BACKGROUND: The management and prognosis of subepithelial tumors (SETs) of the upper gastrointestinal tract depend on the correct preoperative evaluation, including tissue diagnosis in selected cases. Several methods providing deep tissue sampling for cytological and/or histological examinations have been described but their diagnostic yield and precise position in the diagnostic algorithm remain to be established. This prospective randomized study aims to compare the Endosonography-Guided Fine-Needle Aspiration (EUS-FNA) to Key-Hole Biopsy (KHB) in cytological or histological diagnostics of upper gastrointestinal SETs. PATIENTS AND METHODS: This study was conducted in a single tertiary endoscopy center in Ostrava, Czech Republic between November 2010 and October 2015. Patients with endoscopically detected SETs of the upper gastrointestinal tract with a diameter ≥ 2 cm, were randomized to either the EUS-FNA with 22G needle, or to the Key Hole biopsy (forceps biopsy through mucosal incision) groups. The main study outcomes were success rate of tissue diagnostics and, in the cases of Gastrointestinal Stromal Tumours (GIST), possibility of determining mitotic activity. A cross-over examination was performed in situations where the first method had failed. RESULTS: A total of 46 consecutive patients were randomized. Of these, 24 (52%) and 22 (48%) were randomized to EUS-FNA group and KHB arm, respectively. 5 SETs (11%) were detected in the esophagus, 40 (87%) in the stomach and 1 (2%) in the duodenum. The definitive diagnosis was established by the first sampling method in 42 (91%) patients, including 22 (92%) in the EUS-FNA group and 20 (91%) in the KHB group (P=0.999), and after a cross-over in another 3 (7%) patients. The most prevalent SET was GIST (70%). Although some mitotic activity could be observed in 11 patients, the mitotic index could be diagnosed in none of them. Of a total of 20 surgically treated patients, preoperative and postoperative tissue diagnosis corresponded in 19/20 (95%) cases, including 100% in FNA group and 91% in KHB group (P=0.999). No adverse events of tissue sampling occurred in the study. CONCLUSIONS: Deep tissue sampling by EUS-FNA and KHB are equally effective in the diagnostics of SETs of the upper gastrointestinal tract ≥ 2 cm. However, neither EUS-FNA nor KHB provided adequate tissue sample to determine mitotic index. TRIAL REGISTRATION: Clinicaltrials.gov (NCT02025244).

Biopsy and Cytology Department Agel Laboratories Novy Jicin Czech Republic

CGB Laboratories Ostrava Czech Republic

Department of Internal Medicine 2 Gastroenterology and Geriatric Faculty of Medicine and Dentistry Palacky University Olomouc and University Hospital Olomouc Czech Republic

Department of Internal Medicine Gastroenterology and Hepatology Vivantes Clinic Berlin Germany Corresponding author Vincent Zoundjiekpon e mail

Department of Surgery Vitkovice Hospital Ostrava Czech Republic

Digestive Diseases Center Vitkovice Hospital Ostrava Czech Republic

Faculty of Medicine Charles University in Hradec Kralove Czech Republic

StatMed Health Analytics and Business Intelligence Saint Jean Sur Richelieu Quebec Canada

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ClinicalTrials.gov
NCT02025244