Authors (including presenting author) :
Sze SF(1), Cheung WI(2), Wong WC(2), Hui YT(1), Lam TW(1)
Affiliation :
(1) Department of Medicine, Queen Elizabeth Hospital, (2) Department of Medicine & Geriatrics, Our Lady of Maryknoll Hospital
Introduction :
The incidence of colorectal cancer is rising and it is now the commonest cancer in Hong Kong. Colonoscopy screening is proven to reduce mortality rates for colorectal cancer, which relies on early detection and removal of colonic polyps. Methods to improve colonic polyp detection have constantly been sought. AmplifEYE is a FDA-approved device with a row of flexible detection arms attached to the tip of colonoscope which can separate colonic folds during scope withdrawal and is believed to improve polyp detection. Real-life clinical data on this relatively new device is lacking especially in Chinese patients.
Objectives :
The aim of this investigator-initiated study is to find out whether colonoscopy equipped with this novel device AmplifEYE is useful in improving colonic polyp detection (most common types of polyps being colonic adenomas and serrated polyps) when compared to standard colonoscopy. The colonic polyp detection rate (PDR), adenoma detection rate (ADR), serrated polyp detection rate (SDR), proximal serrated polyp detection rate (PSDR), caecal intubation time, colonoscope withdrawal time, procedure pain and any adverse events were analyzed in each group.
Methodology :
Eligible Chinese patients referred for colonoscopy to Queen Elizabeth Hospital and Our Lady of Maryknoll Hospital were randomised to either AmplifEYE-assisted colonoscopy (AC) or standard colonoscopy (SC). Five colonoscopists with experience of at least 1000 colonoscopies performed the procedure. Patients aged between 50 to 79 years old scheduled for screening, surveillance or diagnostic colonoscopy (anaemia, altered bowel habit, abdominal pain) were recruited. Exclusion criteria were patients with colonic strictures, history of bowel surgery, per-rectal bleeding within six weeks, inflammatory bowel disease and pregnancy. Statistical analysis was performed using IBM SPSS Statistics 20.0. Chi-squared test or Fisher's exact test were used for categorical variables and Mann-Whitney U test or independent samples t-test for quantitative variables. A p-value of less than 0.05 is considered as statistically significant.
Result & Outcome :
From March 2017 to June 2018, 355 patients were recruited and 334 included for analysis, with 170 in AmplifEYE group (AC) and 164 in standard colonoscopy group (SC). 21 patients (8 in AC and 13 in SC) were excluded because of incomplete examination due to loopings, obstruction by colonic cancer or extremely poor bowel preparation. The caecal intubation rate was 95.5% in AC and 92.7% in SC, p=0.255. The patient characteristics of both groups including sex, age, smoking status, history of abdominal surgery, family history of colon cancer were comparable. The mean number of polyps detected in AC was 2.04(±2.87) vs 1.19(±1.62) in SC, p=0.002. The mean number of adenomas detected in AC was 1.06(±1.88) vs 0.84(±1.37) in SC, p=0.280, while the mean number of serrated polyps detected in AC was 0.95(±2.17) vs 0.31(±0.70) in SC, p=0.000. The PDR in AC was 68.2%(116/170) vs 54.3%(89/164) in SC, p=0.009, while the ADR in AC was 47.1%(80/170) vs 40.9%(67/164) in SC, p=0.253 and SDR in AC was 37.6%(64/170) vs 20.1%(33/164) in SC, p=0.000. Further sub-analysing the detection rate of the proximal serrated polyp (PSPDR), it was 11.2%(19/170) in AC vs 8.5%(14/164) in SC, p=0.653. The mean caecal intubation time was 7.0±3.0min in AC vs 8.9±6.2min in SC (p=0.030), and the mean scope withdrawal time was 8.2±2.6min in AC vs 7.9±2.5min in SC (p=0.371). The median pain score (0-10) was 3 in AC vs 4 in SC (p=0.121). The flap of the study device caused mild mucosal abrasion in one patient and self-limiting bleeding from a 2cm polyp on another patient who was on warfarin. In conclusion, cuffed colonoscopy with AmplifEYE significantly improved the PDR and SDR. For ADR and PSDR, though both numerically higher in AmplifEYE group, did not reach statistical significance. This study also found that the caecal intubation time was shorter when using AmplifEYE, which could be because the device helped in stabilising and shortening the colonoscope and prevent loop formation. Using the device did not cause more pain during procedure but extra precaution to bleeding is needed if patient is on anticoagulation. Further study with larger number of patients is warranted, and ideally it should only include patients undergoing screening colonoscopy. With its proven safety, the device can be used by trainee endoscopists to see whether it can provide greater benefits.
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