Prospective, Multi-centre, Exploratory and Observational One-arm Study to Evaluate Preemptive Endoluminal Vacuum Therapy to Prevent Anastomotic Leakage After Esophagectomy Due to Esophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Aesculap AG
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Rate of patients with anastomotic leakage
研究概览
简要总结
A prospective, multi-centre, exploratory and observational one-arm study to evaluate preventive Endoluminal Vacuum Therapy(pEVT) to prevent anastomotic leakage after esophagectomy due to esophageal cancer. The main objective is to evaluate the potential protective effect of prophylactic preemptive endoluminal vacuum therapy on esophageal-gastric anastomosis dehiscence after esophagectomy.
详细描述
Prospective, multi-centre, exploratory and observational one-arm study to evaluate preemptive endoluminal vacuum therapy to prevent anastomotic leakage after esophagectomy due to esophageal cancer.
The study comprises a maximum of 5 visits per protocol. At visit 0, informed consent will be obtained, and the patient will be checked for compliance with all inclusion criteria and no exclusion criteria in the study. Demographic characteristics, medical history and oncological parameters will be collected. At visit 1 ttMILE will be carry out and immediately (0-24h) after completion of the anastomosis, in patients who meet selection criteria, the Eso-SPONGE® will be placed endoscopically via an overtube, as usual clinical practice of the centre. The tube will be routed transnasally and then connected to a vacuum pump, generating a continuous negative pressure of 75 mmHg. The Eso-SPONGE system will be checked 6-hourly for leakage and dislocation. The sponge will be removed after 4-6 days (V2). After removal, the anastomosis and the gastric tube will be assessed endoscopically to exclude leakage and evaluate ischemia and stenosis, and the pylorus will be evaluated for spasm. The next visits (V3 and V4) will be carried out at 30 and 90 days after the intervention has been placed. Leakage, ischemia and stenosis will be clinically evaluated at each visit and a new endoscopy will be performed in patient who show symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years
- •Scheduled for total minimally invasive (laparoscopic or robotic and thoracoscopic) transthoracic Ivor Lewis esophagectomy (ttMILE) due to esophageal cancer and subsequent eso-SPONGE application to prevent anastomotic leakage
- •Patients able to read and understand the Patient Information Sheet and sign, if accepted, the Informed Consent Form
- •Patients able, at the discretion of the investigator, to comply with the requirements of the study and without impediments to follow the instructions and assessments throughout the study.
排除标准
- •Patients undergoing transhiatal esophagectomy without reconstruction, open Ivor Lewis esophagectomy or other esophageal resections different to ttMILE.
- •Multi-organ resection during the esophagectomy.
- •Emergent-urgent esophagectomy.
- •Coloplasty or small bowel plasty.
- •Necrotic tissue/gangrene.
- •Blood clotting disorder.
- •Bleeding esophageal varices.
- •Sponge placement required directly on major vessels.
- •Patients with known sensitivities or allergies to its components
- •Participation in any other clinical trial and use of any drug or experimental device, currently or in the 4 weeks prior to inclusion in the study.
- •Women who are pregnant, suspected of being pregnant or breastfeeding.
结局指标
主要结局
Rate of patients with anastomotic leakage
时间窗: throughout the duration of the study (until last follow-up at postoperative day 90)
Anastomotic leakage (AL) is a severe complication following gastric and esophageal surgery. Anastomotic leakage occurs in 5-30% of patients after esophagectomy and may be further complicated by mediastinitis, sepsis, multiple organ failure, or death. The primary objective of the study is to evaluate the potential protective effect of prophylactic preemptive endoluminal vacuum therapy on esophageal-gastric anastomosis dehiscence after esophagectomy.
次要结局
- Comprehensive Complication Index(Postoperative day 30 and day 90)
- Surgical reoperations(throughout the duration of the study (until last follow-up at postoperative day 90))
- Rate of postoperative ischemia(Postoperative day 30 and day 90)
- Rate of postoperative stenosis(throughout the duration of the study (until last follow-up at postoperative day 90))
- Length of hospitalization(until discharge (approximately 10 days postoperatively))
- Anastomotic leakage free survival(throughout the duration of the study (until last follow-up at postoperative day 90))
- Description of Adverse Events(throughout the duration of the study (until last follow-up at postoperative day 90))
- Re-admissions to hospital(throughout the duration of the study (until last follow-up at postoperative day 90))
- Rate of postoperative mortality(Postoperative day 30 and day 90)
- Rate of intraluminal hemorrhage(throughout the duration of the study (until last follow-up at postoperative day 90))