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临床试验/NCT03829098
NCT03829098已完成不适用

TreatmENT of AnastomotiC Leakage After Esophagectomy

Radboud University Medical Center1 个研究点 分布在 1 个国家目标入组 1,509 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,509
试验地点
1
主要终点
90 day mortality

研究概览

简要总结

Rationale: Anastomotic leakage (0% - 30%) is a severe complication after esophagectomy with mortality rates approximately ranging from 2% - 12%. In addition, it is associated with a prolonged ICU treatment and hospital stay. Anastomotic leakage severity is currently graded according to how it is treated (grade I: conservative treatment, grade II endoscopic or radiologic intervention and grade III surgical intervention). However, this scoring system cannot be used to guide decision making when anastomotic leakage is diagnosed in a clinical setting.

Factors that may influence the severity of the anastomotic leakage are (amongst others) location of the anastomosis, estimated surface of the defect, estimated circumference of the defect, extent of contamination, degree of sepsis and time from diagnosis until therapy. However, little is known about to what extent these and other factors contribute to anastomotic leakage severity. In addition, there is a paucity of data on what leakage characteristics dictate the success of a specific treatment.

Primary study objectives

  1. To investigate what factors contribute to anastomotic leakage severity and to compose an evidence based anastomotic leakage severity score.
  2. To investigate what anastomotic leakage characteristics are associated with success of different anastomotic leakage treatments and to compare the effectiveness of different initial anastomotic leakage treatments for leakages classified according to severity and leakage characteristics.

Study design: International multicenter retrospective cohort study.

Study population: Adult patients with anastomotic leakage after esophagectomy and gastric conduit reconstruction for esophageal cancer.

Cohort size: 1000-2000 patients with anastomotic leakage after esophagectomy for cancer.

Primary outcome parameter: 90 day mortality. Secondary outcome parameters: in-hospital mortality, 30-day mortality, 180-day mortality, comprehensive complications index, total number of reinterventions, hospital and ICU length of stay, hospital related costs.

Funding: Radboudumc

详细描述

  1. INTRODUCTION AND RATIONALE

The incidence of esophageal cancer is increasing, with an estimated annual incidence of 480.000 cases worldwide [Jemal 2011]. Esophagectomy remains the cornerstone of curative treatment, often in combination with chemotherapy or chemoradiotherapy. However, esophagectomy is associated with considerable morbidity and anastomotic leakage is a severe postoperative complication.

Anastomotic leakage is defined as a "full thickness gastrointestinal defect involving esophagus, anastomosis, staple line, or conduit irrespective of presentation or method of identification" according to the Esophagectomy Complications Consensus Group (ECCG) definition [Low 2015]. Anastomotic leakage has been described to occur in 0-30%. If anastomotic leakage occurs, it is associated with mortality rates ranging from 2% - 12% [Biere 2011, Saluja 2012]. In addition, it is often associated with a prolonged ICU treatment, hospital length of stay and multiple reinterventions [Lubbers 2019, submitted]. The impact of anastomotic leakage on quality of life is high and it is associated with a substantial burden in terms of hospital resources and costs [Biere 2011, Alanezi 2004, Luketich 2012, Blackmon 2007].

Treatment of anastomotic leakage ranges from conservative management (nil per mouth, antibiotics and nasogastric tube drainage) to radiologic drainage, endoscopic treatment with stents, drains or endoVAC (Vacuum Assisted Closure) systems, and surgical exploration. A recent systematic review performed by our group assessed the current literature for studies that specifically reported on specific therapies and outcome of anastomotic leakage [Verstegen 2018, submitted]. Nineteen studies with 273 patients were included and studies were of low to moderate quality. No meta-analysis was performed because of substantial clinical heterogeneity of the included studies. The main conclusion of the review was that due to small cohorts and clinical heterogeneity no evidence based treatment strategy could be composed from the current literature. A retrospective multicenter study of 79 patients revealed that the used treatment modality of an anastomotic leakage is not only patient dependent, but also hospital dependent [Lubbers 2019, submitted]. Until now the management of an anastomotic leakage is more or less based on expert opinion rather than on an evidence-based anastomotic leakage treatment algorithm. From these studies, it became evident that the absence of an anastomotic leakage severity score complicates performing robust research on this topic.

Anastomotic leakage severity is currently graded according to how it is treated (grade I: conservative treatment, grade II endoscopic or radiologic intervention and grade III surgical intervention) [Low 2015]. Although this scoring system is useful for reporting the consequences of anastomotic leakage, by definition it cannot be used to guide decision making when anastomotic leakage is diagnosed in a clinical setting. Examples of factors that may influence the severity of the anastomotic leakage are location of the anastomosis (intrathoracic or cervical), circumference of the defect, surface of the defect, extent of contamination (i.e. local, mediastinal, intrathoracic), degree of sepsis and time from diagnosis until therapy. However, little is known about to what extent these and other factors contribute to anastomotic leakage severity. In addition, there is a paucity of data on what leakage characteristics dictate the success of a specific treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 years or older;
  • Esophagectomy and gastric conduit reconstruction for resectable esophageal (cT1-4aN0-3M0) cancer;
  • Postoperative anastomotic leakage according to the ECCG definition [Low 2015].

排除标准

  • Esophagectomy for benign disease;
  • Emergency resection;
  • Patients undergoing extended total gastrectomy.

结局指标

主要结局

90 day mortality

时间窗: 90 days

Mortality that occurs within 90 days after esophagectomy

次要结局

  • Reinterventions(During admission for surgery or 30 days)
  • 30 day mortality(30 days)
  • 180 day mortality(180 days)
  • Hospital length of stay(Total hospital length of stay without readmissions, assessed at 180 days)
  • Comprehensive complications index (CCI)(During admission for surgery or 30 days)
  • Hospital based costs(During first hospital length of stay, assessed at 180 days)
  • ICU length of stay(Total ICU length of stay without readmissions, assessed at 180 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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