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Barrett's Esophagus and Adenocarcinoma Risk: The Experience of the North-Eastern Italian Registry (EBRA)

Rugge, Massimo MD*; Zaninotto, Giovanni MD; Parente, Paola MD; Zanatta, Lisa MD; Cavallin, Francesco MS§; Germanà, Bastianello MD; Macrì, Ettore MD; Galliani, Ermenegildo MD; Iuzzolino, Paolo MD; Ferrara, Francesco MD; Marin, Renato MD; Nisi, Emiliano MD; Iaderosa, Gaetano MD; DeBoni, Michele MD#; Bellumat, Angelo MD#; Valiante, Flavio MD#; Florea, Georgeta MD#; Della Libera, Duilio MD#; Benini, Marco MD**; Bortesi, Laura MD**; Meggio, Alberto MD††; Zorzi, Maria G. MD††; Depretis, Giovanni MD‡‡; Miori, Gianni MD‡‡; Morelli, Luca MD‡‡; Cataudella, Giovanni MD§§; D'Amore, Emanuele MD§§; Franceschetti, Ilaria MD§§; Bozzola, Loredana MD§§; Paternello, Elisabetta MD‖‖; Antonini, Cristina MD‖‖; Di Mario, Francesco MD¶¶; Dal Bò, Nadia MD¶¶; Furlanetto, Alberto MD¶¶; Norberto, Lorenzo MD##; Polese, Lino MD##; Iommarini, Silvia MD##; Farinati, Fabio MD##; Battaglia, Giorgio MD§; Diamantis, Giorgio MD§; Realdon, Stefano MD§; Guido, Ennio MD***; Mastropaolo, Gaetano MD†††; Canova, Daniele MD†††; Guerini, Antonello MD†††; Franceschi, Marilisa MD‡‡‡; Zirillo, Maurizio MD‡‡‡

doi: 10.1097/SLA.0b013e3182737a7e
Original Articles From the ESA Proceedings

Objective: To establish the incidence and risk factors for progression to high-grade intraepithelial neoplasia (HG-IEN) or Barrett's esophageal adenocarcinoma (BAc) in a prospective cohort of patients with esophageal intestinal metaplasia [(BE)].

Background: BE is associated with an increased risk of BAc unless cases are detected early by surveillance. No consistent data are available on the prevalence of BE-related cancer, the ideal surveillance schedule, or the risk factors for cancer.

Methods: In 2003, a regional registry of BE patients was created in north-east Italy, establishing the related diagnostic criteria (endoscopic landmarks, biopsy protocol, histological classification) and timing of follow-up (tailored to histology) and recording patient outcomes. Thirteen centers were involved and audited yearly. The probability of progression to HG-IEN/BAc was calculated using the Kaplan-Meier method; the Cox regression model was used to calculate the risk of progression.

Results: HG-IEN (10 cases) and EAc (7 cases) detected at the index endoscopy or in the first year of follow-up were considered to be cases of preexisting disease and excluded; 841 patients with at least 2 endoscopies {median, 3 [interquartile range (IQR): 2–4); median follow-up = 44.6 [IQR: 24.7–60.5] months; total 3083 patient-years} formed the study group [male/female = 646/195; median age, 60 (IQR: 51–68) years]. Twenty-two patients progressed to HG-IEN or BAc (incidence: 0.72 per 100 patient-years) after a median of 40.2 (26.9–50.4) months. At multivariate analysis, endoscopic abnormalities, that is, ulceration or nodularity (P = 0.0002; relative risk [RR] = 7.6; 95% confidence interval, 2.63–21.9), LG-IEN (P = 0.02, RR = 3.7; 95% confidence interval, 1.22–11.43), and BE length (P = 0.01; RR = 1.16; 95% confidence interval, 1.03–1.30) were associated with BE progression. Among the LG-IEN patients, the incidence of HG-IEN/EAc was 3.17 patient-years, that is, 6 times higher than in BE patients without LG-IEN.

Conclusions: These results suggest that in the absence of intraepithelial neoplastic changes, BE carries a low risk of progression to HG-IEN/BAc, and strict surveillance (or ablative therapy) is advisable in cases with endoscopic abnormalities, LG-IEN or long BE segments.

The incidence of high-grade noninvasive neoplasia and adenocarcinoma and the risk factors for progression were established in a prospective cohort of 841 patients with Barrett's esophagus on the basis of regular endoscopic follow-up for a total of 3083 patient-years. The overall incidence of high-grade intraepithelial neoplasia/adenocarcinoma was 7.2 per 1000 patient-years. The presence of endoscopic abnormalities (ulceration or nodularity), low-grade noninvasive neoplasia at histology, and the length of the segment of Barrett's esophagus were independently associated with progression.

Departments of *Pathology and

Surgery, University of Padova, Padova

Department of Pathology, Casa Sollievo della Sofferenza, S. Giovanni Rotondo

§Veneto Institute of Oncology [IOV-IRCCS], Padova

Department of Gastroenterology and Pathology, Belluno Hospital, Belluno

Departments of Gastroenterology and Pathology, Dolo Hospital, Dolo, Venice

#Department of Gastroenterology and Pathology, Feltre Hospital, Feltre

**Departments of Gastroenterology and Pathology, Negrar Hospital, Negrar, Verona

††Departments of Gastroenterology and Pathology, Rovereto Hospital, Rovereto

‡‡Departments of Gastroenterology and Pathology, S. Chiara Hospital, Trento

§§Departments of Gastroenterology and Pathology, S. Bortolo Hospital, Vicenza

‖‖Departments of Surgery and Pathology, S. Donà Hospital, Venice

¶¶Departments of Gastroenterology and Pathology, Cà Foncello Hospital, Treviso

##Departments of Surgery-Gastroenterology and Pathology, University of Padova Hospital, Padova

***Department of Gastroenterology, S. Antonio Hospital, Padova

†††Departments of Gastroenterology and Pathology, Bassano Hospital, Bassano; and

‡‡‡Departments of Gastroenterology and Pathology, S. Camillo Hospital, Schio, Italy.

Reprints: Giovanni Zaninotto, MD, FACS, Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova 35128, Italy, or Department of General Surgery, Sts Giovanni and Paolo Hospital, ULSS 12, Castello 6999 Venezia, Italy. E-mail: Giovanni.zaninotto@unipd.it.

This work was supported by grants from the Berlucchi Foundation for Cancer Research, the Morgagni Foundation, Italian Ministry for Public Health grant, and Veneto Regional Authority grant 166/04.

Disclosure: The authors declare that they have nothing to disclose.

© 2012 Lippincott Williams & Wilkins, Inc.