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临床试验/NCT06070376
NCT06070376
招募中
不适用

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.

Instituto do Cancer do Estado de São Paulo1 个研究点 分布在 1 个国家目标入组 34 人2023年6月26日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Esophageal Neoplasms
发起方
Instituto do Cancer do Estado de São Paulo
入组人数
34
试验地点
1
主要终点
Reinterventions
状态
招募中
最后更新
去年

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.

注册库
clinicaltrials.gov
开始日期
2023年6月26日
结束日期
2026年8月26日
最后更新
去年
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Instituto do Cancer do Estado de São Paulo
责任方
Principal Investigator
主要研究者

Fauze Maluf Filho

MD, PhD, FASGE

Instituto do Cancer do Estado de São Paulo

入排标准

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).

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)

研究点 (1)

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