Copyright
©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
Multicenter, randomized study to optimize bowel preparation for colon capsule endoscopy
David Kastenberg, Wilmot C Burch Jr, David P Romeo, Pankaj K Kashyap, David C Pound, Neophytos Papageorgiou, Ignacio Fernández-Urien Sainz, Carly E Sokach, Douglas K Rex
David Kastenberg, Division of Gastroenterology, Thomas Jefferson University, Philadelphia, PA 19107, United States
Wilmot C Burch Jr, Franklin Gastroenterology, PLLC, Franklin, TN 37067, United States
David P Romeo, Dayton Gastroenterology, Inc., Beavercreek, OH 45540, United States
Pankaj K Kashyap, Pinnacle Research Group LLC, Anniston, AL 36207, United States
David C Pound, Indianapolis Gastroenterology and Hepatology, Indianapolis, IN 46237, United States
Neophytos Papageorgiou, Department of Gastroenterology, American Medical Center, Nicosia 1311, Cyprus
Ignacio Fernández-Urien Sainz, Department of Gastroenterology, Servicio de Digestivo, Hospital de Navarra, Pamplona 31001, Spain
Carly E Sokach, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA 19107, United States
Douglas K Rex, Indiana University Hospital, Indianapolis, IN 19107, United States
Author contributions: Rex DK contributed to conception and design of the study; Kastenberg D, Burch WC, Romeo DP, Kashyap PK, Pound DC, Papageorgiou NP, Fernández-Urien Sainz I and Rex DK acquired the data; Kastenberg D and Rex DK contributed to analysis and interpretation of the data; Kastenberg D and Sokach CE drafted the article; Kastenberg D critically revised the article for important intellectual content; all authors approved the final article.
Institutional review board statement: Each center obtained IRB approval prior to study initiation from the respective IRB or Research Ethics Committee.
Clinical trial registration statement: This study and protocol was registered with clinicaltrials.gov (ID# NCT02481219)
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: Kastenberg D, reports grants and advisory board fees from Ferring, outside the submitted work. Burch WC, Romeo PD, Kashyap PK, Pound DC, and Sokach CE, do not declare any conflict of interests. Fernández-Urien Sainz I, reports personal fees from Medtronic, during the conduct of the study; personal fees from Medtronic, outside the submitted work. Papageorgiou NP, reports personal fees from Medtronic, during the conduct of the study; personal fees from Medtronic, outside the submitted work. Rex DK, reports other from Medtronic, during the conduct of the study; other from Medtronic, outside the submitted work; and Consulting fees, Olympus hororaria; Boston Scientific Research support; Endochoice; Endo Aid, Modivators, Boston Scientific.
Data sharing statement: All of the individual participant data collected during the trial, after de-identification, is available at www.clinicaltrials.gov (NCT 02481219) and will be accessible to anyone who wishes to access the data for any purpose.
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: David Kastenberg, FACP, MD, Professor, Division of Gastroenterology and Hepatology, Thomas Jefferson University, 4
th Floor Main Building, 132 South 10
th St. Philadelphia, PA 19107, United States.
david.kastenberg@jefferson.edu
Telephone: +1-215-9558900 Fax: +1-215-9555513
Received: September 1, 2017
Peer-review started: September 3, 2017
First decision: September 13, 2017
Revised: September 29, 2017
Accepted: November 21, 2017
Article in press: November 21, 2017
Published online: December 28, 2017
Processing time: 117 Days and 8.3 Hours
AIM
To assess the cleansing efficacy and safety of a new Colon capsule endoscopy (CCE) bowel preparation regimen.
METHODS
This was a multicenter, prospective, randomized, controlled study comparing two CCE regimens. Subjects were asymptomatic and average risk for colorectal cancer. The second generation CCE system (PillCam® COLON 2; Medtronic, Yoqneam, Israel) was utilized. Preparation regimens differed in the 1st and 2nd boosts with the Study regimen using oral sulfate solution (89 mL) with diatrizoate meglumine and diatrizoate sodium solution (“diatrizoate solution”) (boost 1 = 60 mL, boost 2 = 30 mL) and the Control regimen oral sulfate solution (89 mL) alone. The primary outcome was overall and segmental colon cleansing. Secondary outcomes included safety, polyp detection, colonic transit, CCE completion and capsule excretion ≤ 12 h.
RESULTS
Both regimens had similar cleansing efficacy for the whole colon (Adequate: Study = 75.9%, Control = 77.3%; P = 0.88) and individual segments. In the Study group, CCE completion was superior (Study = 90.9%, Control = 76.9%; P = 0.048) and colonic transit was more often < 40 min (Study = 21.8%, Control = 4%; P = 0.0073). More Study regimen subjects experienced adverse events (Study = 19.4%, Control = 3.4%; P = 0.0061), and this difference did not appear related to diatrizoate solution. Adverse events were primarily gastrointestinal in nature and no serious adverse events related either to the bowel preparation regimen or the capsule were observed. There was a trend toward higher polyp detection with the Study regimen, but this did not achieve statistical significance for any size category. Mean transit time through the entire gastrointestinal tract, from ingestion to excretion, was shorter with the Study regimen while mean colonic transit times were similar for both study groups.
CONCLUSION
A CCE bowel preparation regimen using oral sulfate solution and diatrizoate solution as a boost agent is effective, safe, and achieved superior CCE completion.
Core tip: Current bowel preparation boost agents for colon capsule endoscopy have associated risks and contraindications. This paper describes a new boost agent comprised of two very low dose hyperosmotic agents, oral sodium sulfate and diatrizoate solution, which appears to be an acceptable alternative regimen for colon capsule endoscopy.
