NCT05468580 Coeliac Artery Release or Sham Operation
| NCT ID | NCT05468580 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medisch Spectrum Twente |
| Condition | Mesenteric Ischemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2023-04-01 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 to cause chronic disabling postprandial abdominal pain, weight loss, and consequently lethargy and social deprivation (3,8). The majority of these patients have had a long medical journey before the diagnosis MALS is considered resulting in a substantial burden of disease and high healthcare and societal costs. Although a Systematic Review have shown a sustainable symptom relief of 68% and a significant and durable improvement of quality of life after surgical treatment for MALS (4), there is still no (inter)national consensus on the existence and treatment of MALS (1, 5, 6, 7). Two recent guidelines (3, 8) concluded that patients with MALS might be considered for surgical CA release (Recommendation 25 GRADE 2D; expert agreement 96%, Terlouw 2020). To end the ongoing debate and to enable the development of evidence-based guidelines for the management of MALS, both guideline committees recommend to perform a blinded, randomised controlled trial comparing a CA release with a sham operation. The proposed Coeliac Artery Release or Sham Operation study will either underline the usefulness of eCAR as a minimal invasive (cost)effective treatment for MALS or it will prohibit a meaningless intervention in patients with disabling abdominal symptoms. If the CARoSO study proves that the treatment of MALS by eCAR is effective, to 490 patients with chronic disabling abdominal symptoms per year can be treated in the Netherlands. Effective treatment of MALS is expected to result in mean health gain of 6.05 Quality Adjusted Life Years (QALYs)/patient and has the potency to reduce the substantial productivity loss and healthcare consumption caused by MALS, resulting in a saving up to M€4.3/year. The outcome of the CARoSO study will be translated into strong recommendations in the coming updates of the relevant (inter)national multidisciplinary guidelines and will be adapted in daily practice.
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.
Contact & Investigator
RH Geelkerken, MD PHD
PRINCIPAL INVESTIGATOR
Medisch Spectrum Twente
Frequently Asked Questions
Who can join the NCT05468580 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mesenteric Ischemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05468580 currently recruiting?
Yes, NCT05468580 is actively recruiting participants. Contact the research team at caroso@mst.nl for enrollment information.
Where is the NCT05468580 trial being conducted?
This trial is being conducted at Enschede, Netherlands.
Who is sponsoring the NCT05468580 clinical trial?
NCT05468580 is sponsored by Medisch Spectrum Twente. The principal investigator is RH Geelkerken, MD PHD at Medisch Spectrum Twente. The trial plans to enroll 70 participants.