Evaluation of EUS-guided FNA for Diagnosing Autoimmune Pancreatitis

Autoimmune Pancreatitis Clinical Trial

Official title:

Evaluation of EUS-guided FNA for Diagnosing Autoimmune Pancreatitis: a Prospective, Single-center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03241797
• Other study ID #: AIP
• Status: Completed
• Phase: N/A
• First received: July 29, 2017
• Last updated: August 4, 2017
• Start date: January 2013
• Est. completion date: May 2017

Study information

• Verified date: August 2017
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim is to evaluate EUS-FNA efficacy for AIP diagnosis using a 22-gauge (G) needle.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Autoimmune Pancreatitis
• Pancreatitis

Intervention

Procedure:
• EUS-FNA
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.

Locations

Country	Name	City	State
China	Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Bin Cheng

Country where clinical trial is conducted

China, 

References & Publications (23)

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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. — View 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 Gastroente — View Citation

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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 n — View 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. Review. — View Citation

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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. — View 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. Review. — View Citation

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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: — View 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. — View 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. — View 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. — View Citation

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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. — View 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. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	52 months