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

NCT06445660 | Recruiting

• 1 other identifier: 03.01.2024
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Frequency rate

  Frequency rate of common radiological signs in AMI patients with and without salvageable bowel.

  up to one month

Secondary Outcomes (1)

• Performance of the radiological score

  up to one month

Study Arms (3)

Controls

Patients included in the AMESI study as suspected AMI

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

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a substudy of the AMESI study - "Incidence, Diagnosis, Management, and Outcome of Acute Mesenteric Ischaemia: A Prospective, Multicentre Observational Study." (Clinical Trials: NCT05218863) As of the end of August 2023, a total of 705 patients from 32 study sites worldwide have been enrolled, with 418 of them having confirmed cases of AMI. For patients with confirmed AMI, comprehensive data collection concerning diagnostics, management, and long-term outcomes has been completed

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Tartu: lead

Study Sites (1)

Tartu University Hospital

Tartu, 50408, Estonia

RECRUITING

Study Officials

• Joel Starkopf

  University of Tartu, Department of Anaesthesiology and Intensive Care

  STUDY CHAIR

Central Study Contacts

Joel Starkopf

CONTACT

53318400; joel.starkopf@ut.ee

Kätlin Eiche

CONTACT

Katlin.Eiche@ut.ee

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 6, 2024
• Study Start: June 6, 2022
• Primary Completion: April 5, 2023
• Study Completion: May 31, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

ES (1)