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Clinical Trials/NCT02041897
NCT02041897
Unknown
Not Applicable

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

Xiaoyin Zhang1 site in 1 country160 target enrollmentJanuary 2014
ConditionsPancreatic Cyst

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pancreatic Cyst
Sponsor
Xiaoyin Zhang
Enrollment
160
Locations
1
Primary Endpoint
Rate of change of diagnosis
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
January 2020
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Xiaoyin Zhang
Responsible Party
Sponsor Investigator
Principal Investigator

Xiaoyin Zhang

Associate professor

Air Force Military Medical University, China

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Rate of change of diagnosis

Time Frame: During 2 weeks

Finish diagnosis before and after getting the results of EUS-FNA

Secondary Outcomes

  • Number of Participants with Adverse Events(5 years)

Study Sites (1)

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