: Colonoscopy is the gold standard for visualization of the colon, but it may be incomplete, not reaching the cecum. Second-generation colon capsule endoscopy (CCE) with low-volume preparations could complement incomplete colonoscopies in 90% of cases, and it could help to detect additional relevant colonic and extracolonic findings. Protocols with either CCE the day following an incomplete colonoscopy or within 30 d after a new low-volume preparation were both feasible and well tolerated; however, the protocols could be improved with respect to bowel cleanliness and complete colon visualization.