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Video Capsule Endoscopy 2021 TECHNOLOGY STATUS EVALUATION REPORT Video capsule endoscopy Prepared by: ASGE TRAINING COMMITTEE Joshua Melson, MD, MPH, FASGE,1 Guru Trikudanathan, MBBS,2 Barham K. Abu Dayyeh, MD, MPH, FASGE,3 Manoop S. Bhutani, MD, FASGE,4 Vinay Chandrasekhara, MD, FASGE,5 Pichamol Jirapinyo, MD, MPH,6 Kumar Krishnan, MD,7 Nikhil A. Kumta, MD, MS,8 Rahul Pannala, MD, MPH, FASGE,9 Mansour A. Parsi, MD, MPH, FASGE,10 Amrita Sethi, MD, FASGE,11 Arvind J. Trindade, MD, FASGE,12 Rabindra R. Watson, MD,13 John T. Maple, DO, FASGE, (previous committee chair, 2016-2019),14 David R. Lichtenstein, MD, FASGE,15(ASGE Technology Committee Chair) The American Society for Gastrointestinal Endoscopy tion (FDA) approval in 2001, this technology has been (ASGE) Technology Committee provides reviews of exist- refined to provide superior resolution, increased battery ing, new, or emerging endoscopic technologies that life, and capabilities to view different parts of the GI tract. have an impact on the practice of GI endoscopy. VCE has an established, essential role in the evaluation of Evidence-based methodology is used, with a MEDLINE small-bowel lesions and bleeding.1 Potential clinical literature search to identify pertinent clinical studies on applications for VCE have expanded to include the the topic and a MAUDE (U.S. Food and Drug Administra- evaluation of inflammatory bowel disease and screening for tion Center for Devices and Radiological Health) data- colorectal neoplasia in selected patients. This document is base search to identify the reported adverse events of a an update of a 2013 ASGE Technology Committee article given technology. Both are supplemented by accessing entitled “Wireless Capsule Endoscopy” and reviews the “related articles” feature of PubMed and by scruti- currently available VCE systems and their applications.2 nizing pertinent references cited by the identified studies. Controlled clinical trials are emphasized, but in many TECHNOLOGY UNDER REVIEW cases data from randomized controlled trials are lack- ing. In such cases, large case series, preliminary clinical Commercially available VCE systems intended for imag- studies, and expert opinions are used. Technical data are ing of the upper GI (UGI) tract, small bowel, and colon are gathered from traditional and Web-based publications, detailed in Table 1. VCE systems marketed in the United proprietary publications, and informal communications States typically consist of a capsule endoscope, a sensing with pertinent vendors. Technology Status Evaluation Re- system attached to the patient that includes either sensing ports are drafted by 1 or 2 members of the ASGE Technol- arrays or a sensing belt, a data recorder and battery pack, ogy Committee, reviewed and edited by the committee as and software for image review and interpretation. Many a whole, and approved by the Governing Board of the fi systems include external viewers or viewers integrated ASGE. When nancial guidance is indicated, the most with the data recorder that allow real-time review of images recent coding data and list prices at the time of publica- during VCE examinations (RAPID Real-Time [Given Imag- tion are provided. For this review, the MEDLINE database ing/Medtronic, Minneapolis, Minn, USA], Real Time Viewer was searched through September 2019 using terms such [Olympus America, Center Valley, Penn, USA], and Miro- as “wireless capsule endoscopy,”“capsule endoscopy,” “ ”“ ” “ View Express [IntroMedic, Seoul, South Korea]). video capsule endoscopy, colon capsule, and colon Capsule endoscopes may be swallowed or placed endo- capsule endoscopy,” among others. Technology Status fi scopically after activation and subsequently progress Evaluation Reports are scienti c reviews provided solely through the GI tract by peristalsis until excreted naturally. for educational and informational purposes. Technology Typical device setup includes placement of a lead sensor Status Evaluation Reports are not rules and should not be array onto the patient’s abdomen; the sensors are con- construed as establishing a legal standard of care or as nected to the recorder, which is worn or carried by the pa- encouraging, advocating, requiring, or discouraging tient. The CapsoCam Plus (CapsoVision, Saratoga, Calif, any particular treatment or payment for such treatment. USA) is the only VCE system that does not include a sensing system. Instead, its capsule endoscope stores im- Video capsule endoscopy (VCE) enables visualization of ages in onboard memory for subsequent download after the mucosal surface throughout the GI tract in a minimally the capsule is retrieved by the patient after excretion.3 invasive manner. Since initial U.S. Food and Drug Administra- For most VCE systems, a simplified belt that includes 784 GASTROINTESTINAL ENDOSCOPY Volume 93, No. 4 : 2021 www.giejournal.org Video capsule endoscopy internal sensors can be used instead of affixing sensor for 10 to 12 hours is commonly recommended; some cen- arrays directly to the patient’s skin. Traditional sensor ters instruct a clear liquid diet for 24 hours before the arrays are generally suggested for use in obese patients. study. A full or partial bowel preparation the night before After ingestion of the capsule, patients are instructed to the study has been advocated to improve visualization of avoid intense exercise or activities that may cause the the small intestine, although data are conflicting.4,5 Adiet sensors to detach. of clear liquids is allowed after 2 hours from capsule Capsule endoscopes measure 24 to 32 mm in length ingestion and a light meal after 4 hours. An exception and 11 to 13 mm in diameter, depending on the manufac- to these dietary recommendations is with the Mirocam turer and product line. All capsule endoscopes have similar system, where the manufacture stipulates that patients components: a disposable plastic-coated capsule, a metal may drink water immediately after the capsule is oxide semiconductor or high-resolution charge-coupled swallowed and may continue to drink water throughout device image capture system, a compact lens, light- the entire procedure. The reusable data recording emitting diode illumination sources, and an internal bat- system can be disconnected from the patient after the tery source. The mode of data transmission from the lifespan of the battery has expired or after the capsule is capsule is either via ultra-high frequency band radio telem- excreted, whichever comes first. Most capsules are etry (PillCam [Medtronic, Minneapolis, Minn, USA], Endo- designed to be excreted without a need for collection. Capsule [Olympus, Center Valley, Penn, USA]) or human The CapsoCam Plus capsule does require that the body communications (Mirocam, Intromedic Seoul, Seoul, capsule be retrieved for data to be uploaded by use of a South Korea). The latter technology uses the capsule itself magnetic wand that retrieves the capsule once excreted. to generate an electrical field that uses human tissue as the After data upload from the capsule, the images are conductor for data transmission. Capsule endoscopes with available for review and interpretation via the extended battery life may be beneficial in patients with de- proprietary software. As an alternative, CapsoVision also layed gastric and small-bowel transit (Table 1). markets a service in which patients mail in their Proprietary software is used to process and display the retrieved capsules to a central download center, which images in single or multiple views at user selectable rates then uploads the examination data into a secure, cloud- of 3 to 40 frames per second (fps). Representative images based portal, allowing remote access and review by the and video clips can be annotated and saved. All available clinician. software can identify red pixels to facilitate detection of bleeding lesions. Additional software features available on Colon VCE all systems include localization data and progress of Two video colon capsule endoscopy (CCE) systems capsule transit within the GI tract, quick reference image (PillCam COLON 2 and PillCam Crohn’s, Medtronic, Sunny- atlases, and report generation capabilities (Table 2). vale, Calif, USA) have been cleared by the FDA for colon visualization. PillCam COLON 2 is designed for visualiza- Upper GI VCE tion of the colon, whereas PillCam Crohn’s is designed The PillCam UGI capsule (Medtronic, Minneapolis, for the visualization of both the small bowel and the colon Minn, USA) is the only VCE system currently marketed and has been specifically marketed for the assessment of for gastric and esophageal applications. The capsule di- Crohn’s disease (CD) activity. Specifications on these sys- mensions, transmission wavelength, field of view, resolu- tems are summarized in Tables 1 and 2, and additional tion, and interpretation software are identical to the information is provided in the next sections. PillCam SB3. However, the capsule battery life is only 90 CCE is intended to completely image the colorectal mu- minutes (vs 8-12 hours for small-bowel capsules), cameras cosa. CCE has been used when colonoscopy is incomplete, are located on both ends of the capsule, and the capsule for colorectal cancer (CRC) screening in patients at captures images at a higher frame rate (18-35 fps). Variable increased risk for procedural adverse events, and for frame rate technology operates at 35 fps for the first 10 mi- assessment of inflammatory bowel disease activity. CCE nutes of the procedure and 18 fps for the last 80 minutes. was first introduced in 2008 and does not require sedation. According to the manufacturer, the patient should be PillCam COLON 2 (CCE-2) has replaced the original Pill- fasting for at least 2 hours before ingestion of the UGI- Cam COLON capsule endoscopy system (Medtronic, Min- VCE. Three thoracic sensors should then be affixed to the neapolis, Minn, USA) and features a wider field of view patient in a designated pattern that are connected to the (up to 172 degrees), improved camera optics, and a higher data recorder. Finally, a specific ingestion protocol is recom- frame rate (up to 35 fps).6 mended by the manufacturer to maximize time for the To ensure adequate colon imaging while maintaining capsule to capture images as it traverses the esophagus.
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