Efficacy of Secretin MRCP in the Diagnosis and Follow up of Auto Immune Pancreatitis
| Status: | Withdrawn |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 19 - 90 |
| Updated: | 1/12/2019 |
| Start Date: | February 2013 |
| End Date: | December 2018 |
Efficacy of Secretin Assisted Dynamic MRCP in the Diagnosis and Follow up of Auto Immune Pancreatitis(AIP)
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.
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.
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.
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
We found this trial at
1
site
1800 Orleans St.
Baltimore, Maryland 21287
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Atif Zaheer, M.D.
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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