Investigation of Chronic Intestinal Ischemia

Chronic Mesenteric Ischemia Clinical Trial

Official title:

Investigation of Chronic Intestinal Ischemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02914912
• Other study ID #: 2016/682
• Status: Active, not recruiting
• Start date: September 2016
• Est. completion date: January 2025

Study information

• Verified date: November 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Patients suspected of chronic mesenteric ischemia shall be investigated with gastroscopy-assisted laser Doppler flowmeter and light spectroscopy (GALS).

Description:

Patients with suspected chronic mesenteric ischemia (included truncus coeliacus compression syndrome) referred to the vascular surgery department for investigation of splanchnic and mesenteric circulation shall be included in this study.

In addition to CT angiography, patients shall be

1. investigated with gastroscopy-assisted laser Doppler flowmetry and light spectroscopy (GALS).

2. Endoscopic ultrasound

3. Transserosal laser Doppler flowmetry and light spectroscopy

4. Ischemia bio-markers

5. Health related quality of life

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Clinical chronic mesenteric ischemia

Exclusion Criteria:

Patients unable to gå through gastroscopy

Related Conditions & MeSH terms

• Chronic Mesenteric Ischemia
• Ischemia
• Mesenteric Ischemia

Locations

Country	Name	City	State
Norway	Department of vascular surgery, Oslo University Hospital	Oslo
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood flow Laser Doppler flowmeter	Repeated measurments at baseline 3, and 12 months	Baseline, 3 months and 12 months
Secondary	Ischemia biomarkers	Plasma levels of intestinal ischemia biomarkers	1-2 years
Secondary	Health-related quality of life in the patients with chronic mesenteric ischemia	Quality of life assesment at baseline and after treatment with EQ-5D	2 years
Secondary	Clinical outcomes of revascularization in the patients with chronic mesenteric ischemia	Chronic mesenteric ischemia patients treated with either open vascular surgery or endovascular treatment shall be routinely followed-up at the out-patients department for post operative complications, effect of revascularization on the mesenteric ischemia symptoms, patency of endovascular or open revascularization procedure. Routine clinical follow-up shall be 30 days post operatively, 3 months, 12 months and yearly thereafter.	6-7 years