NCT01452217

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2011

Completed
Last Updated

October 14, 2011

Status Verified

October 1, 2011

Enrollment Period

1 year

First QC Date

October 10, 2011

Last Update Submit

October 13, 2011

Conditions

Chronic Pancreatitis

Keywords

PancreasChronic pancreatitisPerfusionBlood flowMagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • Pancreatic perfusion

    Overall perfusion of the pancreas

    0, 5, 10, 20, 30 and 40 min

Secondary Outcomes (4)

  • Superior mesenteric artery blood flow

    0, 5, 10, 20, 30 and 40 min

  • Gastroduodenal artery blood flow

    0, 5, 10, 20, 30 and 40 min

  • Hepatic artery blood flow

    0, 5, 10, 20, 30 and 40 min

  • Splenic artery blood flow

    0, 5, 10, 20, 30 and 40 min

Study Arms (1)

Secretin

EXPERIMENTAL
Drug: Secretin

Interventions

SecretinDRUG

Secretin 1 IU/kg over 3 min

Secretin

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • Healthy
  • Able to give informed consent

You may not qualify if:

  • Current illness
  • Contraindications to magnetic resonance imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (13)

  • Delrue L, Blanckaert P, Mertens D, Van Meerbeeck S, Ceelen W, Duyck P. Tissue perfusion in pathologies of the pancreas: assessment using 128-slice computed tomography. Abdom Imaging. 2012 Aug;37(4):595-601. doi: 10.1007/s00261-011-9783-0.

    PMID: 21811851BACKGROUND

  • Tsushima Y, Kusano S. Age-dependent decline in parenchymal perfusion in the normal human pancreas: measurement by dynamic computed tomography. Pancreas. 1998 Aug;17(2):148-52. doi: 10.1097/00006676-199808000-00006.

    PMID: 9700945BACKGROUND

  • Ishida 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.

    PMID: 6223807BACKGROUND

  • Lewis 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.

    PMID: 10650267BACKGROUND

  • Bali 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.

    PMID: 18292476BACKGROUND

  • Hacki WH. Secretin. Clin Gastroenterol. 1980 Sep;9(3):609-32. No abstract available.

    PMID: 7000396BACKGROUND

  • Bize PE, Platon A, Becker CD, Poletti PA. Perfusion measurement in acute pancreatitis using dynamic perfusion MDCT. AJR Am J Roentgenol. 2006 Jan;186(1):114-8. doi: 10.2214/AJR.04.1416.

    PMID: 16357388BACKGROUND

  • Hirota M, Tsuda M, Tsuji Y, Kanno A, Kikuta K, Kume K, Hamada S, Unno J, Ito H, Ariga H, Chiba T, Masamune A, Satoh K, Shimosegawa T. Perfusion computed tomography findings of autoimmune pancreatitis. Pancreas. 2011 Nov;40(8):1295-301. doi: 10.1097/MPA.0b013e31821fcc4f.

    PMID: 21705954BACKGROUND

  • Cuthbertson CM, Christophi C. Disturbances of the microcirculation in acute pancreatitis. Br J Surg. 2006 May;93(5):518-30. doi: 10.1002/bjs.5316.

    PMID: 16607683BACKGROUND

  • Foitzik T, Eibl G, Hotz HG, Faulhaber J, Kirchengast M, Buhr HJ. Endothelin receptor blockade in severe acute pancreatitis leads to systemic enhancement of microcirculation, stabilization of capillary permeability, and improved survival rates. Surgery. 2000 Sep;128(3):399-407. doi: 10.1067/msy.2000.107104.

    PMID: 10965310BACKGROUND

  • Drewes 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.

    PMID: 18566105BACKGROUND

  • Terrace JD, Paterson HM, Garden OJ, Parks RW, Madhavan KK. Results of decompression surgery for pain in chronic pancreatitis. HPB (Oxford). 2007;9(4):308-11. doi: 10.1080/13651820701481497.

    PMID: 18345310BACKGROUND

  • Heverhagen JT, Wagner HJ, Ebel H, Levine AL, Klose KJ, Hellinger A. Pancreatic transplants: noninvasive evaluation with secretin-augmented mr pancreatography and MR perfusion measurements--preliminary results. Radiology. 2004 Oct;233(1):273-80. doi: 10.1148/radiol.2331031188.

    PMID: 15454624BACKGROUND

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

Secretin

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptide HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • John Simpson, PhD FRCS

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2011

First Posted

October 14, 2011

Study Start

September 1, 2010

Primary Completion

September 1, 2011

Study Completion

October 1, 2011

Last Updated

October 14, 2011

Record last verified: 2011-10

Locations

GB(1)