Multicenter, randomized, tandem evaluation of EndoRings colonoscopy – results of the CLEVER study

Abstract

Colonoscopy is the standard method for detection and removal of colorectal adenomas, the precursor lesions of most colorectal cancers [1 -4]. Despite being the most sensitive method, colonoscopy does not fully protect a person from developing future colorectal cancer [5 -10]. This imperfection is for a major part caused by missed precancerous lesions due to inadequate bowel preparation, the presence of flat lesions that are difficult to detect [8,9,11], and the relative difficulty of visualizing lesions on the proximal side of haustral folds and the internal curves of flexures [12,13]. The latter may, at least partly, be caused by the fact that the use of standard 140°and 170°colonoscopes allows visualization of only approximately 90 % of the colonic surface [14]. Moreover, it has been shown that up to twothirds of missed lesions are located on the proximal side of folds [13]. The miss rates of colonoscopy have been widely acknowledged, with back-to-back colonoscopy studies showing polyp and adenoma miss rates of approximately 20 % -25 % in older studies [15] and up to 40 % in more recent studies evaluating novel technologies developed to improve visualization behind folds [16,17]. Alongside the implementation of quality indicators [1,18], technologies such as cap-assisted colonoscopy, virtual chromoendoscopy, Third Eye colonoscopy, and Full Spectrum Endoscopy (Fuse) colonoscopy have been developed to improve adenoma detection [16,17,19,20]. However, some of these techniques have been shown to increase only marginally the detection of adenomas, while others are less practical in use or demand high investments with a change in endoscopy platform [21,22]. Background and study aims: Adenoma miss rate during colonoscopy has become a widely acknowledged proxy measure for post-colonoscopy colorectal cancer. Among other reasons, this can happen because of inadequate visualization of the proximal aspects of colonic folds and flexures. EndoRings (EndoAid Ltd., Caesarea, Israel) is a silicone-rubber device that is fitted onto the distal end of the colonoscope. Its flexible circular rings engage and mechanically stretch colonic folds during withdrawal. The primary aim of this study was to compare adenoma miss rates between standard colonoscopy and colonoscopy using EndoRings. Methods: In this multicenter, randomized, tandem colonoscopy study, we performed same-day, back-to-back colonoscopies with EndoRings followed by standard colonoscopy, or vice versa. Results: After exclusion of 10 patients for protocol violations, 116 patients (38.8 % female; mean age 58.7) remained for analysis. The adenoma miss

Endoscopic Improvement of the Adenoma Detection Rate during Colonoscopy - Where Do We Stand in 2015?

“…Recently, the first tandem study from the United States, Israel and the Netherlands comparing EndoRings assisted with standard colonoscopy has just been completed (ClinicalTrials identifier NCT01955122). Also recently, the first multicenter, randomized trial comparing EndoRings with standard colonoscopy (CLEVER study) was published by Dik et al [80]. In that study, the adenoma miss rate (15%) in subjects undergoing EndoRing-assisted colonoscopy first was statistically and significantly (p < 0.01) lower compared to subjects who underwent standard colonoscopy first (48%).…”

New Developments in Mechanical Enhancement of Colonoscopy: Cuffs, Caps and Rings

“…Six prospective RCTs, 1 each from Germany [10] , Hong Kong [11] , Netherlands [12] , US [13] , South Korea [14] , Australia [15] and 1 retrospective study from Hong Kong [16] describing the CAC were included for the review. One multicenter (Netherlands, Israel and US) RCT describing ERC was also included [17] . All studies have been summarized in table 1 .…”

“…They included patients undergoing screening, surveillance and diagnostic colonoscopies [7][8][9][10][11][12][13][14][15][16][17] . Diagnostic colonoscopies included, but were not limited to symptoms of abdominal pain and evaluation of anemia [7][8][9] .…”

“…Patients who had a prior history of or known colonic strictures, tumors, colorectal surgery, partial colonic resection, extensive diverticulosis, acute diverticulitis within 6 weeks of examination, suspected or proven acute lower gastrointestinal bleeding, history of chronic inflammatory bowel disease or familial adenomatous polyposis, end-stage disease including congestive heart failure and renal insufficiency, coagulopathy which included platelet count of <50,000, physical deconditioning, anticoagulant or anti-platelet use and inadequate bowel preparation were excluded by the respective authors [7][8][9][10][11][12][13][14][15][16][17] . Few authors used additional exclusion criteria like prior colonoscopy [11] or a full colonic examination within 5 years of enrollment in study.…”

“…In the prospective studies, the study subjects were grouped into 2 arms based on the type of intervention: EC [7][8][9] or CAC [10][11][12][13][14][15] or ERC [17] versus standard colonoscopy (SC), regular colonoscopy (RC) or conventional colonoscopy (CC). The retrospective studies looked into the EC [9] and CAC [16] performed.…”