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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Mesenteric Ischemia

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).

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Oslo University Hospital
  • Oslo, Norway
    • Department of vascular surgery, Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients suspected of chronic mesenteric ischemia caused by either atherosclerosis or median arcuate ligament syndrome and confirmed with CTA, duplex ultrasound, and clinical examination shall be included in the study. The included patients are referred to the Department of Vascular Surgery for investigation and treatment of the CMI and MALS.

Description

Inclusion Criteria:

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

Exclusion Criteria:

Patients unable to go through gastroscopy

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
GALS symptomatic patients group; Patients with chronic mesenteric ischemia (CMI) symptoms shall be investigated with gastroscopy-assisted laser Doppler flowmetry and visible light spectroscopy. The examination will be performed before and after the surgical or endovascular treatment for CMI. Besides, the patients treated with either open or laparoscopic mesenteric bypass shall be examined during the operation with transserosal microcirculatory assessment of the stomach and duodenum using laser Doppler flowmetry and visible light spectroscopy.
CMI caused by median arcuate ligament syndrome (MALS); Patients with chronic mesenteric ischemia (CMI) symptoms caused by MALS shall be investigated with gastroscopy-assisted laser Doppler flowmetry and visible light spectroscopy. The examination will be performed before and after the surgical or endovascular treatment for MALS. Besides, the patients treated with an either open or laparoscopic technique for MALS shall be examined during the operation with transserosal microcirculatory assessment of the stomach and duodenum using laser Doppler flowmetry and visible light spectroscopy.
Healthy individuals without CMI or MALS; A group of healthy individuals with no symptoms of CMI or MALS shall be investigated with gastroscopy-assisted laser Doppler flowmetry and visible light spectroscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transmucosal Oxygen concentration of the stomach and duodenum	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.	Baseline, 3 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ischemia biomarkers	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.	10 years
Health-related quality of life in the patients with chronic mesenteric ischemia	Quality of life assesment at baseline and after treatment with EQ-5D	10 years
Clinical outcomes of revascularization in the patients with chronic mesenteric ischemia	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.	10 years
Transserosal microcirculation assessment	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.	10 years

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Syed Sajid Hussain Kazmi, MD PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 14, 2016
• First Submitted That Met QC Criteria: September 22, 2016
• First Posted (Estimated): September 26, 2016

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 19, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Peritoneal Diseases; Gastrointestinal Diseases; Intestinal Diseases; Ischemia; Mesenteric Ischemia
• Other Study ID Numbers: 2016/682

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The PI can share anonymous study data after completion of the study.
• IPD Sharing Time Frame: Anonymous data can be available up to two years after completion of the study.
• IPD Sharing Access Criteria: Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Proposals should be directed to the principal investigator. To gain data access, data requesters will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF