25G and 22G Puncture Needles

Study Overview
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Brief Summary
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The screened patients were randomly assigned 25G puncture needles and 22G puncture needles in a 1;1 ratio, based on the computer-generated random order, before receiving an ultrasound endoscope puncture. Each puncture needle puncture lesions 2 needles, the same type of puncture needle tissue samples taken in the same tissue pathology bottle, all tissues after the completion of the necessary cytological smears, are placed in the Formalin solution to send tissue pathology, pathologists do not know the order of distribution of 2 puncture needles to evaluate the tissue results, all pathology results are reported by the hospital pathology center, audit.

Official Title
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Multicenter, Randomized, Self-matched Design, Positive Control, Non-inferiority Clinical Study of 25G and 22G Puncture Needles in Solid or Submucosal Pancreatic Masses

Conditions
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Submucosal Tumor, Pancreas Tumor

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of real pancreatic swelling or submuscular swelling; Patients need to be guided by ultrasound endoscopy under the guidance of puncture to eliminate malignant lesions or clear lesions; Fully communicate before surgery, understand the risks and benefits of endoscopic operation, and sign an informed consent form. Exclusion Criteria: There are endoscopic operation contraindications, including abnormal blood clotting, or long-term oral anticoagulant antiplatelet drugs, can not guarantee INR < 1.5, or platelets less than 5 x 10 x 9 / L; Pregnant woman

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The acquisition rate of the core tissue sample | A core tissue sample is defined as a sample with an histological structure that is fully used for tissue evaluation of target lesions. | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The length of the tissue strip | The quality of tissue samples obtained by puncture is assessed by the pathologist, whether intact tissue structure is preserved, and the length of tissue strips | One week | 
| the technical success rate 、the success rate of immunogrouping dyeing and the retention of the organizational structure | The quality of tissue samples obtained by punctures is evaluated by pathologists, technical success means that puncture 2 needles can obtain sufficient tissue samples for analysis to be evaluated by endoscopy. | One week | 
| the incidence of adverse events and the incidence of device defects | Adverse events refer to adverse medical events that occur in the course of research, including punctured complications such as bleeding, abdominal pain, infection, pancreatitis, etc. throughout the study process. | one week |