Coeliac Artery Release or Sham Operatio

Recruiting

Conditions: Median Acruate Ligament Syndrome OR Dunbar Syndrome
10003184

Registration Number: NL-OMON51716

Lead Sponsor: Medisch Spectrum Twente

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 70

Inclusion Criteria

1. Patients with a consensus diagnosis of MALS based on a multidisciplinary
discussion (vascular surgeon, MDL
physician, radiologist). The multidisciplinary discussion will be performed in
two seperate multidisciplinary teams (MST and EMC)
o Typical complaints: post-prandial pain and at least one of the following:
dietary modification, unexplained weight loss,
unexplained diarrhea.
o Eccentric stenosis of >=70% of the AC at the medial arcuatum ligament,
demonstrated by two imaging techniques
(duplex, DSA, MRA or CTA), including at least an inspiration and expiration CTA
or MRA 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).
o Ultrasound or CT or MR abdomen without other more common abnormalities.
o Gastroscopy-duodenoscopy without abnormalities, unless appropriate for
mucosal ischemia.
o Age >/=18 years.

Exclusion Criteria

1. Patient not suitable for endoscopic AC release (e.g. previous surgery in the
operating area).
2. Pregnancy.
3. Previous (endovascular) intervention of the visceral arteries.
4. A significant stenosis in the superior or in the inferior mesenteric artery.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the number of patients with significant reduction in<br /><br>abdominal symptoms at 6 months after randomization measured by a composite<br /><br>disease specific primary end point (CPE).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include: (health related) quality of life, productivity<br /><br>loss, cost-effectiveness, healthcare consumption, anatomic patency, return to<br /><br>normal diet, weight, succesfullness of blinding, percentage of patients that<br /><br>underwent secondary interventions during study period, percentage of patients<br /><br>that requires additonal PTA 2 years after eCAR.</p><br>