Investigation of Chronic Intestinal Ischemia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Transmucosal Oxygen concentration of the stomach and duodenum
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical chronic mesenteric ischemia caused by either atherosclerosis or median arcuate ligament syndrome
排除标准
- •Patients unable to go through gastroscopy
研究组 & 干预措施
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.
结局指标
主要结局
Transmucosal Oxygen concentration of the stomach and duodenum
时间窗: 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.
次要结局
- Ischemia biomarkers(10 years)
- Transserosal microcirculation assessment(10 years)
- Health-related quality of life in the patients with chronic mesenteric ischemia(10 years)
- Clinical outcomes of revascularization in the patients with chronic mesenteric ischemia(10 years)
研究者
Syed Sajid Hussain Kazmi
Consultant Surgeon
Oslo University Hospital