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The goal of this clinical trial is to compare the diagnostic efficacy, core tissue acquisition ability, number of punctures and puncture time of macroscopic on-site evaluation (MOSE) and two punctures alone in Endoscopic ultrasound guided fine-needle biopsy (EUS-FNB) for solid pancreatic lesions. The main questions it aims to answer is: whether the diagnostic accuracy of EUS-FNB performed with two needle passes is not inferior to that of MOSE.
Participants with solid pancreatic lesions who needs histological diagnosis will receive EUS-FNB using 22G Franseen.
In Group 1, the macroscopically visible core (MVC) of the specimen was assessed. If the MVC of the sample obtained from the first needle was ≥10mm, the tissue strip was placed in Bottle A and fixed with formalin. A second needle was then used to obtain another tissue strip, which was directly placed into Bottle B containing formalin. However, if the MVC of the first needle sample was < 10mm, the puncture procedure was continued until the cumulative length of sample's MVC was ≥10mm, and all the sample collected during this process were placed into Bottle A and fixed with formalin. In Group 2, two needles were used to obtain tissue strips, and all the tissue strips were placed into Bottle A formalin.
Researchers will compare the diagnostic efficacy, core tissue acquisition ability, number of punctures and puncture time between the MOSE technique and two-needle puncture method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MOSE group | Experimental | Patients assigned to this group will receive EUS-FNB as routine. The obtained tissue will be evaluated by Macroscopic On-site Evaluation |
|
| Non-mose group | Active Comparator | Patients assigned to this group will receive EUS-FNB as routine. Two needles were punctured and all tissue strips were placed into bottle A formalin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOSE application | Procedure | The length of the tissue strips was judged using the specimen table and photographed for record. If the MVC of the first needle sample was ≥10mm, the tissue strip was placed into bottle A formalin for fixation. A second needle of tissue strip was pushed directly into the B-bottle formalin. If the first needle sample MVC was < 10mm, the puncture was continued until the total length of sample MVC was ≥10mm, and all samples were placed into bottle A formalin. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy | Diagnostic accuracy was calculated as the proportion of true positive and true negative in all evaluated cases. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Median puncture number | In the MOSE group, if the MVC of the first needle sample was ≥10mm, an additional needle was inserted. If the MVC of the first stitch is < 10mm, continue to puncture until the total length of the MVC of the sample is ≥10mm. In the non-MOSE group, fixed puncture was performed with 2 needles. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic sensitivity | Diagnostic sensitivity was calculated as the proportion of true positives in patient cases. | 2 months |
| Diagnostic specificity | Diagnostic specificity was calculated as proportion of true negative in healthy cases. |
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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| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| Conventional processing | Procedure | Two needles were punctured and all tissue strips were placed into bottle A formalin. |
|
| 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 |
| Puncture time | The puncture time of the MOSE group was defined as the beginning of puncture to the end of the confirmation of sufficient MOSE, and the puncture time of the non-MOSE group was defined as the beginning of puncture to the end of 2 stitches. | 2 months |
| 2 months |