Randomized controlled trial to evaluate the utility of suction and inner-stylet of EBUS-TBNA for mediastinal and hilar lymphadenopathy.

Background: The optimal procedure for maximizing the diagnostic yield and minimizing the procedural complexity of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is controversial. We conducted a prospective randomized controlled trial to determine the optimal procedure of EBUS-TBNA for mediastinal and hilar lymphadenopathy, with a particular focus on the roles of the inner-stylet and suction.

Methods: Consecutive patients with enlarged mediastinal and hilar lymph nodes (LNs), detected by computed tomography (CT) or positron emission tomography-CT (PET-CT), who underwent EBUS-TBNA were included. Each LN was sampled with three needle passes using suction-stylet, suction-no stylet, and stylet-no suction procedures. The samples were smeared onto glass slides for cytological evaluation. A single, blinded cytopathologist evaluated each set of slides. The primary outcomes were cytological specimen adequacy rate and diagnostic yield of malignant LNs. The secondary outcomes were tissue-core acquisition rate, procedural time, and the amount of bleeding.

Results: This study evaluated 97 patients with a total of 255 LNs. The final LN diagnosis was benign in 144, malignant in 104, and inadequate in 7 cases. There were no significant differences among the suction-stylet, suction-no stylet, and stylet-no suction groups in specimen adequacy rate (87.1, 88.2, 85.9%, respectively) or diagnostic yield of malignancy (32.2, 31.8, 31.0%, respectively). However, the use of suction was associated with an increase in tissue-core acquisition rate (P <  0.001). The no-stylet procedure decreased the average procedural time by 14 s (P <  0.001). There was no significant difference in the amount of bleeding among the procedures.

Conclusions: The use of suction or non-use of an inner-stylet does not make a significant difference in cytological specimen adequacy or diagnostic yield when performing EBUS-TBNA. While omitting the stylet can simplify the procedure, applying suction can increase the tissue-core acquisition rate. These findings may assist endoscopic physicians in determining the optimal EBUS-TBNA procedure and warrant clinical verification in a future multicentre study.

Trial Registration: Trial registration: ( ChiCTR-IOR-17010616 ). Retrospective registered date: 12th February, 2017.