A prospective cohort study evaluating a novel colonoscopy platform featuring full-spectrum endoscopy

<p>Background and study aims: Although colonoscopy is the criterion standard for detecting colorectal adenomas and cancers, a significant percentage of adenomas are missed with this technique. We aimed to establish the feasibility, usability, and safety of a novel colonoscopy platform featuring full-spectrum endoscopy (FUSE). Patients and methods: This was a prospective, single-center pilot and feasibility study. In total, 50 individuals, ages 18 - 70 years, underwent colonoscopy featuring FUSE (up to 330 degrees field of view) for colorectal cancer screening, polyp surveillance, or diagnostic evaluation. Study end points included success of cecal intubation, time to cecal intubation, withdrawal time, total procedure time, success of therapeutic interventions, adverse events, and endoscopists' subjective evaluation of FUSE. Results: Cecal intubation was achieved in 50/50 individuals (100 %). Time to cecum (minutes, mean +/- SD) was 3.1 +/- 1.5 minutes, withdrawal time 12.7 +/- 4.4 minutes, and total procedure time 15.3 +/- 4.6 minutes. In 22/50 cases (44 %), 26 therapeutic interventions were performed: 19 (73.1 %) biopsies and 7 (26.9 %) polypectomies. No acute or delayed adverse events were observed. Patient satisfaction and endoscopist subjective evaluation were high. Conclusions: A colonoscopy platform featuring full-spectrum endoscopy appears feasible, usable, and safe. These results represent an important advance in colonoscopy imaging technology and should be further pursued in comparative human studies.</p>

Endoluminal compression clip: full-thickness resection of the mesenteric bowel wall in a porcine model

Background: Performing a full-thickness intestinal wall resection Of a sessile polyp located on the mesenteric side with a compression clip may lead to compression of mesenteric vessels. The application of such a clip may therefore cause a compromised blood supply in the particular bowel segment, leading to perforation. Objective: To evaluate the performance of a newly developed, nitinol compression clip, called the NiTi clamp, for full-thickness resection of the bowel wall, while the clip is deliberately deployed endoluminally on the mesenteric side. Design: Prospective animal study. Multinational, multidiciplinary; gastroenterology and general surgery, research Cooperation. Setting: Animal research laboratory. Intervention: Six pigs were operated upon and endoscopically evaluated and then killed after 3 weeks. Linear compression closure clips based on nitinol springs were used. Three longitudinal enterotomies were performed: in the cecum, spiral colon, and proximal rectum. Four clips were deployed in each animal. Main Outcome Measurements: A total of 23 clips were deployed. The average expulsion day was 9 days. Results: All but 3 clips were normally expelled. One pig developed bowel ischemia due to intussusception. In endoscopic procedures, no signs of significant segmental mucosal ischemia were found. The macroscopic appearance of the compression closure lines was thin and delicate, but epithelialization was significantly delayed at 5 sites. Limitation: Differences between porcine and human colorectal anatomy. Conclusion: Full-thickness clamping of the bowel with the NiTi clamp, including the local mesenteric vasculature does not significantly impair local healing of the clamp site and gives hope to further development of novel full-thickness endoscopic resection technologies. (Gastrointest Endosc 2009;70:1146-57.

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

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 rate of EndoRings colonoscopy (7/67; 10.4 %) was significantly lower (P < 0.001) compared with standard colonoscopy (28/58; 48.3 %). Similar results were found for polyp miss rates: EndoRings (9.1 %) and standard colonoscopy (52.8 %; P < 0.001). Mean cecal intubation times (9.3 vs. 8.4 minutes; P = 0.142) and withdrawal times (7.4 vs. 7.2 minutes; P = 0.286), respectively, were not significantly different between EndoRings and standard colonoscopy. Mean total procedure time was longer with EndoRings than with standard colonoscopy (21.6 vs. 18.5 minutes, P = 0.001) as more polyps were removed. Conclusions: This study demonstrates that colonoscopy with EndoRings has lower adenoma and polyp miss rates than standard colonoscopy, which may improve the efficacy particularly of screening and surveillance colonoscopies.ClinicalTrials.gov NCT01955122

Comparison of standard forward-viewing mode versus ultrawide-viewing mode of a novel colonoscopy platform:a prospective, multicenter study in the detection of simulated polyps in an in vitro colon model (with video)

<p>Background: Although colonoscopy is the criterion standard for detecting colorectal adenomas and cancers, a significant percentage of adenomas are missed.</p><p>Objective: To compare forward-viewing with ultrawide-viewing colonoscopy in the detection of simulated colon polyps in an in vitro colon model.</p><p>Design: Prospective, multicenter.</p><p>Setting: Six endoscopy units (3 in the United States and 3 in Israel).</p><p>Patients: In vitro colon model with simulated colon polyps (n = 21 metallic beads).</p><p>Interventions: Detection of simulated colon polyps on colonoscope withdrawal.</p><p>Main Outcome Measurements: Incremental detection of simulated colon polyps and endoscopist evaluation of the usability, visibility, and maneuverability of ultrawide-viewing colonoscopy.</p><p>Results: On forward-viewing colonoscopy, the number of simulated polyps (mean +/- standard deviation) detected per endoscopist was 11.1 +/- 2.3 polyps, a 52.9% detection rate. Simulated polyp detection rates per colon segment were 3.0 +/- 0.93 (60.0%) right colon, 2.4 +/- 0.87 (48.0%) transverse colon, and 5.7 +/- 1.5 (51.8%) left colon. On ultrawide-viewing colonoscopy, the simulated polyp detection rate per endoscopist significantly increased to 18.0 +/- 1.98 polyps, an overall 85.7% polyp detection rate (P <.001). Simulated polyp detection rates were also significantly higher by using the ultrawide-viewing mode in each colon segment, 4.5 +/- 0.65 polyps (90.0%) right colon, 4.0 +/- 0.87 (80.0%) polyps transverse colon, and 9.6 +/- 1.28 polyps (87.3%) left colon (all comparisons, P <.001). Importantly, the ultrawide-viewing mode detected significantly more "hidden" simulated polyps (81.9% vs 31.9%, P <.0001).</p><p>Limitations: Nonrandomized design, use of a colon model, and "simulated" colon polyps.</p><p>Conclusions: Ultrawide-view colonoscopy significantly improved simulated polyp detection in a colon model. Clinical studies in human subjects should be pursued to further evaluate this new endoscopic technology. (Gastrointest Endosc 2013;77:472-9.)</p>