P1709 - Comparison of Tissue Acquisition Techniques and Needle Design for EUS-Guided Fine Needle Biopsy Sampling of Pancreatic Lesions: A Randomized Controlled Pilot Clinical Trial

Antonio Mendoza Ladd, MD, FACG¹, Nancy Casner, MS, CCRC¹, Sundar Cherukuri, DO¹, Cesar Garcia, MD², Osvaldo Padilla, MD, MPH¹, Alok K. Dwivedi, PhD¹, Nawar Hakim, MD^1
1Texas Tech University Health Sciences Center at El Paso, El Paso, TX; ²University Medical Center of El Paso, El Paso, TX

Introduction: EUS guided biopsy is the current gold standard for diagnosis of pancreatic lesions. Data on specimen adequacy using conventional FNA needles has been inconclusive; and information on the performance of newer FNB needles is scarce. The aim of this study was to compare the performance of three tissue acquisition techniques (TAT) and two FNB needle designs.

Methods: Single center randomized, observer-blinded pilot clinical trial. Patients undergoing EUS for solid pancreatic lesions were randomized to undergo biopsy with 1 of 3 possible TATs: dry suction (DS), wet suction (WS) and slow pull (SP); and 2 different 22G FNB needles (Acquire^TM or Sharkcore^TM). The primary outcome was the comparison of the specimen’s cellularity (Table 1). Secondary outcomes included comparison of blood contamination and number of passes needed.

Results: A total of 55 patients were enrolled. The mean age was 66 years; 58% were males and 82% were Hispanic. The most common diagnoses were pancreatic ductal adenocarcinoma (74%), chronic pancreatitis (9%) and neuroendocrine tumors (7%). A total of 147 specimens were obtained: 52 (35.3%) with SP; 49 (33.3%) with DS and 46 (31.3%) with WS. Sharkcore^TM was used in 56 (38%) and Acquire^TM in 91 (62%). No significant differences in cellularity scores were identified by TAT [SP 3.28 (0.89) vs DS 3.55 (0.76) vs WS 2.94 (0.75); P= 0.081] or needle type [Sharkcore^TM 3.45 (SD 0.8) vs Acquire^TM 3.15 (SD 0.8); P= 0.19]. The same was true for blood contamination and diagnostic pass. Similar results were observed when specimens were compared by both needle type and TAT. A specimen adequate for histological diagnosis was obtained in 45 specimens (82%) regardless of TAT and needle type. Overall, a diagnosis (regardless of cellularity score) was reached after 2 passes in 40 patients (73%) and after 3 passes in 51 patients (93%). Only 3 patients required >3 passes. Adverse events (AE) included self-limiting bleeding in 3 patients.

Discussion: The cellularity and blood contamination of solid pancreatic lesions specimens obtained with FNB needles was not influenced by TAT or needle design. Three passes were enough for a diagnosis regardless of cellularity in 93% of cases and histological diagnosis was possible in >80% of cases. The rate of AE was similar to that reported in the literature on FNA needles. Larger clinical trials are required to confirm or refute the results of the present pilot study.

Specimen Cellularity scoring system
Score	Category	Explanation
0	Insufficient	Insufficient material for interpretation.
1	Cytological Diagnosis	Sufficient material for limited cytological interpretation; may not be representative of the entire lesion.
2		Sufficient material for adequate cytological interpretation.
3	Histological Diagnosis	Sufficient material for limited histological interpretation.
4		Sufficient material for adequate histological interpretation, low quality (total material < 1 power field in length [10X]).
5		Sufficient material for adequate histological interpretation, high quality (total material > 1 power field in length [10X]).
Blood Contamination scoring system
Score	Explanation
1	Blood present.
2	Blood clots present.

Table: Specimen Cellularity and Blood Contamination Scoring Systems.


Disclosures:
Antonio Mendoza Ladd indicated no relevant financial relationships.
Nancy Casner indicated no relevant financial relationships.
Sundar Cherukuri indicated no relevant financial relationships.
Cesar Garcia indicated no relevant financial relationships.
Osvaldo Padilla indicated no relevant financial relationships.
Alok Dwivedi indicated no relevant financial relationships.
Nawar Hakim indicated no relevant financial relationships.


Antonio Mendoza Ladd, MD, FACG¹, Nancy Casner, MS, CCRC¹, Sundar Cherukuri, DO¹, Cesar Garcia, MD², Osvaldo Padilla, MD, MPH¹, Alok K. Dwivedi, PhD¹, Nawar Hakim, MD¹. P1709 - Comparison of Tissue Acquisition Techniques and Needle Design for EUS-Guided Fine Needle Biopsy Sampling of Pancreatic Lesions: A Randomized Controlled Pilot Clinical Trial, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.