Anastomotic Leakage Prevention by Endovascular Stenting of the Superior Mesenteric Artery

NCT07486570 | Recruiting DMC

• 1 other identifier: NL-010558 • PI-01.05, R25.103
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 18

Brief Summary

Rationale: Anastomotic leakage (AL) is a severe complication of colon surgery, with an incidence of 2.7-11.9%. It is associated with long-term increased mortality, reduced quality of life, and high healthcare costs due to reoperations and prolonged hospitalization. Among colon cancer patients, 5-year survival rates are 70% for those with AL compared to 81% for those without. A retrospective case-control study identified a \>50% stenosis of the Superior Mesenteric Artery (SMA) as a significant risk factor, increasing AL odds by six times (OR: 5.9, 95% CI: 2.7-12.6, p \< .001). Primary objective: The ALPrES2MA study aims to evaluate whether preventive endovascular stenting of a \>50% stenosed SMA origin reduces the risk of AL following colon surgery. Secondary objectives: Classification of severity of AL, incidence of delayed AL (\>90 days), Mesenteric Artery Calcification Score (MACS), surgical complications, hospital (re)admissions, Quality of life (including health related quality of life), healthcare and societal costs, cost-effectiveness (expressed as incremental costs per quality-adjusted life year gained), and budget impact. Additionally, the added value of quantitative fluorescence angiography (qFA) in predicting AL during surgery, in hospitals with suitable equipment and experience, will be explored. This will enhance surgeons' capabilities in preventing AL. Study design: Nationwide multicentre randomized controlled trail with a 1:1 fashion Study population: Patients, 40 years and over, in the participating hospitals in the Netherlands with a \>50% SMA origin stenosis scheduled for elective colorectal resection with a primary anastomosis for malignant or benign colorectal pathology. Intervention: Intervention group will undergo preventive percutaneous transluminal angioplasty (PTA) and endovascular covered stenting of the SMA, within preferably two weeks prior to the colon resection. Control group will not undergo PTA and endovascular stenting of the \>50% SMA stenosis prior to the colon resection. Both groups will be treated with a mono antiplatelet therapy, i.e., carbasalate calcium (Ascal ®), for stent patency and atherosclerotic risk reduction. Intervention group has an indication for lifelong mono antiplatelet therapy and control group for at least 12 months Main study parameters/endpoints: The primary endpoint is the incidence of a clinically relevant AL within 90 days post-surgery. Secondary endpoints include AL classification/severity, calcification scores of aortic and mesenteric vessels, stenting complications, stent patency, intra-operative qFA measurements, operative duration, all causes of post-operative complications within 90 days, all reinterventions; surgical (including endovascular) and non-surgical within 90 days, duration of primary postoperative hospital stay and readmission within 12 months, 12 month mortality, patient-reported outcomes on month 0-3-6-12, cost-effectiveness budget impact analysis and stent patency. The total follow-up duration will be a total of 12 months.

Conditions

Mesenteric Vascular Disease; Colorectal Surgery; Preventive Intervention

Keywords

Anastomotic leakage; Colorectal surgery; Preventive intervention; Superior Mesenteric Artery Stenosis; Percutaneous transluminal angioplasty; Endovascular stenting

Outcome Measures

Primary Outcomes (1)

• Incidence of anstomotic leakage (AL) after colon surgery with primary anastomosis

  The primary objective of this study is to compare the intervention and control group on the incidence of AL following elective colon resection with primary anastomosis in patients with an asymptomatic \>50% origin stenosis of the SMA.

  Anastomotic Leakage within 90 days following colon resection.

Secondary Outcomes (23)

• Classification of severity of anastomotic leakage (AL)

  From enrollment to the end of follow-up (12 months)

• Incidence of delayed anastomotic leakage (AL)

  From 90 days after the colon surgery untill the end of follow-up (12 months)

• The incidence of grade A anastomotic leakage (AL)

  From enrollment to the end of follow-up (12 months)

• Mesenteric Artery Calcification Score (MACS)

  At enrollment

• quantitative Fluorescence Angiography (qFA) with Indocyanine Green (ICG)

  Intra-operative

Study Arms (2)

Intervention arm

EXPERIMENTAL

The intervention group will undergo preventive percutaneous transluminal angioplasty (PTA) and endovascular covered stenting for a ≥50% atherosclerotic SMA stenosis prior to elective colon surgery with primary anastomosis. All patients will receive mono antiplatelet therapy with carbasalate calcium (Ascal®).

Procedure: Percutaneous transluminal angiopasty and endovascular stenting of the superior mesenteric artery; Procedure: Colon surgery; Drug: Mono antiplatelet therapy with Ascal 80mg daily

Control Group

OTHER

Control group will receive standard care for elective colon surgery with primary anastomosis, without preventive SMA PTA for a ≥50% atherosclerotic SMA stenosis. All patients will receive mono antiplatelet therapy with carbasalate calcium (Ascal®).

Procedure: Colon surgery; Drug: Mono antiplatelet therapy with Ascal 80mg daily

Interventions

Colon surgery PROCEDURE

Both groups are scheduled for elective colon resection with primary anastomosis. The intervention will remain unchanged and will follow standard care protocols.

Also known as: Ileocecal resection, Right hemicolectomy, Transverse colectomy, Left hemicolectomy, Sigmoid resection

Control Group; Intervention arm

Mono antiplatelet therapy with Ascal 80mg daily DRUG

Both groups will receive mono antiplatelet therapy with Ascal daily 80mg for atherosclerotic risk reduction throughout the study period. In the intervention group, the therapy will also be administered to maintain stent patency.

Also known as: Carbasalate Calcium, Ascal ®

Control Group; Intervention arm

Percutaneous transluminal angiopasty and endovascular stenting of the superior mesenteric artery PROCEDURE

The intervention group will recieve preventive percutaneous transluminal angiopasty and endovascular covered stenting of a ≥50% atherosclerotic SMA stenosis of the superior mesenteric artery. Stent graft that will be used is: The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX stent graft), which is CE marked.

Also known as: Endovascular Stenting, Percutaneous Angioplasty

Intervention arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medisch Spectrum Twente: lead
• Ziekenhuisgroep Twente: collaborator
• University of Twente: collaborator
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Franciscus Gasthuis: collaborator

Study Sites (18)

Treant

Emmen, Drenthe, Netherlands

NOT YET RECRUITING

Meander

Amersfoort, Gelderland, Netherlands

NOT YET RECRUITING

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

Spaarne Gasthuis

Haarlem, North Holland, Netherlands

NOT YET RECRUITING

Ziekenhuisgroep Twente

Almelo, Overijsel, 7609 PP, Netherlands

RECRUITING

Medisch Spectrum Twente

Enschede, Overijsel, 7512KZ, Netherlands

RECRUITING

Nij Smellinghe

Drachten, Provincie Friesland, Netherlands

RECRUITING

Martini Ziekenhuis

Groningen, Provincie Groningen, Netherlands

NOT YET RECRUITING

Universitair Medisch Centrum Groningen

Groningen, Provincie Groningen, Netherlands

NOT YET RECRUITING

Franciscus

Rotterdam, South Holland, 3004 BA, Netherlands

RECRUITING

Maasstad ziekenhuis

Rotterdam, South Holland, Netherlands

RECRUITING

Haaglanden Medisch Centrum

The Hague, South Holland, Netherlands

NOT YET RECRUITING

Diakonessenhuis

Utrecht, Utrecht, Netherlands

NOT YET RECRUITING

Albert Schweitzer ziekenhuis

Dordrecht, Zuid, Netherlands

NOT YET RECRUITING

Related Publications (32)

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Related Links

• Dutch Mesenteric Ischemia Study Group

MeSH Terms

Conditions

Anastomotic Leak

Interventions

carbaspirin calcium

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bob H. Geelkerken, Prof. dr.

  Medisch Spectrum Twente

  PRINCIPAL INVESTIGATOR

• Desiree van Noord, dr.

  Franciscus

  PRINCIPAL INVESTIGATOR

• Koen J. Vree Egberts, MD, PhD Candidate

  Medisch Spectrum Twente & Franciscus

  STUDY CHAIR

Central Study Contacts

Koen J. Vree Egberts, MD, PhD Candicate

CONTACT

+31 6 15247413; koen.vreeegberts@mst.nl

Research Coordinator Surgery

CONTACT

+ 053 487 34 42; ALPrES2MA@mst.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: March 20, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: July 27, 2026

Record last verified: 2026-03

Locations

NL (18)