Clinical Evaluation of EUS-FNA on Diagnosis of Pancreatic Cystic Lesions

Study Overview
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Brief Summary
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It is still controversial about the necessity of endoscopy ultrasound guide fine needle aspiration (EUS-FNA) on diagnosis of pancreatic cystic lesions(PCL).The aim of this study is to find the influence of EUS-FNA on diagnosis and suggestions of EUS specialists.

Detailed Description
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First, the investigators will send only EUS images of patients with PCL to diagnosis committee that is consisted with 8 EUS specialists from different countries.The diagnosis will be collected. Then the investigators send the results of EUS-FNA. The diagnosis and suggestions will be collected again. The investigators will calculate how much diagnosis has been changed because of results of EUS-FNA. The investigators will also follow up these patients for 5 years at least to find if these patients benefit from EUS-FNA and complications such as needle tract seeding metastases.

Official Title
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Clinical Evaluation of EUS-FNA on Diagnosis of Pancreatic Cystic Lesions----A Multiple Center,Prospective Study

Conditions
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Pancreatic Cyst

Intervention / Treatment
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* Procedure: EUS-FNA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with ages from 18-80 years old. The patients with pancreatic cystic lesions, which diameter of cystic lesion more than 2cm. Sign the informed consent voluntarily. - Exclusion Criteria: The patient can't accept the endoscopic procedure. The patient has blood coagulation dysfunction. The patient has mental disorders. The patient has mild or severe cardiorespiratory insufficiency. The patient has hypertension and can't be controlled to safe level. Patients with alcohol dependence. Pregnant and lactating women. The patients the investigators don't think suitable for this study. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EUS-FNA, Rate of chang on diagnosis<br>It is a single arm study. We will conclude by calculating the rate of change of diagnosis before and after getting the results of EUS-FNA. | Procedure: EUS-FNA<br>* Only one puncture will be performed. First the fluid will be aspirated out for biochemical analysis and cytology. Then the tissue will be aspirated out from the solid part of the lesion for pathology.<br>* Other names: Endoscopic ultrasound guided fine needle aspiration with 22G needle.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of change of diagnosis | Finish diagnosis before and after getting the results of EUS-FNA | During 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events | after EUS-FNA | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EUS-FNA, Pancreatic cystic lesion, Diagnosis