Comparative Study Between Fully Covered Esophageal Prosthesis (FC-SEMS) and Partially Covered Esophageal Prosthesis (PC-SEMS) in the Palliation of Dysphagia Due to Malignant Neoplasm of Esophagus.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Reinterventions
研究概览
简要总结
Esophageal cancer is the seventh most common type of cancer in the world, with an estimated global incidence of 604,100 new cases per year. The main symptom of esophageal cancer is dysphagia, associated or not with weight loss. Unfortunately, due to asymptomatic presentation in the early stages, more than half of patients are diagnosed in advanced stages of the disease, becoming ineligible for treatment with curative intent. In this sense, chemotherapy and radiotherapy are the pillars of palliative treatment, often regressing the injury and improving symptoms. However, some patients persist with dysphagia. In this scenario, esophageal prostheses are one of the main tools in the palliative treatment of esophageal cancer dysphagia, obtaining rapid and lasting relief of dysphagia. This study aims to compare fully covered (FC-SEMS) and partially covered (PC-SEMS) esophageal prostheses in this context, evaluating the number of reinterventions in each group, as well as the occurrence of adverse events. However, it is expected that with the data obtained it is possible to develop clearer and more effective protocols in the palliation of malignant dysphagia of esophageal stenosis.
详细描述
STUDY DESIGN: Prospective and randomized study will be conducted.
PREPARATION AND TECHNICAL STEPS OF THE PROCEDURE: The placement of the esophageal prosthesis will be performed under sedation or general anesthesia supervised by the anesthesiologist at the endoscopy service of the Cancer Institute of the State of São Paulo (ICESP). The tests will be performed under radioscopic control. The tests will be performed on an outpatient basis, and hospitalization may occur in case of clinical need.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 with advanced malignant neoplasm of the esophagus, whether or not undergoing chemotherapy or radiotherapy;
- •Dysphagia score greater than 2 or presence of malignant esophagorespiratory fistula;
- •Indication of palliation of dysphagia through the placement of esophageal prostheses in a multidisciplinary meeting.
排除标准
- •Patients under 18 years;
- •Extraesophageal neoplasms;
- •Lesions with longitudinal extension less than 30 mm;
- •Previous treatment with esophageal prosthesis;
- •Tumors easily transposed to standard endoscope (9.8mm).
研究组 & 干预措施
Group A
placement of the esophageal prostheses fully covered in the palliative treatment of malignant esophageal obstructions.
干预措施: Fully Covered Esophageal Prosthesis (FC-SEMS) (Device)
Group B
placement of the partially covered esophageal prostheses in the palliative treatment of malignant esophageal obstructions.
干预措施: Partially Covered Esophageal Prosthesis (PC-SEMS) (Device)
结局指标
主要结局
Reinterventions
时间窗: 2 years
Number of reinterventions after the procedure.
次要结局
- Patency time of the prostheses.(2 years)
- Adverse events and patency time of the prostheses(2 years)
研究者
Fauze Maluf Filho
MD, PhD, FASGE
Instituto do Cancer do Estado de São Paulo