Pancreatic Perfusion Using Secretin and MRI

February 17, 2016 updated by: University of Nottingham

Study to Assess Pancreatic Blood Flow at Rest and During Stimulation Using Magnetic Resonance Imaging (fMRI) in Patients With Chronic Pancreatitis

The purpose of this study is to assess pancreatic perfusion in patients with chronic pancreatitis at rest and after secretin stimulation and compare this to published data on pancreatic perfusion in normal subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pancreatic blood flow or perfusion is difficult to quantify due to the complex vascular supply to the organ and its retroperitoneal location, adjacent to the abdominal aorta. The pancreas is supplied by the superior gastroduodenal artery from the celiac plexus, branches from the hepatic and splenic arteries, which originate from the celiac plexus, and the inferior gastroduodenal artery, which originates from the superior mesenteric artery. Identifying changes in flow in all these vessels with good spatial and temporal resolution is challenging but important in understanding many of the chronic conditions of the pancreas.

Chronic pancreatitis (CP) is an inflammatory condition of the pancreas leading to irreversible damage to the tissue. It is increasing in incidence in all nations, and is related to rising alcohol consumption and improved diagnostic techniques. In Europe the incidence is approximately 6-7/100,000 population. 73-91% of patients affected are male with an average age of 49-60yrs. Patients affected by CP have a high morbidity, such as diabetes and chronic abdominal and/or post-prandial pain in 80-90%, which required frequent hospital admission, control-drug prescriptions and intervention by specialist hospital services. However the mechanisms of chronic and post-prandial pain for CP patients are not well understood, but tissue ischaemia, inflammation and neurological changes have been proposed. These mechanisms may be inter-related with pancreatic inflammation and neurochemical changes, such as an increase substance P, which can produce vasoconstriction, reducing pancreatic perfusion and worsening ischaemia of intra-pancreatic nerves(3). A greater understanding of the ischaemic and inflammatory mechanisms behind the pain in CP, would greatly enhance the development of treatment for this and other debilitating conditions.

There are a few studies of pancreatic tissue perfusion in humans, those studies which have assessed perfusion have used invasive techniques such as endoscopic or laparoscopic measurement and hydrogen gas clearance methods. Although these methods have demonstrated decreased resting blood flow and little response to secretin stimulation in CP patients compared to healthy controls, the techniques are highly invasive, time consuming and expensive and can cause the participant significant morbidity. This has led to several non-invasive techniques including infusion of oxygen-15 water and positron emission tomography (PET), contrast-material-enhanced trans-abdominal ultrasound (US) or contrast-enhanced dynamic computer tomography (CT). However these techniques involve infusion of an exogenous marker to detect the change in flow rate and often require a radiation exposure or are operator dependant and give poor spatial or temporal resolution, limiting the usefulness of the studies.

MRI is an attractive alternative for the assessment of pancreatic perfusion, providing good spatial and temporal resolution with no radiation exposure. Two methods can be used, Contrast-Enhanced (CE) MRI or Arterial Spin Labelling (ASL) techniques. ASL provides a tool for quantitative assessment of tissue perfusion without the need for contrast administration.

Contrast-enhanced MRI using gadodiamide has been used to explore the changes in pancreatic perfusion with secretin stimulation. This study in 10 healthy volunteers demonstrated that at rest there was a higher blood flow within the body and the tail of the pancreas, compared to the head. With secretin stimulation there was a significant increased perfusion in all regions of the pancreas. ASL techniques, do not require exogenous contrast agents, only two previous studies have measured pancreatic perfusion with ASL, one exploring pancreatic exocrine functions in type 1 diabetics. A recent study at the Nottingham Digestive Diseases Centre on pancreatic perfusion measurement using ASL at baseline and after intravenous secretin stimulation has standardised the MRI technique of measuring pancreatic perfusion.

There are no studies using MRI ASL to measure pancreatic perfusion in patients with chronic pancreatitis after secretin stimulation. This pilot study aims to test the feasibility of using MRI ASL to measure pancreatic perfusion in patients with chronic pancreatitis with a view to perfecting the technique. This will allow future studies comparing pancreatic perfusion in healthy adult controls to patients with chronic pancreatitis thus improving the investigators understanding of the pathophysiology of pain in patients with chronic pancreatitis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2RD
        • Recruiting
        • 1.5T Brain and Body Imaging centre, University of Nottingham Campus
        • Contact:
        • Principal Investigator:
          • Dileep Lobo, PhD
        • Sub-Investigator:
          • Damian Bragg, MBChB
        • Sub-Investigator:
          • Sue Francis, PhD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults with chronic pancreatitis (as defined by the Cambridge criteria)

Exclusion Criteria:

  1. Allergy to secretin
  2. Claustraphobia
  3. Refusal to consent for the study
  4. MRI contraindications e.g. pacemaker, artificial heart valve
  5. Previous abdominal surgery except appendectomy or hernia repair
  6. History of chronic abdominal pain from causes other than pancreatitis eg. inflammatory bowel or coeliac disease
  7. Pregnant women (safety concerns from injection of secretin)
  8. Patients younger than 18 years of age

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Secretin
Secretin 1 IU/kg over 3 min
Drug: Secretin
Secretin 1 IU/kg over 3 min
Other Names:
  • Secrelux" Sanochemia Pharmazeutika AG, Wein, Germany)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Blood flow to pancreas as measured by arterial spin labelling MRI
Time Frame: 1.5 hours
1.5 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in blood flow to pancreas after intravenous secretin
Time Frame: 1.5 hours
1.5 hours
Pancreatic diffusion
Time Frame: T 0, 5, 10, 20, 30, 40
T 0, 5, 10, 20, 30, 40
Pancreatic volume
Time Frame: T 0, 5, 20, 40
T 0, 5, 20, 40

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nottingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John Simpson, 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11109 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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