Surgery for Median Arcuate Ligament Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of endoscopic coeliac artery release (eCAR) compared to a sham operation in patients diagnosed with Median Arcuate Ligament Syndrome (MALS). The study aims to measure symptom relief and quality of life improvements in participants suffering from chronic abdominal pain and weight loss due to coeliac artery compression. A multidisciplinary team will assess patients' eligibility based on specific diagnostic criteria, and outcomes will be evaluated using validated scales over a two-year follow-up period. The design includes patient and observer blinding to enhance the reliability of results.

Why it matters

Who can join: the full rules

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.

Where it's running

• Medisch Spectrum Twente
  Enschede, Overijssel, Netherlands Recruiting

Study contacts

• Principal investigator: RH Geelkerken, MD PHD — Medisch Spectrum Twente
• Study coordinator: Floor FM Metz, MD
• Email: caroso@mst.nl
• Phone: +31 534872000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.