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NCT Number: NCT05468580

Coeliac Artery Release or Sham Operation

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.

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Key information

Conditions

Mesenteric Ischemia Arterial Occlusive Diseases Cardiovascular Abnormalities Cardiovascular Diseases Celiac Artery Compression Syndrome Coeliac Artery Compression Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Dunbar Syndrome Gastrointestinal Diseases Intestinal Diseases Median Arcuate Ligament Syndrome Peritoneal Diseases Vascular Diseases Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medisch Spectrum Twente

Enschede, Overijssel, Netherlands

Location status: Recruiting

Location contact

Bob Geelkerken, Prof

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic Coeliac Artery Release (eCAR)

Procedure

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.

Sham operation

Procedure

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.

Primary outcomes

  1. The number of patients with significant reduction in abdominal symptoms on a VAS scale

    Time frame: 6 months after randomization

    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

  2. The number of patients with significant reduction in abdominal symptoms.

    Time frame: 6 months after randomization

    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.

Secondary outcomes

  1. Abdominal pain measured with mean abdominal pain VAS endpoint)

    Time frame: Preoperative and 3, 6, 12 and 18 months after operation

    Visual Analogue Scale from 0-100

  2. Change in complaints measured with the PGI-I

    Time frame: 3, 6, 12 and 18 months after operation

    PGI-I on a 7-point Likert Scale

  3. Abdominal pain measured with worst abdominal pain VAS

    Time frame: Preoperative and 3, 6, 12, 18 and 24 months after operation

  4. HR-QoL measured with the EQ-5D-5L

    Time frame: Preoperative and 3, 6, 12, 18 and 24 months after operation

    Visual Analogue Scale from 0-100

  5. HR-QoL measured with the SF-12

    Time frame: Preoperative and 3, 6, 12, 18 and 24 months after operation

    SF-12 from 0-100

  6. Productivity loss measured with the iPCQ (Productivity Costs Questionnaire)

    Time frame: 3, 6 and 24 months after randomization

    Measured in euro per patient

  7. Healthcare consumption measured with the iMCQ

    Time frame: 3, 6 and 24 months after operation

    Measured in euro per patient

  8. Cost-utility ratio (ICUR) of AC release compared to a sham operation

    Time frame: 3, 6 and 24 months after operation

    Cost per additional QALY in 6 months

  9. The number of anatomically successful procedures, defined as ≤30% stenosis (diameter permeated lumen/diameter artery*100) measured with a CTa/MRa

    Time frame: 6 months after operation

    Amount of anatomically succesful procedures

  10. The number of days until return to a normal diet

    Time frame: 24 months after operation

  11. Weight

    Time frame: Preoperative and 3, 6, 12 and 18 months after operation

    Kilograms

  12. Success of blinding

    Time frame: 3, 6, 12, 18 and 24months after operation

    By asking the patient in which treatment group they were randomzied

  13. Complications classified in the Clavien-Dindo classification

    Time frame: 30 days after operation

    Questionnaire

  14. Percentage of patients undergoing additional PTA or other surgical treatment

    Time frame: 24 months after operation

    Percentage of patients

  15. QoL measured by WHO-QoL Bref

    Time frame: Preoperative and 3, 6, 12, 18 and 24 months after operation

    Scale 0-100

Study contacts

Contact information is provided by the study sponsor or research team.

Floor FM Metz, MD

CONTACT

[email protected]

+31 534872000

Sponsors and collaborators

Lead sponsor

Medisch Spectrum Twente

Other

Collaborators

  • Erasmus Medical Centre
  • Medical School Medisch Spectrum Twente
  • Techmed University of Twente

Registry information

Official study title

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

Acronym: CARoSO

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jul 21, 2022
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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