Alimentary Tract
The Veneto Region's Barrett's Oesophagus Registry: Aims, methods, preliminary results

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Abstract

Background

The natural history of Barrett's Oeosphagus is not completely clarified and Barrett's Oeosphagus Registries are considered useful tools to expand our knowledge on this disease. A Barrett's Oeosphagus Registry has been therefore established in the Veneto Region and neighbouring provinces.

Aims

The aims of the Registry are to assess the demographical, endoscopical and histological characteristics of Barrett's Oeosphagus patients; the prevalence of non-invasive neoplasia and Barrett's Adenocarcinoma and the timing and incidence of Barrett's Oeosphagus progression to malignancy.

Methods

An interdisciplinary committee of endoscopists, pathologists and information technology experts was established in 2004 to design a website-based Barrett's Oesophagus Registry for the Veneto Region and neighbouring north-eastern Italian provinces. Protocols for endoscopies and biopsies and standard reports were carefully defined.

Results

In the first 18 months, 397 patients with endoscopically visible and histologically proven Barrett's Oeosphagus were enrolled in the Registry; the median age of these patients was 66 years (male:female = 3:1). Most patients (75%) had a Short Segment of Barrett's Oesophagus (≤3 cm) and only 1 in 4 had a Long Segment of Barrett's Oesophagus (>3 cm). Long Segment of Barrett's Oesophagus patients were 5 years older than the Short Segment of Barrett's Oesophagus patients (p < 0.05), suggesting a progression from Short Segment of Barrett's Oesophagus to Long Segment of Barrett's Oesophagus. Though no data are available on the incidence of non-invasive neoplasia or Barrett's Adenocarcinoma (i.e., progression to cancer at least 12 months after enrolment), the prevalence of neoplastic lesions (found within 12 months of enrolment) was 5% for Short Segment of Barrett's Oesophagus and 19% for Long Segment of Barrett's Oesophagus, indicating that a careful multiple-biopsy endoscopic protocol is needed, especially when Long Segment of Barrett's Oesophagus are suspected at endoscopy. The prevalence of Barrett's Adenocarcinoma among patients with non-invasive neoplasia was 1/17 cases of low-grade non-invasive neoplasia and 2/3 cases of high-grade non-invasive neoplasia, indicating that these patients require strict endoscopic and bioptic follow-up.

Conclusion

A regional Barrett's Oeosphagus Registry is feasible at a relatively low cost and enables significant data to be collected in a relatively short time. The use of a standardised endoscopic nomenclature and report form, a strict biopsy protocol, a standard report for pathologists improves the quality of endoscopic and histological diagnoses.

Introduction

The lining of the distal oesophagus with columnar epithelium is known by the eponym of Barrett's Oesophagus (BO) from the English surgeon who first described this condition in 1950 [1]. Since then, BO has been recognised as an acquired disease due to exposure of the oesophageal mucosa to gastrointestinal contents [2] that increases the risk of primary oesophageal adenocarcinoma [3]. The cancer risk associated with BO has been more specifically linked to a subtype of glandular mucosa showing intestinalized glands (i.e., the presence of goblet cells and so-called ‘specialised’ metaplasia) [4], so the definition of BO has been further restricted to cases showing metaplastic intestinalisation of the native squamous oesophageal mucosa (i.e., ‘a change in the oesophageal epithelium of any length that can be recognised at endoscopy and confirmed to have intestinal metaplasia at biopsy’) [5]. The cancer risk associated with BO has been estimated to be 30–150 times higher than in the reference population, with a cancer incidence of 80–500/100,000 patients a year [6], [7], [8].

Barrett's Adenocarcinoma (BAd) is assumed to be preceded by a spectrum of morphological alterations previously defined as dysplasia. In BO, as in other districts, dysplasia has recently been renamed as non-invasive neoplasia (NiN), distinguishing between low-grade (LG) and high-grade (HG) NiN, depending on its degree of dedifferentiation. BAd is considered the final step in a cascade of phenotypic and genotypic alterations starting with the initial metaplastic transformation and developing into an invasive (potentially metastasising) adenocarcinoma.

The biological hypothesis for BAd morphogenesis provides the rationale for its secondary prevention. The identification and (surgical) treatment of the lesions developing before invasive cancer are currently considered the best way to reduce the high mortality rate associated with BAd. A generalised policy of endoscopic surveillance for BO patients has recently been challenged, however, since only a small proportion of BO patients progresses to adenocarcinoma and extensive endoscopic surveillance programs are costly [9], [10].

While awaiting suitable biological markers for identifying patients prone to BO-related cancer, current secondary cancer prevention strategy focuses on characterising the clinico-pathological profile of patients in whom surveillance programs are more likely to be cost-effective.

To improve our understanding of the natural history of BO, a Registry on this disease has recently been established for the Veneto Region and neighbouring provinces in north-eastern Italy. This report describes the Registry's aims, methods and preliminary results.

Section snippets

Aims of the Registry

The main aims of the Barrett's Oesophagus Registry are:

  • 1.

    to assess the demographical, endoscopical and histological characteristics of BO patients,

  • 2.

    to assess the prevalence of BO-associated non-invasive and early invasive neoplasia in consecutive patients enrolled in a given geographical area,

  • 3.

    to assess the timing and rate of BO progression to malignancy (i.e., its incidence).

Secondary aims are:

  • 1.

    to launch a BO surveillance programme, also with a view to BAd secondary prevention,

  • 2.

    to create a regional

Methods

In 2004, an interdisciplinary committee of endoscopists, gastroenterologists, pathologists and surgeons, and an information technology expert was established at Padova University with a view to creating a computer-based Registry of patients with BO. The committee met twice a week for a month with the following agenda:

  • (1)

    to select the clinico-pathological variables to include in the Registry,

  • (2)

    to decide on the biopsy sampling protocol to adopt in the initial assessment of BO and its follow-up,

  • (3)

    to

Results

Thirty-six centres have joined the Registry and 25 (2 university hospitals, 22 regional hospitals and 1 private hospital) were already active as at December 2005. The main reason for their not all being active was a backlog of endoscopic workload. The median number of BO patients enrolled per centre was 10 (range 1–80). Three centres enrolled more than 50 patients. The Registry's activity involved 19 Pathology Units because in several cases the same Pathology Department was co-operating with

Discussion

In the United States, the incidence of oesophageal adenocarcinoma is increasing at a pace unequalled by any other solid tumour [11]. Similar trends have been observed in Denmark [12], Switzerland [13], Sweden and Norway [14]: among the European populations, the highest incidence is in Scotland with an astonishing 9 cases per 100,000 a year [15]. Being a lethal disease, the rising incidence of BAd is causing growing concern [16]: despite advances in surgical oncology and the use of multimodal

Conflict of interest statement

None declared.

Acknowledgements

This study was generously supported by the Fondazione Berlucchi per la Ricerca sul Cancro, the Fondazione Morgagni per la Ricerca in Chirurgia, the Veneto Region (Ricerche Sanitarie Finalizzate 2004 research grant no.166/04) and the Italian Ministry for Public Health.

E.B.R.A. Italian Link participants: Maurizio Azzurro, Giuseppe Faccioli (Bussolengo Hospital, Verona); Domenico Madia, Antonio Scapinello (Castelfranco Veneto Hospital, Padova); Daniela Bartolini, Gianluca Bersani, Gianluigi

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  • Cited by (0)

    The names of the other participants in the Veneto Region's Barrett's Oesophagus Registry (EBRA-Link) are listed in the acknowledgement section of this article. They should all be considered as authors in the light of their precious contribution.

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