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Sham surgery showdown: is MALS release a real fix or just a myth?

NCT ID NCT05468580

Symptom relief Sponsor: Medisch Spectrum Twente Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aims to settle the debate about whether surgery for Median Arcuate Ligament Syndrome (MALS) actually works. About 70 patients with chronic abdominal pain after eating will be randomly assigned to get either a real keyhole surgery to release a compressed artery or a sham (fake) operation. The goal is to see if the real surgery provides meaningful pain relief compared to the placebo effect.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

celiac trunk compression syndrome Median Arcuate Ligament Syndrome Mesenteric Ischemia mesenteric vascular occlusion

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Celiac artery compression syndrome Coeliac artery compression Dunbar syndrome Median arcuate ligament syndrome Mesenteric ischemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Medisch Spectrum Twente

    RECRUITING

    Enschede, Overijssel, Netherlands