Differentiating between autoimmune pancreatitis and pancreatic cancer using endoscopic ultrasound
Construction and Validation of a Diagnosis Model Based on Endoscopic Ultrasound Characteristics for Differentiating Between Focal Autoimmune Pancreatitis and Pancreatic Cancer
This study is trying to see if special ultrasound images can help doctors tell the difference between autoimmune pancreatitis and pancreatic cancer in patients who have symptoms of both.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | N/A to 75 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT04834505 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a diagnostic model to distinguish focal autoimmune pancreatitis (FAIP) from pancreatic cancer (PC) through endoscopic ultrasound (EUS) imaging. By retrospectively analyzing EUS images from approximately 100 FAIP patients and 200 PC patients, the study will evaluate various pancreatic parenchymal and ductal characteristics. The findings will be used to create a multivariate logistic regression model, which will then be prospectively validated in about 90 patients facing diagnostic challenges. The study seeks to improve diagnostic accuracy for these two conditions that often present similarly.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who are experiencing difficulties in distinguishing between focal autoimmune pancreatitis and pancreatic cancer.
Not a fit: Patients who have already been conclusively diagnosed with autoimmune pancreatitis or pancreatic cancer, or those with other specific types of pancreatitis, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses for patients with suspected focal autoimmune pancreatitis or pancreatic cancer, potentially improving treatment outcomes.
How similar studies have performed: While the approach of using endoscopic ultrasound for differentiation in this context is promising, it is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with difficulty in distinguishing between FAIP and PC Exclusion Criteria: * 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.
Where this trial is running
Beijing, Beijing
- Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Tao Guo, MD — Peking Union Medical College Hospital
- Study coordinator: Tao Guo, MD
- Email: guoqiong990@126.com
- Phone: 8610-69155017
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.