Download PDF
Endoscopy 2013; 45(02): 98-105
DOI: 10.1055/s-0032-1325932
Original article
© Georg Thieme Verlag KG Stuttgart · New York

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

Y. Mori
1   Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan
,
S. Kudo
1   Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan
,
N. Ikehara
1   Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan
,
K. Wakamura
1   Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan
,
Y. Wada
1   Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan
,
M. Kutsukawa
1   Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan
,
M. Misawa
1   Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan
,
T. Kudo
1   Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan
,
Y. Kobayashi
1   Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan
,
H. Miyachi
1   Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan
,
F. Yamamura
1   Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan
,
K. Ohtsuka
1   Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan
,
H. Inoue
1   Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan
,
S. Hamatani
2   Department of Pathology, Showa University, Northern Yokohama Hospital, Yokohama, Japan
› Author Affiliations
Further Information

Publication History

submitted21 February 2012

accepted after revision25 September 2012

Publication Date:
10 January 2013 (online)

Also available at
    Permissions and Reprints

See also:

Commentaire de travail de Y. Mori et al., pp.98Endoscopy 2013; 45(02): 232-232
DOI: 10.1055/s-0032-1326340

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.

 

  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 6 Neumann H, Fuchs FS, Vieth M et al. Review article: in vivo imaging by endocytoscopy. Aliment Pharmacol Ther 2011; 33: 1183-1193
    CrossrefPubMedGoogle Scholar
  • 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
    Article in Thieme ConnectPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    Article in Thieme ConnectPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    Article in Thieme ConnectPubMedGoogle Scholar
  • 12 Dixon MF. Gastrointestinal epithelial neoplasia: Vienna revisited. Gut 2002; 51: 130-131
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    PubMedGoogle Scholar
  • 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
    PubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    Article in Thieme ConnectPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 27 Davila RE, Rajan E, Baron TH et al. ASGE guideline: Colorectal cancer screening and surveillance. Gastrointest Endosc 2006; 63: 546-557
    CrossrefPubMedGoogle Scholar
  • 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
    Google Scholar