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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABC group | Experimental |
| |
| ACB group | Experimental |
| |
| BAC group | Experimental |
| |
| BCA group | Experimental |
| |
| CAB group | Experimental |
| |
| CBA group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABC suction sequence | Procedure | Suction sampling should be conducted in the sequence of dry-suction, slow-pull and wet-suction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 months |
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Inclusion Criteria:
(Before the trial, subjects must meet all of the requirements listed below in order to be enrolled)
Exclusion Criteria:
(Before the trial, participants could not be enrolled if they met any of the following requirements)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia Yi Ma, M.D | Contact | +8613621819595 | 504043536@qq.com | |
| Kai Xuan Wang, M.D | Contact | wangkaixuan224007@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhao Shen Li, M.D | Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), shanghai, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Shanghai | Shanghai Municipality | 200433 | China |
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| ACB suction sequence | Procedure | Suction sampling should be conducted in the sequence of dry-suction, wet-suction and slow-pull. |
|
| BAC suction sequence | Procedure | Suction sampling should be conducted in the sequence of slow-pull, dry-suction and wet-suction. |
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| BCA suction sequence | Procedure | Suction sampling should be conducted in the sequence of slow-pull, wet-suction and dry-suction. |
|
| CAB suction sequence | Procedure | Suction sampling should be conducted in the sequence of wet-suction, dry-suction and slow-pull. |
|
| CBA suction sequence | Procedure | Suction sampling should be conducted in the sequence of wet-suction, slow-pull and dry-suction. |
|
| 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. | 2 months |
| Diagnostic accuracy | Diagnostic accuracy was calculated as the proportion of true positive and true negative in all evaluated cases. | 6 months |
| Diagnostic sensitivity | Diagnostic sensitivity was calculated as the proportion of true positives in patient cases. | 6 months |
| Diagnostic specificity | Diagnostic specificity was calculated as proportion of true negative in healthy cases. | 6 months |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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