Coeliac Artery Release or Sham Operation in Patients Suspected of the Median Arcuate Ligament Syndrome

What this Trial Is About

Researchers are evaluating the effectiveness of endoscopic Coeliac Artery Release (eCAR) compared to a sham operation in patients suspected of Median Arcuate Ligament Syndrome (MALS). MALS involves significant external compression of the coeliac artery causing chronic disabling abdominal pain, weight loss, and related symptoms. The study aims to resolve ongoing debates about this condition by providing evidence on whether surgical release improves symptoms and quality of life. Participants are randomly assigned to either the eCAR procedure or a sham operation, both involving similar incisions to maintain blinding. The eCAR involves cleaving the median arcuate ligament via an endoscopic retroperitoneal approach using a specific four-trocar technique. The sham group undergoes incisions and anesthesia for a similar duration without ligament release. Procedures are performed by experienced surgeons, and patients and observers remain blinded to treatment allocation. During the study, participants are followed up for two years with assessments of abdominal pain, symptom relief using VAS and PGI-I scales, quality of life, productivity loss, healthcare use, and anatomical success measured by imaging. Safety is monitored through complication classification and additional treatments recorded. The primary outcome is symptom reduction measured six months after randomization. This comprehensive monitoring helps determine the value of eCAR for managing MALS and its impact on patient wellbeing and healthcare costs.

Coeliac Artery Release or Sham Operation