Investigation of Chronic Intestinal Ischemia
- Conditions
- Chronic Mesenteric Ischemia
- Registration Number
- NCT02914912
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
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.
- Detailed Description
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
1. with gastroscopy-assisted laser Doppler flowmetry and light spectroscopy (GALS) before and after the surgical or endovascular treatment
2. Endoscopic ultrasound before and after the surgical or endovascular treatment
3. Transserosal laser Doppler flowmetry and light spectroscopy during the surgical treatment
4. Plasma Ischemia bio-markers, before and after the surgical or endovascular treatment
5. Health related quality of life assessed with EQ5D and SF36 before and after the treatment
6. clinical outcomes of the treatment (early and late results).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
Clinical chronic mesenteric ischemia caused by either atherosclerosis or median arcuate ligament syndrome
Patients unable to go through gastroscopy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Transmucosal Oxygen concentration of the stomach and duodenum 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 Outcome Measures
Name Time Method Ischemia biomarkers 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.
Transserosal microcirculation assessment 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.
Health-related quality of life in the patients with chronic mesenteric ischemia 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 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.
Trial Locations
- Locations (2)
Department of vascular surgery, Oslo University Hospital
🇳🇴Oslo, Norway
Oslo University Hospital
🇳🇴Oslo, Norway