Linear endoscopic ultrasonography (EUS) allows the visualization, identification, and characterization of the extent of lesions of the gastrointestinal (GI) tract and adjacent structures. EUS-guided fine-needle aspiration (EUS-FNA) facilitates a more accurate diagnosis of mediastinal, intra-abdominal, and pancreatic lesions through the collection of the cytological material under direct visualization. Recent reports suggest that histological samples can be obtained by EUS-FNA with a reverse, bevel-tipped needle (the ProCore needle) to collect the core samples (fine needle biopsy, FNB), thereby adding a new dimension to the diagnostic usefulness of this technique. Certain neoplasms, such as lymphoma and stromal tumors, can be assessed by EUS-FNB to confirm the diagnosis. Here, we aimed to carry out a prospective, multicenter, single-blind, randomized, controlled trial to compare EUS-FNB and EUS-FNA. A total of 408 patients will be enrolled from five endoscopic centers. Patients will be divided into two groups: (1) group A, which is the EUS regular needle group (EUS-FNA) and (2) group B, which is the EUS ProCore needle group (EUS-FNB). Patients in group A will be examined with a 22G EchoTip Ultra needle, and patients in group B, with a 22G EchoTip ProCore needle. For all included patients, four EUS-guided passes will be made in each lesion. In the first and second pass, a slow-pull suction method of the stylet will be done. The third and fourth pass will use manual suction of 5 cc. The primary objective is to compare the diagnostic yield of malignancy by EUS-FNA versus EUS-FNB. The trial will compare samples obtained by EUS-FNA versus EUS-FNB for the diagnostic yield of solid lesions. The efficacy of these two sampling methods will be assessed on various lesions, which may provide insights into developing practice guidelines for their future indications. Clinical Trials.gov, NCT02327065 .

Several suction techniques have been developed recently to enhance tissue acquisition when sampling solid lesions using endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA). The aim of this study is to determine whether a new modified wet suction technique (MWST) compared with the conventional dry suction technique (DRST) shall present better outcomes with respect to diagnostic yield and specimen quality of solid lesions in the intra-abdomen and mediastinum. This is a single-blind, randomized, controlled, superiority trial conducted at four large tertiary care centers in China. Two hundred and ninety-six patients with solid lesions referred for EUS-FNA will be randomly assigned to group A, using DRST for the first pass, or group B, using MWST for the first pass in a ratio of 1:1. Following a 2 × 2 cross-over design, the pass sequence for group A is DRST, MWST, DRST, MWST. For group B, the pass sequence is MWST, DRST, MWST, DRST. All procedures will be performed by experienced echoendoscopists, and the patients and assessors (cytologists and pathologists) will be blinded during the entire study. The primary outcome measure is the diagnosis yield. Secondary outcome measures are specimen quality, including assessment of quantity of cell, tissue integrity, and blood contamination. To our knowledge, this is the first large-scale randomized controlled trial to compare MWST with DRST when sampling solid lesions in the intra-abdomen and mediastinum. The results may contribute to future multicenter clinical trials in standardizing suction techniques during EUS-FNA. Clinical Trials.gov, NCT02789371 . Retrospectively registered on 6 June 2016.