Safety of first surveillance colonoscopy at 12 months after piecemeal endoscopic mucosal resection of large non-pedunculated colorectal lesions.

BACKGROUND AND AIMS: After piecemeal endoscopic mucosal resection (pEMR) of nonpedunculated colorectal lesions ≥ 20 mm, guidelines recommend first endoscopic surveillance at 6 months. However, initial surveillance at 12 months may be adequate for selected low-risk lesions, and could save the cost, risk and inconvenience of one surveillance examination. METHODS: We retrospectively examined a prospectively collected database of all colorectal lesions referred to our center for endoscopic resection between August 2019 and April 2023. We report recurrence rates of colorectal lesions ≥ 20 mm removed by pEMR who were assigned to 6-month first surveillance or assigned to 12-month first surveillance (or assigned to 6-month but did not return until after 10 months). RESULTS: There were 561 nonpedunculated lesions ≥ 20 mm that underwent first follow-up, including 490 lesions in 443 patients assigned to 6-month, and 71 lesions in 65 patients assigned to 12-month surveillance. Lesions assigned to 12-month surveillance were smaller (mean size 25.9 ± 6.1mm vs. 37.0 ± 17.4mm), more likely serrated (63.4% vs. 9.6%), and more often removed by cold pEMR (74.6% vs 20.4%). Twenty-nine lesions in 24 patients assigned 6-month surveillance presented after 10 months and their recurrence data were included in the group assigned 12-month surveillance. Overall recurrence rates at 6 months and 12 months were 10.0% (46/461) and 9.0% (9/100), respectively. Mean recurrence sizes at 6 and 12 months were 10.9 ± 6.2mm and 4.2 ± 1.9mm, respectively. One patient in the 6-month surveillance group had cancer at the pEMR site, but no other recurrences at 6 or 12 months had either cancer or high-grade dysplasia. CONCLUSION: Twelve-month surveillance appears acceptable for selected colorectal lesions ≥ 20 mm removed by pEMR. A randomized trial comparing initial 6-month to 12-month surveillance is warranted for selected lesions.

One-device colonoscopy: feasibility, cost savings, and plastic waste reduction by procedure indication, when performed by a high detecting colonoscopist.

BACKGROUND: Cold forceps and snares are each effective for removing polyps of 1-3 mm, while snares are more effective for polyps of 4-10 mm in size. If, in the same patient, polyps of 1-3 mm are removed with forceps and those of 4-10 mm with snares, two devices are used. If cold snares are used to resect all lesions of 1-10 mm (one-device colonoscopy), there is a potential for lower costs and less plastic waste. METHODS: A single high detecting colonoscopist prospectively measured the feasibility of cold snaring all colorectal lesions of ≤10 mm in size, along with the associated costs and plastic waste reduction. RESULTS: 677 consecutive lower gastrointestinal endoscopies (not for inflammatory bowel disease) were assessed. Of 1430 lesions of 1-3 mm and 1685 lesions of 4-10 mm in size, 1428 (99.9%, 95%CI 99.5%-100%) and 1674 (99.3%, 95%CI 98.8%-99.7%), respectively, were successfully resected using cold snaring. Among 379 screening and surveillance patients, universal cold snaring of lesions ≤10 mm saved 35 and 47 cold forceps per 100 screening and surveillance patients, respectively. CONCLUSION: Cold snare resection of all lesions ≤10 mm (one-device colonoscopy) was feasible, and reduced costs and plastic waste.

2021 Patient Perceptions Regarding Colonoscopy Experience.

GOAL: We sought to document patient perceptions in 2021 regarding colonoscopy experience and potential deterrents to repeat colonoscopy. BACKGROUND AND AIM: Bowel preparation has been previously considered by patients to be the worst part of a colonoscopy. MATERIALS AND METHODS: We conducted a prospective survey of consecutive patients age 18 years and older who had just completed colonoscopy at 2 outpatient endoscopy centers at a tertiary academic hospital. The short survey was conducted in the recovery area. The main outcome measure was patient perceptions of the worst part of their colonoscopy experience and which factor would most deter them from a future colonoscopy. RESULTS: Four hundred patients completed the survey of 405 approached. Average patient age was 64 years, and 48% were women. Seventy-five percent of patients used low-volume preparations. Bowel preparation was considered the worst part of colonoscopy by 71% of patients. Women were more likely to choose laxatives as the worst part of a colonoscopy. Bowel preparation was chosen most often (55%) as the most likely deterrent to a future colonoscopy. There were minimal differences in responses between those receiving low-volume versus high-volume (4 L) preparations. CONCLUSION: Bowel preparation remains the worst part of the colonoscopy experience for patients, and the most likely deterrent to future colonoscopy.

Impact of including epinephrine in the submucosal injectate for colorectal EMR on postprocedural pain: a randomized controlled trial.

BACKGROUND AND AIMS: EMR is first-line therapy for colorectal laterally spreading lesions. Some colonoscopists include epinephrine in the submucosal injectate, which we observed increased postprocedure discomfort. Our aim was to determine whether inclusion of epinephrine in the submucosal injectate increases postprocedure pain after EMR. METHODS: We performed a randomized, controlled, double-blind trial comparing epinephrine in submucosal injectate versus injectate alone for abdominal pain at 30 and 60 minutes after EMR. RESULTS: Mean polyp diameter in both arms was >40 mm. There were no differences in procedure times or amounts of fluid injected. Mean pain was higher on a visual analog scale in the epinephrine group at 30 minutes (47 vs 14, P = .022) and at 60 minutes (44 vs 13, P = .035). Recovery room stay was longer in the epinephrine group (68 vs 53 minutes, P = .034). CONCLUSIONS: Epinephrine in the submucosal injectate for EMR increases postprocedural pain, which could cause diagnostic confusion and prolong observation time in the recovery area. (Clinical trial registration number: NCT04065451.).

Implications of stable or increasing adenoma detection rate on the need for continuous measurement.

BACKGROUND AND AIMS: Measurement of the adenoma detection rate (ADR) is resource intensive, and the benefit of continuous measurement for colonoscopists with high ADR is unclear. We examined the ADR trends at our center to determine whether continuous measurement for consistently high ADR is warranted. METHODS: Among colonoscopies performed between January 1999 and November 2019 at a tertiary center, we analyzed data from colonoscopists performing at least 50 screening colonoscopies annually for 5 consecutive years. ADR trends for individual colonoscopists were examined using Joinpoint regression models. RESULTS: Eleven colonoscopists performed screening colonoscopies on 14,047 patients, and 5912 among them had at least 1 conventional adenoma removed (42.0%). Of 25,829 polyps, 13,585 (52.6%) were conventional adenomas or adenocarcinomas and contributed to ADR calculation. All but 1 colonoscopist included met the recommended minimum threshold ADR of 25% continuously over the study period. Of the 11 colonoscopists, 5 had an increase in their ADR and the remaining 6 had stable ADRs over the study period. CONCLUSIONS: For colonoscopists consistently performing above the minimum threshold, diversion of resources toward improvement of quality measures other than ADR is justified.

Yield of a second right colon examination during colonoscopy after a first examination using a mucosal exposure device.

BACKGROUND AND AIMS: Double right colon examination during colonoscopy has been advocated to reduce the risk of interval cancer in the right colon. Whether 2 examinations are necessary when the first examination is performed with a mucosal exposure device is uncertain. We documented the rates of missed adenomas, sessile serrated lesions, and hyperplastic polyps after an initial right colon examination by a high-level detector using a mucosal exposure device. METHODS: At a single tertiary hospital outpatient practice, we prospectively collected data on the yield of a second examination of the right colon after an initial examination by a single high-detecting colonoscopist using a mucosal exposure device. RESULTS: During the study period, 1331 eligible consecutive patients underwent colonoscopy. Right colon adenoma, sessile serrated lesion, and hyperplastic polyp miss rates were 15.8%, 14.1%, and 16.7%, respectively. Four percent of patients had adenomas detected in the right colon only with a second examination. CONCLUSIONS: A second examination of the right colon is warranted, even when using a distal mucosal exposure device to perform colonoscopy.

Risk of total metachronous advanced neoplasia in patients with both small tubular adenomas and serrated polyps.

BACKGROUND AND AIMS: The impact of concomitant small serrated polyps (SPs) on the risk of subsequent neoplasia when small tubular adenomas (TAs) are found is uncertain. METHODS: Patients who on index colonoscopy had ≤2 TAs of <10 mm in size in isolation were compared with those with concomitant ≤2 small-sized SPs. SP was inclusive of polyps described by pathology as sessile serrated lesions (SSLs) or proximal hyperplastic polyps (HPs) <10 mm in size. The primary endpoint was the rate of total metachronous advanced neoplasia (T-MAN) compared among the TAs in the isolation group and the groups inclusive of SPs (SSLs or proximal HPs). RESULTS: For patients with TAs and small SPs found concomitantly, the rate of T-MAN was 9.6% (24/251), which was significantly higher than the rate of T-MAN in patients with isolated small TAs (5.2% [59/1138], P = .011). Within the concomitant SP cohort, the rate of T-MAN in the proximal HP subgroup remained significantly increased (9% [19/212]) compared with the isolated small TA group (P = .037). CONCLUSIONS: When small TAs are found concomitantly with small SPs, there is an increase in the rate of T-MAN in comparison with isolated TAs. This increase in T-MAN also occurs when small TAs are found in conjunction with small proximal HPs. The presence of concomitant small SPs should be considered in determining surveillance intervals when small TAs are identified in colonoscopy screening programs.

Cold versus hot snare resection with or without submucosal injection of 6- to 15-mm colorectal polyps: a randomized controlled trial.

BACKGROUND AND AIMS: Cold snare resection of colorectal lesions has been found to be safe and effective for an expanding set of colorectal lesions. In this study, we sought to understand the efficacy of simple cold snare resection and cold EMR versus hot snare resection and hot EMR for colorectal lesions 6 to 15 mm in size. METHODS: At 3 U.S. centers, 235 patients with 286 colorectal lesions 6 to 15 mm in size were randomized to cold snaring, cold EMR, hot snaring, or hot EMR for nonpedunculated colorectal lesions 6 to 15 mm in size. The primary outcome was complete resection determined by 4 biopsy samples from the defect margin and 1 biopsy sample from the center of the resection defect. RESULTS: The overall incomplete resection rate was 2.4% (95% confidence interval [CI], .8%-7.5%). All 7 incompletely removed polyps were 10 to 15 mm in size and removed by hot EMR (n = 4, 6.2%), hot snare (n = 2, 2.2%), or cold EMR (n = 1, 1.8%). Cold snaring had no incomplete resections, required less procedural time than the other methods, and was not associated with serious adverse events. CONCLUSIONS: Cold snaring is a dominant resection technique for nonpedunculated colorectal lesions 6 to 15 mm in size. (Clinical trial registration number: NCT03462706.).

Impact of Expanding Screening Colonoscopy Interval on Providers Choice of Prescribing Colonoscopy for Colorectal Cancer Screening.

GOALS: We investigated if increasing the colonoscopy screening interval from 10 to 15 years would increase provider preferences for colonoscopy as a screening test. We further examined whether having colonoscopy performed at a 15-year interval by an endoscopist with a high adenoma detection rate would influence preferences. BACKGROUND: Colonoscopy is recommended every 10 years in average risk individuals without polyps for colorectal cancer (CRC) screening. The use of a 15-year interval offers substantial protection, increases cost-effectiveness, and might make colonoscopy more attractive to patients and health care providers who order CRC screening tests. STUDY: An anonymous online survey of health care providers across a health care system that serves a single US state and encompasses both academic and community physicians was conducted. Physicians and nurse practitioners in family medicine, obstetrics-gynecology, and internal medicine were included. Providers were asked to indicate their preference for CRC screening tests as a proportion of tests they prescribe among 5 common screening tools. Responses were compared for current colonoscopy screening intervals and if the screening intervals are increased to 15 years. RESULTS: One hundred and twelve (34%) responded of 326 providers. Colonoscopy was the most frequently ordered test for CRC screening. Increasing screening interval from 10 to 15 years increased the choice of colonoscopy from 75.2% to 78.6% ( P =0.003). CONCLUSIONS: Expanding colonoscopy screening interval to 15 years could produce an increase in physicians and nurse practitioners choice of using colonoscopy for CRC screening, but the clinical impact appears minor. Additional surveys of patients and providers are needed.

Colorectal EMR outcomes in octogenarians versus younger patients referred for removal of large (≥20 mm) nonpedunculated polyps.

BACKGROUND AND AIMS: Data are limited on safety and outcomes of colorectal EMR in octogenarians (≥80 years old). We sought to review outcome data for patients aged ≥80 in a prospectively collected database of patients referred for large polyp removal. METHODS: We retrospectively evaluated a database of patients referred for large (≥20 mm) nonpedunculated polyp removal. From 2000 to 2019, we compared the rates of follow-up, recurrence, adverse events, and synchronous neoplasia detection between younger patients and patients aged ≥80. RESULTS: There were 167 patients aged ≥80 years and 1686 <80 years. Patients in the elderly group returned for surveillance less often (67.1% vs 75.1%, P = .024), had greater first follow-up recurrence rates (27.5% vs 13.8%, P < .001), but had similar adverse event rates (1.8% vs 2.8%, P = .619) compared with younger patients. Rates of synchronous neoplasia were similar and high in both groups. CONCLUSIONS: EMR is safe and well tolerated for large polyp removal in patients over 80 years old. Patients aged ≥80 years are less likely to present for follow-up after EMR. They had a higher recurrence rate and a similarly high prevalence of synchronous precancerous lesions. Follow-up after EMR should be encouraged in the elderly, and an attempt to clear the colon of synchronous disease at the time of the initial EMR may be warranted.

Adverse events and residual lesion rate after cold endoscopic mucosal resection of serrated lesions ≥10 mm.

BACKGROUND AND AIMS: Cold EMR is being increasingly used for large serrated lesions. We sought to measure residual lesion rates and adverse events after cold EMR of large serrated lesions. METHODS: In a single academic center, we retrospectively examined a database of serrated class lesions ≥10 mm removed with cold EMR for safety and efficacy. RESULTS: Five hundred sixty-six serrated lesions ≥10 mm in size were removed from 312 patients. We successfully contacted 223 patients (71.5%) with no reported serious adverse events that required hospitalization, repeat endoscopy, or transfusion. The residual lesion rate per lesion at first follow-up colonoscopy was 18 of 225 (8%; 95% confidence interval, 5-12.1). Lesions with residual were larger at polypectomy compared with lesions without recurrence (median, 23 mm versus 16 mm, P = .017). CONCLUSION: Cold EMR appears to be safe and effective for the removal of large serrated lesions.

Narrow-Band Imaging for Detection of Neoplasia at Colonoscopy: A Meta-analysis of Data From Individual Patients in Randomized Controlled Trials.

BACKGROUND & AIMS: Adenoma detection rate (ADR) is an important quality assurance measure for colonoscopy. Some studies suggest that narrow-band imaging (NBI) may be more effective at detecting adenomas than white-light endoscopy (WLE) when bowel preparation is optimal. We conducted a meta-analysis of data from individual patients in randomized controlled trials that compared the efficacy of NBI to WLE in detection of adenomas. METHODS: We searched MEDLINE, EMBASE, and Cochrane Library databases through April 2017 for randomized controlled trials that assessed detection of colon polyps by high-definition WLE vs NBI and from which data on individual patients were available. The primary outcome measure was ADR adjusted for bowel preparation quality. Multilevel regression models were used with patients nested within trials, and trial included as a random effect. RESULTS: We collected data from 11 trials, comprising 4491 patients and 6636 polyps detected. Adenomas were detected in 952 of 2251 (42.3%) participants examined by WLE vs 1011 of 2239 (45.2%) participants examined by NBI (unadjusted odds ratio [OR] for detection of adenoma by WLE vs NBI, 1.14; 95% CI, 1.01-1.29; P = .04). NBI outperformed WLE only when bowel preparation was best: adequate preparation OR, 1.07 (95% CI, 0.92-1.24; P = .38) vs best preparation OR, 1.30 (95% CI, 1.04-1.62; P = .02). Second-generation bright NBI had a better ADR than WLE (second-generation NBI OR, 1.28; 95% CI, 1.05-1.56; P = .02), whereas first-generation NBI did not. NBI detected more non-adenomatous polyps than WLE (OR, 1.24; 95% CI, 1.06-1.44; P = .008) and flat polyps than WLE (OR, 1.24; 95% CI, 1.02-1.51; P = .03). CONCLUSIONS: In a meta-analysis of data from individual patients in randomized controlled trials, we found NBI to have a higher ADR than WLE, and that this effect is greater when bowel preparation is optimal.

Performance of radiographic imaging after incomplete colonoscopy for nonmalignant causes in clinical practice.

BACKGROUND AND AIMS: CT colonography (CTC) or barium enema are commonly ordered to complete colorectal imaging after an incomplete colonoscopy. We evaluated the sensitivity of radiographic studies performed for this purpose in clinical practice outside clinical trials. METHODS: Adult patients referred to an expert endoscopist for incomplete colonoscopy because of a redundant colon or a difficult sigmoid and who underwent previous radiographic imaging between July 2001 and July 2019 were identified. None of the patients had a malignant obstruction as the cause of incomplete colonoscopy. Data on polyp size, location, and pathology were obtained from colonoscopy and radiology reports. Polyps identified on imaging and colonoscopy were matched based on polyp size and location. RESULTS: Among 769 patients referred for incomplete colonoscopy, we identified 65 with a radiographic examination performed within 36 months of colonoscopy at our center. Per-patient sensitivity for CTC was suboptimal (70%) and was very low for barium enema (26.7%). Per-polyp sensitivity for both CTC and barium enema was poor (23.8% and 7.6%). Quality of the examination did not seem to affect procedure sensitivity. CONCLUSIONS: Radiographic imaging after incomplete colonoscopy for reasons other than malignant obstruction had poor sensitivity for polyps. Patients with incomplete colonoscopies should be considered for repeat colonoscopy by an expert.

The predictive value of small versus diminutive adenomas for subsequent advanced neoplasia.

BACKGROUND AND AIMS: Patients with previous colorectal adenomas are at increased risk of colorectal cancer. Current guidelines for postpolypectomy surveillance intervals treat all tubular adenomas 1 to 9 mm in size with low-grade dysplasia as carrying the same level of risk. We evaluated whether 6 to 9 mm adenomas detected at colonoscopy are associated with greater risk of advanced neoplasia at follow-up compared with baseline 1 to 5 mm adenomas. METHODS: We retrospectively evaluated a colonoscopy database at a single U.S. academic center. Patients with baseline examinations demonstrating tubular adenomas 1 to 9 mm in size with low-grade dysplasia and no advanced adenomas were included. Follow-up colonoscopies were performed at least 200 days later and were assessed for incident advanced neoplasia (cancer, high-grade dysplasia, adenoma ≥10 mm in size, or villous elements). RESULTS: There were 2477 qualifying baseline colonoscopies. The absolute risk of metachronous advanced neoplasia increased from 3.6% in patients with 1 to 5 mm adenomas to 6.9% in patients with at least 1 adenoma of 6 to 9 mm (P = .001). Patients with 5 or more adenomas 1 of which was at least 6 to 9 mm had the highest risk of advanced neoplasia at follow-up (10.4%, P = .006). When only screening colonoscopies were considered, all baseline groups (1-2 adenomas, 3-4 adenomas, ≥5 adenomas) with adenomas 6 to 9 mm in size had an increased risk for metachronous advanced neoplasia (odds ratio [OR], 4.07; 95% confidence interval [CI], 1.50-11.04; OR, 4.91; 95% CI, 1.44-16.75; OR, 4.71; 95% CI, 1.30-17.05, respectively). CONCLUSIONS: Patients with baseline small (6-9 mm) adenomas have an increased risk of advanced lesions on follow-up compared with patients with only diminutive (1-5 mm) adenomas. Postpolypectomy guidelines should consider risk stratification based on small versus diminutive adenomas.

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.

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.).

Room temperature water infusion during colonoscopy insertion induces rectosigmoid colon mucus production.

BACKGROUND: Water filling during colonoscopy improves several colonoscopy outcomes. We evaluated an anecdotal observation that room temperature water filling during colonoscope insertion results in mucus production in the left colon, which may impair mucosal visualization during withdrawal. METHODS: We performed 55 colonoscopies with either water or saline filling during insertion, and video recorded the examinations. Three blinded observers scored the amount of mucus visible on the video recordings. RESULTS: 29 patients had water filling and 26 patients had saline filling during insertion. Demographic features, procedure indications, volume of infused fluid, and insertion time to the cecum were similar in the two groups. All three blinded observers rated the mucus as greater after water filling than after saline (median 3 out of 5 vs. 1 out of 5; P < 0.001), with a kappa value for interobserver agreement of 0.364 (P < 0.001). CONCLUSION: Room temperature water filling is associated with mucus production by the rectosigmoid colon, requiring additional cleansing during withdrawal.

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.).