Endocuff Vision Reduces Inspection Time Without Decreasing Lesion Detection: A Clinical Randomized Trial

Abstract

Background & Aims: Mucosal exposure devices improve detection of lesions during colonoscopy and have reduced examination times in uncontrolled studies. We performed a randomized trial of Endocuff Vision vs standard colonoscopy to compare differences in withdrawal time (the primary end point). We proposed that Endocuff Vision would allow complete mucosal inspection in a shorter time without impairing lesion detection. Methods: Adults older than 40 years undergoing screening or surveillance colonoscopies were randomly assigned to the Endocuff group (n=101, 43.6% women) or the standard colonoscopy group (n=99; 57.6% women). One of 2 experienced endoscopists performed the colonoscopies, aiming for a thorough evaluation of the proximal sides of all haustral folds, flexures, and valves in the shortest time possible. Inspection time was measured with a stopwatch and calculated by subtracting washing, suctioning, polypectomy and biopsy times from total withdrawal time. Results: There were significantly fewer women in the Endocuff arm (P=.0475) but there were no other demographic differences between groups. Mean insertion time with Endocuff was 4.0 min vs 4.4 min for standard colonoscopy (P=.14). Mean inspection time with Endocuff was 6.5 min vs 8.4 min for standard colonoscopy (P<.0001). Numbers of adenomas detected per colonoscopy (1.43 vs 1.07; P=.07), adenoma detection rate (61.4% vs 52%; P=0.21), number of sessile serrated polyps per colonoscopy (0.27 vs 0.21; P=0.12), and sessile serrated polyp detection rate (19.8% vs 11.1%; P= 0.09) were all higher with Endocuff Vision. Results did not differ significantly when we controlled for age, sex, or race. Conclusion: In a randomized trial, we found inclusion of Endocuff in screening or surveillance colonoscopies to decrease examination time without reducing lesion detection. ClinicalTrials.gov no.: NCT03361917 KEY WORDS: colonoscopy, colorectal polyp, colon cancer; colorectal What You Need to Know Background: We performed a randomized trial of Endocuff Vision vs standard colonoscopy to compare differences in withdrawal time and lesion detection in 200 patients. Findings: Mean inspection time with Endocuff was 6.5 min vs 8.4 min for standard colonoscopy. Numbers of adenomas detected per colonoscopy, adenoma detection rate, number of sessile serrated polyps per colonoscopy, and sessile serrated polyp detection rate did not differ significantly with vs without Endocuff. Limitations: The study was performed by 2 examiners with extensive experience with Endocuff Vision. Implications for patient care: Inclusion of Endocuff in screening or surveillance colonoscopies decreases examination time without reducing lesion detection.

EndoCuff‐assisted colonoscopy could improve adenoma detection rate: A meta‐analysis of randomized controlled trials

“…Six studies were eligible for the analysis of SSA/P detection rate. At least one SSA/P was detected in 15.5% of patients in the EAC group and 13.2% in the SC group.…”

“…Four studies evaluated cecal intubation time between two groups. The mean cecal intubation time ranged 4.05–10.0 minutes in the EAC group and 4.1–12.0 minutes in the SC group.…”

“…Eight studies evaluated adverse events between two groups. Adverse events occurred in 2.6% of patients in the EAC group and 0.8% in the SC group.…”

“…Multiple sensitivity and subgroup analyses were performed to identify the reasons for statistically significant heterogeneity. Review Manager Overall, these 13 trials 12,13,17-19,21-28 included 10 full-text articles 12,13,[17][18][19][21][22][23][24][25] and three abstracts, [26][27][28] comprising six multicenter, 12,13,17,22,26,28 three bicenter, 19,21,23 and four singlecenter 18,24,25,27 studies. The majority of the operators were experienced endoscopists who had been trained for the use of Endo-Cuff.…”

“…12,13,[17][18][19]22,24,28 Nine thousand and thirty-eight patients with a mean age ranging from 58 to 68 years were enrolled. The indications of most studies 12,13,[17][18][19][21][22][23][24]27 were mixed (screening, surveillance, and/or diagnostic). Only three studies 25,26,28 included pure screening populations.…”