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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Enrollment
148
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.
Two needles were punctured and all tissue strips were placed into bottle A formalin.
Changhai Hospital
Shanghai, Shanghai Municipality, China
Diagnostic accuracy
Diagnostic accuracy was calculated as the proportion of true positive and true negative in all evaluated cases.
Time frame: 6 months
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.
Time frame: 2 months
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
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.
Time frame: 2 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.