Diagnostic performance of fine-needle aspiration vs fine-needle biopsy in solid pancreatic lesions based on pathologist expertise: A prospective multicenter trial

Table 1 Clinical and demographic characteristics of patients included in the study (n = 30)

Variable	n (%)	95%CI/mean ± SD
Sex
Male	11 (36.7)	21.3-54.5
Female	19 (63.3)	45.5-78.7
Age (years)		65.0 ± 12.0
Comorbidities
Systemic arterial hypertension	16 (53.3)	35.9-70.2
Type 2 diabetes mellitus	15 (50.0)	32.8-67.2
Dyslipidemia	3 (10.0)	2.9-24.3
Overweight or obesity	7 (23.3)	11.1-40.4
Liver disease	2 (6.7)	1.4-19.7
Pancreas disease	1 (3.3)	0.4-14.5
Other1	14 (46.7)	29.8-64.1
Imaging
Suspicious lesion (NMR)	9 (30.0)	16.0-47.7
Suspicious lesion (CT)	20 (66.7)	48.9-81.4
Suspicious lesion (USG)	1 (3.3)	0.4-14.5
Pancreatic lesion (head/neck)	21 (70.0)	52.3-84.0
Pancreatic lesion (body/tail)	9 (30.0)	16.0-47.7
Pancreatic lesion > 3 cm	21 (70.0)	52.3-84.0
Dilated pancreatic duct	13 (43.3)	26.9-61.0
Doppler signal
Hypervascularization	13 (43.3)	26.9-61.0
Hypovascularization	17 (56.7)	39.0-73.1
Post-procedure adverse events
Self-limiting bleeding	2 (6.7)	1.4-19.7
Self-limiting pain	2 (6.7)	1.4-19.7
Total examination duration (minutes)		49.0 ± 18.0
Laboratory findings
Hemoglobin (g/dL)		12.0 ± 2.1
Alkaline phosphatase (U/L)		815.5 ± 1011.9
Gamma-GT (U/L)		851.4 ± 895.6
Total bilirubin (mg/dL)		9.5 ± 11.9
Direct bilirubin (mg/dL)		6.9 ± 9.9

¹Hypothyroidism, heart disease, and coronary heart disease.

NMR: Nuclear magnetic resonance; CT: Computed tomography; USG: Ultrasound guided; GT: Glutamyl transpeptidase; CI: Confidence interval.

Table 2 Distribution of the results of both general and expert pathologist evaluations according to participating center

Total sample	n (%)	95%CI
General pathologist
Negative	8 (6.7)	3.2-12.2
Positive	100 (83.3)	75.9-89.2
Inconclusive	12 (10.0)	5.6-16.3
Expert pathologist
Negative	12 (10.0)	5.6-16.3
Positive	95 (79.2)	71.3-85.7
Inconclusive	13 (10.8)	6.2-17.3
HC-FMUSP sample
General pathologist
Negative	0
Positive	36 (90.0)	78-96.5
Inconclusive	4 (10.0)	3.5-22
Expert pathologist	0
Negative	0
Positive	35 (87.5)	74.8-95.1
Inconclusive	5 (12.5)	4.9-25.2
HC-FMRP sample
General pathologist
Negative	4 (10.0)	3.5-22
Positive	36 (90.0)	78-96.5
Inconclusive	0
Expert pathologist
Negative	4 (10.0)	3.5-22
Positive	36 (90.0)	78-96.5
Inconclusive	0
HGF sample
General pathologist
Negative	4 (10.0)	3.5-22.0
Positive	28 (70.0)	54.8-82.4
Inconclusive	8 (20.0)	9.9-34.2
Expert pathologist
Negative	8 (20.0)	9.9-34.2
Positive	24 (60.0)	44.6-74.1
Inconclusive	8 (20.0)	9.9-34.2

HC-FMUSP: Hospital das Clínicas of the Medical School of the University of São Paulo; HC-FMRP: Hospital das Clínicas of the Medical School of Ribeirão Preto; HGF: Hospital Geral de Fortaleza; CI: Confidence interval.