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.