Prospective Randomized Clinical Trial on Delay Phenomenon Utility in Preventing Oesophagogastric Anastomotic Dehiscence After Ivor-Lewis Esophagectomy. Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Anastomotic leakage
研究概览
简要总结
This is a randomized clinical trial to clarify if the delay phenomenon could reduce the incidence of oesophagogastric dehiscence after an esophagectomy for esophageal cancer comparing an experimental group vs control group. The delay phenomenon will be performed by an arteriographic approach.
详细描述
Subtotal esophagectomy with tubular gastroplasty to upper mediastinum and esophagogastric anastomosis (Ivor-Lewis procedure) is a very complex surgical technique. It is performed in patients with infracarinal esophageal carcinoma and is associated with a high morbidity rate in specialized centers (up to 60% in some groups). One of the most important postoperative complications is the oesophagogastric anastomotic leakage which leads to high morbidity (mediastinitis, respiratory failure, pleural effusion) and mortality rate (up to 60% depending on the reports).
The most important cause of anastomotic leakage is the stomach's extreme sensitivity to ischemic injury. There are several experimental studies that have demonstrated that the delay phenomenon before the esophageal resection surgery aims to improve blood perfusion after a period of time. Few studies, only case-reports, describe a decrease in the incidence of intrathoracic and cervical anastomotic leakage. May the delay phenomenon reduce the incidence of anastomotic intrathoracic leakage?. There aren't any prospective randomized controlled trials to answer this question.
For this reason the investigators propose to perform a prospective randomized controlled trial in patients who underwent a subtotal esophagectomy (Ivor-Lewis procedure), comparing two groups: one of them will be submitted to a delay phenomenon by arteriographic procedure before esophageal resection surgery, and the other one will be operated on directly, to demonstrate if the delay phenomenon can reduce the incidence of anastomotic esophagogastric leakage.
We decided to conduct this trial as a pilot study due to the fact that the number of patients needed to achieve statistical significance was to high and would have taken almost 10 years. We established a recruitment period of 3 years, in wich we intend to include 60 patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients requiring a subtotal esophagectomy with en-bloc resection and an intrathoracic esophagogastrostomy for esophageal cancer
- •18 or above years old
- •Acceptance and signing the full informed consent
排除标准
- •Absence of pancreatitis
- •Anatomic vascular alteration that contraindicate the embolization (congenital celiac trunk stenosis, presence of arcuate ligament,etc,..)
- •refuse to collaborate in the study
研究组 & 干预措施
delay phenomenon by arteriography
intervention: delay phenomenon by arteriography. Patients who will be subjected a delay phenomenon by arteriographic procedure before esophageal resection surgery minimum 14 days before surgery.
An angiogram of the celiac trunk is performed through a femoral access before and after the embolization. A 4-5 Fr Simmons or Cobra catheter is used for the catheterization and embolization of the left gastric artery, and 0.035-inch platinum coils are proximally placed from the main trunk in the splenic artery. When accessory left gastric arteries are present, they are catheterized and embolized as well. The right gastric artery catheterization is realized by a 4-5 Fr catheter and coils or microcoils are proximally placed in the artery as well.
干预措施: delay phenomenon by arteriographic approach (Procedure)
control group
Patients who will be operated directly without gastric ischemic conditioning. The investigators don't performed any arteriography before the esophageal surgical resection
结局指标
主要结局
Anastomotic leakage
时间窗: 7 days
investigators will consider anastomotic dehiscence the presence of one or more of the following conditions: radiologic confirmation by water-soluble contrast study (gastrografin administered orally) or thoracoabdominal Tc with oral contrast of dehiscence of oesophagogastric anastomosis or the stapler end of the gastroplasty. When the clinical conditions of patient don't allow a Rx control investigators will consider an anastomotic leakage in these conditions: Thoracic drain output of oesophagogastric content with amylase \> 40 ukAT/L, confirmation of anastomotic dehiscence by the surgeon during a reintervention, endoscopic confirmation of anastomotic leakage of the stapled end of the plasty and methylene blue output after oral administration (100 ml of water with 10ml of methylene blue)
次要结局
- plasty ischemia(7 days)
- hospital stay(90 days)
- major and minor morbidity(90 days)
- postoperative mortality(during hospitalization and/or 30 days after surgery)
- post-embolization morbidity(30 days)
- anastomotic stricture(6 months)
研究者
Leandre Farran Teixidor
Chief of oesophagogastric surgery department
Hospital Universitari de Bellvitge