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

Not Applicable

• Conditions: Pancreatic Cyst
• Interventions: Procedure: EUS-FNA

• Registration Number: NCT02041897
• Lead Sponsor: Xiaoyin Zhang

Brief Summary

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

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.

Study Timeline

• Status Verified: 2014-01
• Study Start: 2014-01
• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-18
• Last Update Submitted: 2014-01-18
• Study First Posted: 2014-01-22
• Last Update Posted: 2014-01-22
• Primary Completion: 2015-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Adults with ages from 18-80 years old.
2. The patients with pancreatic cystic lesions, which diameter of cystic lesion more than 2cm.
3. Sign the informed consent voluntarily. -

Exclusion Criteria

1. The patient can't accept the endoscopic procedure.

2. The patient has blood coagulation dysfunction.

3. The patient has mental disorders.

4. The patient has mild or severe cardiorespiratory insufficiency.

5. The patient has hypertension and can't be controlled to safe level.

6. Patients with alcohol dependence.

7. Pregnant and lactating women.

8. The patients the investigators don't think suitable for this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EUS-FNA, Rate of chang on diagnosis	EUS-FNA	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.

Primary Outcome Measures

Name	Time	Method
Rate of change of diagnosis	During 2 weeks	Finish diagnosis before and after getting the results of EUS-FNA

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	5 years	after EUS-FNA

Trial Locations

Locations (1)

Department of Gastroenterology,Xijing Hospital; 🇨🇳 Xian, Shanxi, China