To Differentiate Focal Autoimmune Pancreatitis From Pancreatic Cancer by Endoscopic Ultrasound

NCT04834505 | Completed

• 1 other identifier: EUS-AIP-PC-1
• Study Type: observational
• Target: 286
• Locations: 1 country
• Sites: 1

Brief Summary

Autoimmune pancreatitis (AIP) is a special type of chronic pancreatitis mediated by autoimmunity. The classic manifestation of AIP is diffuse pancreatic enlargement, some of which are characterized by focal enlargement. Clinically, it is divided into diffuse AIP (DAIP) and focal AIP (FAIP) according to morphology. FAIP can be clinically manifested as obstructive jaundice, peripancreatic lymphadenopathy and vascular involvement, which may mimic pancreatic cancer (PC). CT/MRI is the important imaging tool for diagnosing pancreatic diseases. However, due to the overlap of the imaging features of FAIP and PC, it is challenging to differentiate the two by CT/MRI. Endoscopic ultrasound (EUS) can clearly display the pancreatic parenchyma and pancreatic duct system and has become a routine modality for the evaluation of pancreatic diseases. The aim of this study is to construct a diagnosis model for distinguishing between FAIP and PC by comparing the EUS characteristics of the two, and further validate its diagnostic efficacy.

Conditions

Autoimmune Pancreatitis; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• To construct a diagnosis model for distinguishing FAIP from PC and further validate its efficacy

  Score is assigned to each predictor based on the odd ratio (OR) value, individual risk is estimated based on the sum of weighted score for each predictor and optimal cut-off point is obtained based on receiver operating characteristic (ROC) analysis. Sensitivity and specificity were used to assess the diagnostic efficacy.

  1 week after the diagnosis is conclusive

Secondary Outcomes (1)

• Compare the efficacy of EUS based on the model with that of CT/MRI/PET-CT in differentiating between FAIP and PC

  1 week after the diagnosis is conclusive

Study Arms (2)

Derivation sample

The patients conclusively diagnosed as FAIP or PC are retrospectively collected.

Other: EUS for derivation sample

Validation sample

The patients with difficulty in distinguishing between FAIP and PC are prospectively enrolled.

Other: Diagnostic imaging modalities for validation sample

Interventions

Diagnostic imaging modalities for validation sample OTHER

Endoscopic ultrasound and other imaging modalities such as CT, MRI, or PET-CT are performed.

Validation sample

EUS for derivation sample OTHER

Endoscopic ultrasound was performed.

Derivation sample

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In derivation sample, the patients conclusively diagnosed as FAIP or PC are retrospectively collected. In validation sample, the patients with difficulty in distinguishing between FAIP and PC are prospectively enrolled. In the end, the patient with a diagnosis that is neither FAIP nor PC and the patient without conclusive diagnosis are withdrawn from the study.

You may qualify if:

• Patients with difficulty in distinguishing between FAIP and PC

You may not qualify if:

• Referred patients with a history of having being conclusively diagnosed as AIP or PC; Patients with DAIP; Patients with alcoholic pancreatitis, hypertriglyceridemia pancreatitis or pancreatitis due to gallstones; Patients with pancreatic cystic tumors, pancreatic neuroendocrine tumors or solid pseudopapillary tumors of pancreas; Patients who cannot undergo EUS due to unsuitable conditions.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Tianjin Medical University General Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Tongji Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• The Second Hospital of Hebei Medical University: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (7)

• Hart PA, Zen Y, Chari ST. Recent Advances in Autoimmune Pancreatitis. Gastroenterology. 2015 Jul;149(1):39-51. doi: 10.1053/j.gastro.2015.03.010. Epub 2015 Mar 12.

  PMID: 25770706 BACKGROUND

• Kamisawa T, Okamoto A. Autoimmune pancreatitis: proposal of IgG4-related sclerosing disease. J Gastroenterol. 2006 Jul;41(7):613-25. doi: 10.1007/s00535-006-1862-6.

  PMID: 16932997 BACKGROUND

• Miyabe K, Zen Y, Cornell LD, Rajagopalan G, Chowdhary VR, Roberts LR, Chari ST. Gastrointestinal and Extra-Intestinal Manifestations of IgG4-Related Disease. Gastroenterology. 2018 Oct;155(4):990-1003.e1. doi: 10.1053/j.gastro.2018.06.082. Epub 2018 Sep 12.

  PMID: 30012334 BACKGROUND

• Muhi A, Ichikawa T, Motosugi U, Sou H, Sano K, Tsukamoto T, Fatima Z, Araki T. Mass-forming autoimmune pancreatitis and pancreatic carcinoma: differential diagnosis on the basis of computed tomography and magnetic resonance cholangiopancreatography, and diffusion-weighted imaging findings. J Magn Reson Imaging. 2012 Apr;35(4):827-36. doi: 10.1002/jmri.22881. Epub 2011 Nov 8.

  PMID: 22069025 BACKGROUND

• Gardner TB, Levy MJ. EUS diagnosis of chronic pancreatitis. Gastrointest Endosc. 2010 Jun;71(7):1280-9. doi: 10.1016/j.gie.2010.02.038. No abstract available.

  PMID: 20598255 BACKGROUND

• 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 BACKGROUND

• Chari ST, Takahashi N, Levy MJ, Smyrk TC, Clain JE, Pearson RK, Petersen BT, Topazian MA, Vege SS. A diagnostic strategy to distinguish autoimmune pancreatitis from pancreatic cancer. Clin Gastroenterol Hepatol. 2009 Oct;7(10):1097-103. doi: 10.1016/j.cgh.2009.04.020. Epub 2009 May 4.

  PMID: 19410017 BACKGROUND

MeSH Terms

Conditions

Autoimmune Pancreatitis; Pancreatic Neoplasms

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; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Endocrine System Diseases

Study Officials

• Tao Guo, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor in Department of Gastroenterolgy

Study Record Dates

• First Submitted: April 4, 2021
• First Posted: April 8, 2021
• Study Start: May 11, 2021
• Primary Completion: September 30, 2024
• Study Completion: December 30, 2024
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)