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

Primary Purpose

Pancreatic Cancer

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Synthetic Human Secretin

About this trial

This is an interventional diagnostic trial for Pancreatic Cancer focused on measuring Pancreatic cancer, Pancreatic resection, Synthetic human secretin, Secretin-enhanced MRCP, Endoscopic pancreatic function test, Pancreatic exocrine insufficiency

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Secretin

Arm Description

Single arm (open label).

Outcomes

Primary Outcome Measures

Primary outcome: correlation between S-MRCP with ePFT

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01094600

First Posted

March 25, 2010

Last Updated

June 29, 2012

Sponsor

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT01094600

Brief Title

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

Official Title

Comparison of Secretin Enhanced MRCP to Endoscopic Pancreatic Function Testing in Diagnosing Exocrine Insufficiency in Patients Who Have Undergone Pancreas Cancer Resection

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Withdrawn

Study Start Date

June 2012 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Columbia University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

Pancreatic cancer, Pancreatic resection, Synthetic human secretin, Secretin-enhanced MRCP, Endoscopic pancreatic function test, Pancreatic exocrine insufficiency

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Secretin

Arm Type

Experimental

Arm Description

Single arm (open label).

Intervention Type

Drug

Intervention Name(s)

Synthetic Human Secretin

Other Intervention Name(s)

RG1068

Intervention Description

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.

Primary Outcome Measure Information:

Title

Primary outcome: correlation between S-MRCP with ePFT

Description

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Harold Frucht, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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