NCT02458118

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2012

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

February 18, 2016

Status Verified

February 1, 2016

Enrollment Period

3.8 years

First QC Date

May 27, 2015

Last Update Submit

February 17, 2016

Conditions

Chronic Pancreatitis

Keywords

chronicpancreatitissecretinBlood flow

Outcome Measures

Primary Outcomes (1)

  • Blood flow to pancreas as measured by arterial spin labelling MRI

    1.5 hours

Secondary Outcomes (3)

  • Change in blood flow to pancreas after intravenous secretin

    1.5 hours

  • Pancreatic diffusion

    T 0, 5, 10, 20, 30, 40

  • Pancreatic volume

    T 0, 5, 20, 40

Study Arms (1)

Secretin

EXPERIMENTAL

Secretin 1 IU/kg over 3 min

Drug: Secretin

Interventions

SecretinDRUG

Secretin 1 IU/kg over 3 min

Also known as: Secrelux" Sanochemia Pharmazeutika AG, Wein, Germany)
Secretin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1.5T Brain and Body Imaging centre, University of Nottingham Campus

Nottingham, Nottinghamshire, NG7 2RD, United Kingdom

RECRUITING

Related Publications (12)

  • 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.

    PMID: 12352215BACKGROUND

  • Jupp 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.

    PMID: 20510824BACKGROUND

  • 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

  • Ceyhan 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.

    PMID: 20510831BACKGROUND

  • 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

  • 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

  • Kubo 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.

    PMID: 1797067BACKGROUND

  • D'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.

    PMID: 21160942BACKGROUND

  • Miles 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.

    PMID: 7788231BACKGROUND

  • 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

  • Schraml 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.

    PMID: 19025955BACKGROUND

  • Hirshberg 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.

    PMID: 19488737BACKGROUND

MeSH Terms

Conditions

Pancreatitis, ChronicBronchiolitis Obliterans SyndromePancreatitis

Interventions

Secretin

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • John Simpson

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John Simpson

CONTACT

j.simpson@nottingham.ac.uk

Study Design

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

Study Record Dates

First Submitted

May 27, 2015

First Posted

May 29, 2015

Study Start

June 1, 2012

Primary Completion

April 1, 2016

Study Completion

June 1, 2016

Last Updated

February 18, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)