Abstract
EVALUATION OF FINE NEEDLE BIOPSY (FNB) FOR ENDOSCOPIC ULTRASOUND (EUS)-GUIDED TISSUE ACQUISITION OF PANCREATIC MASSES TO NEGATE THE NEED FOR RAPID ON-SITE EVALUATION: A RANDOMIZED CONTROL TRIAL
Mark Anthony A. De Lusong, MD1 and A. Nico Nahar I. Pajes, MD1
Department of Medicine, Division of Gastroenterology, University of the Philippines – College of Medicine and Philippine General Hospital
Significance: The benefits of rapid on-site evaluation (ROSE) of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of solid masses have not been convincingly shown in large, randomized trials. New equipment using EUS-guided fine needle biopsy (FNB) allows for more material to be acquired that may obviate the need for ROSE. This study aimed to evaluate if EUS-FNB without ROSE was non-inferior to EUS-FNA with ROSE in solid pancreatic masses (SPMs).
Methodology: This study is a single center, blinded, randomized, noninferiority study conducted at the Philippine General Hospital (PGH). Patients with SPMs requiring tissue sampling were randomly assigned to undergo either EUS-FNA with ROSE or EUS-FNB without ROSE. The touch-imprint cytology technique was used to perform ROSE. The primary endpoint was diagnostic accuracy, and secondary endpoints were specimen quality, complication rates and procedure time. This study is a single center, blinded, randomized, noninferiority study conducted at the Philippine General Hospital (PGH). Patients with SPMs requiring tissue sampling were randomly assigned to undergo either EUS-FNA with ROSE or EUS-FNB without ROSE. The touch-imprint cytology technique was used to perform ROSE. The primary endpoint was diagnostic accuracy, and secondary endpoints were specimen quality, complication rates and procedure time.
Results: Seventy-eight patients were randomized and analyzed (39 EUS-FNA with ROSE and 39 EUS-FNB without ROSE). Non-significantly different diagnostic accuracies were noted in both groups (97% with ROSE and 100% without ROSE, P < 0.371). The bloodiness of histologic samples and complication rates were not significantly different between groups. A significantly shorter mean sampling procedural time was noted for EUS-FNB over EUS-FNA with ROSE (30.4 ± 10.4 vs 35.8 ± 9.8 minutes, P < .02).
Conclusion: EUS-FNB demonstrated equal diagnostic accuracy with shorter procedure times in evaluating SPMs compared to EUS-FNA with ROSE. These new-generation FNB needles may obviate the need for ROSE.
Keywords: Pancreatic Masses, Pancreatic Cancer; Endoscopic Ultrasound Tissue Acquisition; Diagnostic Accuracy.
Important Dates to Remember
| JRRE Activities 2023-2024 |
Proposed Dates |
|---|---|
| Resumption of face-to-face Evidence-Based Medicine Workshop Venue to be announced once finalized. |
July 21, 2023 (Friday), 1-5pm |
| Monthly Critical Appraisal of Topics Conferences to be gaciliated by Research Coordinators per Institution | Monthly Critical Appraisal of Topics Conferences per Institution |
| CAT Plenary/Liver Con Dates: September 23, 2023 December 16, 2023 March 2024 (During the JAC) Resumption of face-to-face Quarterly Critical Appraisal of Topics facilitated by the JRRE |
2 Clinical scenarios and articles are to be sent to institutions each on August 2023, November 2023, and February 2024; |
| Hybrid Research Workshop 4 week asynchronous via Moodle, followed by a 1 day on-site Onsite Workshop Research Protocol Presentation for Level I GI Fellows-In-Training - Research Protocol Presentation: August 12, 2023 - Research Forums of the Tripartite Societies |
Week 1: July 15-21, 2023 Week 2: July 22-28, 2023 Week 3: July 29-August 4, 2023 Week 4: August 5-11, 2023 |
| Research Manuscript Workshop for level II GI Fellows-In-Training | January 6, 2024 |