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Investigation of Chronic Intestinal Ischemia

Investigation of Chronic Intestinal Ischemia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02914912
Enrollment
100
Registered
2016-09-26
Start date
2016-09-01
Completion date
2026-12-01
Last updated
2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Mesenteric Ischemia

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).

Interventions

None listed

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Patients unable to go through gastroscopy

Design outcomes

Primary

MeasureTime frameDescription
Transmucosal Oxygen concentration of the stomach and duodenumBaseline, 3 months and 12 monthsRepeated 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

MeasureTime frameDescription
Ischemia biomarkers10 yearsPlasma 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 ischemia10 yearsQuality of life assesment at baseline and after treatment with EQ-5D
Clinical outcomes of revascularization in the patients with chronic mesenteric ischemia10 yearsChronic 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 assessment10 yearsThe 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.

Countries

Norway

Contacts

PRINCIPAL_INVESTIGATORSyed Sajid Hussain Kazmi, MD PhD

Oslo University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026