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

Pancreatic Cyst Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02041897
• Other study ID #: PCL-EUS-FNA
• Status: Recruiting
• Phase: N/A
• First received: January 14, 2014
• Last updated: January 18, 2014
• Start date: January 2014
• Est. completion date: January 2020

Study information

• Verified date: January 2014
• Source: Fourth Military Medical University
• Contact: Xiaoyin Zhang, MD,Ph.D
• Phone: 86-29-84771540
• Email: zhangxy[@]fmmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: January 2020
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pancreatic Cyst

Intervention

Procedure:
• EUS-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.

Locations

Country	Name	City	State
China	Department of Gastroenterology,Xijing Hospital	Xian	Shanxi

Sponsors (2)

Lead Sponsor	Collaborator
Xiaoyin Zhang	Second Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of change of diagnosis	Finish diagnosis before and after getting the results of EUS-FNA	During 2 weeks	No
Secondary	Number of Participants with Adverse Events	after EUS-FNA	5 years	Yes