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Investigation of Chronic Intestinal Ischemia

University of Oslo (UIO) logo

University of Oslo (UIO)

Status

Active, not recruiting

Conditions

Chronic Mesenteric Ischemia

Study type

Observational

Funder types

Other

Identifiers

NCT02914912
2016/682

Details and patient eligibility

About

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.

Full 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).

Enrollment

100 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Patients unable to go through gastroscopy

Trial design

100 participants in 3 patient groups

GALS symptomatic patients group
Description:
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)
Description:
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
Description:
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.

Trial contacts and locations

2

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Central trial contact

Simen Tveten Berge, MD; Syed Sajid Hussain Kazmi, MD PhD

Data sourced from clinicaltrials.gov

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