The objective of the study is to assess the efficacy and costeffectiveness of eCAR in patients with MALS.
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the number of patients with significant reduction in
abdominal symptoms at 6 months after randomization measured by a composite
disease specific primary end point (CPE).
Secondary outcome
Secondary endpoints include: (health related) quality of life, productivity
loss, cost-effectiveness, healthcare consumption, anatomic patency, return to
normal diet, weight, succesfullness of blinding, percentage of patients that
underwent secondary interventions during study period, percentage of patients
that requires additonal PTA 2 years after eCAR.
Background summary
Median Arcuate Ligament Syndrome (MALS) is a rare condition in which
significant external compression of the celiac artery (CA) by the median
arcuate ligament causes postprandial abdominal pain and weight loss. For years
there has been a discussion among experts about the existence and the
effectiveness of the surgical treatment of MALS. Two systematic reviews
concluded a long-term symptom reduction and a sustainable improvement in
quality of life after surgical treatment of MALS, however the quality of the
articles is low. (1, 2) The recent guidelines recommend that surgical treatment
can be considered based on the reported symptom reduction. (3,4) There is a
need for evidence that MALS exists and that the effect of treatment is not
based on a placebo effect. To end years of discussion, the advice of two
guideline committees is to set up a blinded, randomized controlled trial in
which MAL release is compared to a sham operation.
We assume that endoscopic CA Release (eCAR) results in a significant reduction
of symptoms measured with a composite
disease specific outcome measure at 6 months in 70% of patients suspected of
MALS, when compared with a significant
reduction in 30% of patients after a sham operation.
Study objective
The objective of the study is to assess the efficacy and costeffectiveness of
eCAR in patients with MALS.
Study design
A nationwide monocenter randomized placebo-controlled patient and observer
blinded clinical trial will be conducted in 70 patients (35 eCAR en 35 Sham).
Intervention
The eCAR is an operation in which the MAL will be cleaved via an endoscopic
retroperitoneal approach using a 4 trocar technique.
The sham operation consists of making 4 incisions up to the fascia.
Study burden and risks
Burden that are the same with normal practice: four visits to the MST hospital
((intake & shared decision making, operation, follow-up after 6 months, ).
Burden specific for the CARoSO study: One extra hospital visit (after 24
months). Questionaires: Abdominal pain, Quality of life (2 questionaires),
iPCQ, succesfullness of blinding. An extra CTA after 6 months.
The risk of occurrence of sham operation related severe complications
(anesthesia and 4 small (< 12 mm) skin
incisions) in the MALS patient shamcohort is negligible. Besides that they have
the risks of not having treatment. Possible risks may be ungoing abdominal pain
and loss of weight.
Patiets that undergo eCAR have risks on complication of this operation (<2 risk
on complications mostly: bleeding, infection, scars, chyloma, pneumothorax,
injury of left renal artery, conversion to open surgery).
Koninsplein 1
Enschede 7512KZ
NL
Koninsplein 1
Enschede 7512KZ
NL
Listed location countries
Age
Inclusion criteria
1. Patients with a consensus diagnosis of MALS based on a multidisciplinary
discussion (vascular surgeon, MDL
physician, radiologist). The multidisciplinary discussion will be performed in
two seperate multidisciplinary teams (MST and EMC)
o Typical complaints: post-prandial pain and at least one of the following:
dietary modification, unexplained weight loss,
unexplained diarrhea.
o Eccentric stenosis of >=70% of the AC at the medial arcuatum ligament,
demonstrated by two imaging techniques
(duplex, DSA, MRA or CTA), including at least an inspiration and expiration CTA
or MRA 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).
o Ultrasound or CT or MR abdomen without other more common abnormalities.
o Gastroscopy-duodenoscopy without abnormalities, unless appropriate for
mucosal ischemia.
o Age >/=18 years.
Exclusion criteria
1. Patient not suitable for endoscopic AC release (e.g. previous surgery in the
operating area).
2. Pregnancy.
3. Previous (endovascular) intervention of the visceral arteries.
4. A significant stenosis in the superior or in the inferior mesenteric artery.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05468580 |
| CCMO | NL81443.100.22 |