Authors' objectives: To assess the clinical utility (impact on healthcare), the diagnostic accuracy and safety of endomicroscopy-based biopsy method in comparison to the standard of care during an endoscopic evaluation of patients with Barrett's esophagus (BE) using white light endoscopy (WLE) +/- high-definition (HD) view. The standard of care is currently the Seattle protocol which correspond to biopsy any visible lesion and practice complementary random four-quadrant biopsy of the remaining metaplastic mucosa. The aim of this heath technology assessment (HTA) is to decide on the coverage by French National Health Insurance of medical procedure using esophagus's endomicroscopy in two different clinical situations: surveillance of patients with non-dysplastic BE (for diagnosis of BE early neoplasia) or pre-therapeutic mapping with dysplastic BE (for diagnosis of synchronous early neoplasia). The target lesion in this assessment was early oesophageal adenocarcinoma.

Authors' recommendations: Concerning this domain, confocal laser endomicroscopy (CLE) was the only one technology evaluable with CE approval requirement. No professional guideline concerning the role of CLE in oesophageal mapping has clearly been identified despite relatively long-dated clinical development of this technology. Meta-analyses did not provide any additional information to the primary studies because the eligible studies were too heterogeneous and based on others criteria than those adopted by HAS. No primary study has reported CLE's accuracy in identification of low-grade dysplasia. Five CLE's accuracy studies (out of 21 preselected studies) involved analysis of 4 930 biopsies. The attrition rate of patients was 11 %. No study collected longitudinal follow-up clinical data The HAS final appraisal was that CLE-guided biopsy method cannot replace the standard method (oesophageal mapping with systematic biopsies according to the Seattle protocol). However, it can be integrated exclusively at the level of the pre-therapeutic management for dysplastic-confirmed BE at high risk of synchronous cancer and recurrence, after first identification usually managed in primary care centres. A biopsy providing histopathological confirmation of early neoplasia remains a prerequisite for any treatment decision (resection or ablation). CLE must be used exclusively in the population at high risk of cancer and in centres of excellence (specialised in interventional oesophageal endoscopy). These guidelines could be based on article 1151-1 of the French Public Health Code.

Project Status: Completed

Year Published: 2014

URL for published report: http://www.has-sante.fr/portail/upload/docs/application/pdf/2014-10/evaluation_de_lendomicroscopie_optique_realisee_lors_de_la_cartographie_dun_endo-brachy-oesophage_-_rapport_devaluation_2014-10-07_12-39-6_765.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: France

Organisation Name: Haute Autorité de Santé

Contact Address: 2 avenue du Stade de France, 93218 Saint-Denis La Plaine Cedex, France. Tel: +33 01 55 93 71 88; Fax: +33 01 55 93 74 35;

Contact Name: has.seap.secretariat@has-sante.fr

Contact Email: has.seap.secretariat@has-sante.fr