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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Medisch Spectrum Twente

Enschede, Overijssel, Netherlands