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A Pilot Study on the Using a Newer Computed Tomography (CT) Based Technique for the Detection of Altered Bowel Blood Flow Among Patients Suffering From Chronic Mesenteric Ischemia During Meal Digestion.

Primary Purpose

Bowel; Ischemic, Chronic, Tomography, X-Ray Computed, Dual-energy CT

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dual-energy CT
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bowel; Ischemic, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed CMI patients planned for endovascular stent placement treatment

Exclusion Criteria:

  • Noncomplete dataset
  • Allergies to contrast agents
  • Suboptimal CT images
  • Issues related to the administration of the calorie drink

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Pre- and post-operative DECT scans on CMI patients

    Secondary Outcome Measures

    Full Information

    First Posted
    March 9, 2021
    Last Updated
    March 9, 2021
    Sponsor
    Rigshospitalet, Denmark
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04794959
    Brief Title
    A Pilot Study on the Using a Newer Computed Tomography (CT) Based Technique for the Detection of Altered Bowel Blood Flow Among Patients Suffering From Chronic Mesenteric Ischemia During Meal Digestion.
    Official Title
    Detection of Bowel Hypoperfusion Among Chronic Mesenteric Ischemia Patients During Meal Digestion Using Dual-Energy CT (DECT) - A Pilot Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2021 (Anticipated)
    Primary Completion Date
    June 2022 (Anticipated)
    Study Completion Date
    June 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rigshospitalet, Denmark

    4. Oversight

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

    5. Study Description

    Brief Summary
    Chronic meseteric ischemia (CMI) is a disease characterized by an insufficient blood supply to the intestines due to a narrowing (stenosis) of one or multiple intestinal arteries. The primary symptom is abdominal pain especially during meal digestion. Currently the diagnosis of CMI is heavily reliant on the exclusion of differential diagnoses. With this study we wish to evaluate whether a newer CT technology called dual-energy CT (DECT) may be able to visualize this altered blood flow during meal consumption.
    Detailed Description
    CMI is a relatively rare condition mainly affecting elderly patients >60 years old. CMI is characterized by an insufficient blood supply to the intestines due to a narrowing (stenosis) of one or multiple intestinal arteries. The main symptoms associated with CMI are abdominal pain following mealtimes and weight loss. Diagnosis for CMI is difficult as >10% of all elderly patients have stenotic changes in their intestinal arteries, however only a fraction of these patients are symptomatic. The diagnosis of CMI is therefore mainly based on the clinical history and evaluation. The challenging diagnosis is most likely the main contributing factor to why five to 19% of patients experience no symptomatic relief following surgical treatment. The surgical treatment consists of either open surgical bypass or, more commonly, endovascular stent placement, opening the stenotic artery. Endovascular stent placement for patients with symptomatic CMI is a common procedure at the Department of Diagnostic Radiology and Department of Vascular Surgery, Rigshospitalet, with approximately 60 patients undergoing the procedure annually. Patients undergo a preoperative CT scan including a non-contrast and arterial phase scan to evaluate the abdominal arterial vessels and the degree of stenosis, however the bowel wall is not routinely evaluated. This is mainly due to the fact that mesenteric blood flow is adequate during times of fasting, however insufficient blood flow may occur at times of peak demand i.e. during digestion of a meal. DECT has shown improved conspicuity for bowel ischemia using monoenergetic images and allows for iodine selective maps which have been used in the evaluation of pulmonary emboli. To our knowledge, there are no current studies that have investigated applications of DECT in the evaluation of CMI. We intend to investigate whether it is possible to visualize bowel hypoperfusion using DECT following administration of a standardized meal.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bowel; Ischemic, Chronic, Tomography, X-Ray Computed, Dual-energy CT

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Outcomes Assessor
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Dual-energy CT
    Intervention Description
    CMI patients planned for endovascular stent placement will be contacted and informed about this study prior to their procedure. If they wish to take part in the study, then a date for a pre-operative DECT scan will be arranged. Before scanning the patient will be given a standardized calorie dense drink (Nutridrink). This will take place one week prior to their surgical procedure. Following the surgical procedure, the patient will undergo another DECT scan before discharge.
    Primary Outcome Measure Information:
    Title
    Pre- and post-operative DECT scans on CMI patients
    Time Frame
    10 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed CMI patients planned for endovascular stent placement treatment Exclusion Criteria: Noncomplete dataset Allergies to contrast agents Suboptimal CT images Issues related to the administration of the calorie drink
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jack J Xu, MD
    Phone
    +4525122159
    Email
    jack.junchi.xu@regionh.dk

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Pilot Study on the Using a Newer Computed Tomography (CT) Based Technique for the Detection of Altered Bowel Blood Flow Among Patients Suffering From Chronic Mesenteric Ischemia During Meal Digestion.

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