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
About this trial
This is an interventional diagnostic trial for Bowel; Ischemic, Chronic
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
Sites / Locations
Outcomes
Primary Outcome Measures
Pre- and post-operative DECT scans on CMI patients
Secondary Outcome Measures
Full Information
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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