EUS-guided 22-gauge fine needle biopsy versus single-incision with needle knife for the diagnosis of upper gastrointestinal subepithelial lesions: a randomized controlled trial

Abstract

Background and study aims EUS-FNA has suboptimal accuracy in diagnosing gastrointestinal subepithelial tumors (SETs). EUS-guided 22-gauge fine needle biopsy (EUS-FNB) and single-incision with needle knife (SINK) were proposed to increase accuracy of diagnosis. This study aimed to prospectively compare the diagnostic accuracy and safety of EUS-FNB with SINK in patients with upper gastrointestinal SETs. Patients and methods All adult patients referred for EUS evaluation of upper gastrointestinal SETs ≥ 15 mm in size were eligible for inclusion. Patients were randomized to undergo EUS-FNB or SINK. Lesions were sampled with a 22-gauge reverse beveled core needle in the EUS-FNB group and by a conventional needle-knife sphincterotome and biopsy forceps in the SINK group. Patients were blinded to the technique used. The primary outcome was diagnostic accuracy. Secondary outcomes included adverse events, histological yield and procedure duration. Study enrollment was terminated early due to poor recruitment. Results A total of 56 patients (31 male (55.37 %); mean age, 67.41 ± 12.70 years) were randomized to either EUS-FNB (n = 26) or SINK (n = 30). Technical success was 96.15 % and 96.66 %, respectively. The majority of lesions were gastrointestinal stromal tumors (51.78 %). No significant difference was found between EUS-FNB and SINK in terms of diagnostic accuracy for a malignant or benign disease (76 % vs. 89.28 %, respectively; P = 0.278). The rate of adverse events (none severe) was also comparable (7.69 % vs. 10 %, respectively; P = 1.0) including two abdominal pain episodes in the EUS-FNB group compared to two delayed bleeding (one requiring hospitalization and radiologic embolization) and 1 abdominal pain in the SINK group. Conclusion EUS-FNB and SINK are equally effective techniques for upper gastrointestinal SETs sampling. SINK can be associated with mild to moderate delayed bleeding.

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.…”

“…Newer techniques involve unroofing the SEL to expose its surface, or submucosal tunneling allowing direct biopsy sampling of the tumor [47]. Several variants of this technique exist; here they are collectively referred to as MIAB [48,49]. MIAB was evaluated in a meta-analysis of 7, mostly retrospective series including a total of 159 patients with upper GI SELs (mean diameter 21 mm, 94.8 % located in the stomach).…”

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.…”

Efficiency of an endoscopic resection strategy for management of submucosal tumors < 20 mm in the upper gastrointestinal tract

“…Incisional biopsies were not performed. Incisional or stacked biopsy offers greater accuracy (90 %) for tumors with a mean size ranging from 20.3 mm to 25 mm 8 , but their AE rate can reach 10 % 9 .…”

“…However, their accuracy is not excellent, with a pooled rate of 59.9 % 7 . The accuracy of EUS-FNA for a mean tumor size of 21 mm ranges from 49 % 8 to 78 % 4 , while that of EUS -guided fine-needle biopsy (EUS-FNB) ranges from 76 % 9 to 88 % 10 . However, EUS-FNA is possible in only 46 % of gastric SMTs with a mean size of 20 mm 11 .…”