Pilot study of cytological testing for oesophageal squamous cell dysplasia in a high-risk area in Northern Iran

G Roshandel, S Merat, M Sotoudeh, M Khoshnia, H Poustchi, P Lao-Sirieix, S Malhotra, M O'Donovan, A Etemadi, A Nickmanesh, A Pourshams, A Norouzi, I Debiram, S Semnani, C C Abnet, S M Dawsey, R C Fitzgerald, R Malekzadeh, G Roshandel, S Merat, M Sotoudeh, M Khoshnia, H Poustchi, P Lao-Sirieix, S Malhotra, M O'Donovan, A Etemadi, A Nickmanesh, A Pourshams, A Norouzi, I Debiram, S Semnani, C C Abnet, S M Dawsey, R C Fitzgerald, R Malekzadeh

Abstract

Background: Oesophageal squamous cell carcinoma (ESCC) is a fatal disease with 5-year survival rates of <5% in Northern Iran. Oesophageal squamous dysplasia (ESD) is the precursor histologic lesion of ESCC. This pilot study was conducted to assess the feasibility, safety, and acceptability of non-endoscopic cytological examination of the oesophagus and to provide initial data on the accuracy of cytological atypia for identifying patients with ESD in this very-high-risk area.

Methods: Randomly selected asymptomatic participants of the Golestan Cohort Study were recruited. A cytological specimen was taken using a capsule sponge device and evaluated for atypical cells. Sections of the cytological specimen were also stained for p53 protein. Patient acceptability was assessed using a visual analogue scale. The cytological diagnosis was compared with a chromoendoscopic examination using Lugol's solution.

Results: Three hundred and forty-four subjects (43% male, mean (s.d.) age 55.6 (7.9) years) were referred to the study clinic. Three hundred and twelve met eligibility criteria and consented, of which 301 subjects (96.5%) completed both cytological and endoscopic examinations. There were no complications. Most of the participants (279; 92.7%) were satisfied with the examination. The sensitivity and specificity of the cytological examination for identifying subjects with high-grade ESD were 100 and 97%, respectively. We found an accuracy of 100% (95% CI=99-100%) for a combination of cytological examination and p53 staining to detect high-grade ESD.

Conclusions: The capsule sponge methodology seems to be a feasible, safe, and acceptable method for diagnosing precancerous lesions of the oesophagus in this population, with promising initial accuracy data for the detection of high-grade ESD.

Figures

Figure 1
Figure 1
Study flow chart (GCS=Golestan Cohort Study).
Figure 2
Figure 2
Subjects' level of satisfaction on capsule sponge examination.

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Source: PubMed

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