Status:
RECRUITING
Coeliac Artery Release or Sham Operation
Lead Sponsor:
Medisch Spectrum Twente
Collaborating Sponsors:
Medical School Medisch Spectrum Twente
Techmed University of Twente
Conditions:
Mesenteric Ischemia
Median Arcuate Ligament Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In patients with Median Arcuate Ligament Syndrome (MALS), significant external compression of the coeliac artery (CA) by the median arcuate ligament (MAL) increasing mucosal ischemia (1,2) is assumed ...
Detailed Description
The involved professions and the patient representatives unanimously recommend as primary endpoint for this study the proposed disease specific outcome measure: symptom relief measured on a VAS and PG...
Eligibility Criteria
Inclusion Criteria:
- Patients with a consensus diagnosis of MALS based on a multidisciplinary discussion in the two Dutch expert centers for Mesenteric Ischemia (Medisch Spectrum Twente and Erasmus Medical Centre). The multidisciplinary team contains of a vascular surgeon, gastroenterologist, radiologist as recommended in the guidelines.
- Typical complaints: post-prandial pain and at least two of the following: dietary modification, unexplained weight loss, unexplained diarrhea.
- Eccentric stenosis of ≥70% of the AC at the medial arcuatum ligament, demonstrated by two imaging techniques (duplex, MRA, CTA or DSA), including at least an inspiration and expiration CTA with 1mm sections. (Definition percent stenosis according to ECST 1998 formula: % stenosis = (1 - [diameter at the site of stenosis/estimated original diameter at the site of the stenosis]) x 100).
- Ultrasound Abdomen without other more common abnormalities.
- Gastroscopy-duodenoscopy without abnormalities, unless appropriate for mucosal ischemia.
Exclusion Criteria:
- Patient not suitable for endoscopic AC release (e.g. previous surgery in the operating area).
- Pregnancy.
- Previous (endovascular) intervention of the visceral arteries.
- A significant stenosis in the superior or in the inferior mesenteric artery.
Key Trial Info
Start Date :
April 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05468580
Start Date
April 1 2023
End Date
November 1 2028
Last Update
March 16 2026
Active Locations (1)
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1
Medisch Spectrum Twente
Enschede, Overijssel, Netherlands