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Evaluation of EUS-guided FNA for Diagnosing Autoimmune Pancreatitis

Primary Purpose

Autoimmune Pancreatitis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EUS-FNA
Sponsored by
Bin Cheng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Autoimmune Pancreatitis focused on measuring AIP, EUS-FNA

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age >20 years old, <85 years old ; probable AIP.

Exclusion Criteria:

  • steroid administration within 3 months before the initiation of treatment; refusal or inability to provide informed consent; acute pancreatitis in previous 2 weeks; cardiorespiratory dysfunction; mental diseases; coagulopathy; drug addiction(asprin, clopidogrel).

Sites / Locations

  • Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients who suggested having AIP

Arm Description

Patients who suggested having AIP and underwent EUS-FNA biopsy by using a standard 22-gauge aspiration needle were enrolled between January 2013 and May 2017.

Outcomes

Primary Outcome Measures

evaluate the diagnostic yield of AIP patients by EUS-FNA .
The primary outcome measure is to evaluate the usefulness of EUS-FNA with 22-Gauge (G) needle in histological diagnosis of AIP patients.

Secondary Outcome Measures

Full Information

First Posted
July 29, 2017
Last Updated
August 4, 2017
Sponsor
Bin Cheng
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1. Study Identification

Unique Protocol Identification Number
NCT03241797
Brief Title
Evaluation of EUS-guided FNA for Diagnosing Autoimmune Pancreatitis
Official Title
Evaluation of EUS-guided FNA for Diagnosing Autoimmune Pancreatitis: a Prospective, Single-center Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bin Cheng

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim is to evaluate EUS-FNA efficacy for AIP diagnosis using a 22-gauge (G) needle.
Detailed Description
Patients who suggested having Autoimmune pancreatitis (AIP) and underwent endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) by using a standard 22-gauge aspiration needle were enrolled between January 2013 and May 2017. The enrollment criteria included age greater than 20 years at the time of enrollment; presence of imaging characteristics of AIP, as specified in the International Consensus Diagnostic Criteria(ICDC) (diffuse or segmental/focal enlargement with delayed enhancement and diffuse or segmental/focal or multiple irregular narrowing of the main pancreatic duct without marked upstream dilatation) was confirmed by computed tomography (CT), magnetic resonance imaging (MRI), or EUS. The exclusion criteria were steroid administration within 3 months before the initiation of treatment; refusal or inability to provide informed consent; episode of acute pancreatitis in previous 2 weeks; inability to safely perform EUS-FNA, such as cardiorespiratory dysfunction, mental diseases, coagulopathy and drug addiction.All procedures were performed under deep sedation by a single experienced endosonographer who had performed more than 500 cases. EUS-FNA was performed by using Olympus linear echoendoscopes , Diagnostic Ultrasound System and 22-G needle . Once the lesion was evaluated by EUS, the echoendoscopist would select the shortest pathway, while avoiding blood vessels, to reach the lesion. Under real-time visualization, slow-pull technique and suction technique were used to punctured each lesions. The specimens were expelled onto glass slides, and then prepared for histological and cytological examinations. Because neither pathologists nor cytologists were present on-site at our institution, the puncture was repeated until a whitish material could be observed macroscopically.Tissue samples were fixed in formalin and embedded in paraffin. A paraffin block was thin cut into serial sections and stained with hematoxylin-eosin(H&E). To detect infiltrated plasma cells, anti-IgG4 antibody would be done if necessary. The histologic analysis was made by an experienced pathologist who was blind to the kinds of studies referring to the histological criteria of the ICDC. The Lymphoplasmacytic sclerosing pancreatitis (LPSP ) findings are as follow: (1) Periductal lymphoplasmacytic infiltrate without granulocytic infiltration; (2) Obliterative phlebitis; (3)Storiform fibrosis; (4) Abundant (>10cells/HPF) immunoglobulin G4 (IgG 4)positive cells. The level-1 criteria of LPSP were positive for 3 or more of the 4 LPSP findings, and the level-2 criteria were positive for 2 of the 4 items. The idiopathic duct-centric chronic pancreatitis (IDCP) findings are as follow: (1) Granulocytic infiltration of duct wall (GEL) with or without granulocytic acinar inflammation; (2)Granulocytic and lymphoplasmacytic acinar infiltrate; (3)Absent or scant (0-10 cells/ High-power fields) IgG4-positive cells. The level-1 criteria of IDCP were positive for items (1) and (3), and the level-2 criteria were positive for items (2) and (3).Statistical analyses were performed with Statistical Analysis System (SAS) version 9.2. All tests were 2-tailed and a P value of less than 0.05 was considered to indicate a statistically significant difference. All category variables will be described in terms of the count and percentage using the χ 2 test, whereas the continuous variables will be described as mean ± standard deviation using τ tests or Wilcoxon rank-sum tests. Outpatients were observed for immediate complications in the recovery room for 2 hours and followed up on the day after the procedure to monitor for possible complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Pancreatitis
Keywords
AIP, EUS-FNA

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Patients who suggested having AIP
Arm Type
Experimental
Arm Description
Patients who suggested having AIP and underwent EUS-FNA biopsy by using a standard 22-gauge aspiration needle were enrolled between January 2013 and May 2017.
Intervention Type
Procedure
Intervention Name(s)
EUS-FNA
Intervention Description
Once the lesion was evaluated by EUS, the echoendoscopist would select the shortest pathway, while avoiding blood vessels, to reach the lesion. Under real-time visualization, slow-pull technique and suction technique were used to punctured each lesions. The specimens were expelled onto glass slides, and then prepared for histological and cytological examinations.
Primary Outcome Measure Information:
Title
evaluate the diagnostic yield of AIP patients by EUS-FNA .
Description
The primary outcome measure is to evaluate the usefulness of EUS-FNA with 22-Gauge (G) needle in histological diagnosis of AIP patients.
Time Frame
52 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age >20 years old, <85 years old ; probable AIP. Exclusion Criteria: steroid administration within 3 months before the initiation of treatment; refusal or inability to provide informed consent; acute pancreatitis in previous 2 weeks; cardiorespiratory dysfunction; mental diseases; coagulopathy; drug addiction(asprin, clopidogrel).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bin Cheng, Doctor
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yun Wang, Doctor
Organizational Affiliation
Tongji Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Li Cao, Doctor
Organizational Affiliation
Tongji Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Evaluation of EUS-guided FNA for Diagnosing Autoimmune Pancreatitis

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