An interventional study of Endoscopic Coeliac Artery Release (eCAR) and Sham Operation in Mesenteric Ischemia, Median Arcuate Ligament Syndrome and Dunbar Syndrome, sponsored by Medisch Spectrum Twente. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Medisch Spectrum Twente · Not applicable, Interventional, and Treatment
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.
The involved professions and the patient representatives unanimously recommend as primary endpoint for this study the proposed disease specific outcome measure: symptom relief measured on a VAS and PGI-I scale. This clinical outcome parameter can be reliable assessed within 6 months after the CA release (1, 9, 10). A two years follow up is suggested to extinguish the positive effect of attention in the diagnostic phase (11).
This study design allows for patient and observer blinding and for the sham group the eCAR approach is still feasible if the CARoSO outcome support this without applying additional scar tissue. A sham operation without skin incisions results in unblinding for the patient and the observer and thus undermines the basis of the evidential value of this study. There are no known cases where irreversible damage such as the intestinal infarction has occurred due to not treating this condition. Possible risks of not treating are continuous (pain) complaints and weight loss. The patients who undergo the sham operation and who still have complaints after unblinding of the study and proven effectivity of eCAR can still undergo the endoscopic AC release.
40 studies on the registry are indexed under Mesenteric Ischemia; 14 are open to participants now.
This study's planned enrollment of 70 is below the median of 110 across 14 interventional studies indexed under Mesenteric Ischemia.
Browse Mesenteric Ischemia studies →Medisch Spectrum Twente is the lead sponsor of 23 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Patients randomized in the Intervention Group.
Procedure: Endoscopic Coeliac Artery Release (eCAR)
Patients randomized in the Sham group.
Procedure: Sham Operation
Endoscopic Coeliac Artery Release (eCAR); The Median Arcuate Ligament will be cleaved via an endoscopic retroperitoneal approach using a 4 trocar technique described in detail by van Petersen (12). To rule out learning curves and procedural variation all the procedures will be performed by two experienced eCAR surgeons in the MST-Dutch Expert Centre of Gastrointestinal Ischemia. All procedures will be videotaped. Both eCAR surgeons will not be involved in the follow up procedures.
The sham operation consists of making 4 incisions up to the fascia similar to endoscopic AC release (eCAR). After 60 to 75 minutes of general anesthesia, in accordance with the average operating time of eCAR, the sham operation is ended. This study design allows for patient and observer blinding and for the sham group the eCAR approach is still feasible if the CARoSO outcome support this without applying additional scar tissue.
The number of patients with significant reduction in abdominal symptoms on a VAS scale
The change in abdominal symptoms is measured with a composite primary end point (CPE) at 6 months after randomization existing of o the daily visual analogue scale (VAS) for abdominal pain * every day for seven days, the patients is asked to indicate the average abdominal pain of the past 24 hours on a VAS, this calculates the average VAS for that week. * The PGI-I consists of one question about the change in symptoms compared to before surgery indicated on a 7-point Likert scale with the possible answers: "very much improved", "greatly improved", "somewhat improved", " no change", "slightly deteriorated", "greatly deteriorated" and "very much worse". - A significant reduction in abdominal symptoms at 6 months after randomization is defined as an o a reduction in mean abdominal pain VAS (0-100) of ≥50% compared to baseline
Time frame: 6 months after randomization
The number of patients with significant reduction in abdominal symptoms.
The change in abdominal symptoms is measured with a composite primary end point (CPE) at 6 months after randomization o "much improved" or "very much improved" symptoms on the PGI-I (12) (7-point Likert Scale). The PGI-I consists of one question about the change in symptoms compared to before surgery.
Time frame: 6 months after randomization
Abdominal pain measured with mean abdominal pain VAS endpoint)
Visual Analogue Scale from 0-100
Time frame: Preoperative and 3, 6, 12 and 18 months after operation
Change in complaints measured with the PGI-I
PGI-I on a 7-point Likert Scale
Time frame: 3, 6, 12 and 18 months after operation
Abdominal pain measured with worst abdominal pain VAS
Time frame: Preoperative and 3, 6, 12, 18 and 24 months after operation
HR-QoL measured with the EQ-5D-5L
Visual Analogue Scale from 0-100
Time frame: Preoperative and 3, 6, 12, 18 and 24 months after operation
HR-QoL measured with the SF-12
SF-12 from 0-100
Time frame: Preoperative and 3, 6, 12, 18 and 24 months after operation
Productivity loss measured with the iPCQ (Productivity Costs Questionnaire)
Measured in euro per patient
Time frame: 3, 6 and 24 months after randomization
Healthcare consumption measured with the iMCQ
Measured in euro per patient
Time frame: 3, 6 and 24 months after operation
Cost-utility ratio (ICUR) of AC release compared to a sham operation
Cost per additional QALY in 6 months
Time frame: 3, 6 and 24 months after operation
The number of anatomically successful procedures, defined as ≤30% stenosis (diameter permeated lumen/diameter artery*100) measured with a CTa/MRa
Amount of anatomically succesful procedures
Time frame: 6 months after operation
The number of days until return to a normal diet
Time frame: 24 months after operation
Weight
Kilograms
Time frame: Preoperative and 3, 6, 12 and 18 months after operation
Success of blinding
By asking the patient in which treatment group they were randomzied
Time frame: 3, 6, 12, 18 and 24months after operation
Complications classified in the Clavien-Dindo classification
Questionnaire
Time frame: 30 days after operation
Percentage of patients undergoing additional PTA or other surgical treatment
Percentage of patients
Time frame: 24 months after operation
QoL measured by WHO-QoL Bref
Scale 0-100
Time frame: Preoperative and 3, 6, 12, 18 and 24 months after operation
Started Apr 2023 (actual). Primary completion is estimated for Apr 2027, 48 months after the start.
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