Anastomotic Leakage Prevention by Endovascular Stenting of the Superior Mesenteric Artery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 18
- 主要终点
- Incidence of anstomotic leakage (AL) after colon surgery with primary anastomosis
研究概览
简要总结
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.
详细描述
Background and Rationale:
Anastomotic leakage (AL) is one of the most severe complications following colon surgery. The pathogenesis of AL is multifactorial and includes patient-related, surgical, and perfusion-related factors. However, reliable preoperative identification of patients at high risk for AL remains challenging. Existing prediction models are heterogeneous and rarely incorporate mesenteric vascular disease as a risk factor.
A retrospective multicenter case-control study demonstrated that an asymptomatic >50% atherosclerotic stenosis at the origin of the superior mesenteric artery (SMA) is associated with a six-fold increased risk of AL following elective colon resection. Despite this association, current surgical and vascular guidelines do not address preventive treatment of asymptomatic SMA stenosis in patients undergoing colorectal surgery, and preventive endovascular revascularization is not standard practice.
Endovascular revascularization of the SMA using percutaneous transluminal angioplasty (PTA) and covered stent placement is a minimally invasive, low-risk procedure widely used in the treatment of chronic and acute mesenteric ischemia. The procedure has a low incidence of serious adverse events and is supported by international guidelines. Whether preventive SMA stenting can improve colon perfusion and reduce the risk of AL in asymptomatic patients undergoing colon surgery has not been prospectively evaluated.
The ALPrES²MA study (Anastomotic Leakage Prevention by Endovascular Stenting of the Superior Mesenteric Artery) is a multicenter randomized controlled trial designed to address this evidence gap.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Intervention arm
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®).
干预措施: Percutaneous transluminal angiopasty and endovascular stenting of the superior mesenteric artery (Procedure)
Intervention arm
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®).
干预措施: Colon surgery (Procedure)
Intervention arm
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®).
干预措施: Mono antiplatelet therapy with Ascal 80mg daily (Drug)
Control Group
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®).
干预措施: Colon surgery (Procedure)
Control Group
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®).
干预措施: Mono antiplatelet therapy with Ascal 80mg daily (Drug)
结局指标
主要结局
Incidence of anstomotic leakage (AL) after colon surgery with primary anastomosis
时间窗: Anastomotic Leakage within 90 days following colon resection.
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.
次要结局
- 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))
- Complications related to the colon surgery(From colon surgery untill 30 days post-operative.)
- Mesenteric Artery Calcification Score (MACS)(At enrollment)
- quantitative Fluorescence Angiography (qFA) with Indocyanine Green (ICG)(Intra-operative)
- Operation time(intra-operative)
- Anastomotic Leakage related complications(From enrollment to the end of follow-up (12 months))
- Non-AL related additional treatment and re-intervention(From enrollment to 30 days post-operative.)
- Length of hospital stay(From enrollment to the end of follow-up (12 months).)
- Mortality(From enrollment untill the end of follow-up (12 months))
- Quality of life (QoL)(Preoperative (-2 weeks) and after 3, 6, 9, and 12 months post operative.)
- Health related Quality of Life(Preoperative (-2 weeks) and after 3, 6, 9, and 12 months post operative.)
- Stent Patency(12 months after PTA)
- Healthcare Consumption(Preoperative (-2 weeks) and after 3, 6, 9, and 12 months post operative.)
- Productivity Losses(Preoperative (-2 weeks) and after 6 weeks, 3, 6, 9 and 12 months post operative.)
- Cost-Effectiveness(From enrollment untill the end of follow-up (12 months))
- Budget Impact Analysis to access the budget impact for the dutch society for the intervention(From enrollment untill the end of follow-up (12 months))
- Endovascular Stenting Complications(From PTA untill the end of follow-up (12 months))
- Access Site Complications(From PTA untill the end of follow-up (12 months))
- Hospital Stay after PTA(From the PTA untill 30 days after.)
- PTA related mortality(From PTA untill 30 days after.)
- Inability to perform colon resection.(From enrollment untill the colon surgery)
研究者
Koen Vree Egberts
MD
Medisch Spectrum Twente