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

NCT01845467 | Withdrawn DMC

• 1 other identifier: NA_00068830
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cellular Diagnosis, Pancreatic Cancer; Autoimmune Pancreatitis

Keywords

Secretin MRCP, diagnosis, Autoimmune pancreatitis

Outcome Measures

Primary Outcomes (1)

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

  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.

  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

Secondary Outcomes (1)

• Efficacy of Secretin MRCP in monitoring therapeutic improvement in AIP patients on steroid trial

  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

Study Arms (1)

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.

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Male or female \>18 years of age.
• Patients suspected of having AIP based on prior clinical work up

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• ChiRhoClin, Inc.: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Related Publications (3)

• 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.

  PMID: 14687819 BACKGROUND

• 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.

  PMID: 19789959 BACKGROUND

• 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.

  PMID: 19410017 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms; Autoimmune Pancreatitis; Disease

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Pancreatitis, Chronic; Pancreatitis; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Atif Zaheer, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2013
• First Posted: May 3, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

US (1)