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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02041897

Enrollment

160

Registered

2014-01-22

Start date

2014-01-31

Completion date

2020-01-31

Last updated

2014-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cyst

Keywords

EUS-FNA, Pancreatic cystic lesion, Diagnosis

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.

Interventions

PROCEDUREEUS-FNA

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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. \-

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Number of Participants with Adverse Events	5 years	after EUS-FNA

Countries

China

Contacts

Primary ContactXiaoyin Zhang, MD,Ph.D

zhangxy@fmmu.edu.cn86-29-84771540

Backup ContactXin Wang, MD,Ph.D

wangx@fmmu.edu.cn86-29-84771516

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026