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Abstract Background Studies have shown that the wet suction technique in endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) generates better histological diagnostic accuracy and specimen quality than the dry suction technique. However, conclusions of wet suction on the diagnostic accuracy of endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) are still controversial. Besides, the optimal number of passes for EUS-FNB has not been determined. We aimed to design a large multicenter randomized trial to compare the diagnostic accuracy of dry suction versus wet suction technique in solid pancreatic lesions (SPLs) using 22G Franseen needles and determine the optimal number of passes required for EUS-FNB. Methods This is a multi-center open-label, randomized controlled non-inferiority trial with two parallel groups. Two hundred patients with SPLs will undergo EUS-FNB using 22G Franseen needles in 4 tertiary hospitals in China and will be randomly assigned to the dry suction group and wet suction group in a ratio of 1:1. The primary endpoint is diagnostic accuracy. Secondary endpoints include the optimal number of needle passes, sensitivity, specificity, specimen quality, cytological diagnoses, time of the procedure, and incidence of complications. Discussion This study has been designed to determine (i) whether EUS-FNB using 22G Franseen needle with dry suction is non-inferior to wet suction in terms of diagnostic accuracy and (ii) the optimal number of passes during EUS-FNB of SPLs using 22G Franseen needle. Trial registration ClinicalTrials.gov NCT05549856. Registered on September 22, 2022.

Background: Studies have shown that the wet suction technique in endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) generates better histological diagnostic accuracy and specimen quality than the dry suction technique. However, conclusions of wet suction on the diagnostic accuracy of endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) are still controversial. Besides, the optimal number of passes for EUS-FNB has not been determined. We aimed to design a large multicenter randomized trial to compare the diagnostic accuracy of dry suction versus wet suction technique in solid pancreatic lesions (SPLs) using 22G Franseen needles and determine the optimal number of passes required for EUS-FNB. Methods: This is a multi-center open-label, randomized controlled non-inferiority trial with two parallel groups. Two hundred patients with SPLs will undergo EUS-FNB using 22G Franseen needles in 4 tertiary hospitals in China and will be randomly assigned to the dry suction group and wet suction group in a ratio of 1:1. The primary endpoint is diagnostic accuracy. Secondary endpoints include the optimal number of needle passes, sensitivity, specificity, specimen quality, cytological diagnoses, time of the procedure, and incidence of complications. Discussion: This study has been designed to determine (i) whether EUS-FNB using 22G Franseen needle with dry suction is non-inferior to wet suction in terms of diagnostic accuracy and (ii) the optimal number of passes during EUS-FNB of SPLs using 22G Franseen needle. Trial registration: ClinicalTrials.gov NCT05549856. Registered on September 22, 2022. [ABSTRACT FROM AUTHOR]

The optimal sampling techniques for EUS-FNA remain unclear and have not been standardized. To improve diagnostic accuracy, suction techniques for EUS-FNA have been developed and are widely used among endoscopists. The aim of this study was to compare wet-suction and dry-suction EUS-FNA techniques for sampling solid lesions. We performed a comprehensive literature search of major databases (from inception to June 2020) to identify prospective studies comparing wet-suction EUS-FNA and dry-suction EUS-FNA. Specimen adequacy, sample contamination, and histologic accuracy were assessed by pooling data using a random-effects model expressed in terms of odds ratio (OR) and 95% confidence interval (CI). Six studies including a total of 418 patients (365 wet suction vs. 377 dry suction) were included in our final analysis. The study included a total of 535 lesions (332 pancreatic lesions and 203 nonpancreatic lesions). The pooled odds of sample adequacy was 3.18 (CI: 1.82-5.54, P = 0.001) comparing wet- and dry-suction cohorts. The pooled odds of blood contamination was 1.18 (CI: 0.75-1.86, P = 0.1). The pooled rate for blood contamination was 58.33% (CI: 53.65%-62.90%) in the wet-suction cohort and 54.60% (CI 49.90%- 59.24%) in the dry-suction cohort (P = 0.256). The pooled odds of histological diagnosis was 3.68 (CI 0.82-16.42, P = 0.1). Very few adverse events were observed and did not have an impact on patient outcomes using either method. EUS-FNA using the wet-suction technique offers higher specimen quality through comparable rates of blood contamination and histological accuracy compared to dry-suction EUS-FNA., Competing Interests: None