<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03241797</url>
  </required_header>
  <id_info>
    <org_study_id>AIP</org_study_id>
    <nct_id>NCT03241797</nct_id>
  </id_info>
  <brief_title>Evaluation of EUS-guided FNA for Diagnosing Autoimmune Pancreatitis</brief_title>
  <official_title>Evaluation of EUS-guided FNA for Diagnosing Autoimmune Pancreatitis: a Prospective, Single-center Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bin Cheng</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Huazhong University of Science and Technology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim is to evaluate EUS-FNA efficacy for AIP diagnosis using a 22-gauge (G) needle.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who suggested having Autoimmune pancreatitis (AIP) and underwent endoscopic&#xD;
      ultrasound-guided fine needle aspiration (EUS-FNA） by using a standard 22-gauge aspiration&#xD;
      needle were enrolled between January 2013 and May 2017. The enrollment criteria included age&#xD;
      greater than 20 years at the time of enrollment; presence of imaging characteristics of AIP,&#xD;
      as specified in the International Consensus Diagnostic Criteria（ICDC） (diffuse or&#xD;
      segmental/focal enlargement with delayed enhancement and diffuse or segmental/focal or&#xD;
      multiple irregular narrowing of the main pancreatic duct without marked upstream dilatation)&#xD;
      was confirmed by computed tomography (CT), magnetic resonance imaging (MRI), or EUS. The&#xD;
      exclusion criteria were steroid administration within 3 months before the initiation of&#xD;
      treatment; refusal or inability to provide informed consent; episode of acute pancreatitis in&#xD;
      previous 2 weeks; inability to safely perform EUS-FNA, such as cardiorespiratory dysfunction,&#xD;
      mental diseases, coagulopathy and drug addiction.All procedures were performed under deep&#xD;
      sedation by a single experienced endosonographer who had performed more than 500 cases.&#xD;
      EUS-FNA was performed by using Olympus linear echoendoscopes , Diagnostic Ultrasound System&#xD;
      and 22-G needle . Once the lesion was evaluated by EUS, the echoendoscopist would select the&#xD;
      shortest pathway, while avoiding blood vessels, to reach the lesion. Under real-time&#xD;
      visualization, slow-pull technique and suction technique were used to punctured each lesions.&#xD;
      The specimens were expelled onto glass slides, and then prepared for histological and&#xD;
      cytological examinations. Because neither pathologists nor cytologists were present on-site&#xD;
      at our institution, the puncture was repeated until a whitish material could be observed&#xD;
      macroscopically.Tissue samples were fixed in formalin and embedded in paraffin. A paraffin&#xD;
      block was thin cut into serial sections and stained with hematoxylin-eosin(H&amp;E). To detect&#xD;
      infiltrated plasma cells, anti-IgG4 antibody would be done if necessary. The histologic&#xD;
      analysis was made by an experienced pathologist who was blind to the kinds of studies&#xD;
      referring to the histological criteria of the ICDC. The Lymphoplasmacytic sclerosing&#xD;
      pancreatitis (LPSP ) findings are as follow: (1) Periductal lymphoplasmacytic infiltrate&#xD;
      without granulocytic infiltration; (2) Obliterative phlebitis; (3)Storiform fibrosis; (4)&#xD;
      Abundant (&gt;10cells/HPF) immunoglobulin G4 (IgG 4)positive cells. The level-1 criteria of LPSP&#xD;
      were positive for 3 or more of the 4 LPSP findings, and the level-2 criteria were positive&#xD;
      for 2 of the 4 items. The idiopathic duct-centric chronic pancreatitis (IDCP) findings are as&#xD;
      follow: (1) Granulocytic infiltration of duct wall (GEL) with or without granulocytic acinar&#xD;
      inflammation; (2)Granulocytic and lymphoplasmacytic acinar infiltrate; (3)Absent or scant&#xD;
      (0-10 cells/ High-power fields) IgG4-positive cells. The level-1 criteria of IDCP were&#xD;
      positive for items (1) and (3), and the level-2 criteria were positive for items (2) and&#xD;
      (3).Statistical analyses were performed with Statistical Analysis System (SAS) version 9.2.&#xD;
      All tests were 2-tailed and a P value of less than 0.05 was considered to indicate a&#xD;
      statistically significant difference. All category variables will be described in terms of&#xD;
      the count and percentage using the χ 2 test, whereas the continuous variables will be&#xD;
      described as mean ± standard deviation using τ tests or Wilcoxon rank-sum tests. Outpatients&#xD;
      were observed for immediate complications in the recovery room for 2 hours and followed up on&#xD;
      the day after the procedure to monitor for possible complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2013</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>evaluate the diagnostic yield of AIP patients by EUS-FNA .</measure>
    <time_frame>52 months</time_frame>
    <description>The primary outcome measure is to evaluate the usefulness of EUS-FNA with 22-Gauge (G) needle in histological diagnosis of AIP patients.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Autoimmune Pancreatitis</condition>
  <arm_group>
    <arm_group_label>Patients who suggested having AIP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>EUS-FNA</intervention_name>
    <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.</description>
    <arm_group_label>Patients who suggested having AIP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt;20 years old, &lt;85 years old ; probable AIP.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  steroid administration within 3 months before the initiation of treatment; refusal or&#xD;
             inability to provide informed consent; acute pancreatitis in previous 2 weeks;&#xD;
             cardiorespiratory dysfunction; mental diseases; coagulopathy; drug addiction(asprin,&#xD;
             clopidogrel).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bin Cheng, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tongji Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yun Wang, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Tongji Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Li Cao, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>Tongji Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>SARLES H, SARLES JC, MURATORE R, GUIEN C. Chronic inflammatory sclerosis of the pancreas--an autonomous pancreatic disease? Am J Dig Dis. 1961 Jul;6:688-98. doi: 10.1007/BF02232341. No abstract available.</citation>
    <PMID>13746542</PMID>
  </results_reference>
  <results_reference>
    <citation>Hart PA, Kamisawa T, Brugge WR, Chung JB, Culver EL, Czako L, Frulloni L, Go VL, Gress TM, Kim MH, Kawa S, Lee KT, Lerch MM, Liao WC, Lohr M, Okazaki K, Ryu JK, Schleinitz N, Shimizu K, Shimosegawa T, Soetikno R, Webster G, Yadav D, Zen Y, Chari ST. Long-term outcomes of autoimmune pancreatitis: a multicentre, international analysis. Gut. 2013 Dec;62(12):1771-6. doi: 10.1136/gutjnl-2012-303617. Epub 2012 Dec 11.</citation>
    <PMID>23232048</PMID>
  </results_reference>
  <results_reference>
    <citation>Meng Q, Xin L, Liu W, Lin H, Tian B, Wang L, Li Z. Diagnosis and Treatment of Autoimmune Pancreatitis in China: A Systematic Review. PLoS One. 2015 Jun 25;10(6):e0130466. doi: 10.1371/journal.pone.0130466. eCollection 2015.</citation>
    <PMID>26110658</PMID>
  </results_reference>
  <results_reference>
    <citation>Hoki N, Mizuno N, Sawaki A, Tajika M, Takayama R, Shimizu Y, Bhatia V, Yamao K. Diagnosis of autoimmune pancreatitis using endoscopic ultrasonography. J Gastroenterol. 2009;44(2):154-9. doi: 10.1007/s00535-008-2294-2. Epub 2009 Feb 13.</citation>
    <PMID>19214678</PMID>
  </results_reference>
  <results_reference>
    <citation>Pearson RK, Longnecker DS, Chari ST, Smyrk TC, Okazaki K, Frulloni L, Cavallini G. Controversies in clinical pancreatology: autoimmune pancreatitis: does it exist? Pancreas. 2003 Jul;27(1):1-13. doi: 10.1097/00006676-200307000-00001. No abstract available.</citation>
    <PMID>12826899</PMID>
  </results_reference>
  <results_reference>
    <citation>Kim KP, Kim MH, Kim JC, Lee SS, Seo DW, Lee SK. Diagnostic criteria for autoimmune chronic pancreatitis revisited. World J Gastroenterol. 2006 Apr 28;12(16):2487-96. doi: 10.3748/wjg.v12.i16.2487.</citation>
    <PMID>16688792</PMID>
  </results_reference>
  <results_reference>
    <citation>Kim MH, Kwon S. Diagnostic criteria for autoimmune chronic pancreatitis. J Gastroenterol. 2007 May;42 Suppl 18:42-9. doi: 10.1007/s00535-007-2050-z.</citation>
    <PMID>17520223</PMID>
  </results_reference>
  <results_reference>
    <citation>Levy MJ, Reddy RP, Wiersema MJ, Smyrk TC, Clain JE, Harewood GC, Pearson RK, Rajan E, Topazian MD, Yusuf TE, Chari ST, Petersen BT. EUS-guided trucut biopsy in establishing autoimmune pancreatitis as the cause of obstructive jaundice. Gastrointest Endosc. 2005 Mar;61(3):467-72. doi: 10.1016/s0016-5107(04)02802-0.</citation>
    <PMID>15758927</PMID>
  </results_reference>
  <results_reference>
    <citation>Ishikawa T, Itoh A, Kawashima H, Ohno E, Matsubara H, Itoh Y, Nakamura Y, Nakamura M, Miyahara R, Hayashi K, Ishigami M, Katano Y, Ohmiya N, Goto H, Hirooka Y. Usefulness of EUS combined with contrast-enhancement in the differential diagnosis of malignant versus benign and preoperative localization of pancreatic endocrine tumors. Gastrointest Endosc. 2010 May;71(6):951-9. doi: 10.1016/j.gie.2009.12.023.</citation>
    <PMID>20438884</PMID>
  </results_reference>
  <results_reference>
    <citation>Iwashita T, Yasuda I, Doi S, Ando N, Nakashima M, Adachi S, Hirose Y, Mukai T, Iwata K, Tomita E, Itoi T, Moriwaki H. Use of samples from endoscopic ultrasound-guided 19-gauge fine-needle aspiration in diagnosis of autoimmune pancreatitis. Clin Gastroenterol Hepatol. 2012 Mar;10(3):316-22. doi: 10.1016/j.cgh.2011.09.032. Epub 2011 Oct 20.</citation>
    <PMID>22019795</PMID>
  </results_reference>
  <results_reference>
    <citation>Kanno A, Masamune A, Fujishima F, Iwashita T, Kodama Y, Katanuma A, Ohara H, Kitano M, Inoue H, Itoi T, Mizuno N, Miyakawa H, Mikata R, Irisawa A, Sato S, Notohara K, Shimosegawa T. Diagnosis of autoimmune pancreatitis by EUS-guided FNA using a 22-gauge needle: a prospective multicenter study. Gastrointest Endosc. 2016 Nov;84(5):797-804.e1. doi: 10.1016/j.gie.2016.03.1511. Epub 2016 Apr 9.</citation>
    <PMID>27068878</PMID>
  </results_reference>
  <results_reference>
    <citation>Kanno A, Ishida K, Hamada S, Fujishima F, Unno J, Kume K, Kikuta K, Hirota M, Masamune A, Satoh K, Notohara K, Shimosegawa T. Diagnosis of autoimmune pancreatitis by EUS-FNA by using a 22-gauge needle based on the International Consensus Diagnostic Criteria. Gastrointest Endosc. 2012 Sep;76(3):594-602. doi: 10.1016/j.gie.2012.05.014.</citation>
    <PMID>22898417</PMID>
  </results_reference>
  <results_reference>
    <citation>Yasuda I, Tsurumi H, Omar S, Iwashita T, Kojima Y, Yamada T, Sawada M, Takami T, Moriwaki H, Soehendra N. Endoscopic ultrasound-guided fine-needle aspiration biopsy for lymphadenopathy of unknown origin. Endoscopy. 2006 Sep;38(9):919-24. doi: 10.1055/s-2006-944665.</citation>
    <PMID>16981110</PMID>
  </results_reference>
  <results_reference>
    <citation>Iwashita T, Yasuda I, Tsurumi H, Goto N, Nakashima M, Doi S, Hirose Y, Takami T, Moriwaki H. Endoscopic ultrasound-guided fine needle aspiration biopsy for splenic tumor: a case series. Endoscopy. 2009 Feb;41(2):179-82. doi: 10.1055/s-0028-1119474. Epub 2009 Feb 12.</citation>
    <PMID>19214901</PMID>
  </results_reference>
  <results_reference>
    <citation>Mizuno N, Bhatia V, Hosoda W, Sawaki A, Hoki N, Hara K, Takagi T, Ko SB, Yatabe Y, Goto H, Yamao K. Histological diagnosis of autoimmune pancreatitis using EUS-guided trucut biopsy: a comparison study with EUS-FNA. J Gastroenterol. 2009;44(7):742-50. doi: 10.1007/s00535-009-0062-6. Epub 2009 May 12.</citation>
    <PMID>19434362</PMID>
  </results_reference>
  <results_reference>
    <citation>Na HK, Lee JH, Park YS, Ahn JY, Choi KS, Kim DH, Choi KD, Song HJ, Lee GH, Jung HY, Kim JH. Yields and Utility of Endoscopic Ultrasonography-Guided 19-Gauge Trucut Biopsy versus 22-Gauge Fine Needle Aspiration for Diagnosing Gastric Subepithelial Tumors. Clin Endosc. 2015 Mar;48(2):152-7. doi: 10.5946/ce.2015.48.2.152. Epub 2015 Mar 27.</citation>
    <PMID>25844344</PMID>
  </results_reference>
  <results_reference>
    <citation>Itoi T, Itokawa F, Kurihara T, Sofuni A, Tsuchiya T, Ishii K, Tsuji S, Ikeuchi N, Kawai T, Moriyasu F. Experimental endoscopy: objective evaluation of EUS needles. Gastrointest Endosc. 2009 Mar;69(3 Pt 1):509-16. doi: 10.1016/j.gie.2008.07.017.</citation>
    <PMID>19231491</PMID>
  </results_reference>
  <results_reference>
    <citation>Levy MJ, Wiersema MJ, Chari ST. Chronic pancreatitis: focal pancreatitis or cancer? Is there a role for FNA/biopsy? Autoimmune pancreatitis. Endoscopy. 2006 Jun;38 Suppl 1:S30-5. doi: 10.1055/s-2006-946648. No abstract available.</citation>
    <PMID>16802220</PMID>
  </results_reference>
  <results_reference>
    <citation>Levy MJ. Endoscopic ultrasound-guided trucut biopsy of the pancreas: prospects and problems. Pancreatology. 2007;7(2-3):163-6. doi: 10.1159/000104240. Epub 2007 Jun 21.</citation>
    <PMID>17592229</PMID>
  </results_reference>
  <results_reference>
    <citation>Suda K, Takase M, Fukumura Y, Ogura K, Ueda A, Matsuda T, Suzuki F. Histopathologic characteristics of autoimmune pancreatitis based on comparison with chronic pancreatitis. Pancreas. 2005 May;30(4):355-8. doi: 10.1097/01.mpa.0000160283.41580.88.</citation>
    <PMID>15841047</PMID>
  </results_reference>
  <results_reference>
    <citation>Notohara K, Burgart LJ, Yadav D, Chari S, Smyrk TC. Idiopathic chronic pancreatitis with periductal lymphoplasmacytic infiltration: clinicopathologic features of 35 cases. Am J Surg Pathol. 2003 Aug;27(8):1119-27. doi: 10.1097/00000478-200308000-00009.</citation>
    <PMID>12883244</PMID>
  </results_reference>
  <results_reference>
    <citation>Hoshimoto S, Aiura K, Tanaka M, Shito M, Kakefuda T, Sugiura H. Mass-forming type 1 autoimmune pancreatitis mimicking pancreatic cancer. J Dig Dis. 2016 Mar;17(3):202-209. doi: 10.1111/1751-2980.12316.</citation>
    <PMID>27121246</PMID>
  </results_reference>
  <results_reference>
    <citation>Weber SM, Cubukcu-Dimopulo O, Palesty JA, Suriawinata A, Klimstra D, Brennan MF, Conlon K. Lymphoplasmacytic sclerosing pancreatitis: inflammatory mimic of pancreatic carcinoma. J Gastrointest Surg. 2003 Jan;7(1):129-37; discussion 137-9. doi: 10.1016/s1091-255x(02)00148-8.</citation>
    <PMID>12559194</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>August 4, 2017</last_update_submitted>
  <last_update_submitted_qc>August 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Huazhong University of Science and Technology</investigator_affiliation>
    <investigator_full_name>Bin Cheng</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>AIP</keyword>
  <keyword>EUS-FNA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
    <mesh_term>Autoimmune Pancreatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03241797
org study id: AIP
nct id: NCT03241797
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim is to evaluate EUS-FNA efficacy for AIP diagnosis using a 22-gauge (G) needle.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: evaluate the diagnostic yield of AIP patients by EUS-FNA .
time frame: 52 months
description: The primary outcome measure is to evaluate the usefulness of EUS-FNA with 22-Gauge (G) needle in histological diagnosis of AIP patients.
arm group label: Patients who suggested having AIP
arm group type: Experimental
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: EUS-FNA
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.
arm group label: Patients who suggested having AIP
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: No
last name: Bin Cheng, Doctor
role: Principal Investigator
affiliation: Tongji Hospital
last name: Yun Wang, Doctor
role: Study Chair
affiliation: Tongji Hospital
last name: Li Cao, Doctor
role: Study Director
affiliation: Tongji Hospital
facility: 
country: China
citation: SARLES H, SARLES JC, MURATORE R, GUIEN C. Chronic inflammatory sclerosis of the pancreas--an autonomous pancreatic disease? Am J Dig Dis. 1961 Jul;6:688-98. doi: 10.1007/BF02232341. No abstract available.
PMID: 13746542
citation: Hart PA, Kamisawa T, Brugge WR, Chung JB, Culver EL, Czako L, Frulloni L, Go VL, Gress TM, Kim MH, Kawa S, Lee KT, Lerch MM, Liao WC, Lohr M, Okazaki K, Ryu JK, Schleinitz N, Shimizu K, Shimosegawa T, Soetikno R, Webster G, Yadav D, Zen Y, Chari ST. Long-term outcomes of autoimmune pancreatitis: a multicentre, international analysis. Gut. 2013 Dec;62(12):1771-6. doi: 10.1136/gutjnl-2012-303617. Epub 2012 Dec 11.
PMID: 23232048
citation: Meng Q, Xin L, Liu W, Lin H, Tian B, Wang L, Li Z. Diagnosis and Treatment of Autoimmune Pancreatitis in China: A Systematic Review. PLoS One. 2015 Jun 25;10(6):e0130466. doi: 10.1371/journal.pone.0130466. eCollection 2015.
PMID: 26110658
citation: Hoki N, Mizuno N, Sawaki A, Tajika M, Takayama R, Shimizu Y, Bhatia V, Yamao K. Diagnosis of autoimmune pancreatitis using endoscopic ultrasonography. J Gastroenterol. 2009;44(2):154-9. doi: 10.1007/s00535-008-2294-2. Epub 2009 Feb 13.
PMID: 19214678
citation: Pearson RK, Longnecker DS, Chari ST, Smyrk TC, Okazaki K, Frulloni L, Cavallini G. Controversies in clinical pancreatology: autoimmune pancreatitis: does it exist? Pancreas. 2003 Jul;27(1):1-13. doi: 10.1097/00006676-200307000-00001. No abstract available.
PMID: 12826899
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responsible party type: Sponsor-Investigator
investigator affiliation: Huazhong University of Science and Technology
investigator full name: Bin Cheng
investigator title: professor
mesh term: Pancreatitis
mesh term: Autoimmune Pancreatitis
sharing ipd: Undecided