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Efficacy of Secretin Assisted Dynamic MRCP in the Diagnosis and Follow up of Auto Immune Pancreatitis(AIP)

Phase 4
19 Years
90 Years
Open (Enrolling)
Cellular Diagnosis, Pancreatic Cancer, Autoimmune Pancreatitis

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Trial Information

Efficacy of Secretin Assisted Dynamic MRCP in the Diagnosis and Follow up of Auto Immune Pancreatitis(AIP)

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.

Inclusion Criteria:

1. Male or female >18 years of age.

2. Patients suspected of having AIP based on prior clinical work up

Exclusion Criteria:

1. Unwilling or unable to give written, informed consent.

2. Presence of pace makers, aneurysm clips, artificial heart valves, ear implants, metal
fragments or foreign objects in the eyes, skin or body.

3. Patients with acute pancreatitis

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Evaluating the additive benefit of Secretin MRCP in differentiating focal AIP and Pancreatic malignancy

Outcome Description:

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.

Outcome 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

Safety Issue:


Principal Investigator

Atif Zaheer, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University


United States: The Johns Hopkins Medicine Institutional Review Board

Study ID:




Start Date:

February 2013

Completion Date:

April 2014

Related Keywords:

  • Cellular Diagnosis, Pancreatic Cancer
  • Autoimmune Pancreatitis
  • Secretin MRCP, diagnosis, Autoimmune pancreatitis
  • Pancreatic Neoplasms
  • Pancreatitis



Johns Hopkins HospitalBaltimore, Maryland  21287