The goal of this clinical study is to compare the tissue adequacy, cellularity, blood contamination, accuracy, sensitivity, specificity of the 22G Trident needle combined with three different aspiration techniques (dry-suction, wet-suction, and slow-pull) in Endoscopic ultrasound-guided fine-needle biopsy for solid pancreatic lesions.
(Before the trial, subjects must meet all of the requirements listed below in order to be enrolled)
18-80 years old (inclusive), male and female;
patients with pancreatic solid mass > 1cm detected by CT/MRI/PET-CT or EUS and requiring EUS-FNB diagnosis.
written informed consent was obtained.
(Before the trial, participants could not be enrolled if they met any of the following requirements)
contraindications to endoscopy, such as severe cardiovascular and cerebrovascular diseases;
bleeding coagulation dysfunction (prothrombin international normalized ratio ≥1.5, platelet count ≤ 50 000) or use of antiplatelet drugs;
confirmed pregnancy or possible pregnancy;
Crossover
ABC suction sequence
Procedure/SurgerySuction sampling should be conducted in the sequence of dry-suction, slow-pull and wet-suction.
ACB suction sequence
Procedure/SurgerySuction sampling should be conducted in the sequence of dry-suction, wet-suction and slow-pull.
BAC suction sequence
Procedure/SurgerySuction sampling should be conducted in the sequence of slow-pull, dry-suction and wet-suction.
BCA suction sequence
Procedure/SurgerySuction sampling should be conducted in the sequence of slow-pull, wet-suction and dry-suction.
CAB suction sequence
Procedure/SurgerySuction sampling should be conducted in the sequence of wet-suction, dry-suction and slow-pull.
CBA suction sequence
Procedure/SurgerySuction sampling should be conducted in the sequence of wet-suction, slow-pull and dry-suction.
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Treatment groupsSee each treatment group below.
Tissue adequacy
Grade A, existing core tissue (defined as structurally intact tissue with a long axis length of at least 550 μm) that clearly characterizes the lesion and is sufficient for diagnosis; Grade B, the presence of core fragments that do not meet the histological criteria for structural integrity, but can still be diagnosed based on cell morphology; Grade C, no diseased tissue is found and no diagnosis can be made based on the sample.
Cellularity
Grade A: Satisfactory, with more than 4 clusters, each containing at least 10 cells for cytological analysis; Grade B: Adequate, with 2-4 clusters, each containing at least 10 cells for cytological analysis; Grade C: Insufficient, with\<2 clusters suitable for cytological analysis or non-representative samples, or\<50 cells with clear nuclear structures.
Blood contamination
The histological blood contamination score is assessed by grading the percentage of red blood cells in the entire 40x magnified field of view. Grade A: Red blood cells are present in\<25%of the slides; Grade B: Red blood cells occupy 25%-50%of the slide; Grade C: Red blood cells are present in\>50%of the slides; Grade D: No tissue.
Diagnostic accuracy
Diagnostic accuracy was calculated as the proportion of true positive and true negative in all evaluated cases.
Diagnostic sensitivity
Diagnostic sensitivity was calculated as the proportion of true positives in patient cases.
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