Comparison of Secretin Enhanced MRCP to Endoscopic Pancreatic Function Testing in Diagnosing Exocrine Insufficiency in Patients Who Have Undergone Pancreas Cancer Resection
18 Years
75 Years
Both
Pancreatic Cancer
Trial Information
Comparison of Secretin Enhanced MRCP to Endoscopic Pancreatic Function Testing in Diagnosing Exocrine Insufficiency in Patients Who Have Undergone Pancreas Cancer Resection
Surgical resection offers the only hope of cure for pancreatic adenocarcinoma. While
perioperative mortality rates have declined in recent years, pancreatic resection is still
associated with significant postoperative malnutrition, maldigestion, and glucose
intolerance, mostly as a result of pancreatic insufficiency. Quantifying individual
pancreatic function remains a challenge, but is essential in improving the survival and
quality of life of pancreatic cancer patients. Secretin-enhanced magnetic resonance
cholangiopancreatography (S-MRCP) has recently emerged as a widely-accepted noninvasive
technique to assess morphological changes in pancreatic ducts, as well as functional
secretory capacity of the gland. The aim of our study is to evaluate S-MRCP as a means to
evaluate for pancreatic exocrine insufficiency. This will be a prospective study of twelve
patients who have undergone pancreatic resection and who have symptoms of abdominal pain,
steatorrhea or weight loss. We will be comparing quantitative parameters of S-MRCP (maximal
change in pancreatic duct diameter and volume before and after secretin administration) with
endoscopic pancreatic function testing (maximal bicarbonate concentration in duodenal
aspirate after secretin administration).
Inclusion Criteria:
- 18 years of age and older
- Tissue-confirmed diagnosis of pancreatic adenocarcinoma
- Undergone surgical resection for adenocarcinoma no less than 3 months prior to
enrollment
- Report significant abdominal pain/bloating or steatorrhea >3x/week or demonstrate
weight loss corresponding to >10% of pre-surgery BMI.
- Scheduled for EGD/EUS to investigate the above clinical indicators.
Exclusion Criteria:
- History of any radiation therapy to the abdomen prior to surgery
- Any contraindication to MRI, including but not limited to implanted metal devices
(e.g. pacemaker, berry aneurysm clips, neural stimulator, cochlear implants, or metal
in the eye)
- Presence of pancreatic duct stent
- Treatment with an investigational drug within 1 month prior to the day of the study
drug administration
- Current enrollment in any other interventional study
- Creatinine greater than 2.0
- Significant liver disease, liver masses, or evidence of portal hypertension
- Pregnancy
- History of sensitivity to secretin
- Unwilling or unable to sign informed consent
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Primary outcome: correlation between S-MRCP with ePFT
Outcome Description:
The primary outcome that we will be measuring will be correlation between duodenal filling on S-MRCP (expressed as percent of duct volume change from baseline and maximal values following secretin administration) with maximal bicarbonate concentration from ePFT.
Outcome Time Frame:
30 days
Safety Issue:
No
Principal Investigator
Harold Frucht, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Columbia University
Authority:
United States: Food and Drug Administration
Study ID:
AAAC7911
NCT ID:
NCT01094600
Start Date:
June 2012
Completion Date:
June 2012
Related Keywords:
- Pancreatic Cancer
- Pancreatic cancer
- Pancreatic resection
- Synthetic human secretin
- Secretin-enhanced MRCP
- Endoscopic pancreatic function test
- Pancreatic exocrine insufficiency
- Pancreatic Neoplasms
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