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.
Patients who met the inclusion criteria of this trial and did not meet the exclusion criteria were randomly divided into six groups according to the crossover grouping design. Samples were collected using a 22G Trident needle in different suction sequences. The advantages and disadvantages of different suction techniques in terms of sample quality and diagnostic efficacy were compared to further clarify the optimal suction sampling scheme for Endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) using a 22G Trident needle.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Enrollment
270
Suction sampling should be conducted in the sequence of dry-suction, slow-pull and wet-suction.
Suction sampling should be conducted in the sequence of dry-suction, wet-suction and slow-pull.
Suction sampling should be conducted in the sequence of slow-pull, dry-suction and wet-suction.
Changhai Hospital
Shanghai, Shanghai Municipality, China
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.
Time frame: 2 months
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.
Time frame: 2 months
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.
Time frame: 2 months
Diagnostic accuracy
Diagnostic accuracy was calculated as the proportion of true positive and true negative in all evaluated cases.
Time frame: 6 months
Diagnostic sensitivity
Diagnostic sensitivity was calculated as the proportion of true positives in patient cases.
Time frame: 6 months
Diagnostic specificity
Diagnostic specificity was calculated as proportion of true negative in healthy cases.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Suction sampling should be conducted in the sequence of slow-pull, wet-suction and dry-suction.
Suction sampling should be conducted in the sequence of wet-suction, dry-suction and slow-pull.
Suction sampling should be conducted in the sequence of wet-suction, slow-pull and dry-suction.
Time frame: 6 months