Non-invasive MRI to Quantify the Effect of Secretin on Pancreatic Blood Flow and Perfusion in Healthy Volunteers

October 13, 2011 updated by: University of Nottingham

The Use of Non-invasive MRI to Quantify the Effect of Secretin on Pancreatic Blood Flow and Perfusion in Healthy Volunteers

Alterations in pancreatic blood have been implicated in pancreatic inflammation and pain. Several modalities have been used to assess pancreatic blood flow although some of these methods are invasive, use ionising radiation or intravenous contrast media. This is the first study to utilise non-invasive magnetic resonance imaging to quantify flow within arteries supplying the pancreas and pancreatic perfusion is response to secretin stimulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background An alteration in pancreatic blood flow may be important in a number of clinical conditions. Reduction of blood flow is seen in patients with acute and chronic pancreatitis and the quantification of perfusion may be useful in the management of pancreatic malignancy and assessment of pancreatic transplants. Unfortunately, the measurement of pancreatic blood flow is technically difficult due to the anatomical location of the organ and complex blood supply.

The pancreas receives its blood supply from a rich plexus of arteries but the foremost arterial supply arises from the splenic and pancreaticoduodenal arteries, both superior and inferior.

Various methods have been used in an attempt to quantify the blood flow but all have potential drawbacks. The use of endoscopic and laparoscopic methods are invasive as is the use of intravenous contrast media. Furthermore, the use of computed tomography exposes patients to ionising radiation.

As the arterial supply to the pancreas is complex, measuring single artery flow does not provide an accurate measure of perfusion. Furthermore, as some of the named branches supplying the arteries are secondary or tertiary branches of more major vessels, narrow arterial diameter precludes accurate radiological measurement. Arterial Spin Labelling (ASL) magnetic resonance imaging (MRI), on the other hand is a validated technique allowing accurate measurement of visceral perfusion.

Transient physiological changes occur in pancreatic blood flow secondary to increased demands such as eating. Changes can also be induced pharmacologically using pancreatic stimulating agents, such as secretin. This naturally occuring peptide is produced within the S cells of the proximal small bowel mucosa. It causes an increase in bicarbonate secretion by the duct cells of the pancreas and biliary tract via an oxygen dependant cyclic AMP mediated pathway. Secretin has been used previously to assess alterations in blood flow and is used clinically in the assessment of sphincter of Oddi dysfunction in conjunction with magnetic resonance cholangiopancreatography.

Aims and Hypothesis This pilot study aims to evaluate the MRI techniques of measuring pancreatic perfusion and blood flow at rest and during secretin stimulation in healthy volunteers, prior to an evaluation in the chronic pancreatitis patient group.

Experimental protocol and methods Volunteers will be recruited from advertisements placed on designated University of Nottingham notice boards. All volunteers will complete a questionnaire of abdominal symptoms, Hospital anxiety and depression scale (HAD) and the patient health questionnaire 15 (PhQ15). Each volunteers will attend the 1.5T Brain and Body Imaging centre on the University of Nottingham Campus for all study evaluations.

Following an overnight fast a baseline MRI scan will be undertaken. Volunteers will then receive 1 IU/kg of secretin (Sanochemia Pharmazeutika AG, Wien, Germany) via the intravenous route over 3 minutes.

The volunteers will then be scanned again at 5, 10, 20, 30 and 40 min following the stimulus.

MRI scanning will be carried out on the Philips 1.5T Achieva MRI scanner located in the Brain and Body Imaging Centre University of Nottingham. The volunteers will be placed supine in the scanner with a receiver body coil wrapped around the abdomen. All image analysis will be carried out using commercial and/or in house packages.

Outcome measures at baseline and following secretin stimulation:

  1. Pancreatic perfusion
  2. Superior mesenteric artery blood flow
  3. Gastroduodenal artery blood flow
  4. Hepatic artery blood flow
  5. Splenic artery blood flow

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
        • University of Nottingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male
  • Healthy
  • Able to give informed consent

Exclusion Criteria:

  • Current illness
  • Contraindications to magnetic resonance imaging

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Secretin
Drug: Secretin
Secretin 1 IU/kg over 3 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pancreatic perfusion
Time Frame: 0, 5, 10, 20, 30 and 40 min
Overall perfusion of the pancreas
0, 5, 10, 20, 30 and 40 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Superior mesenteric artery blood flow
Time Frame: 0, 5, 10, 20, 30 and 40 min
Blood flow in the superior mesenteric artery
0, 5, 10, 20, 30 and 40 min
Gastroduodenal artery blood flow
Time Frame: 0, 5, 10, 20, 30 and 40 min
Blood flow in the gastroduodenal artery
0, 5, 10, 20, 30 and 40 min
Hepatic artery blood flow
Time Frame: 0, 5, 10, 20, 30 and 40 min
Blood flow in the hepatic artery
0, 5, 10, 20, 30 and 40 min
Splenic artery blood flow
Time Frame: 0, 5, 10, 20, 30 and 40 min
Blood flow in the splenic artery
0, 5, 10, 20, 30 and 40 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Investigators

  • Principal Investigator: John Simpson, PhD FRCS, University of Nottingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

October 10, 2011

First Submitted That Met QC Criteria

October 13, 2011

First Posted (Estimate)

October 14, 2011

Study Record Updates

Last Update Posted (Estimate)

October 14, 2011

Last Update Submitted That Met QC Criteria

October 13, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D/07/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Pancreatitis

Clinical Trials on Secretin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe