Comparing the Diagnostic Efficacy of Different Suction Techniques for EUS-FNB of Pancreatic Solid Lesions

Study Overview
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Brief Summary
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There are many factors that can affect the diagnostic yield of EUS-FNA, including lesion factors, the endoscoist experience, the needle size, the number of needle passes, and the suction technique. since diagnostic efficacy of different suction techniques for EUS-FNB is still uncertain, thus we decided to compare the diagnostic efficacy of three common methods: the 10 ml standard negative pressure, slow pull and wet suction.

Detailed Description
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the standard suction: after the needle is inserted in the mass, removing the stylet before performing EUS-FNA. Then attach a 10mL syringe to the end of needle. 20 times of for-backward Suction was applied after the lesion was punctured. slow-pull : after the needle is inserted in the mass, slowly pull the stylet out while performing EUS-FNA with 20 times for-backward. wet suction: after removing the stylet, the needle was flushed with 5mL of saline solution to replace the column of air with saline. A 10mL syringe was attached to the end of the needle. 20 times of for-backward Suction was applied after the lesion was punctured.

Official Title
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Comparing the Diagnostic Efficacy of Different Suction Techniques for Endoscopic Ultrasound-guided Fine-needle Biopsy of Pancreatic Solid Lesions Using 25G Procore Needle: a Prospective Randomized Controlled Multicentric Clinical Study

Conditions
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Pancreatic Mass

Intervention / Treatment
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* Diagnostic Test: standard suction
* Diagnostic Test: slow pull
* Diagnostic Test: wet suction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-75 years,male or female diagnosis or suspection of solid pancreatic mass based on previous imaging examination (ultrasonography, CT or MRI) lesion diameter larger than 1 cm signed informed consent letter Exclusion Criteria: pregnant female Pancreatic cystic lesions Anticoagulant/antiplatelet therapy cannot be suspended unable or refuse to provide informed consent Coagulopathy (platelet count < 50× 103/μL,international normalized ratio > 1.5) Severe cardiopulmonary dysfunction that cannot tolerate intravenous anesthesia with history of mental disease other medical conditions that are not suitable for EUS-FNB

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: standard suction<br>This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the standard suction technique with 10ml negative pressure | Diagnostic Test: standard suction<br>* After the needle is inserted in the mass, removing the stylet before performing EUS-FNA. Then attach a 10mL syringe to the end of needle. 20 times of for-backward Suction was applied after the lesion was punctured.<br>|
| Experimental: slow pull<br>This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique | Diagnostic Test: slow pull<br>* After the needle is inserted in the mass, slowly pull the stylet out while performing EUS-FNA with 20 times for-backward.<br>|
| Experimental: wet suction<br>This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique | Diagnostic Test: wet suction<br>* After removing the stylet, the needle was flushed with 5mL of saline solution to replace the column of air with saline. A 10mL syringe was attached to the end of the needle. 20 times of for-backward Suction was applied after the lesion was punctured.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic accuracy of each individual technique | The results are compared with the gold standard and calculated the accuracy | 1 year | 
| diagnostic sensitivity of each individual technique | The results are compared with the gold standard and calculated the sensitivity | 1 year | 
| specificity of each individual technique | The results are compared with the gold standard and calculated the specificity | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse event rate of each individual technique | record any adverse events related to the procedure | 1 year | 
| adequacy of specimens obtained by each individual technique | the adequacy will be determined by the pathologists analyzing the sample using a pre-defined scale. They will be blinded to the technique used | 1 year | 
| cellularity | the cellularity will be determined by the pathologists analyzing the sample using a pre-defined scale. They will be blinded to the technique used | 1 year | 
| blood contamination | the blood contamination will be determined by the pathologists analyzing the sample using a pre-defined scale. They will be blinded to the technique used | 1 year |