Prospective randomized study comparing Franseen 22-gauge vs standard 22-gauge needle for endoscopic ultrasound guided sampling of pancreatic solid lesions

Table 1 Patient details and pancreatic mass characteristics (n = 50)

Characteristics	n (%)
mean age	64.1
Range	(36-88)
Gender
Female	26
Male	24
Mean pancreatic mass size (cm)
Mean	3.47
Range	1.7-7.0
Pancreatic mass location
Head	31 (62)
Uncinate	6 (12)
Neck	6 (12)
Body	5 (10)
Tail	2 (4)
Vascular invasion	32 (64)
Venous vascular invasion
Portal vein	16 (51.6)
Superior mesenteric vein	19 (61.3)
Splenic vein	13 (41.9)

Table 2 Pathological analysis diagnosis

Definitive diagnosis (n = 50)	Standard needle (n = 50)		Franseen needle (n = 50)
Adenocarcinoma/pancreatic cancer (n = 38)	n = 31		n = 35
	Benign lesion	Chronic pancreatitis (n = 3)	Benign lesion	Chronic pancreatitis (n = 2)
		Mucinous neoplasia (n = 1)		Mucinous neoplasia (n = 1)
	Inconclusive (n = 3)		Inconclusive (n = 0)
Neuroendocrine tumor	n = 4		n = 4
Metastasis	n = 2		n = 2
Lymphoma	Chromic pancreatitis (n = 1); Lymphoma (n = 0)		Chronic pancreatitis (n = 1); Lymphoma (n = 0)
Plasmocitoma	n = 1		n = 1
Solid pseudopapillary tumor	n = 1		n = 1
Chronic pancreatitis	n = 3		n = 3

Table 3 Performance of standard needle for the diagnosis of pancreatic malignancy

Diagnostic method	Disease
	Pancreatic malignancy1 (n = 47)	Chronic pancreatis (n = 3)	Total
Positive for malignancy	38	1	39
Negative for malignancy	9	2	11
Total	47	3	50
95%CI
Sensitivity		0.81 (0.67-0.91)
Specificity		0.67 (0.09-0.99)
PPV		0.97 (0.87-1.00)
NPV		0.18 (0.02-0.52)
Accuracy		0.80 (0.66-0.90)

¹Pancreatic malignancy included adenocarcinoma, neuroendocrine tumor, distant metastasis, lymphoma, plasmocitoma, solid pseudopapillary tumor.

CI: Confidence interval; PPV: Positive predictive value; NPV: Negative predictive value.

Table 4 Performance of Franseen needle for the diagnosis of pancreatic malignancy

Diagnostic method	Disease
	Pancreatic malignancy1 (n = 47)	Chronic pancreatis (n = 3)	Total
Positive for malignancy	43	1	44
Negative for malignancy	4	2	6
Total	47	3	50
95%CI
Sensitivity		0.91 (0.83-0.98)
Specificity		0.67 (0.09-0.98)
PPV		0.98 (0.88-1.00)
NPV		0.33 (0.04-0.78)
Accuracy		0.90 (0.78-0.97)

¹Pancreatic malignancy included adenocarcinoma, neuroendocrine tumor, metastasis, lymphoma, plasmocitoma, Frantz tumor.

CI: Confidence interval; PPV: Positive predictive value; NPV: Negative predictive value.

Table 5 Comparison of the diagnostic performance of standard (fine needle aspiration) and Franseen (fine needle biopsy) needles

Metrics	FNA	FNB	Statistical difference	P value1
Sensitivity	0.809	0.915	5.000	0.025
Specificity	0.667	0.667	-	-
PPV	0.974	0.977	0.913	0.361
NPV	0.182	0.333	2.202	0.028
Accuracy	0.800	0.900	3.200	0.074

¹McNemar (for sensitivity and specificity comparisons), Moskowitz and Pepe (for positive predictive value and negative predictive value comparisons) tests.

FNA: Fine needle aspiration; FNB: Fine needle biopsy; PPV: Positive predictive value; NPV: Negative predictive value.

Table 6 Comparison of procured histologic tissue areas (in mm²) between standard needle versus Franseen needle

	Standard needle	Franseen needle	P value
Mean total tissue area, mm2 (SD)	1.16 (0.17)	2.07 (0.22)	0.001
Median	0.45	1.09
75% IQR	1.53	2.89
Range	0-9.76	0-9.22
Mean total tumor area, mm2 (SD)	0.42 (0.09)	0.47 (0.09)	0.8
Median	0.05	0.05
75% IQR	0.51	0.50
Range	0-7.03	0-4.88

IQR: Interquartile range

Table 7 Randomized clinical trials comparing fine needle aspiration vs fine needle biopsy needles for endoscopic ultrasound-guided sampling of solid pancreatic tumors

Ref.	FNA (n)	FNB (n)	ROSE	Randomization	Technique of sampling	Sensitivity for malignancy (95%CI)-FNA	Sensitivity for malignancy (95%CI)-FNB	P value	Accuracy malignancy (95%CI)-FNA	Accuracy malignancy (95%CI)-FNB	P value
Bang et al[14]	22-gauge (28)	Reverse bevel (28)	Yes	Sequence of the needle	Capillarity and dry suction				100	83.3	0.26
Bang et al[15]	22-gauge (46)	Franseen 22-gauge (46)	Yes	Sequence of the needle					82.6	97.8	0.03
Noh et al[16]	22-gauge (30)	Reverse bevel 22-gauge (30)	Yes	Sequence of the needle	Dry suction				95	93.3	0.564
Vanbiervliet et al[17]	22-gauge (39)	Reverse bevel 22-gauge (41)	Yes	First needle FNA	Dry suction				92.5	90	0.68
Mavrogenis et al[18]	22-gauge (19)	Reverse bevel 25-gauge (19)	No	Sequence of the needle	Capillarity and dry suction	89.5 (66.82-98.39)	89.5 (66.82-98.39)		84.8 (67.3-94.2)	84.8 (67.3-94.2)
Kovacevic et al[19]	22-gauge (33)	22-gauge (31)	No	Sequence of the needle	Capillarity	65.5%	89.7%	> 0.5	69.7 (51.3-84.4)	90.3 (74.2-98%)
Our study	22-gauge (50)	Franseen 22-gauge (50)	No	Sequence of the needle	Capillarity and dry suction	0.83 (0.69-0.92)	0.91 (0.80-0.98)		0.84 (0.71-0.93)	0.92 (0.81-0.98)

CI: Confidence interval; FNA: Fine needle aspiration; FNB: Fine needle biopsy; ROSE: Rapid onsite evaluation.