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

Abstract

Urban a 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 KeyHole 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).

Endoscopic management of subepithelial lesions including neuroendocrine neoplasms: European Society of Gastrointestinal Endoscopy (ESGE) Guideline

“…MIAB was compared with EUS-FNA and EUS-FNB in three randomized controlled trials (RCTs) [48,49,52]. No significant differences in the rates of diagnostic samples or adverse events were observed; however, these RCTs were powered to detect only large differences between the compared techniques.…”

Mucosal incision-assisted biopsy versus endoscopic ultrasound-assisted tissue acquisition for subepithelial lesions: a systematic review and meta-analysis

“…Figure 1 shows the PRIS-MA flowchart of the article selection process. Seven studies [17][18][19][20][21][22][23] were included in the meta-analysis. Table 1 summarizes the characteristics of the included studies.…”

“…Table 1 summarizes the characteristics of the included studies. The majority of the studies were from Asia, [17][18][19][20][21] one study was from Europe, 22 and another multicenter study involved centers in North America and Europe. 23 Three studies were prospective, 18,20,21 three were RCTs 1,19,23 and one was retrospective.…”

“…23 Three studies were prospective, 18,20,21 three were RCTs 1,19,23 and one was retrospective. 21 The SEL was located in the stomach in most of the studies, [17][18][19]21 while three studies 20,22,23 included lesions in the esophagus and duodenum along with the stomach. The pooled mean age of the population was 61.1±12.1 years.…”

Computed tomography in the size measurement of gastric gastrointestinal stromal tumors: Implication to risk stratification and “wait-and-see” tactics

“…GISTs can be classified as very-low risk; low-risk; intermediate-risk and high-risk based on four parameters: tumor size, mitotic index, location and tumor rupture [9]. However, fresh tissue obtained by needle biopsy is often inadequate to accurately assess mitotic count, preoperative risk prediction predominantly hinges on imaging examinations [10,11]. Xu et al [12] established a preoperative score system to predict the risk of gastric GISTs based on CT features, tumor size, margin, intratumoral vessels, enhancement pattern and growth pattern are well-performed indicators.…”