Comprehensive diagnostic ability of endocytoscopy compared with biopsy for colorectal neoplasms: a prospective randomized noninferiority trial

Y. Mori; S. Kudo; N. Ikehara; K. Wakamura; Y. Wada; M. Kutsukawa; M. Misawa; T. Kudo; Y. Kobayashi; H. Miyachi; F. Yamamura; K. Ohtsuka; H. Inoue; S. Hamatani

doi:10.1055/s-0032-1325932

Endoscopy, Table of Contents

Endoscopy 2013; 45(02): 98-105
DOI: 10.1055/s-0032-1325932

Original article

Comprehensive diagnostic ability of endocytoscopy compared with biopsy for colorectal neoplasms: a prospective randomized noninferiority trial

Y. Mori

¹Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan

,

S. Kudo

¹Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan

,

N. Ikehara

¹Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan

,

K. Wakamura

¹Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan

,

Y. Wada

¹Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan

,

M. Kutsukawa

¹Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan

,

M. Misawa

¹Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan

,

T. Kudo

¹Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan

,

Y. Kobayashi

¹Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan

,

H. Miyachi

¹Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan

,

F. Yamamura

¹Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan

,

K. Ohtsuka

¹Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan

,

H. Inoue

¹Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan

,

S. Hamatani

²Department of Pathology, Showa University, Northern Yokohama Hospital, Yokohama, Japan

› Author Affiliations

Abstract

Background and study aims: Endocytoscopy enables observation at 450-fold magnification during gastrointestinal endoscopy, allowing on-site “optical biopsy.” We compared the accuracies of endocytoscopy and standard biopsy for the diagnosis of colorectal neoplasms.

Patients and methods: We performed a randomized, controlled, open-label trial of patients with colorectal lesions ( ≥ 5 mm) detected during colonoscopy in a tertiary referral center. We randomly assigned the 203 detected lesions of 170 eligible patients to either the endocytoscopy or standard biopsy group. An on-site endoscopist assessed the histopathology of the endocytoscopy group lesions according to the endocytoscopic findings, whereas a pathologist later assessed standard biopsy group lesions by microscopic examination of the biopsy specimens. We calculated the diagnostic accuracies in both groups with reference to the final histopathology of the resected specimens. The primary endpoint was to determine whether the diagnostic accuracy of endocytoscopy for neoplastic lesions was noninferior to that of standard biopsy (with a predefined noninferiority margin of 10 %). Analyses were by intention-to-treat and per-protocol. The study is registered, number UMIN000003923.

Results: Overall, 102 lesions in the endocytoscopy group and 101 in the standard biopsy group were available for primary outcome analysis. There were no complications. The diagnostic accuracy of endocytoscopy for the discrimination of neoplastic lesions was 94.1 % (95 % confidence interval 87.6 % to 97.8 %), whereas that of standard biopsy was 96.0 % (90.2 % to 98.9 %), which is within the noninferiority margin (absolute difference − 1.9 %, − 8.6 % to + 5.0 %).

Conclusions: Endocytoscopy is noninferior to standard biopsy for the discrimination of neoplastic lesions. With its advantage of providing an on-site diagnosis, endocytoscopy could provide a novel alternative to standard biopsy in routine colonoscopy.

Full Text

References

References
1 Winawer SJ, Zauber AG, Ho MN. The National Polyp Study Workgroup et al. Prevention of colorectal cancer by colonoscopic polypectomy. N Engl J Med 1993; 329: 1977-1981
2 East JE, Tan EK, Bergman JJ et al. Meta-analysis: narrow band imaging for lesion characterization in the colon, oesophagus, duodenal ampulla and lung. Aliment Pharmacol Ther 2008; 28: 854-867
3 Hurlstone DP, Cross SS, Adam I et al. Efficacy of high magnification chromoscopic colonoscopy for the diagnosis of neoplasia in flat and depressed lesions of the colorectum: a prospective analysis. Gut 2004; 53: 284-290
4 East JE, Suzuki N, Saunders BP. Comparison of magnified pit pattern interpretation with narrow band imaging versus chromoendoscopy for diminutive colonic polyps: a pilot study. Gastrointest Endosc 2007; 66: 310-316
5 Wada Y, Kudo SE, Kashida H et al. Diagnosis of colorectal lesions with the magnifying narrow-band imaging system. Gastrointest Endosc 2009; 70: 522-531
6 Neumann H, Fuchs FS, Vieth M et al. Review article: in vivo imaging by endocytoscopy. Aliment Pharmacol Ther 2011; 33: 1183-1193
7 Pohl H, Koch M, Khalifa A et al. Evaluation of endocytoscopy in the surveillance of patients with Barrett's esophagus. Endoscopy 2007; 39: 492-496
8 Sasajima K, Kudo SE, Inoue H et al. Real-time in vivo virtual histology of colorectal lesions when using the endocytoscopy system. Gastrointest Endosc 2006; 63: 1010-1017
9 Kumagai Y, Monma K, Kawada K. Magnifying chromoendoscopy of the esophagus: in-vivo pathological diagnosis using an endocytoscopy system. Endoscopy 2004; 36: 590-594
10 Rotondano G, Bianco MA, Salerno R et al. Endocytoscopic classification of preneoplastic lesions in the colorectum. Int J Colorectal Dis 2010; 25: 1111-1116
11 Kudo S, Wakamura K, Ikehara N et al. Diagnosis of colorectal lesions with a novel endocytoscopic classification – a pilot study. Endoscopy 2011; 43: 869-875
12 Dixon MF. Gastrointestinal epithelial neoplasia: Vienna revisited. Gut 2002; 51: 130-131
13 Baba H. The Paris endoscopic classification of superficial neoplastic lesions: esophagus, stomach, and colon: November 30 to December 1, 2002. Gastrointest Endosc 2003; 58: 3-43
14 Piaggio G, Elbourne DR, Altman DG et al. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA 2006; 295: 1152-1160
15 Hiraoka S, Kato J, Fujiki S et al. The presence of large serrated polyps increases risk for colorectal cancer. Gastroenterology 2010; 139: 1503-1510 , 1510 e1501-1503
16 Schreiner MA, Weiss DG, Lieberman DA. Proximal and large hyperplastic and nondysplastic serrated polyps detected by colonoscopy are associated with neoplasia. Gastroenterology 2010; 139: 1497-1502
17 Kudo S, Tamegai Y, Yamano H et al. Endoscopic mucosal resection of the colon: the Japanese technique. Gastrointest Endosc Clin N Am 2001; 11: 519-535
18 Kitajima K, Fujimori T, Fujii S et al. Correlations between lymph node metastasis and depth of submucosal invasion in submucosal invasive colorectal carcinoma: a Japanese collaborative study. J Gastroenterol 2004; 39: 534-543
19 Goetz M, Toermer T, Vieth M et al. Simultaneous confocal laser endomicroscopy and chromoendoscopy with topical cresyl violet. Gastrointest Endosc 2009; 70: 959-968
20 Shahid MW, Buchner AM, Heckman MG et al. Diagnostic accuracy of probe-based confocal laser endomicroscopy and narrow band imaging for small colorectal polyps: a feasibility study. Am J Gastroenterol 2012; 107: 231-239 Epub 2011 Nov 8
21 Kuiper T, van den Broek FJ, van Eeden S et al. New classification for probe-based confocal laser endomicroscopy in the colon. Endoscopy 2011; 43: 1076-1081
22 Neumann H, Kiesslich R, Wallace MB et al. Confocal laser endomicroscopy: technical advances and clinical applications. Gastroenterology 2010; 139: 388-392 , 392 e381-382
23 Buchner AM, Shahid MW, Heckman MG et al. Comparison of probe-based confocal laser endomicroscopy with virtual chromoendoscopy for classification of colon polyps. Gastroenterology 2010; 138: 834-842
24 Kiesslich R, Burg J, Vieth M et al. Confocal laser endoscopy for diagnosing intraepithelial neoplasias and colorectal cancer in vivo. Gastroenterology 2004; 127: 706-713
25 Shiffman ML, Farrel MT, Yee YS. Risk of bleeding after endoscopic biopsy or polypectomy in patients taking aspirin or other NSAIDS. Gastrointest Endosc 1994; 40: 458-462
26 Rex DK, Kahi C, O’Brien M et al. The American Society for Gastrointestinal Endoscopy PIVI (Preservation and Incorporation of Valuable Endoscopic Innovations) on real-time endoscopic assessment of the histology of diminutive colorectal polyps. Gastrointest Endosc 2011; 73: 419-422
27 Davila RE, Rajan E, Baron TH et al. ASGE guideline: Colorectal cancer screening and surveillance. Gastrointest Endosc 2006; 63: 546-557
28 Fred TB, Fatima C, Ralph HH, Neil DD. WHO classification of tumours of the digestive system. 4th. edn. Lyon, France: International Agency for Research on Cancer; 2010