Preventing colon anastomotic leaks by stenting the superior mesenteric artery
Anastomotic Leakage Prevention by Endovascular Stenting of the Superior Mesenteric Artery
This trial tests whether placing a stent in the superior mesenteric artery before elective colon surgery can reduce anastomotic leaks in patients over 40 with an asymptomatic >50% SMA stenosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Medisch Spectrum Twente Academic / other |
| Locations | 10 sites (Apeldoorn, Gelderland and 9 other locations) |
| Trial ID | NCT07486570 on ClinicalTrials.gov |
What this trial studies
The study offers preoperative percutaneous transluminal angioplasty with covered stent placement of the superior mesenteric artery for patients who have an asymptomatic >50% origin stenosis and are scheduled for elective colon resection with a primary anastomosis. Enrolled patients receive the endovascular procedure and mono antiplatelet therapy, then undergo the planned colectomy; outcomes include rate and severity of anastomotic leakage, delayed leaks, mesenteric artery calcification score, surgical complications, readmissions, and quality of life. It is a multicenter effort at hospitals in the Netherlands and enrolls adults over 40 without symptoms of chronic or acute mesenteric ischemia. The trial aims to determine whether preventive SMA revascularization improves perfusion-related surgical outcomes compared with expected baseline rates.
Who should consider this trial
Good fit: Ideal candidates are adults >40 years scheduled for elective colon resection above the recto‑sigmoid junction with a primary anastomosis and an asymptomatic >50% atherosclerotic stenosis at the SMA origin.
Not a fit: Patients with symptomatic mesenteric ischemia, a >50% celiac artery stenosis, those undergoing extensive multiorgan or T4b/T4c resections, or whose leak risk is driven by non-perfusion factors are unlikely to gain benefit from preventive SMA stenting.
Why it matters
Potential benefit: If successful, preventive SMA stenting could substantially reduce anastomotic leakage after colon surgery, cutting reoperations and improving long-term survival and quality of life.
How similar studies have performed: Retrospective multicenter case-control data linked >50% SMA stenosis to a six-fold higher leak risk and SMA stenting is established for mesenteric ischemia, but preventive stenting in asymptomatic colorectal surgery patients has not been prospectively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>40 years. * Patient scheduled for elective colon resection above the recto-sigmoid junction with a primary anastomosis (side-to-side, side-to-end, or end-to-end). * Presence of an asymptomatic \>50% atherosclerotic origin stenosis of the superior mesenteric artery (SMA) Exclusion Criteria: * All patients with symptomatic chronic or acute mesenteric ischemia (i.e., mesenteric artery stenosis in combination with symptoms as postprandial abdominal pain, fear of eating, altered eating patterns, weight loss, diarrhoea, nausea, or exercise-induced abdominal pain). * Presence of a \>50% stenosis of the celiac artery, regardless of the underlying pathology (i.e., intra-articular atherosclerosis, intra articular thrombus or external compression by the median accurate ligament). * Simultaneous performed during the colon resection: a substantial abdominal organ resection, or T4b/T4c colon tumour resection, or a second colon anastomosis or a diverting stoma * History of mesenteric revascularization, including endovascular stenting, thrombectomy, or bypass surgery involving any of the mesenteric arteries * Patients with a history of heparin induced thrombocytopenia-type 2 due to contraindication for VBX Stent Graft. * Patients with a contra-indication for mono antiplatelet therapy with Ascal due to comorbidities, allergy or intolerance. * Pregnancy
Where this trial is running
Apeldoorn, Gelderland and 9 other locations
- Gelre ziekenhuis — Apeldoorn, Gelderland, Netherlands (Recruiting)
- Zuyderland — Heerlen, Limburg, Netherlands (Recruiting)
- Maastricht Universitair Medisch Centrum (MUMC+) — Maastricht, Limburg, Netherlands (Recruiting)
- Jeroen Bosch Ziekenhuis — 's-Hertogenbosch, North Brabant, Netherlands (Recruiting)
- Noordwest Ziekenhuisgroep — Alkmaar, North Holland, Netherlands (Recruiting)
- Ziekenhuisgroep Twente — Almelo, Overijsel, Netherlands (Recruiting)
- Medisch Spectrum Twente — Enschede, Overijsel, Netherlands (Recruiting)
- Nij Smellinghe — Drachten, Provincie Friesland, Netherlands (Recruiting)
- Franciscus — Rotterdam, South Holland, Netherlands (Recruiting)
- Maasstad ziekenhuis — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Bob H. Geelkerken, Prof. dr. — Medisch Spectrum Twente
- Study coordinator: Koen J. Vree Egberts, MD, PhD Candicate
- Email: koen.vreeegberts@mst.nl
- Phone: +31 6 15247413
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.