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

Primary Purpose

Pancreatic Cyst

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EUS-FNA
Sponsored by
Xiaoyin Zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Cyst focused on measuring EUS-FNA, Pancreatic cystic lesion, Diagnosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

    -

Sites / Locations

  • Department of Gastroenterology,Xijing HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

EUS-FNA, Rate of chang on diagnosis

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants with Adverse Events
after EUS-FNA

Full Information

First Posted
January 14, 2014
Last Updated
January 18, 2014
Sponsor
Xiaoyin Zhang
Collaborators
Second Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02041897
Brief Title
Clinical Evaluation of EUS-FNA on Diagnosis of Pancreatic Cystic Lesions
Official Title
Clinical Evaluation of EUS-FNA on Diagnosis of Pancreatic Cystic Lesions----A Multiple Center,Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiaoyin Zhang
Collaborators
Second Military Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cyst
Keywords
EUS-FNA, Pancreatic cystic lesion, Diagnosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EUS-FNA, Rate of chang on diagnosis
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
EUS-FNA
Other Intervention Name(s)
Endoscopic ultrasound guided fine needle aspiration with 22G needle.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of change of diagnosis
Description
Finish diagnosis before and after getting the results of EUS-FNA
Time Frame
During 2 weeks
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events
Description
after EUS-FNA
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoyin Zhang, MD,Ph.D
Phone
86-29-84771540
Email
zhangxy@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Wang, MD,Ph.D
Phone
86-29-84771516
Email
wangx@fmmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaichun Wu, MD,Ph.D
Organizational Affiliation
Xijing hospital,The Fourth Military Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Gastroenterology,Xijing Hospital
City
Xian
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoyin Zhang, MD,Ph.D
Phone
86-29-84771540
Email
zhangxy@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yan Pan, Master
Phone
86-29-84771540
Email
panpan@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Xiaoyin Zhang, MD,Ph.D

12. IPD Sharing Statement

Learn more about this trial

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

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