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Multicenter,randomized study to optimize bowel for colon capsule endoscopy

World Journal of Gastroenterology 2017年第48期23卷 8615-8625页

作者： 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 Division of Gastroenterology Thomas Jefferson University Franklin Gastroenterology PLLC Dayton Gastroenterology Inc. Pinnacle Research Group LLC Indianapolis Gastroenterology and hepatology Department of Gastroenterology American Medical Center Department of Gastroenterology Servicio de Digestivohospital de Navarra Sidney Kimmel Medical College at Thomas Jefferson University Indiana University hospital

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(Pill Cam? COLON 2;Medtronic,Yoqneam,Israel) was utilized. Preparation regimens differed in the 1 st and 2 nd boosts with the Study regimen using oral sulfate solution(89 m L) with diatrizoate meglumine and diatrizoate sodium solution("diatrizoate solution")(boost 1 = 60 m L,boost 2 = 30 m L) and the Control regimen oral sulfate solution(89 m L) 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.

关键词： Bowel preparation Purgative Capsule endoscopy Endoscopy Capsule colonoscopy Large intestine

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