Investigation of Chronic Intestinal Ischemia

Patients suspected of chronic mesenteric ischemia caused by atherosclerosis or median arcuate ligament syndrome shall be investigated with trans mucosal and transserosal laser Doppler flowmeter and visible light spectroscopy.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Mesenteric Ischemia

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of vascular surgery, Oslo University Hospital, Oslo, Norway

About this study

Patients with suspected chronic mesenteric ischemia (included median arcuate ligament syndrome/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 investigated

with gastroscopy-assisted laser Doppler flowmetry and light spectroscopy (GALS) before and after the surgical or endovascular treatment
Endoscopic ultrasound before and after the surgical or endovascular treatment
Transserosal laser Doppler flowmetry and light spectroscopy during the surgical treatment
Plasma Ischemia bio-markers, before and after the surgical or endovascular treatment
Health related quality of life assessed with EQ5D and SF36 before and after the treatment
clinical outcomes of the treatment (early and late results).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical chronic mesenteric ischemia caused by either atherosclerosis or median arcuate ligament syndrome

Exclusion criteria

Patients unable to go through gastroscopy

Treatment and study plan

Primary outcomes

Transmucosal Oxygen concentration of the stomach and duodenum

Time frame: Baseline, 3 months and 12 months

Repeated measurments at baseline 3, and 12 months after the surgical or endovascular treatment of chronic mesenteric ischemia (CMI) and median arcuate ligament syndrome (MALS) shall be performed. With the help of gastoscopy assisted Laser Doppler flowmeter and visible light spectroscopy, transmocosal SaO2, rHb concentration, flow and velocity in arbitrary units shall be measured.

Secondary outcomes

Ischemia biomarkers

Time frame: 10 years

Plasma levels of intestinal ischemia biomarkers, alpha glutathione s transeferase, intestinal fatty acid binding protein, human immune modified globulin and plasma citrolline shall be examined before and after the surgical or endovascular treatment of the patients with either open or laparoscopic surgery, or endovascular treatment. Blood samples from a cohort of healthy individuals without any symptoms of CMI or MALS shall be tested for the same ischemia biomarkers.
Health-related quality of life in the patients with chronic mesenteric ischemia

Time frame: 10 years

Quality of life assesment at baseline and after treatment with EQ-5D
Clinical outcomes of revascularization in the patients with chronic mesenteric ischemia

Time frame: 10 years

Chronic mesenteric ischemia and median arcuate ligament syndrome patients treated with either open/ laparoscopic vascular surgery or endovascular treatment shall be routinely followed-up at the out-patients department for the results of the treatment and the 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. Besides the patency of the revascularized mesenteric artery will be determined with duplex ultrasound.
Transserosal microcirculation assessment

Time frame: 10 years

The patients with MALS and CMI treated with an either open or laparoscopic surgery shall be examined with transserosal Laser Doppler flowmetery and visible light spectroscopy of the stomach and duodenum during the operation. Transserosal SaO2, relative Hb concentration, blood flow and velocity in arbitrary units will be measured with the Laser doppler flowmeter and visible light spectroscope applaied directly to the surface of stomach and duodenum under the surgical procedure.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2026
Study completion: 2026
First posted: Sep 26, 2016
Registry last updated: Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Not Yet Recruiting