- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01845467
Efficacy of Secretin MRCP in the Diagnosis and Follow up of Auto Immune Pancreatitis (S-MRCP)
Efficacy of Secretin Assisted Dynamic MRCP in the Diagnosis and Follow up of Auto Immune Pancreatitis(AIP)
BACKGROUND:
Auto immune pancreatitis (AIP), a benign pancreatic disease has certain morphological forms which mimics pancreatic malignancy in radiological appearance. There is no singe diagnostic test which can accurately differentiate these two conditions. In the past, AIP accounted for up to 27% of Whipple resections performed for suspected adenocarcinoma.
AIMS:
To evaluate the efficacy of Secretin assisted Magnetic resonance cholangio pancreatography (MRCP) in differentiating AIP and pancreatic malignancy.
METHODS:
100 patients suspected with AIP will be consented to participate in the study to undergo secretin MRCP in addition to their other standard investigations. Patients will be categorized as those with AIP and with pancreatic malignancy based on these results and will be followed. Follow up will eventually give the true diagnosis when patients with pancreatic malignancy undergo pancreatic surgery and their pancreatic tissue is examined by histopathologist. AIP patients will undergo steroid trial which will give the true diagnosis. The preliminary diagnosis results based on standard investigations with and without inclusion of secretin MRCP will be compared to the true diagnosis.
Study Overview
Status
Detailed Description
A total of 100 patients with suspicion of Auto Immune Pancreatitis will be identified from the multidisciplinary pancreatic cancer clinic at Johns Hopkins and from the Pancreatitis clinic of the Division of Gastroenterology, Johns Hopkins Hospital.
After written, informed consent is obtained; preliminary screening will be done which includes medical history and physical examination including weight and vital signs. Serum immunoglobulin G4 (IgG4) levels will also be evaluated. If the patient meets exclusion/inclusion criteria, screening eligibility and signs informed consent, they will be included in the study.
Study investigators and/or their delegate will complete the patient demographic form, medical history form, baseline physical examination, baseline laboratory evaluation and concomitant medication evaluation as per the protocol. Any other investigational procedure such as endoscopic ultrasonography - fine-needle aspiration (EUS - FNA) or esophagogastroduodenoscopy (EGD) with papillary biopsy for IgG4 which assists in the differentiation between AIP and Pancreatic malignancy may be performed based on the treating physician's discretion.
Involvement of other organs by AIP and Pancreatic malignancy will be obtained based on the medical history, examination and imaging findings. The patients will be subjected to MRI and MRCP with the MRCP performed in two stages namely before injection of secretin and after intravenous injection of 0.4mcg/Kg of synthetic human secretin (CHIROSTIM, Human Secretin, CHIRHOCLIN Inc., Burtonsville, MD). All the subjects will be given 3 cups (approximately 500-600cc) of pineapple juice 5-10 minutes before the imaging procedure. Pineapple juice will act as a negative oral contrast which nulls the signal in stomach and duodenum, thereby suppressing gastrointestinal overlap over pancreas. MR Examination will be performed using 3.0 T magnet and it will include non contrast enhanced scanning followed by gadolinium enhanced scanning, performed during the arterial dominant, venous dominant and late phases. The secretin MRCP is performed through serial breath-hold T2-weighted sequences run during the first 8-12 min after the intravenous administration of secretin.
Based on the result from the above investigations, the patients will be categorized as those suspected with AIP and those suspected with Pancreatic malignancy. Patients with suspected malignancy will eventually undergo surgical resection of pancreas under their treating physician and the pancreatic tissue examination will provide the true diagnosis. Patients with suspected AIP will undergo a steroid trial for at least 3 months, at the end of which a repeat MRI, secretin MRCP will be performed and the diagnosis will be confirmed based on the response to steroid therapy.
Study Type
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male or female >18 years of age.
- Patients suspected of having AIP based on prior clinical work up
Exclusion Criteria:
- Unwilling or unable to give written, informed consent.
- Presence of pace makers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body.
- Patients with acute pancreatitis
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Auto-immune pancreatitis, suspected
Patients suspected with auto-immune pancreatitis (AIP) and undergoing secretin assisted MRCP as per the standard of care at our institute.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluating the additive benefit of Secretin MRCP in differentiating focal AIP and Pancreatic malignancy
Time Frame: Participants will be followed during the interval between initial S MRCP and a repeat S MRCP after steroid treatment or a pancreatic surgery; an expected 4 weeks
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Patients with suspected auto-immune pancreatitis (AIP)will undergo secretin assisted MRCP.
The MRCP will be evaluated for post secretin changes in pancreatic dimensions, duodenal filling, pre and post contrast parenchymal signal intensities, ADC values, changes in pancreatic duct strictures due to secretin, extra pancreatic lesions.
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Participants will be followed during the interval between initial S MRCP and a repeat S MRCP after steroid treatment or a pancreatic surgery; an expected 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of Secretin MRCP in monitoring therapeutic improvement in AIP patients on steroid trial
Time Frame: Participants will be followed up from initial S MRCP till resolution of pathology or till end of S MRCP follow-up studies; an expected 8 weeks
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The patients with suspected AIP based on secretin MRCP will undergo a steroid trial.
The initial and follow up MRCP findings will be compared for changes in pancreatic parenchyma after injecting secretin, T1 signal intensities, ADC values, changes in pancreatic duct strictures,extra pancreatic lesions and duodenal filling.
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Participants will be followed up from initial S MRCP till resolution of pathology or till end of S MRCP follow-up studies; an expected 8 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Atif Zaheer, M.D., Johns Hopkins University
Publications and helpful links
General Publications
- 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.
- Kamisawa T, Egawa N, Nakajima H, Tsuruta K, Okamoto A, Kamata N. Clinical difficulties in the differentiation of autoimmune pancreatitis and pancreatic carcinoma. Am J Gastroenterol. 2003 Dec;98(12):2694-9. doi: 10.1111/j.1572-0241.2003.08775.x.
- Carbognin G, Girardi V, Biasiutti C, Camera L, Manfredi R, Frulloni L, Hermans JJ, Mucelli RP. Autoimmune pancreatitis: imaging findings on contrast-enhanced MR, MRCP and dynamic secretin-enhanced MRCP. Radiol Med. 2009 Dec;114(8):1214-31. doi: 10.1007/s11547-009-0452-0. Epub 2009 Sep 30.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00068830
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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