Bowel; Ischemic, ChronicNCT04794959
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.
A study testing Dual-energy CT in people with Bowel; Ischemic, Chronic and Tomography, X-Ray Computed, run by Copenhagen University Hospital, Rigshospitalet.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel; Ischemic, Chronic, Tomography, X-Ray Computed, Dual-energy CT
- What is being tested?
- Dual-energy CT
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed CMI patients planned for endovascular stent placement treatment
Who cannot join
- Noncomplete dataset
- Allergies to contrast agents
- Suboptimal CT images
- Issues related to the administration of the calorie drink
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Detection of Bowel Hypoperfusion Among Chronic Mesenteric Ischemia Patients During Meal Digestion Using Dual-Energy CT (DECT) - A Pilot Study.
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.
Read the 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.
- Being tested
- Dual-energy CT
- Medical subject headings
- Ischemia, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-energy CTDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre- and post-operative DECT scans on CMI patients
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study startMay 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel; Ischemic, ChronicStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jack Xu, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794959
- Sponsor's protocol ID
- H-20066374
- Status last verified
- Mar 2021
- First submitted
- 9 Mar 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Bowel Hypoperfusion Among Chronic Mesenteric Ischemia Patients During Meal Digestion Using Dual-Energy CT (DECT) - A Pilot Study.
- ClinicalTrials.gov ID
- NCT04794959
- Acronym / sponsor ID
- H-20066374
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed CMI patients planned for endovascular stent placement treatment
Key exclusion criteria (4 listed)
- Noncomplete dataset
- Allergies to contrast agents
- Suboptimal CT images
- Issues related to the administration of the calorie drink
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-energy CTCMI 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. | Diagnostic test | – |
Primary outcome
Pre- and post-operative DECT scans on CMI patients
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-energy CT in people with Bowel; Ischemic, Chronic and Tomography, X-Ray Computed, run by Copenhagen University Hospital, Rigshospitalet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jack J Xu, MD (+4525122159, jack.junchi.xu@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre- and post-operative DECT scans on CMI patients (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2021.