NCT02914912

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Sep 2016

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Sep 2016Dec 2026

Study Start

First participant enrolled

September 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

10.3 years

First QC Date

September 14, 2016

Last Update Submit

April 19, 2026

Conditions

Chronic Mesenteric Ischemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Ischemia biomarkers

    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

  • Transserosal microcirculation assessment

    10 years

Study Arms (3)

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.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Patients unable to go through gastroscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oslo University Hospital

Oslo, 0424, Norway

Location

Department of vascular surgery, Oslo University Hospital

Oslo, Norway

Location

Study Officials

  • Syed Sajid Hussain Kazmi, MD PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Surgeon

Study Record Dates

First Submitted

September 14, 2016

First Posted

September 26, 2016

Study Start

September 1, 2016

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

The PI can share anonymous study data after completion of the study.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Anonymous data can be available up to two years after completion of the study.
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.

Locations

NO(2)