Colonoscopic adenoma detection – new super wide-angle scopes versus new caps
Thomas Rösch, Hamburg and Jens Aschenbeck, Berlin
Gut. 2016 Aug 9. pii: gutjnl-2016-311906
|Full-spectrum (FUSE) versus standard forward – viewing colonoscopy in an organised colorectal cancer screening programme|
|Cesare Hassan1, Carlo Senore2, Franco Radaelli3, Giovanni De Pretis4, Romano Sassatelli5, Arrigo Arrigoni6, Gianpiero Manes7, Arnaldo Amato3, Andrea Anderloni8, Franco Armelao4, Alessandra Mondardini6, Cristiano Spada9, Barbara Omazzi7, Maurizio Cavina5, Gianni Miori4, Chiara Campanale9, Giuliana Sereni5, Nereo Segnan2, Alessandro Repici8,10|
Miss rate of polyps has been shown to be substantially lower with full-spectrum en-doscopy (FUSE) compared with standard forward-viewing (SFV) colonoscopy in a tan-dem study at per polyp analysis. However, there is uncertainty on whether FUSE is also associated with a higher detection rate of colorectal neoplasia, especially advan-ced lesions, in per patient analysis.
Consecutive subjects undergoing colonoscopy following a positive faecal immuno-chemical test (FIT) by experienced endoscopists and performed in the context of a re-gional colorectal cancer population-screening programme were randomised between colonoscopy with either FUSE or SFV colonoscopy in seven Italian centres. Randomi-sation was stratified by gender, age group and screening history. Primary outcomes included detection rates of advanced adenomas (A-ADR), adenomas (ADR) and sessi-le-serrated polyps (SSPDR).
Of 741 eligible subjects, 658 were randomised to either FUSE (n=328) or SFV (n=330) colonoscopy and included in the analysis. Overall, 293/658 and 143/658 subjects had at least one adenoma (ADR 44.5%) and advanced adenoma (A-ADR 21.7%), re-spectively, while SSP was the most advanced lesion in 18 cases (SSPDR 2.7%). ADR and A-ADR were 43.6% and 19.5% in the FUSE arm, and 45.5% and 23.9% in the SFV arm, with no difference for both ADR (OR for FUSE: 0.96, 95% CI 0.81 to 1.14) and A-ADR (OR for FUSE: 0.82, 95% CI 0.61 to 1.09). No difference in SSPDR or multipli-city was detected between the two arms. In the per polyp analysis, the mean number of adenomas and proximal adenomas per patient was 0.81Â±1.25 and 0.47Â±0.93 in the FUSE arm, and 0.85Â±1.33 and 0.48 Â±0.96 in the SFV colonoscopy arm (p=NS for both comparisons).
No statistically significant difference in ADR and A-ADR between FUSE and SFV colo-noscopy was detected in a per patient analysis in FIT-positive patients.
Gut. 2015 Dec 16. pii: gutjnl-2015-310097
|Adenoma detection with Endocuff colonoscopy versus conventional colonoscopy: a multicentre randomised controlled trial|
|SC van Doorn1, M van der Vlugt1, ACTM Depla2, CA Wientjes3, RC Mallant-Hent4, PD Siersema5, KMAJ Tytgat, H Tuynman1,2, SD Kuiken3, GMP Houben2, PCF Stokkers3, LMG Moons5, PMM Bossuyt6, P Fockens1, MW Mundt4, E Dekker1|
Background and aims
Colonoscopy is the current reference standard for the detection of colorectal neopla-sia, but nevertheless adenomas remain undetected. The Endocuff, an endoscopic cap with plastic projections, may improve colonic visualisation and adenoma detection. The aim of this study was to compare the mean number of adenomas per patient (MAP) and the adenoma detection rate (ADR) between Endocuff-assisted colonoscopy (EAC) and conventional colonoscopy (CC).
We performed a multicentre, randomised controlled trial in five hospitals and included fecal immonochemical test (FIT)-positive screening participants as well as sympto-matic patients (>45 years). Consenting patients were randomised 1:1 to EAC or CC. All colonoscopies were performed by experienced colonoscopists (≥500 colonoscopies) who were trained in EAC. All colonoscopy quality indicators were prospectively recorded.
Of the 1063 included patients (52% male, median age 65 years), 530 were allocated to EAC and 533 to CC. More adenomas were detected with EAC, 722 vs 621, but the gain in MAP was not significant: on average 1.36 per patient in the EAC group versus 1.17 in the CC group ( p=0.08). In a per-protocol analysis, the gain was 1.44 vs 1.19 (p=0.02), respectively. In the EAC group, 275 patients (52%) had one or more adenomas detected versus 278 in the CC group (52%; p=0.92). For advanced adenomas these numbers were 109 (21%) vs 117 (22%). The adjusted caecal intubation rate was lower with EAC (94% vs 99%; p<0.001), however when allowing crossover from EAC to CC, they were similar in both groups (98% vs 99%; p value=0.25).
Though more adenomas are detected with EAC, the routine use of Endocuff does not translate in a higher number of patients with one or more adenomas detected. Whether increased detection ultimately results in a lower rate of interval carcinomas is not yet known.
What you should know about these papers
Adenoma detection rate (ADR) has become the holy grail of colonoscopy outcome quality measurement and efforts to increase ADR are ongoing. The relevance of ADR as surrogate parameter of outcome quality is backed up by data showing correlations of ADR in interval cancers 1-3. Although the relevance of small adenomas is unknown or even doubted4, and increases in ADR in screening programmes have often been caused mainly by increased detection of such small ademomas5, efforts to increase ADR by different technical modifications of colonoscopy are multiple using different approaches6. Among those, image processing (NBI/narrow band imaging, i-Scan, FICE) and red flag techniques (autofluorescence) as well as widening the colonoscopic view and mechanical methods (caps, balloons), most of them without great success. Neither HDTV imaging7 nor NBI and similar techniques from different companies8-10 nor autofluorescence endoscopy as the only red flag technique evaluated in several clinical trials11 have not shown to consistently increase ADR. Normal transparent caps have not been successful either, although here the data were more conflicting10, 12. Wide angle colonoscopy (increases from 140° to 170°) were not successful either13. There are two new kids on the block: Super-wide angle colonoscopies and new caps. The former increase the angle of view to 330° using the so-called FUSE colonoscopy or instruments from other companies. An initial study was very promising, showing greatly reduced adenoma miss rates. This tandem study in 185 patients had adenoma miss rates of 7% for the FUSE scope versus 41% for the conventional colonoscopies of different companies, mostly not of the latest generation14. Usually, studies of that kind should be reproduced by other groups. The new study on the FUSE colonoscope came from the Italian FIT-based colorectal cancer screening programme, used a simple comparison instead of a tandem design and did not show any difference in any of the parameters. 658 patients were randomized to either FUSE or conventional colonoscopy, again mostly not of the latest generation15. ADR was 44.5% in the entire study, without any differences between the two groups (43.6% FUSE vs. 45.5% control), as were the rates of advanced adenomas (19.5% vs 23.5%). Similarly, rates of small and large adenomas and of sessile serrated polyps were also the same. How can this be explained ? First of all the tandem design is in my opinion an interesting methodology and requires less patient numbers, but does not reflect daily practice (patients undergoing only one colonoscopy) and is perhaps more prone to bias, since examiners care may be different depending on their willingness to find more lesions with one scope or the other (it can be discussed whether the same bias would apply to simple comparative randomized trials). Furthermore, the setting (screening vs. diagnostic) and the overall ADR may be different, although not so much in the two studies here14, 15. In addition, studies using super-wide angle scopes did not suggest that ADR would be dramatically increased16. Finally, positive results are more credible if confirmed by several studies. The other candidate is the endocuff a cap with small soft lateral rubber arms arranged in two, or more recently, one rings around the cap (Endocuff Vision) in order to avert and flatten folds on colonoscope withdrawal. Initial studies were promising, but the ADR in the control group was rather low. In two subsequent very similar studies with about 500 patients each from the same group, ADR was 36%17 and 35.4%18 for endocuff colonoscopy, but decreased in the control group from 28%17 in the first to 20.7%18 in the second. Could these results be confirmed ? Partially with a marginal benefit by a large subsequent study from the Netherlands and fully (higher ADR) by an even larger UK trial presented at UEGW. Both were performed in mixed collectives (screening, surveillance and diagnostic). In the Dutch study only the number of adenomas, but not the adenoma detection rates which were rather high. The study included 1063 patients, and ADR was 52% in both in the per-protocol analysis, but not in the overall analysis (1.36 vs. 1.17). Advanced adenomas and sessile serrated lesions were exactly the same, but small adenomas < 6 mm and flat adenomas were more frequently detected in the endocuff group19. Finally, the recent very large UK study (n=1772) again showed superiority of endocuff, this time with the second generation (Endocuff Vision), in achieving again a higher ADR, namely 40.9% vs 36.2% in the control arm20. Here, subgroup analysis showed significant differences in favour of endocuff vision for left sided adenomas (26.1% vs 22.2%), small adenomas < 10 mm, sessile serrated adenomas – and surprisingly even in cancers (4.1% vs 2.3%), a bit hard to believe. Thus, it seems that mechanical methods flattening the inner colonic surface are superior to increasing the endoscopic angle of view – and they are simpler. The next device, a balloon, as already around the corner. The so-called G-eye consists of a balloon mounted around the endoscope tip (of any colonoscope) which stays there permanently for a large number of examinations and is reprocessed with the scope. A multinational group published dramatically reduced miss rates in a small tandem study (n=126), namely from 44.7% with conventional scopes to 7.5% with a balloon around the endoscope tip (G scope)21. The same group has now presented a large randomized multicenter study at UEGW, in which 13 hospitals included 408 patients (mixed hospital collective, simple comparison) in the published abstract22 and 1000 in the oral presentation with dramatic differences in ADR including all subgroups: In the abstract, ADR was 49.2% vs. 33.8%, accounting for a 45.6% increase; increases were even more dramatic for almost all subgroups (96% increase of large and advanced adenomas by G-eye22). In the oral presentation, flat adenomas and sessile serrated adenomas (SSA) in the right colon were increased by 160% and 550%, respectively, in figures flat adenomas 62 vs 24 and right-sided SSA 13 vs 2 – not very many for 1000 cases anyway. In view of the most dramatic increase of ADR by any method shown by any group in recent years we are glad to await confirmatory results by other groups, e.g. in a pure screening setting.
- Kaminski MF, Regula J, Kraszewska E, et al. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med 2010;362:1795-803.
- Corley DA, Jensen CD, Marks AR, et al. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med 2014;370:1298-306.
- Bretagne JF, Ponchon T. Do we need to embrace adenoma detection rate as the main quality control parameter during colonoscopy? Endoscopy 2008;40:523-8.
- Loberg M, Kalager M, Holme O, et al. Long-term colorectal-cancer mortality after adenoma removal. N Engl J Med 2014;371:799-807.
- Brenner H, Altenhofen L, Kretschmann J, et al. Trends in Adenoma Detection Rates During the First 10 y of the German Screening Colonoscopy Program. Gastroenterology 2015.
- Bond A, Sarkar S. New technologies and techniques to improve adenoma detection in colonoscopy. World J Gastrointest Endosc 2015;7:969-80.
- Subramanian V, Mannath J, Hawkey CJ, et al. High definition colonoscopy vs. standard video endoscopy for the detection of colonic polyps: a meta-analysis. Endoscopy 2011;43:499-505.
- Nagorni A, Bjelakovic G, Petrovic B. Narrow band imaging versus conventional white light colonoscopy for the detection of colorectal polyps. Cochrane Database Syst Rev 2012;1:Cd008361.
- Dinesen L, Chua TJ, Kaffes AJ. Meta-analysis of narrow-band imaging versus conventional colonoscopy for adenoma detection. Gastrointest Endosc 2012;75:604-11.
- Omata F, Ohde S, Deshpande GA, et al. Image-enhanced, chromo, and cap-assisted colonoscopy for improving adenoma/neoplasia detection rate: a systematic review and meta-analysis. Scand J Gastroenterol 2014;49:222-37.
- Zhao ZY, Guan YG, Li BR, et al. Detection and miss rates of autofluorescence imaging of adenomatous and polypoid lesions during colonoscopy: a systematic review and meta-analysis. Endosc Int Open 2015;3:E226-35.
- Morgan JL, Thomas K, Braungart S, et al. Transparent cap colonoscopy versus standard colonoscopy: a systematic review and meta-analysis. Tech Coloproctol 2013;17:353-60.
- Rex DK, Chadalawada V, Helper DJ. Wide angle colonoscopy with a prototype instrument: impact on miss rates and efficiency as determined by back-to-back colonoscopies. Am J Gastroenterol 2003;98:2000-5.
- Gralnek IM, Siersema PD, Halpern Z, et al. Standard forward-viewing colonoscopy versus full-spectrum endoscopy: an international, multicentre, randomised, tandem colonoscopy trial. Lancet Oncol 2014;15:353-60.
- Hassan C, Senore C, Radaelli F, et al. Full-spectrum (FUSE) versus standard forward-viewing colonoscopy in an organised colorectal cancer screening programme. Gut 2016.
- Uraoka T, Tanaka S, Oka S, et al. Feasibility of a novel colonoscope with extra-wide angle of view:a clinical study. Endoscopy 2015;47:444-8.
- Biecker E, Floer M, Heinecke A, et al. Novel Endocuff-assisted Colonoscopy Significantly Increases the Polyp Detection Rate: A Randomized Controlled Trial. J Clin Gastroenterol 2014.
- Floer M, Biecker E, Fitzlaff R, et al. Higher adenoma detection rates with endocuff-assisted colonoscopy – a randomized controlled multicenter trial. PLoS One 2014;9:e114267.
- van Doorn SC, van der Vlugt M, Depla A, et al. Adenoma detection with Endocuff colonoscopy versus conventional colonoscopy: a multicentre randomised controlled trial. Gut 2015.
- Ngu WS BR, Tsiamoulos Z, Bassett P, Hoare Z, Rutter M,Totton N, Lee TJ, Ramadas A, Silcock J, Painter J, Neilson LJ, Saunders BP, Rees CJ. Improved adenoma detection with endocuff vision – a multicentre randomised controlled trial. UEGW late breaking abstract 2016.
- Halpern Z, Gross SA, Gralnek IM, et al. Comparison of adenoma detection and miss rates between a novel balloon colonoscope and standard colonoscopy: a randomized tandem study. Endoscopy 2015;47:238-44.
- Shirin H. SB, Epshtein J., Vilmann P., Hoffmann A., Sanduleanu S., Ishaq S., Testoni P.A., Gross S.A., Neumann H., Goetz M., Siersema P.D., Abramowich D., Shnell M., Mizrahi M., Hendel J., Rey J.F., de Ridder R., Viale E., Pochapin M., Yair M., Gluck N., Yaari S., Stigaard T., Simantov R., Moshkowitz M., Israeli E., Sloth S., Matalon S., Vilkin A., Benson A., Maliar A., Waizbard A., Hershcovici T., Shachar E., Rochberger S., Tsvang E., Barverman M., Jacob H., Brachmann Y., Karstensen J.G., Teubner D., Bogie R.M.m., Kiesslich R. Increased adenoma detection rate by G-eye high definition colonoscopy in comparison to standard high definition colonoscopy – a prospective randomized multicenter study. UEG Journal 2016;4:A145.