Background: Although endoscopic ultrasound (EUS) allows sensitive imag
ing of the upper gastrointestinal (GI) tract, it remains difficult to
differentiate between benign and malignant lesions on the basis of ult
rasound morphology, The purpose of this study was to determine the val
ue of EUS-guided biopsy for the diagnosis of submucosal and extralumin
al tumors, Methods: EUS-guided biopsy was carried out in 50 patients w
ith upper GI-tract lesions, All patients were examined using a flexibl
e echoendoscope with a 5/7.5 MHz curved array transducer, A specially
designed biopsy device (type Vilmann) with a fine needle (diameter 0.8
mm) was used for EUS-guided biopsy, Results: EUS-guided biopsy was pe
rformed for evaluation of mediastinal lesions (n=15), pancreatic tumor
s (n=26) and submucosal (n=5) or stenotic tumors of the esophagus (n=4
), Fine-needle aspiration yielded diagnostic tissue samples in 44 of 5
0 patients (88%). Histology demonstrated benign lesions in 20 of 44 pa
tients and malignant tumors in the other 24 patients. EUS-guided biops
y failed in only six patients (12%): in four patients it was impossibl
e to advance the needle into very hard pancreatic tumors; non-represen
tative biopsy material was obtained in two further cases. The results
of EUS-guided biopsy were validated by surgery (n=21), autopsy (n=3) o
r clinical follow-up (n=20). After a mean follow-up of 16 months there
is no evidence of malignancy in any of the patients with benign histo
logy, The sensitivity and specificity of EUS-guided biopsy in the diag
nosis of malignancy were 88% and 100%, respectively, None of the patie
nts experienced complications related to endosonographic biopsy, Concl
usions: EUS-guided biopsy with the Vilmann needle device is a safe and
accurate method for tissue sampling of extraluminal lesions, This tec
hnique considerably improves the diagnostic value of endosonography.