Chronic PancreatitisPhase 1/2NCT02458118
Pancreatic Perfusion Using Secretin and MRI
A Phase 1/2 study testing Secretin in people with Chronic Pancreatitis, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- Secretin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2012to Jun 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with chronic pancreatitis (as defined by the Cambridge criteria)
Who cannot join
- Allergy to secretin
- Claustraphobia
- Refusal to consent for the study
- MRI contraindications e.g. pacemaker, artificial heart valve
- Previous abdominal surgery except appendectomy or hernia repair
- History of chronic abdominal pain from causes other than pancreatitis eg. inflammatory bowel or coeliac disease
- Pregnant women (safety concerns from injection of secretin)
- Patients younger than 18 years of age
Trial locations and contacts
1 site in 1 country.
John Simpson contact
United Kingdom1 site, 1 recruiting
- Recruiting
1.5T Brain and Body Imaging centre, University of Nottingham Campus
Nottingham, Nottinghamshire, NG7 2RD
Eleanor Cox, PhD, 0115 9514747, spmmrc@nottingham.ac.uk
Dileep Lobo, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pancreatitis
- Being tested
- Secretin
- Keywords
- chronic, pancreatitis, secretin, Blood flow
- Medical subject headings
- Pancreatitis, Chronic, Bronchiolitis Obliterans Syndrome, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecretinDrug
Also called Secrelux" Sanochemia Pharmazeutika AG, Wein, Germany)
Secretin 1 IU/kg over 3 min
| Study group | Role | What they receive |
|---|---|---|
| Secretin | Experimental | Secretin 1 IU/kg over 3 min Receives: Drug: Secretin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow to pancreas as measured by arterial spin labelling MRI
Measured: 1.5 hours
Secondary outcomes (3)
Change in blood flow to pancreas after intravenous secretin
Measured: 1.5 hours
Pancreatic diffusion
Measured: T 0, 5, 10, 20, 30, 40
Pancreatic volume
Measured: T 0, 5, 20, 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startJun 2012
- Primary completionApr 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Simpson, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458118
- Sponsor's protocol ID
- 11109
- Status last verified
- Feb 2016
- First submitted
- 27 May 2015
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Andren-Sandberg A, Hoem D, Gislason H. Pain management in chronic pancreatitis. Eur J Gastroenterol Hepatol. 2002 Sep;14(9):957-70. doi: 10.1097/00042737-200209000-00006. No abstract available.
PubMed 12352215Jupp J, Fine D, Johnson CD. The epidemiology and socioeconomic impact of chronic pancreatitis. Best Pract Res Clin Gastroenterol. 2010 Jun;24(3):219-31. doi: 10.1016/j.bpg.2010.03.005.
PubMed 20510824Drewes AM, Krarup AL, Detlefsen S, Malmstrom ML, Dimcevski G, Funch-Jensen P. Pain in chronic pancreatitis: the role of neuropathic pain mechanisms. Gut. 2008 Nov;57(11):1616-27. doi: 10.1136/gut.2007.146621. Epub 2008 Jun 19.
PubMed 18566105Ceyhan GO, Demir IE, Maak M, Friess H. Fate of nerves in chronic pancreatitis: Neural remodeling and pancreatic neuropathy. Best Pract Res Clin Gastroenterol. 2010 Jun;24(3):311-22. doi: 10.1016/j.bpg.2010.03.001.
PubMed 20510831Lewis MP, Lo SK, Reber PU, Patel A, Gloor B, Todd KE, Toyama MT, Sherman S, Ashley SW, Reber HA. Endoscopic measurement of pancreatic tissue perfusion in patients with chronic pancreatitis and control patients. Gastrointest Endosc. 2000 Feb;51(2):195-9. doi: 10.1016/s0016-5107(00)70417-2.
PubMed 10650267Ishida H, Makino T, Kobayashi M, Tsuneoka K. Laparoscopic measurement of pancreatic blood flow. Endoscopy. 1983 May;15(3):107-10. doi: 10.1055/s-2007-1021480.
PubMed 6223807Kubo S, Yamamoto K, Magata Y, Iwasaki Y, Tamaki N, Yonekura Y, Konishi J. Assessment of pancreatic blood flow with positron emission tomography and oxygen-15 water. Ann Nucl Med. 1991 Nov;5(4):133-8. doi: 10.1007/BF03164627.
PubMed 1797067D'Onofrio M, Gallotti A, Principe F, Mucelli RP. Contrast-enhanced ultrasound of the pancreas. World J Radiol. 2010 Mar 28;2(3):97-102. doi: 10.4329/wjr.v2.i3.97.
PubMed 21160942Miles KA, Hayball MP, Dixon AK. Measurement of human pancreatic perfusion using dynamic computed tomography with perfusion imaging. Br J Radiol. 1995 May;68(809):471-5. doi: 10.1259/0007-1285-68-809-471.
PubMed 7788231Bali MA, Metens T, Denolin V, De Maertelaer V, Deviere J, Matos C. Pancreatic perfusion: noninvasive quantitative assessment with dynamic contrast-enhanced MR imaging without and with secretin stimulation in healthy volunteers--initial results. Radiology. 2008 Apr;247(1):115-21. doi: 10.1148/radiol.2471070685. Epub 2008 Feb 21.
PubMed 18292476Schraml C, Schwenzer NF, Martirosian P, Claussen CD, Schick F. Perfusion imaging of the pancreas using an arterial spin labeling technique. J Magn Reson Imaging. 2008 Dec;28(6):1459-65. doi: 10.1002/jmri.21564.
PubMed 19025955Hirshberg B, Qiu M, Cali AM, Sherwin R, Constable T, Calle RA, Tal MG. Pancreatic perfusion of healthy individuals and type 1 diabetic patients as assessed by magnetic resonance perfusion imaging. Diabetologia. 2009 Aug;52(8):1561-5. doi: 10.1007/s00125-009-1406-8. Epub 2009 Jun 3.
PubMed 19488737
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess Pancreatic Blood Flow at Rest and During Stimulation Using Magnetic Resonance Imaging (fMRI) in Patients With Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT02458118
- Acronym / sponsor ID
- 11109
- Conditions
- Chronic Pancreatitis
- Keywords
- chronic, pancreatitis, secretin, Blood flow
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 29 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Secretin | Experimental | Drug: SecretinSecretin 1 IU/kg over 3 min |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with chronic pancreatitis (as defined by the Cambridge criteria)
Key exclusion criteria (8 listed)
- Allergy to secretin
- Claustraphobia
- Refusal to consent for the study
- MRI contraindications e.g. pacemaker, artificial heart valve
- Previous abdominal surgery except appendectomy or hernia repair
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SecretinAlso: Secrelux" Sanochemia Pharmazeutika AG, Wein, Germany)Secretin 1 IU/kg over 3 min | Drug | Secretin |
Primary outcome
Blood flow to pancreas as measured by arterial spin labelling MRI
Time frame: 1.5 hours
3 secondary outcomes
Change in blood flow to pancreas after intravenous secretin
Time frame: 1.5 hours
Pancreatic diffusion
Time frame: T 0, 5, 10, 20, 30, 40
Pancreatic volume
Time frame: T 0, 5, 20, 40
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Background: PubMed 12352215Andren-Sandberg A, Hoem D, Gislason H. Pain management in chronic pancreatitis. Eur J Gastroenterol Hepatol. 2002 Sep;14(9):957-70. doi: 10.1097/00042737-200209000-00006. No abstract available.
- Background: PubMed 20510824Jupp J, Fine D, Johnson CD. The epidemiology and socioeconomic impact of chronic pancreatitis. Best Pract Res Clin Gastroenterol. 2010 Jun;24(3):219-31. doi: 10.1016/j.bpg.2010.03.005.
- Background: PubMed 18566105Drewes AM, Krarup AL, Detlefsen S, Malmstrom ML, Dimcevski G, Funch-Jensen P. Pain in chronic pancreatitis: the role of neuropathic pain mechanisms. Gut. 2008 Nov;57(11):1616-27. doi: 10.1136/gut.2007.146621. Epub 2008 Jun 19.
- Background: PubMed 20510831Ceyhan GO, Demir IE, Maak M, Friess H. Fate of nerves in chronic pancreatitis: Neural remodeling and pancreatic neuropathy. Best Pract Res Clin Gastroenterol. 2010 Jun;24(3):311-22. doi: 10.1016/j.bpg.2010.03.001.
- Background: PubMed 10650267Lewis MP, Lo SK, Reber PU, Patel A, Gloor B, Todd KE, Toyama MT, Sherman S, Ashley SW, Reber HA. Endoscopic measurement of pancreatic tissue perfusion in patients with chronic pancreatitis and control patients. Gastrointest Endosc. 2000 Feb;51(2):195-9. doi: 10.1016/s0016-5107(00)70417-2.
- Background: PubMed 6223807Ishida H, Makino T, Kobayashi M, Tsuneoka K. Laparoscopic measurement of pancreatic blood flow. Endoscopy. 1983 May;15(3):107-10. doi: 10.1055/s-2007-1021480.
- Background: PubMed 1797067Kubo S, Yamamoto K, Magata Y, Iwasaki Y, Tamaki N, Yonekura Y, Konishi J. Assessment of pancreatic blood flow with positron emission tomography and oxygen-15 water. Ann Nucl Med. 1991 Nov;5(4):133-8. doi: 10.1007/BF03164627.
- Background: PubMed 21160942D'Onofrio M, Gallotti A, Principe F, Mucelli RP. Contrast-enhanced ultrasound of the pancreas. World J Radiol. 2010 Mar 28;2(3):97-102. doi: 10.4329/wjr.v2.i3.97.
- Background: PubMed 7788231Miles KA, Hayball MP, Dixon AK. Measurement of human pancreatic perfusion using dynamic computed tomography with perfusion imaging. Br J Radiol. 1995 May;68(809):471-5. doi: 10.1259/0007-1285-68-809-471.
- Background: PubMed 18292476Bali MA, Metens T, Denolin V, De Maertelaer V, Deviere J, Matos C. Pancreatic perfusion: noninvasive quantitative assessment with dynamic contrast-enhanced MR imaging without and with secretin stimulation in healthy volunteers--initial results. Radiology. 2008 Apr;247(1):115-21. doi: 10.1148/radiol.2471070685. Epub 2008 Feb 21.
- Background: PubMed 19025955Schraml C, Schwenzer NF, Martirosian P, Claussen CD, Schick F. Perfusion imaging of the pancreas using an arterial spin labeling technique. J Magn Reson Imaging. 2008 Dec;28(6):1459-65. doi: 10.1002/jmri.21564.
- Background: PubMed 19488737Hirshberg B, Qiu M, Cali AM, Sherwin R, Constable T, Calle RA, Tal MG. Pancreatic perfusion of healthy individuals and type 1 diabetic patients as assessed by magnetic resonance perfusion imaging. Diabetologia. 2009 Aug;52(8):1561-5. doi: 10.1007/s00125-009-1406-8. Epub 2009 Jun 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Simpson contact
John Simpson principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Secretin in people with Chronic Pancreatitis, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Simpson (j.simpson@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood flow to pancreas as measured by arterial spin labelling MRI (time frame: 1.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02458118, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.