Fine-needle Biopsy Combined With Macroscopic On-site Evaluation for Diagnosis of Solid Pancreatic Lesions

Condition(s) studied

Investigational drug(s) / intervention(s)

MOSE application: 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.

Conventional processing: Two needles were punctured and all tissue strips were placed into bottle A formalin.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Diagnostic accuracy — 6 months
  Diagnostic accuracy was calculated as the proportion of true positive and true negative in all evaluated cases.

Trial sites (1)

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