22-gauge core vs 22-gauge aspiration needle for endoscopic ultrasound-guided sampling of abdominal masses

Table 1 Patient demographics and baseline characteristics

Parameter	Value
No. of patients	56
Age (yr), mean (SD)	68 (12)
Sex, n (%)
Male	29 (51.8)
Female	27 (48.2)
BMI (kg.m-2), mean (SD)	25.6 (3.6)
Presenting symptom(s) (% )
Pain	22.4
Weight loss	28.3
Jaundice	19.6

BMI: Body mass index.

Table 2 Lesion characteristics

Parameter	n (%)
Location
Pancreas	38 (67.9)
Lymph nodes	13 (23.2)
SMT	4 (7.1)
Other	1 (1.8)
Diameter (mm), mean (SD)	33 (12)
Echogenicity on EUS1
Hyper-/hypo-/iso-echoic	7 (12.7)/44 (80)/2 (3.6)
Non-homogeneous	2 (3.6)
Final diagnosis
Pancreatic adenocarcinoma	25 (44.6)
Pancreatic NET	7 (12.5)
Lymph node metastasis	6 (10.7)
Inflammatory lymph node	5 (8.9)
GIST	3 (5.4)
Chronic pancreatitis	2 (3.6)
Pancreatic metastasis2	2 (3.6)
Cholangiocarcinoma	1 (1.8)
Pancreatic lymphoma	1 (1.8)
Lymphoma	1 (1.8)
Leiomyoma	1 (1.8)
IPMN	1 (1.8)
Lymphoma renal infiltration	1 (1.8)
Gold standard method
Surgery	26 (46.4)
Definite EUS-FNA	16 (28.6)
Clinical follow-up (> 12 mo)	6 (10.7)
Combination	8 (14.3)

¹Data available in 55/56 patients;

²Non-small-cell lung cancer (n = 1), malignant melanoma (n = 1). EUS-FNA: Endoscopic ultrasound-guided fine needle aspiration; NET: Neuroendocrine tumor; SMT: Submucosal tumor; IPMN: Intraductal papillary mucinous neoplasm.

Table 3 Technical characteristics and outcomes of endoscopic ultrasound-guided fine needle aspiration with the 2 needles in all patients (n = 56) and in patients with an available histological specimen (n = 36)

Characteristic	Type of needle (all cases/histology cases)
	AN (n = 56/36)	PC (n = 56/36)	P value
Needle passes, mean (SD)	1.5 (0.6)/1.5 (0.7)	1.7 (0.6)/1.7 (0.6)	0.14/0.16
Cellularity, mean (SD)	1.7 (0.6)/1.7 (0.6)	1.1 (0.3)/1 (0)	0.058/0.0342
Cytologic/histologic quality, median (range)	2.6 (0-3)/ 3 (0-3)	2.4 (0-3)/3 (0-3)	0.083/0.49
Adequacy for diagnosis, n (%)	54 (96.4)/35 (97.2)	51 (91.1)/36 (100)	0.38/0.99
Correct diagnosis1, n (%)	48/54 (88.9)/30/35 (85.7)	49/51 (96.1)/34/36 (94.4)	0.25/0.25

¹When adequate for analysis material was obtained;

²Statistically significant difference (P < 0.05). A difference is considered as statistically significant if P < 0.05. AN: Aspiration needle; PC: ProCore needle.

Table 4 Sensitivity, specificity and diagnostic accuracy of the 2 needles for the diagnosis of malignancy

	Sensitivity	Specificity	Diagnostic accuracy
All lesions1
AN	91.5%	71.4%	88.9%
PC	95.4%	85.7%	94.1%
Pancreatic mass2
AN	88.5%	100.0%	89.2%
PC	93.8%	100.0%	94.1%
Lymph nodes3
AN	100.0%	60.0%	84.6%
PC	100.0%	80.0%	92.3%

¹Evaluable cases; AN: 54/56, PC: 51/56;

²Evaluable cases; AN: 37/38, PC: 34/38;

³Evaluable cases; both needles: 13/13. AN: Aspiration needle; PC: ProCore needle.

Table 5 Published comparative trials regarding EchoTip ProCore needle performance

Ref.	Design	No. of lesions	Target	Needles	Diagnostic yield	Sample adequacy	Comments
Witt et al[32]	Retrospective	18 per needle type	Diverse	PC 22G vs AN 22G	Equivalent	Equivalent	PC: fewer passes needed
Strand et al[33]	RCT	32 punctured by both needles	Pancreas	PC 22G vs AN 22G	AN > PC	Equivalent	Only 2 passes with PC vs 5 with AN, PC technical failure in 16 cases
Bang et al[34]	RCT	28 per needle type	Pancreas	PC 22G vs AN 22G	Equivalent	Equivalent	On-site cytopathologist, needles of different manufactures
Lee et al[35]	RCT	58 per needle type	Pancreas	PC 22/25G vs AN 22/25G	Equivalent	N/A	On-site cytopathologist, PC: fewer passes needed
Hucl et al[36]	RCT	145 punctured by both needles	Diverse	PC 22G vs AN 22G	Equivalent	Equivalent	Only histology, PC: fewer passes needed
Mavrogenis et al[37]	RCT	28 punctured by both needles	Pancreas + LNs	PC 25G vs AN 22G	Equivalent	Equivalent	Different needle gauges, “slow pull” sampling technique
Vanbiervliet et al[39]	RCT	80 punctured by both needles	Pancreas	PC 22G vs AN 22G	Equivalent	Cytology: equivalent	Only 1 pass with PC vs 2 with AN
						Histology: PC > AN
Kim et al[40]	RCT	10 with AN, 12 with PC	SET	PC 22G vs AN 22G	PC > AN	PC > AN	Only histology, PC: fewer passes needed
Alatawi et al[41]	RCT	50 per needle type	Pancreas	PC 22G vs AN 22G	Equivalent	Equivalent, cellularity: PC > AN	Equivalent results after 2 passes with PC vs 3 with AN

PC: ProCore needle; AN: Aspiration needle; RCT: Randomized controlled trial; SET: Subepithelial tumors; LNs: Lymph nodes.