Pancreatic Solid Lesions Clinical Trial
Official title:
Stylet Slow-Pull Technique Compared To Standard Suction For Endoscopic Ultrasound-Guided Fine-Needle Biopsy In Pancreatic Solid Lesions: Data From A National Multicenter Randomized Trial
Ultrasound-guided fine-needle aspiration represents the gold-standard for the pathological diagnosis of solid pancreatic lesions. New needles design allowed to obtain samples suitable for histological evaluation (endoscopic ultrasound-guided fine needle biopsy). the aim was to compare two different techniques during ultrasound-guided fine needle biopsy, for diagnosis of suspect pancreatic solid lesions.
Materials and methods This is a prospective, randomized, multicenter study comparing the
slow-pull technique with the standard suction technique during Ultrasound-guided fine-needle
biopsy in patients with pancreatic solid lesions. The study involved three referral centers
for pancreatico-biliary diseases: the Gastroenterology and Endoscopy Unit. ARNAS Civico-Di
Cristina-Benfratelli Hospital, Palermo, Italy; the Gastroenterology and Endoscopy Unit.
Marche Polytechnic University, Ospedale A. Murri, Fermo, Italy; the Gastroenterology Unit.
AUSL Bologna, Bellaria-Maggiore, Bologna, Italy. The protocol was approved by the
institutional medical ethical committee at each participating institution and written
informed consent was obtained from all patients for participation in the study. All
consecutive patients with a newly diagnosed pancreatic solid lesions suitable for endoscopic
ultrasound-guided tissue acquisition were considered for enrollment. Written informed consent
was obtained from all patients before the procedure. All the endoscopic ultrasound procedures
were carried out by a skilled endosonographer with the patients under conscious sedation or
deep sedation according to the anesthesiological guidelines approved in each participating
center. All Ultrasound-guided fine-needle biopsy were done using a 20 Gauge needle (EchoTip
ProCore 20G with ReCoil Styletâ„¢, Cook Medical, Bloomington, IN, USA). The ReCoil Stylet´s has
an automatic recoiling capability designed to help users to manage more easily the stylet,
thus minimising the risk of contamination. Before puncturing, color doppler examination was
performed to exclude the presence of interposing vessels. The needle tip was sharpened by
withdrawing the stylet of approximately 2 mm, and then it was advanced into the lesion under
real-time endoscopic ultrasound guidance. In patients randomized to the stylet slow-pull
techniques, 15 to-and-fro movements within the lesion were performed while gently pulling the
needle stylet slowly and continuously upwards. In patients randomized to the standard suction
technique, 15 to-and-fro movements within the lesion were performed using a 10-mL suction
syringe. In both sampling procedures the fanning technique was used to maximized sample
acquisition. Tissue samples were expelled onto slides by reinserting the stylet and the
visible core was physically lifted off the slides placing it into a formalin vial for
histological evaluation. For the macroscopic adequacy, the endosonographer evaluated for the
presence of a visible core defined as a worm-like material whitish/yellowish or red, not
including fluid-like specimens in the formalin vial, which was judged to be adequate to
perform a pathological analysis. The pathologists were "blinded" on which group the vials
received were belonging to.
Randomization was performed using random sequences generated by a computer and then closed in
consecutive numbered envelopes.
The degree of blood contamination of the specimen was based on the pathologist evaluation of
the formalin fixed and paraffin embedded tissue samples and defined as significant when a
large amount of blood cells made pathological diagnosis difficult to be made. On the other
hand, blood contamination of the specimen was defined as not significant when no or only few
blood cells were present without any influence on the pathological diagnosis.
Sensitivity was defined as the true positive rate whereby the test was the final cytologic
diagnosis, Specificity as the true negative rate (proportion of actual negatives that are
correctly identified as such), positive predictive value was defined as the number of true
positive divided the number of positive calls (true positive and false positive), negative
predictive value was defined as the number of true negative divided the number of negative
calls (true negative and false negative). Diagnostic accuracy was defined as the ratio
between the sum of true positive and true negative values divided by the total number of
masses.
Technical success was defined as the capability of sampling the target lesion associated with
the presence of a visible core, according to endosonographer's judgment, potentially useful
for the final pathological analysis.
Adverse events were defined based on the criteria expressed by Cotton et al. [Cotton PB.
Gastrointest Endosc 2010;71:446-54] Samples positive for malignancy were considered
diagnostic for malignancy, while in patients with negative Ultrasound-guided fine-needle
biopsy, surgical specimen evaluation, results of other diagnostic investigations and/or a
clinical follow-up of at least 6 months were used to establish the definitive diagnosis.
Statistical Analysis The sample size was calculated based on the results of a previous study
[Nakai Y H. Dig Dis Sci. 2014;59:1578-85] that showed that blood contamination of the
specimen was lower with the stylet slow-pull technique as compared with the standard suction
technique (25% vs 70%), with a consequent increase in the diagnostic accuracy. Based on these
data we calculated for a difference of 25%, at a power of 80% and an alpha of 0.05 (two-sided
test), a final sample size of 110 patients (55 patients in each group). Continuous variables
will be reported as mean +/- standard deviation (SD) or as median with interquartile range.
Categorical variables will be presented as numbers and percentage and will be compared either
using the chi-square test (with Yates' correction when appropriate) or Fisher exact test.
Statistical was conducted using the Fisher's exact test for categorical variables and the
Mann-Whitney U-test for continuous variables. Sensitivity, specificity, positive predictive
value, negative predictive value, and overall diagnostic accuracy for each arm were
investigated by comparing the results with the definitive diagnosis. Statistical tests were
considered significant at a corresponding p value of <0.05. Data handling and analyses were
done with SPSS 14.
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