Efficacy of Secretin MRCP in the Diagnosis and Follow up of Auto Immune Pancreatitis (S-MRCP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Johns Hopkins University
Sponsor:
Collaborator:
ChiRhoClin, Inc.
Information provided by (Responsible Party):
Atif Zaheer, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01845467
First received: April 15, 2013
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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.


Condition Phase
Cellular Diagnosis, Pancreatic Cancer
Autoimmune Pancreatitis
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of Secretin Assisted Dynamic MRCP in the Diagnosis and Follow up of Auto Immune Pancreatitis(AIP)

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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. The patients will be managed as part of standard of care.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01845467

Contacts
Contact: Atif Zaheer, M.D. 4109557396 azaheer1@jhmi.edu
Contact: Venkata S Akshintala, M.D. 4106246955 vakshin1@jhu.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205
Principal Investigator: Atif Zaheer, M.D.         
Sub-Investigator: Vikesh K Singh, M.D.         
Sub-Investigator: Venkata S Akshintala, M.D.         
Sponsors and Collaborators
Johns Hopkins University
ChiRhoClin, Inc.
Investigators
Principal Investigator: Atif Zaheer, M.D. Johns Hopkins University
  More Information

Publications:
Responsible Party: Atif Zaheer, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01845467     History of Changes
Other Study ID Numbers: SMRCP-ChiRhoClin-JHMI
Study First Received: April 15, 2013
Last Updated: April 30, 2013
Health Authority: United States: The Johns Hopkins Medicine Institutional Review Board

Keywords provided by Johns Hopkins University:
Secretin MRCP, diagnosis, Autoimmune pancreatitis

Additional relevant MeSH terms:
Pancreatic Neoplasms
Pancreatitis
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Secretin
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014