Pancreatic Diseases
Conditions
Keywords
22G Franseen needle, solid pancreatic lesion, aspiration technique, Endoscopic ultrasound-guided fine-needle biopsy
Brief summary
The goal of this clinical study is to compare the tissue adequacy, cellularity, blood contamination, accuracy, sensitivity, specificity of the 22G Franseen needle combined with three different suction techniques (dry-suction, wet-suction, and slow-pull) in Endoscopic ultrasound-guided fine-needle biopsy for solid pancreatic lesions.
Detailed description
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 Franseen 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 using a 22G Franseen needle.
Interventions
PROCEDUREABC
Suction sampling should be conducted in the sequence of dry-suction, slow-pull and wet-suction.
PROCEDUREACB
Suction sampling should be conducted in the sequence of dry-suction, wet-suction and slow-pull.
PROCEDUREBAC
Suction sampling should be conducted in the sequence of slow-pull, dry-suction and wet-suction.
PROCEDUREBCA
Suction sampling should be conducted in the sequence of slow-pull, wet-suction and dry-suction.
PROCEDURECAB
Suction sampling should be conducted in the sequence of wet-suction, dry-suction and slow-pull.
PROCEDURECBA
Suction sampling should be conducted in the sequence of wet-suction, slow-pull and dry-suction.
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
（1）18-80 years old (inclusive), male and female; （2）patients with pancreatic solid mass \> 1cm detected by CT/MRI/PET-CT or EUS and requiring EUS-FNB diagnosis. （3）written informed consent was obtained.
Exclusion criteria
1. contraindications to endoscopy, such as severe cardiovascular and cerebrovascular diseases; 2. bleeding coagulation dysfunction (prothrombin international normalized ratio ≥1.5, platelet count ≤ 50 000) or use of antiplatelet drugs; 3. confirmed pregnancy or possible pregnancy; 4. pathological diagnosis has been obtained by other methods; 5. refuse to participate in the study, are participating in another observational clinical trial, or have participated in another clinical trial within 60 days; 6. other situations where EUS-FNB could not be performed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tissue adequacy | 2 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cellularity | 2 months | 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 | 2 months | 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 | 6 months | Diagnostic accuracy was calculated as the proportion of true positive and true negative in all evaluated cases. |
| Diagnostic sensitivity | 6 months | Diagnostic sensitivity was calculated as the proportion of true positives in patient cases. |
| Diagnostic specificity | 6 months | Diagnostic specificity was calculated as proportion of true negative in healthy cases. |
Countries
China
Contacts
Primary ContactJia Yi Ma, M.D
Backup ContactKai Xuan Wang, M.D
Outcome results
None listed