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

NCT ID: NCT01094600

Last Updated: 2012-07-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2012-06-30

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).

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Secretin

Single arm (open label).

Group Type: EXPERIMENTAL

Synthetic Human Secretin

Intervention Type: DRUG

Twelve patients will undergo S-MRCP, at a dose of 0.2 ucg/kg per exam. Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg.

Interventions

Synthetic Human Secretin

Twelve patients will undergo S-MRCP, at a dose of 0.2 ucg/kg per exam. Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg.

Intervention Type: DRUG

Other Intervention Names

RG1068

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harold Frucht, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Other Identifiers

AAAC7911

Identifier Type: -

Identifier Source: org_study_id