Autoimmune PancreatitisNCT04834505
To Differentiate Focal Autoimmune Pancreatitis From Pancreatic Cancer by Endoscopic Ultrasound
An observational study of Autoimmune Pancreatitis and Pancreatic Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Autoimmune Pancreatitis, Pancreatic Cancer
- What is being tested?
- Diagnostic imaging modalities for validation sample and EUS for derivation sample
- How many people
- 286 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2021to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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 In the end, the patient with a diagnosis that is neither FAIP nor PC and the patient without conclusive diagnosis are withdrawn from the study.
Who may be able to join
- Patients with difficulty in distinguishing between FAIP and PC
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Construction and Validation of a Diagnosis Model Based on Endoscopic Ultrasound Characteristics for Differentiating Between Focal Autoimmune Pancreatitis and Pancreatic Cancer
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.
Read the detailed description
A derivation sample is established by retrospectively collecting the EUS images of about 100 FAIP patients and about 200 PC patients who were diagnosed for the first time in Peking Union Medical College Hospital in the past 6 years and underwent EUS at the same time. The parenchymal and ductal changes of pancreas were defined according to the Rosemont criteria. The parenchymal characteristics included hyperechoic foci/strands and lobularity, and the ductal changes included main pancreatic duct (MPD) dilation. Other EUS characteristics not included in the conventional criteria were described based on the literatures, including pancreatic diffuse hypoechogenicity, focal hypoechogenicity, pancreatic diffuse enlargement, focal enlargement, peripancreatic hypoechoic margin, common bile duct (CBD) dilation, bile duct wall thickening, lymphadenopathy and vessel involvement. The EUS characteristics of the two groups of patients are included in the multivariate stepwise logistic regression and receiver operating characteristics (ROC) analyses to construct a differential diagnosis model in derivation sample. Further, the differential diagnosis model will be prospectively validated by calculating the sensitivity and specificity in about 90 patients who are going to undergo EUS due to the difficulty in distinguishing between FAIP and PC. Diagnosis of AIP meets the revised Mayo clinic criteria (revised HISORt criteria) including features of histology, imaging, serology, other organs involvement and response to steroid therapy. Diagnosis of pancreatic duct adenocarcinoma is confirmed by surgical pathology or by cytology/histology after EUS-guided fine needle aspiration or biopsy.
- Conditions
- Autoimmune Pancreatitis, Pancreatic Cancer
- Being tested
- Diagnostic imaging modalities for validation sample, EUS for derivation sample
- Medical subject headings
- Autoimmune Pancreatitis, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic imaging modalities for validation sampleOther
Endoscopic ultrasound and other imaging modalities such as CT, MRI, or PET-CT are performed.
EUS for derivation sampleOther
Endoscopic ultrasound was performed.
| Study group | Role | What they receive |
|---|---|---|
| Derivation sample | The patients conclusively diagnosed as FAIP or PC are retrospectively collected. Receives: Other: EUS for derivation sample | |
| Validation sample | The patients with difficulty in distinguishing between FAIP and PC are prospectively enrolled. Receives: Other: Diagnostic imaging modalities for validation sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Sensitivity and specificity were used to assess the diagnostic efficacy
Measured: 1 week after the diagnosis is conclusive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start11 May 2021
- Primary completion30 Sep 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Autoimmune PancreatitisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University General Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Tongji Hospital, Qilu Hospital of Shandong University, The Second Hospital of Hebei Medical University
- Responsible party
- Principal investigator, Tao Guo, Peking Union Medical College Hospital
- Investigators
- Tao Guo, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834505
- Sponsor's protocol ID
- EUS-AIP-PC-1
- Status last verified
- May 2025
- First submitted
- 4 Apr 2021
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The protocol of the study is private.
Publications
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.
PubMed 25770706Kamisawa 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.
PubMed 16932997Miyabe 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.
PubMed 30012334Muhi 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.
PubMed 22069025Gardner 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.
PubMed 20598255Hoki 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.
PubMed 19214678Chari 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.
PubMed 19410017
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Validation of a Diagnosis Model Based on Endoscopic Ultrasound Characteristics for Differentiating Between Focal Autoimmune Pancreatitis and Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04834505
- Acronym / sponsor ID
- EUS-AIP-PC-1
- Conditions
- Autoimmune Pancreatitis, Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Tianjin Medical University General Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Tongji Hospital, Qilu Hospital of Shandong University, The Second Hospital of Hebei Medical University
- Study start
- 11 May 2021 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A derivation sample is established by retrospectively collecting the EUS images of about 100 FAIP patients and about 200 PC patients who were diagnosed for the first time in Peking Union Medical College Hospital in the past 6 years and underwent EUS at the same time. The parenchymal and ductal changes of pancreas were defined according to the Rosemont criteria. The parenchymal characteristics included hyperechoic foci/strands and lobularity, and the ductal changes included main pancreatic duct (MPD) dilation. Other EUS characteristics not included in the conventional criteria were described based on the literatures, including pancreatic diffuse hypoechogenicity, focal hypoechogenicity, pancreatic diffuse enlargement, focal enlargement, peripancreatic hypoechoic margin, common bile duct (CBD) dilation, bile duct wall thickening, lymphadenopathy and vessel involvement. The EUS characteristics of the two groups of patients are included in the multivariate stepwise logistic regression and receiver operating characteristics (ROC) analyses to construct a differential diagnosis model in derivation sample. Further, the differential diagnosis model will be prospectively validated by calculating the sensitivity and specificity in about 90 patients who are going to undergo EUS due to the difficulty in distinguishing between FAIP and PC. Diagnosis of AIP meets the revised Mayo clinic criteria (revised HISORt criteria) including features of histology, imaging, serology, other organs involvement and response to steroid therapy. Diagnosis of pancreatic duct adenocarcinoma is confirmed by surgical pathology or by cytology/histology after EUS-guided fine needle aspiration or biopsy.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Derivation sample | – | Other: EUS for derivation sampleThe patients conclusively diagnosed as FAIP or PC are retrospectively collected. |
| Validation sample | – | Other: Diagnostic imaging modalities for validation sampleThe patients with difficulty in distinguishing between FAIP and PC are prospectively enrolled. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with difficulty in distinguishing between FAIP and PC
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic imaging modalities for validation sampleEndoscopic ultrasound and other imaging modalities such as CT, MRI, or PET-CT are performed. | Other | Validation sample |
| EUS for derivation sampleEndoscopic ultrasound was performed. | Other | Derivation sample |
Primary outcome
To construct a diagnosis model for distinguishing FAIP from PC and further validate its efficacy
Time frame: 1 week after the diagnosis is conclusive
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 secondary outcome
Compare the efficacy of EUS based on the model with that of CT/MRI/PET-CT in differentiating between FAIP and PC
Time frame: 1 week after the diagnosis is conclusive
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Background: PubMed 25770706Hart 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.
- Background: PubMed 16932997Kamisawa 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.
- Background: PubMed 30012334Miyabe 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.
- Background: PubMed 22069025Muhi 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.
- Background: PubMed 20598255Gardner 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.
- Background: PubMed 19214678Hoki 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.
- Background: PubMed 19410017Chari 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.
- Individual participant dataSharing planned: No. The protocol of the study is private.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tao Guo, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Pancreatitis and Pancreatic Cancer, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To construct a diagnosis model for distinguishing FAIP from PC and further validate its efficacy (time frame: 1 week after the diagnosis is conclusive). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04834505, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.