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

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.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Cyst
• Intervention / Treatment: Procedure: EUS-FNA

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 Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaoyin Zhang, MD,Ph.D; Phone Number: 86-29-84771540; Email: zhangxy@fmmu.edu.cn
• Study Contact Backup: Name: Xin Wang, MD,Ph.D; Phone Number: 86-29-84771516; Email: wangx@fmmu.edu.cn

Study Locations

• China
  • Shanxi
    • Xian, Shanxi, China, 710032
      • Recruiting
      • Department of Gastroenterology,Xijing Hospital
      • Contact: Xiaoyin Zhang, MD,Ph.D; Phone Number: 86-29-84771540; Email: zhangxy@fmmu.edu.cn
      • Contact: Yan Pan, Master; Phone Number: 86-29-84771540; Email: panpan@fmmu.edu.cn
      • Principal Investigator: Xiaoyin Zhang, MD,Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: EUS-FNA, Rate of chang on diagnosis; 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; 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.; Other Names: Endoscopic ultrasound guided fine needle aspiration with 22G needle.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xiaoyin Zhang
• Collaborators: Second Military Medical University
• Investigators: Study Chair: Kaichun Wu, MD,Ph.D, Xijing hospital,The Fourth Military Medical University

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): January 1, 2015
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: January 14, 2014
• First Submitted That Met QC Criteria: January 18, 2014
• First Posted (Estimate): January 22, 2014

Study Record Updates

• Last Update Posted (Estimate): January 22, 2014
• Last Update Submitted That Met QC Criteria: January 18, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Diagnosis; EUS-FNA; Pancreatic cystic lesion
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Cysts; Pancreatic Diseases; Pancreatic Cyst
• Other Study ID Numbers: PCL-EUS-FNA