Surgery for Median Arcuate Ligament Syndrome
Coeliac Artery Release or Sham Operation in Patients Suspected of the Median Arcuate Ligament Syndrome
This study is testing if a new surgery for Median Arcuate Ligament Syndrome can help people with chronic abdominal pain and weight loss feel better compared to a fake surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medisch Spectrum Twente Academic / other |
| Locations | 1 site (Enschede, Overijssel) |
| Trial ID | NCT05468580 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with MALS who experience post-prandial pain and have specific imaging-confirmed artery compression.
Not a fit: Patients without a confirmed diagnosis of MALS or those with alternative abdominal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide significant symptom relief and improved quality of life for patients suffering from MALS.
How similar studies have performed: Previous studies have shown promising results for surgical treatment of MALS, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Enschede, Overijssel
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.