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

NCT02041897 | Unknown

• 1 other identifier: PCL-EUS-FNA
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cyst

Keywords

EUS-FNA; Pancreatic cystic lesion; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Rate of change of diagnosis

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

  During 2 weeks

Secondary Outcomes (1)

• Number of Participants with Adverse Events

  5 years

Study Arms (1)

EUS-FNA, Rate of chang on diagnosis

OTHER

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

Interventions

EUS-FNA PROCEDURE

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.

Also known as: Endoscopic ultrasound guided fine needle aspiration with 22G needle.

EUS-FNA, Rate of chang on diagnosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiaoyin Zhang: lead
• Second Military Medical University: collaborator

Study Sites (1)

Department of Gastroenterology,Xijing Hospital

Xian, Shanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Cyst; Disease

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration; Needles

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Equipment and Supplies

Study Officials

• Kaichun Wu, MD,Ph.D

  Xijing hospital,The Fourth Military Medical University

  STUDY CHAIR

Central Study Contacts

Xiaoyin Zhang, MD,Ph.D

CONTACT

86-29-84771540; zhangxy@fmmu.edu.cn

Xin Wang, MD,Ph.D

CONTACT

86-29-84771516; wangx@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 22, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2020
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

CN (1)