Evaluation of EUS-guided FNA for Diagnosing Autoimmune Pancreatitis

NCT03241797 | Completed DMC

• 1 other identifier: AIP
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Autoimmune Pancreatitis

Keywords

AIP; EUS-FNA

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients who suggested having AIP

EXPERIMENTAL

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.

Procedure: EUS-FNA

Interventions

EUS-FNA PROCEDURE

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.

Patients who suggested having AIP

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bin Cheng: lead

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

Related Publications (23)

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  PMID: 19214678 RESULT

• 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.

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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. 2005 Mar;61(3):467-72. doi: 10.1016/s0016-5107(04)02802-0.

  PMID: 15758927 RESULT

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  PMID: 20438884 RESULT

• 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.

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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 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.

  PMID: 27068878 RESULT

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• 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.

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MeSH Terms

Conditions

Autoimmune Pancreatitis

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Pancreatitis, Chronic; Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; 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

Study Officials

• Bin Cheng, Doctor

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

• Yun Wang, Doctor

  Tongji Hospital

  STUDY CHAIR

• Li Cao, Doctor

  Tongji Hospital

  STUDY DIRECTOR

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: professor

Study Record Dates

• First Submitted: July 29, 2017
• First Posted: August 8, 2017
• Study Start: January 1, 2013
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: August 8, 2017

Record last verified: 2017-08

Locations

CN (1)