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DRY SUCTION VERSUS WET SUCTION TECHNIQUE OF ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE BIOPSY FOR DIAGNOSIS OF SOLID PANCREATIC LESIONS: A MULTICENTER RANDOMIZED CONTROLLED NON-INFERIORITY TRIAL

Shenglin Xu 1, Junfen Wang 1, Jianian Guo 2, Fang Xie 1, Yiteng Meng 3, Peng Peng 4, Haiyan Hu 5, Ying Huang 5, Side Liu 1, Mengbin Qin 4, Jun Yao 3, Yue Li 1

Affiliations

1 Nanfang Hospital, Southern Medical University, Guangzhou, China

2 Second Affiliated Hospital, Guangzhou Medical University, Guangzhou, China

3 Shenzhen People’s Hospital, Second Clinical Medical Sciences of Jinan University, Shenzhen, China

4 The Second Affiliated Hospital of Guangxi Medical University, Nanning, China

5 Nanfang Hospital, Southern Meidcal University, Guangzhou, China

Summary

AI Generated

A multicenter randomized trial demonstrates that dry suction is non-inferior to wet suction for EUS-FNB of solid pancreatic lesions using 22G Franseen needles, with one pass sufficient for diagnosis.

In 195 patients randomized to dry versus wet suction EUS-FNB, diagnostic accuracy was nearly identical at 98.95% and 98.98% respectively, meeting non-inferiority criteria with a 0.05% difference and 90% CI of -4.88% to 4.82%.
Sensitivity and specificity did not differ significantly between groups, with sensitivity at 98.80% for dry and 98.77% for wet suction, and specificity at 100% in both groups.
In the absence of rapid on-site evaluation, only one needle pass was required to achieve diagnostic accuracy of at least 95%, as no significant improvement was seen with second or third passes.
Adverse event rates were low overall at 0.52%, with no significant difference between dry and wet groups, and specimen quality including sample adequacy and blood contamination was comparable.
This trial is relevant for endoscopists performing EUS-FNB of pancreatic lesions, particularly in settings without on-site cytopathology support.

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This summary was generated by an AI large language model based on the content transcript. It is for informational purposes only and should not be considered a substitute for clinical judgment. Always rely on your professional expertise and the full clinical context when making clinical decisions.

Abstract

Introduction

Endoscopic ultrasound-guided fine-needle aspiration/biopsy (EUS-FNA/B) has been widely used for the diagnosis of solid pancreatic lesion. Studies have shown that the wet suction technique in EUS-FNA generates better histologic diagnostic accuracy and specimen quality than the dry suction technique. However, conclusions of wet suction on the diagnostic accuracy of EUS-FNB are still controversial. Besides, the optimal number of passes for EUS-FNB has not been determined. We aimed to design a multicenter randomized trial to compare the diagnostic accuracy of dry suction versus wet suction technique in solid pancreatic lesions using 22G Franseen needles and determine the optimal number of passes required for EUS-FNB without onsite cytopathologist.

Aims & Methods

This is a multi-center, open-label, randomized controlled and non-inferiority trial with two parallel groups. The patients with solid pancreatic lesion will undergo EUS-FNB using 22G Franseen needle 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 of this study is to compare the diagnostic accuracy of EUS-FNB for solid pancreatic lesions using the dry or wet suction technique. Secondary endpoints include the optimal number of needle passes, sensitivity, specificity, specimen quality, time of the procedure, and rates of complications.

Results

Of the 195 patients undergoing EUS-FNB enrolled in the final analysis, 96 were randomized to the dry suction group and 99 to the wet suction group. The diagnostic accuracy was 98.95% and 98.98% in the dry and wet groups, respectively, with a 0.05% difference in accuracy between the study groups (two-sided 90% CI, -4.88% to 4.82%, P=0.989). Diagnostic accuracy was shown to be non-inferior because the lower bound of the 90% confidence interval falls to the right of the non-inferiority margin. Compared to the wet group, no significant differences were seen in the sensitivity (98.80 % vs 98.77 %, P = 1) and specificity (100 % vs 100 %, P = 1) in the dry suction group. The overall adverse event rate was 0.52 %, with 0 and 1.02 % in the dry and wet groups, respectively (P = 1). In terms of specimen quality, no significant differences were also seen in the two groups in sample adequacy (100 % vs 98.3 %, P = 0.492) and level of blood contamination (P = 0.319). In terms of puncture time in the dry group compared to the wet group, there was no statistically significant (18.82±8.21 min vs. 18.92±8.99 min, P=0.952), but the wet suction required more time to prepare the saline and the needle. No significant improvement in diagnostic accuracy was seen with the 2nd needle compared to the 1st needle of EUS-FNB (97.41% vs 95.34%，P=0.276), and no significant improvement in diagnostic accuracy was seen with the 3rd shot compared to the 2nd shot of EUS-FNB (98.96% vs 97.41%，P=0.446).

Conclusion

The dry suction technique is non-inferior to the wet suction technique, while saving steps and time. In the absence of rapid on-site evaluation (ROSE), only 1 pass was required to reach the diagnositic accuracy≥ 95% using EUS-FNB with Franseen needle.

Disclosure

The authors disclose no conflicts.

Conference

UEG Week Vienna 2024

Topics

Pancreas

Submission format

Abstract

Session

Pancreatic endoscopy (Posters)

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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REAL-WORLD SPECTRUM OF PERIANAL CROHN’S DISEASE: A MULTICENTER CROSS-SECTIONAL STUDY FROM TERTIARY IBD CENTERS

Simone Parello 1, Damiano Martino 1, Federica Di Vincenzo 1,2, Carmen Nesci 3, Simone Di Cola 4, Francesca Sofia Puca 1, Pierluigi Puca 1,2, Martina Barletta 4, Marco Murgiano 1, Angelo Del Gaudio 2,1, Sonia Distante 5, Angelo Eugenio Potenza 3, Fabrizio Pizzolante 2, Gionata Fiorino 6, Emma Calabrese 7, Loris Riccardo Lopetuso 2,8, Alfredo Papa 1,2, Lucrezia Laterza 1,2, Antonio Gasbarrini 1,2, Franco Scaldaferri 1,2

Affiliations

1 Università Cattolica del Sacro Cuore, Rome, Italy

2 Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy

3 Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy

4 University of Rome Sapienza, Rome, Italy

5 Fondazione Policlinico Universitario “A.Gemelli” IRCCS, Rome, Italy

6 A.O. "S. Camillo-Forlanini", Rome, Italy

7 University of Rome Tor Vergata, Rome, Italy

8 Link Campus University, Rome, Italy