Colorectal polyp prevalence and aspirational detection targets determined using high definition colonoscopy and a high level detector in 2017.

BACKGROUND: Colorectal adenoma prevalence can be determined by autopsy studies, or imaging studies such as colonoscopy. We describe the prevalence of colorectal adenomas determined by a single high detecting colonoscopist using high definition colonoscopes. METHODS: We conducted a cross-sectional study of consecutive patients aged ≥18 years undergoing colonoscopy with a high level detector for the indications of screening, surveillance, and diagnostic reasons from December 29, 2016 to January 12, 2018. RESULTS: During the study period, 1172 eligible patients underwent colonoscopy. Women comprised 55% (n = 646) and the majority (89%, n = 1038) were aged ≥50 years (mean age, 62.1 years). In persons aged ≥50 years undergoing screening, the prevalence of ≥1 conventional adenoma was 48.5% and ≥1 sessile serrated polyp was 15.3%. Diminutive polyps (1-5 mm in size) comprised three-quarters of all resected polyps (2236/2986). Among 246 patients (21%), 1050 hyperplastic appearing polyps were not resected from the recto-sigmoid. Adenoma prevalence was strongly associated with age and indication but serrated lesion prevalence was not. CONCLUSIONS: The true prevalence of precancerous lesions in the colorectum determined by modern colonoscopy exceeds determination by autopsy studies. These data help define aspirational detection targets for colonoscopy. The economic burden associated with colonoscopic resection of tiny lesions is substantial.

Impact of a ring-fitted cap on insertion time and adenoma detection: a randomized controlled trial.

BACKGROUND AND AIMS: Devices for flattening colon folds can improve polyp detection at colonoscopy. However, there are few data on the endoscopic ring-fitted cap (EndoRings; EndoAid, Caesarea, Israel). We sought to compare adenoma detection with EndoRings with that of standard high-definition colonoscopy. METHODS: This was a single-center, randomized controlled trial of 562 patients (284 randomized to EndoRings and 278 to standard colonoscopy) at 2 outpatient endoscopy units in the Indiana University Hospital system. Adenoma detection was the primary outcome measured as adenoma detection rate (ADR) and adenomas per colonoscopy (APC). We also compared sessile serrated polyp detection rate, insertion times, withdrawal times, and ease of passage through the sigmoid colon. RESULTS: EndoRings was superior to standard colonoscopy in terms of APC (1.46 vs 1.06, P = .025), but there were no statistically significant differences in ADR or sessile serrated polyp detection rate. Mean withdrawal time (in patients with no polyps) was shorter and insertion time (all patients) was longer in the EndoRings arm by 1.8 minutes and 0.75 minutes, respectively. One provider had significantly higher detection with Endo-Rings and contributed substantially to the overall results. CONCLUSIONS: EndoRings can increase adenoma detection without a significant increase in procedure time, but the effect varies between operators. The use of EndoRings slows colonoscope insertion. (Clinical trial registration number: NCT03418662.).

Impact of water filling on terminal ileum intubation with a distal-tip mucosal exposure device.

BACKGROUND AND AIMS: Endocuff improves detection at colonoscopy but seems to impede terminal ileal (TI) intubation. We assessed the impact of Endocuff Vision (EV) on TI intubation using adult or pediatric colonoscopes and evaluated whether filling the cecum with gas versus water affected the impact of EV on TI intubation. METHODS: Using a prospectively recorded quality control database, we explored the impact of EV on TI intubation in ≤1 minute. We used adult and pediatric colonoscopes and tested the effect of filling the cecum with gas versus water. If the initial attempt failed, then the alternative (water vs gas) was tried as a rescue method. RESULTS: TI intubation in ≤1 minute occurred in 91% of colonoscopies without EV versus 65% with EV, but the use of the pediatric colonoscope with EV had a higher success rate for TI intubation in ≤1 minute compared with the adult colonoscope with EV (73% vs 57%, P = .043). TI intubation in ≤1 minute was more successful with EV when the cecum was filled with water rather than gas (74% vs 56%, P = .019), but the benefit of water filling was limited to the adult colonoscope with EV. When EV was in place, water filling was more successful as a rescue method of TI intubation (58% vs 21%, P = .011). CONCLUSIONS: EV adversely affects TI intubation, particularly for adult colonoscopes. Water filling of the cecum mitigates the impact of EV on TI intubation with adult colonoscopes.

A comparison of 2 distal attachment mucosal exposure devices: a noninferiority randomized controlled trial.

BACKGROUND AND AIMS: Endocuff (Arc Medical Design, Leeds, UK) and Endocuff Vision (Arc Medical Design, Leeds, UK) are effective mucosal exposure devices for improving polyp detection during colonoscopy. AmplifEYE (Medivators Inc, Minneapolis, Minn, USA) is a device that appears similar to the Endocuff devices but has received minimal clinical testing. METHODS: We performed a randomized controlled clinical trial using a noninferiority design to compare Endocuff Vision with AmplifEYE. RESULTS: The primary endpoint of adenomas per colonoscopy was similar in AmplifEYE at 1.63 (standard deviation 2.83) versus 1.51 (2.29) with Endocuff Vision (P = .535). The 95% lower confidence limit was 0.88 for ratio of means, establishing noninferiority of AmplifEYE (P = .008). There was no difference between the arms for mean insertion time, and mean inspection time (withdrawal time minus polypectomy time and time for washing and suctioning) was shorter with AmplifEYE (6.8 minutes vs 6.9 minutes, P = .042). CONCLUSIONS: AmplifEYE is noninferior to Endocuff Vision for adenoma detection. The decision on which device to use can be based on cost. Additional comparisons of AmplifEYE with Endocuff by other investigators are warranted. (Clinical trial registration number: NCT03560128.).

SIC-8000 versus hetastarch as a submucosal injection fluid for EMR: a randomized controlled trial.

BACKGROUND AND AIMS: Viscous solutions provide a superior submucosal cushion for EMR. SIC-8000 (Eleview; Aries Pharmaceuticals, La Jolla, Calif) is a commercially available U.S. Food and Drug Administration-approved solution, but hetastarch is also advocated. We performed a randomized trial comparing SIC-8000 with hetastarch as submucosal injection agents for colorectal EMR. METHODS: This was a single-center, double-blinded, randomized controlled trial performed at a tertiary referral center. Patients were referred to our center with flat or sessile lesions measuring ≥15 mm in size. The primary outcome measures were the Sydney resection quotient (SRQ) and the rate of en bloc resections. Secondary outcomes were total volume needed for a sufficient lift, number of resected pieces, and adverse events. RESULTS: There were 158 patients with 159 adenomas (SIC-8000, 84; hetastarch, 75) and 57 serrated lesions (SIC-8000, 30; hetastarch, 27). SRQ was significantly better in the SIC-8000 group compared with hetastarch group (9.3 vs 8.1, P = .001). There was no difference in the proportion of lesions with en bloc resections. The total volume of injectate was significantly lower with SIC-8000 (14.8 mL vs 20.6 mL, P = .038). CONCLUSIONS: SIC-8000 is superior to hetastarch for use during EMR in terms of SRQ and total volume needed, although the absolute differences were small. (Clinical trial registration number: NCT03350217.).

Disagreement between high confidence endoscopic adenoma prediction and histopathological diagnosis in colonic lesions ≤ 3 mm in size.

BACKGROUND: Diminutive colorectal polyps resected during colonoscopy are sometimes histologically interpreted as normal tissue. The aim of this observational study was to explore whether errors in specimen handling or processing account in part for polyps ≤ 3 mm in size being interpreted as normal tissue by pathology when they were considered high confidence adenomas by an experienced endoscopist at colonoscopy. METHODS: One endoscopist photographed 900 consecutive colorectal lesions that were ≤ 3 mm in size and considered endoscopically to be high confidence conventional adenomas. The photographs were reviewed blindly to eliminate poor quality images. The remaining 644 endoscopy images were reviewed by two external experts who predicted the histology while blinded to the pathology results. RESULTS: Of 644 consecutive lesions ≤ 3 mm in size considered high confidence conventional adenomas by a single experienced colonoscopist, 15.4 % were reported as normal mucosa by pathology. The prevalence of reports of normal mucosa in polyps removed by cold snare and cold forceps were 15.2 % and 16.0 %, respectively. When endoscopy photographs were reviewed by two blinded outside experts, the lesions found pathologically to be adenomas and normal mucosa were interpreted as high confidence adenomas by endoscopic appearance in 96.9 % and 93.9 %, respectively, by Expert 1 (P = 0.15), and in 99.6 % and 100 %, respectively, by Expert 2 (P = 0.51). CONCLUSION: Retrieval and/or processing of tissue specimens of tiny colorectal polyps resulted in some lesions being diagnosed as normal tissue by pathology despite being considered endoscopically to be high confidence adenomas. These findings suggest that pathology interpretation is not a gold standard for lesion management when this phenomenon is observed.

Impact of scribing history and physical notes and procedure reports on endoscopist efficiency during routine procedures: a proof-of-concept study.

BACKGROUND: Efficiency is an important aspect of endoscopic practice that has received limited study. We evaluated the impact of scribing electronic pre-procedure history and physical examinations, and electronic procedure reports on endoscopist efficiency. METHODS: We used a stopwatch to measure the time between the procedures (scope out to scope in), pre-procedure patient assessment time, and procedure report generation time for 180 consecutive procedures performed by a single endoscopist with or without a scribe for recording history and physical and procedure reports. Schedulers were unaware of whether a scribe would be present. RESULTS: Mean times for recording the pre-procedure history and physical and procedure reports were reduced by 34% (p = 0.001) and 71% (p < 0.0001), respectively, when scribes were used. The mean time saved by the endoscopist from scribing the history and the physical and procedure reports was 2.12 and 1.59 min, respectively. When both processes were scribed, the endoscopist spent 42% (p = 0.033) longer in the recovery area (absolute mean increase 1.01 min) compared with when no scribes were utilized. The total time saved per 6.5-h procedure block with both scribes averaged to 41.7 min. CONCLUSION: The use of scribes to record history and physical examination notes and procedure reports saved enough endoscopist time to allow additional procedures or longer procedures, or to free the time for other tasks.

Faster colonoscope withdrawal time without impaired detection using EndoRings.

BACKGROUND AND STUDY AIMS: Mucosal exposure devices on the colonoscope tip have improved detection. We evaluated detection and procedure times in colonoscopies performed with EndoRings. PATIENTS AND METHODS: We had 14 endoscopists in a university practice trial EndoRings. We compared detection and procedure times to age- and indication-matched procedures by the same endoscopists. RESULTS: There were 137 procedures with EndoRings. The adenoma detection rate was 44 % with EndoRings vs. 39 % without ( P  = 0.39). Mean adenomas per colonoscopy (standard deviation) was 1.2 (2.3) with EndoRings vs. 0.9 (1.6) without ( P  = 0.055). Mean insertion time with EndoRings was 6.2 (3.2) minutes vs. 6.6 (6.7) minutes without ( P  = 0.81). Mean withdrawal time with EndoRings in all patients with or without polypectomy was 12.2 (5.3) minutes and 16.1 (10.3) minutes without ( P  = 0.0005). CONCLUSION: EndoRings may allow faster withdrawal during colonoscopy without any reduction in detection. Prospective trials with mucosal exposure devices targeting procedure times as primary endpoints are warranted.

High-definition colonoscopy versus Endocuff versus EndoRings versus full-spectrum endoscopy for adenoma detection at colonoscopy: a multicenter randomized trial.

BACKGROUND AND AIMS: Devices used to improve polyp detection during colonoscopy have seldom been compared with each other. METHODS: We performed a 3-center prospective randomized trial comparing high-definition (HD) forward-viewing colonoscopy alone to HD with Endocuff to HD with EndoRings to the full spectrum endoscopy (FUSE) system. Patients were age ≥50 years and had routine indications and intact colons. The study colonoscopists were all proven high-level detectors. The primary endpoint was adenomas per colonoscopy (APC). RESULTS: Among 1188 patients who completed the study, APC with Endocuff (APC mean ± standard deviation: 1.82 ± 2.58), EndoRings (1.55 ± 2.42), and standard HD colonoscopy (1.53 ± 2.33) were all higher than FUSE (1.30 ± 1.96; P < .001 for APC). The APC for Endocuff was higher than standard HD colonoscopy (P = .014). Mean cecal insertion times with FUSE (468 ± 311 seconds) and EndoRings (403 ± 263 seconds) were both longer than with Endocuff (354 ± 216 seconds; P = .006 and .018, respectively). CONCLUSIONS: For high-level detectors at colonoscopy, forward-viewing HD instruments dominate the FUSE system, indicating that for these examiners image resolution trumps angle of view. Further, Endocuff is a dominant strategy over EndoRings and no mucosal exposure device on a forward-viewing HD colonoscope. (Clinical trial registration number: NCT02345889.).

A compact high resolution flat panel PET detector based on the new 4-side buttable MPPC for biomedical applications.

Compact high-resolution panel detectors using virtual pinhole (VP) PET geometry can be inserted into existing clinical or pre-clinical PET systems to improve regional spatial resolution and sensitivity. Here we describe a compact panel PET detector built using the new Though Silicon Via (TSV) multi-pixel photon counters (MPPC) detector. This insert provides high spatial resolution and good timing performance for multiple bio-medical applications. Because the TSV MPPC design eliminates wire bonding and has a package dimension which is very close to the MPPC's active area, it is 4-side buttable. The custom designed MPPC array (based on Hamamatsu S12641-PA-50(x)) used in the prototype is composed of 4 × 4 TSV-MPPC cells with a 4.46 mm pitch in both directions. The detector module has 16 × 16 lutetium yttrium oxyorthosilicate (LYSO) crystal array, with each crystal measuring 0.92 × 0.92 × 3 mm3 with 1.0 mm pitch. The outer diameter of the detector block is 16.8 × 16.8 mm2. Thirty-two such blocks will be arranged in a 4 × 8 array with 1 mm gaps to form a panel detector with detection area around 7 cm × 14 cm in the full-size detector. The flood histogram acquired with Ge-68 source showed excellent crystal separation capability with all 256 crystals clearly resolved. The detector module's mean, standard deviation, minimum (best) and maximum (worst) energy resolution were 10.19%, +/-0.68%, 8.36% and 13.45% FWHM, respectively. The measured coincidence time resolution between the block detector and a fast reference detector (around 200 ps single photon timing resolution) was 0.95 ns. When tested with Siemens Cardinal electronics the performance of the detector blocks remain consistent. These results demonstrate that the TSV-MPPC is a promising photon sensor for use in a flat panel PET insert composed of many high resolution compact detector modules.