Endosonography-Guided Fine-Needle Aspiration versus "Key-Hole Biopsy" in the diagnostics of upper gastrointestinal subepithelial tumors. A prospective randomized interventional study.

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).

Local residual neoplasia after endoscopic treatment of laterally spreading tumors during 15 months of follow-up.

BACKGROUND: Among superficial neoplastic lesions of the colon and rectum, a laterally spreading tumor (LST) is a flat elevated type at least 10 mm in size. It can be treated by conventional endoscopic resection (CER). Nevertheless, local residual neoplasia (LRN) may occur during follow-up. The aim of this prospective study was to evaluate the occurrence of LRN and the risk factors for its presence. METHODS: Consecutive patients referred for CER of an LST were included. Follow-up colonoscopies were performed after 3 and 15 months. LRN was defined histologically as the presence of neoplastic tissue in the post-CER site. RESULTS: Of a total of 127 patients with 127 lesions, follow-up could not be completed in 48 (37.8%). Of the remaining 79 (62.2%) patients (64.6% men, mean age 66.1±9.7 years), 63 (79.7%) were negative and 16 (20.3%) were positive for the presence of LRN after 15 months. Of 62 (78.5%) patients without LRN after 3 months, 55 (88.7%) remained negative after 15 months. Of 17 (21.5%) patients with LRN after 3 months, eight (47.1%) were negative after 15 months. In a multivariate analysis, LST size of at least 20 mm was found to be a significant risk factor after 3 months (odds ratio, 5.837; 95% confidence interval 1.199-28.425; P=0.029). After 15 months, the only significant risk factor was the presence of LRN observed after 3 months (odds ratio, 6.0; 95% confidence interval, 1.793-20.073; P=0.004). CONCLUSION: This prospective study shows that the occurrence of LRN is frequent and its treatment is less effective than reported previously. These are important limitations of CER and should be taken into consideration for the management of patients with LSTs.