The Feasibility of a Radiological Score Based on CT Signs for Recognizing Salvageable Bowel in Acute Mesenteric Ischemia

NCT ID: NCT06445660

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-06
• Study Completion Date: 2025-05-31

Brief Summary

Computed tomography (CT) is the standard modality for scanning patients with critical acute abdominal conditions, including suspected acute mesenteric ischemia (AMI). CT imaging can potentially differentiate between reversible and irreversible ischaemic damage of the bowel. This moment is pivotal in selecting the treatment strategy for AMI - in the absence of irreversible damage; reperfusion therapy can preserve intestinal viability, thereby avoiding the need for bowel resection. The present study tests the hypothesis that combining several symptoms may enhance the diagnostic performance of CT scanning in detecting salvageable bowel in patients with AMI. This study is an ancillary component of the AMESI study (Clinical Trials: NCT05218863) - a prospective, multicentre observational study aimed at identifying the incidence and describing the outcomes of acute mesenteric ischemia (AMI) in adult hospitalized patients. The ultimate purpose of the present study is to create a computed tomography-based radiological score for the assessment of bowel viability in patients with AMI.

Conditions

Acute Mesenteric Ischemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Controls

Patients included in the AMESI study as suspected AMI

No interventions assigned to this group

AMI patients with salvageable bowel

Patients included in the AMESI study with confirmed AMI, who did not undergo bowel resection

Patients with one of the following:

1. treated endovascularly and did not undergo bowel resection secondarily

2. received surgical revascularization without bowel resection (initial or secondary)

3. received explorative laparoscopy or laparotomy without the need for bowel resection (initially or secondarily)

4. received conservative treatment without the need for secondary bowel resection

No interventions assigned to this group

AMI patients with non-salvageable bowel

Patients included in the AMESI study with confirmed AMI who (one of the following):

1. underwent bowel resection initially

2. underwent bowel resection secondarily

3. did not undergo bowel resection because non-salvageable bowel

4. were changed to palliation due to the progression of ischaemia after any initial treatment with curative intention (including endovascular and conservative)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Participant in AMESI study
• confirmed or suspected acute mesenteric ischaemia
• CT scan of the entire abdominal cavity / full body using intravenous contrast media is available

Exclusion Criteria

• Scans without the use of an intravenous contrast media or those covering only a partial area of the abdomen will be excluded.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Tartu

OTHER

Sponsor Role: lead

Responsible Party

Annika Reintam Blaser

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joel Starkopf

Role: STUDY_CHAIR

University of Tartu, Department of Anaesthesiology and Intensive Care

Locations

Tartu University Hospital

Tartu, , Estonia

Site Status: RECRUITING

Countries

Estonia

Central Contacts

Joel Starkopf

Role: CONTACT

joel.starkopf@ut.ee

53318400 ext. 372

Kätlin Eiche

Role: CONTACT

Katlin.Eiche@ut.ee

Facility Contacts

Martin Reim, Dr

Role: primary

Martin.Reim@kliinikum.ee

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

03.01.2024

Identifier Type: -

Identifier Source: org_study_id