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Early MRI in Acute GallstonE Disease (E-MAGED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03709030
Recruitment Status : Not yet recruiting
First Posted : October 17, 2018
Last Update Posted : October 17, 2018
Sponsor:
Collaborator:
Oxford University Hospitals NHS Trust
Information provided by (Responsible Party):
Perspectum Diagnostics Ltd

Brief Summary:

This pilot study aims to determine the utility of direct Magnetic Resonance Cholangiopancreatography (MRCP) in the assessment of suspected acute gallstone disease presentations. This will take the form of a randomized controlled trial, the design of which is based on recent internal audit data which indicated that a high proportion of patients ultimately require MRCP prior to diagnosis, treatment and discharge, and suggested that early scan may improve overall costs and outcomes. Patients with symptoms and signs suggestive of suspected gallstone disease and deranged liver function tests/amylase (i.e. suggestive of a potentially obstructive gallstone disease), will be enrolled across the full range of 'front-door' locations for surgical presentations within the hospital (Emergency Department, Surgical Emergency Unit, Ambulatory Assessment Unit), and randomized to one of two diagnostic pathways which are both existing variations in current clinical care:

  1. MRCP is used as the first mode of imaging;
  2. following a standard care model (ultrasound then MRCP if deemed appropriate). An assessment will then be undertaken of the cost-effectiveness of early MRCP versus standard care, using the primary outcome measure of cost to diagnostic scan report calculated using hospital episode statistics (HES), with secondary outcome measures to assess the overall utility which include length of stay, time to diagnosis, overall cost of admission using HES, in-hospital complications, Patient Reported Outcome Measures (PROMs), readmission and re-attendance rates (ED/GP), and service/radiology costs.

Condition or disease Intervention/treatment Phase
Cholecystitis; Acute, Choledocholithiasis Diagnostic Test: magnetic resonance cholangiopancreatography (MRCP) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised Controlled Trial
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Determining the Utility of Direct Access Magnetic Resonance Cholangiopancreatography (MRCP) in the Assessment of Suspected Acute Gallstone Disease Presentations
Estimated Study Start Date : November 26, 2018
Estimated Primary Completion Date : November 26, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones

Arm Intervention/treatment
No Intervention: Standard Care
Patients with suspected acute gallstone disease and deranged liver function tests/amylase will be investigated with abdominal ultrasound as first line imaging, as per standard care
Experimental: Direct MRCP
Patients with suspected acute gallstone disease and deranged liver function tests/amylase will be investigated with magnetic resonance cholangiopancreatography (MRCP) as first-line imaging
Diagnostic Test: magnetic resonance cholangiopancreatography (MRCP)
magnetic resonance imaging of liver, gall bladder, pancreas




Primary Outcome Measures :
  1. Cost to diagnosis [ Time Frame: 3 months ]
    Total cost of admission up to the final diagnostic scan report


Secondary Outcome Measures :
  1. Overall cost of admission [ Time Frame: 3 months ]
    Mean total cost of hospital admission for patients undergoing direct MRCP

  2. Length of stay [ Time Frame: 3 months ]
    Mean length of hospital admission for patients undergoing direct MRCP

  3. Time to final diagnostic scan report [ Time Frame: 3 months ]
    Mean time to final diagnostic scan report for patients undergoing direct MRCP

  4. In-hospital complications [ Time Frame: 3 months ]
    Percentage rate of patient-reported significant 30-day complications throughout study duration

  5. readmission and re-attendance rates [ Time Frame: 3 months ]
    Percentage rate of readmission/re-attendance throughout study duration



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 16 years or above.
  • Suspected gallstone/biliary disease presenting with acute abdominal pain AND
  • At least one of the following blood test results to reflect abnormal liver function;

    • Bilirubin > 23 IU/L
    • Alanine Aminotransferase > 50 IU/L
    • Aspartate Aminotransferase >46 IU/L
    • Gamma Glutamyl Transpeptidase > 44 IU/L
    • Amylase > 138 IU/L

Exclusion Criteria:

  • Pregnant or nursing (lactating) women
  • Previous diagnosis of chronic pancreatitis/hepatitis or chronic alcohol abuse
  • Patients with contraindications to MR imaging
  • Unstable disease as per judgment of the investigator which would render the patient unsuitable for MR imaging
  • If not suitable for study intervention on admission - e.g. requiring immediate ERCP/surgery, or ICU admission
  • Previous enrolment in the study (i.e. on repeat attendance to hospital)
  • Already admitted to hospital for more than 16 hours

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709030


Contacts
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Contact: Soubera Rymell 01865655343 soubera.rymell@perspectum-diagnostics.com
Contact: Alex Novak, BSc MBChB 07944653970 alex.novak@ouh.nhs.uk

Sponsors and Collaborators
Perspectum Diagnostics Ltd
Oxford University Hospitals NHS Trust
Investigators
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Principal Investigator: Alex Novak, BSc MBChB Oxford University Hospitals NHS Trust

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Responsible Party: Perspectum Diagnostics Ltd
ClinicalTrials.gov Identifier: NCT03709030     History of Changes
Other Study ID Numbers: 13946
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cholecystitis
Acalculous Cholecystitis
Gallstones
Choledocholithiasis
Cholelithiasis
Cholecystolithiasis
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Calculi
Pathological Conditions, Anatomical
Common Bile Duct Diseases
Bile Duct Diseases