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临床试验/NCT04268654
NCT04268654已完成不适用

Trial on Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer. Effects on Oxygenation and Anastomotic Leakage.

Fundación para la Investigación del Hospital Clínico de Valencia2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年6月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Anastomotic leakage

研究概览

简要总结

This study is a randomized clinical trial to clarify if preoperative embolization of gastric arteries can reduce the incidence of oesophagogastric leakage after an esophagectomy for esophageal cancer comparing an experimental group vs control group.

详细描述

In patients with infracarinal esophageal carcinoma, the surgery is a complex procedure and with a high morbidity. It consists of a subtotal esophagectomy with tubular gastroplasty and cervical esophagogastric anastomosis. The most important complication is the anastomotic leakage with a high mortality. Among the possible causes of anastomotic leakage an important factor is the impaired microcirculation in the anastomotic region after the partial devascularization of the stomach during the surgery. There are several experimental studies about the different techniques to improve this vascularization and their effects on mucosal oxygenation. There are several methods currently used for assessing tissue oxygenation. The polarographic partial pressure of oxygen (pO2) electrode has been considered as the 'gold standard' for measuring oxygen tension. This is the reason why tissue pressure of oxygen (PtiO2) will be measured by Licox® (Integra Neuroscience) system in two groups. There aren't prospective randomized controlled trials to answer these questions. For this reason the investigators propose to perform a prospective randomized controlled trial in patients underwent on this surgery, comparing two groups: one of them will be carried out a preoperative arterial embolization (PAE), and the other one will be operated directly, to demonstrate if the ischemic conditioning by PAE can reduce the incidence of anastomotic esophagogastric leakage and improve the gastric conduit oxygenation.

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
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients requiring a esophagectomy with cervical esophagogastrostomy for esophageal cancer
  • 18 or above years old
  • Karnofsky>50%
  • Acceptance and signing the full informed consent

排除标准

  • Fistula tracheobronchial
  • Metastatic disease
  • Anatomic vascular alteration that contraindicate the embolization (congenital celiac trunk stenosis, presence of arcuate ligament, atherosclerotic stenosis, etc,..)
  • Severe cardiorespiratory failure
  • Refuse to collaborate in the study

结局指标

主要结局

Anastomotic leakage

时间窗: 90 days

Clinic, endoscopy or computed tomography with oral contrast of dehiscence of oesophagogastric anastomosis.

次要结局

  • Relation between PtiO2 and anastomotic leakage(90 days)
  • Hospital Stay(90 days)
  • Tissue pressure oxygen (Ptio2)(48 hours)
  • Mortality(90 days)
  • Morbidity(90 days)
  • Gastric Conduit ischemia(90 days)

研究者

发起方
Fundación para la Investigación del Hospital Clínico de Valencia
申办方类型
Other
责任方
Sponsor

研究点 (2)

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