The Use of Fibrin Glue Sealant (Tisseel®) as a Reinforcement of Esophagojejunal Anastomoses Will Decrease the Rate of Anastomotic Leak.
试验速览
- 阶段
- 4 期
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Rate of esophagojejunal anastomotic leak in immediate postoperative period
研究概览
简要总结
Background:
The dehiscence of esophagojejunal anastomoses is one of the most serious complications after total gastrectomy in patients with gastric cancer. Any method of avoiding this problem will affect not only the postoperative course but also the prognostic of disease.
Methods:
This is a prospective, randomized and multicenter trial, within the Spanish EURECCA Esophagogastric Cancer Group, to investigate the efficacy of Tisseel® in reducing the rate of esophagojejunal anastomosis leakage in patients with gastric cancer. The rate of anastomosis leak will be measured with clinical, radiological and analytic parameters.
Objective:
Analyze the efficacy of Tisseel® as a reinforcement in reducing the rate of anastomotic esophagojejunal anastomoses.
详细描述
Introduction The dehiscence of the esophagojejunal anastomosis is one of the most serious complications after a total gastrectomy not only in the short term but it has been shown to be an independent risk factor for survival. The rate of esophagojejunal anastomosis leakage after cancer gastrectomies is described to be between 1-12.3%.
Any method to prevent this complication would be of vital importance to improve the evolution of these patients. Likewise, when the dehiscence has been established, early detection could contribute to an early intervention, avoiding more serious consequences and, therefore, improving the short and long term prognosis.
Little progress has been made during recent decades in the prevention of anastomotic leakage in high-risk digestive tract anastomosis. Some authors have tried the use of new methods of suture, reinforcements or patches in the anastomosis. Fibrin adhesives were introduced more than 30 years ago, in order to favor hemostasis and tissue adhesion. Numerous studies have demonstrated their effectiveness in reducing surgical bleeding in cardiovascular surgery but its role as a sealant in gastrointestinal anastomosis is more debated. There have been some experimental studies that have shown a possible protective effect of this material in enteric anastomoses. With the evolution of bariatric surgery and with the high volume of surgeries handled, several studies have been published that assess the effect of fibrin sealants on gastrojejunal anastomoses. In esophagogastric surgery, the number of published studies is reduced and there are only 2 studies that assess the effect of fibrin sealants on esophagojejunal anastomosis. The results of these studies seem to indicate that the application of fibrin sealants in this anastomosis could have a favorable effect in reducing the number of anastomotic dehiscences.
There are different definitions for the concept of "anastomotic dehiscence". The dehiscence of the esophago-jejunal anastomotic can be defined as any clinical and / or radiological evidence of dehiscence of the anastomosis. Although early diagnosis is key to avoiding major consequences, in clinical practice, the diagnosis of anastomotic dehiscence is often delayed. Direct observation of the debit of surgical drainage, fever or persistent ileus or clear symptoms of peritonitis are indirect signs that make us suspect a possible anastomotic dehiscence. The possibility of having a parameter that allows us to diagnose early a problem in the suture would allow us to act earlier and, therefore, improve the prognosis of these patients in the short and long term.
In colorectal surgery, serological parameters such as procalcitonin or C-reactive protein have been studied as early predictors of anastomotic dehiscence. In esophagogastric surgery, publications are scarce and all of them analyze results in esophagogastric anastomoses.
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
- Single (Participant)
盲法说明
Patients won't know if his anastomoses has been reinforced with Tisseel®.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years diagnosed with gastric adenocarcinoma and scheduled for a total gastrectomy with curative intent in EURECCA Esophagogastric Cancer Group who agree to participate in the study and sign the informed consent
排除标准
- •Patients with non-epithelial neoplasms, with metastases, not resected or undergoing palliative resections. Patients who do not sign informed consent.
研究组 & 干预措施
Tisseel®
Once the esophagojejunal anastomosis is done the patient is randomized (Tisseel® vs no product). In the arm "Tisseel®" surgeon dispenses the product all over the anastomosis. The rest of the surgical procedure is as usual.
干预措施: Tisseel (Drug)
no Tisseel®
Once the esophagojejunal anastomosis is done the patient is randomized (Tisseel® vs no product). In the arm " noTisseel®" surgeon performs the surgical procedure as usual.
干预措施: No Tisseel (Device)
结局指标
主要结局
Rate of esophagojejunal anastomotic leak in immediate postoperative period
时间窗: 7 days
Clinical or radiological (see anex 1: Score Goense) evidence of esophagojejunal anastomotic leak.
次要结局
- CRP (C-reactive protein) in blood(days 1,3,5,7 postoperatively)
- Results of Computed Tomography with oral contrast.(between 3th and 5th postoperative day)
- Postoperative complications(30 days after surgery)
- Procalcitonin in blood(days 1,3,5,7 postoperatively)
- White cell levels in blood(days 1,3,5,7 postoperatively)
- Type of esophagojejunal anastomoses performed(day of intervention)
- Hospital stay(30 days after surgery)
- Readmission(30 days after discharge)
- Amylases level in drainage(days 1,3,5,7 postoperatively)
- 90-day mortality(90 days after surgery)
- Need for urgent surgical re-intervention(30 days after surgery)
研究者
Elisenda Garsot Savall
Head of Upper Gastrointestinal Surgery Unit
Germans Trias i Pujol Hospital
