Clinical Trial: Efficacy of Secretin MRCP in the Diagnosis and Follow up of Auto Immune Pancreatitis

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational

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

Brief Summary:

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.


Detailed Summary:

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 suppressi
Sponsor: Johns Hopkins University

Current Primary Outcome: 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 ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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 ]

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.


Original Secondary Outcome: Same as current

Information By: Johns Hopkins University

Dates:
Date Received: April 15, 2013
Date Started: February 2013
Date Completion: April 2014
Last Updated: April 30, 2013
Last Verified: April 2013