Comparison of Secretin-enhanced Magnetic Resonance Cholangiopancreatography (S-MRCP) to Endoscopic Pancreatic Function Test (ePFT) in Diagnosing Pancreatic Exocrine Insufficiency

Not Applicable

Withdrawn

• Conditions: Pancreatic Cancer
• Interventions: Drug: Synthetic Human Secretin

• Registration Number: NCT01094600
• Lead Sponsor: Columbia University

Brief Summary

The aim of our study is to evaluate S-MRCP, in comparison to direct pancreatic function, to measure pancreatic exocrine function in patients who have symptoms suspicious for insufficiency. We hypothesize that S-MRCP imaging parameters will correlate well with the direct pancreatic exocrine functioning.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2010-03-25
• Study First Submitted QC: 2010-03-26
• Study First Posted: 2010-03-29
• Status Verified: 2012-06
• Study Start: 2012-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2012-06-29
• Last Update Posted: 2012-07-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Secretin	Synthetic Human Secretin	Single arm (open label).

Primary Outcome Measures

Name	Time	Method
Primary outcome: correlation between S-MRCP with ePFT	30 days	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.