Идёт набор NCT06070376

Comparative Study Between (FC-SEMS) and (PC-SEMS) in the Palliation of Dysphagia Due to Malignant Neoplasm of Esophagus.

Без фазы С лечением Esophageal Neoplasms Dysphagia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Fully Covered Esophageal Prosthesis (FC-SEMS), Partially Covered Esophageal Prosthesis (PC-SEMS).
Кому может быть актуально: Состояния в реестре: Esophageal Neoplasms, Dysphagia. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Бразилия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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.

Обзор

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.

Подробное описание

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.

Вмешательства

Устройство Fully Covered Esophageal Prosthesis (FC-SEMS)
The placement of the Fully Covered Esophageal Prosthesis (FC-SEMS) 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.
Устройство Partially Covered Esophageal Prosthesis (PC-SEMS)
The placement of the Partially Covered Esophageal Prosthesis (PC-SEMS) 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.

Первичные конечные точки

Reinterventions [Срок оценки: 2 years]

Вторичные конечные точки (2)

Adverse events and patency time of the prostheses [Срок оценки: 2 years]
Patency time of the prostheses. [Срок оценки: 2 years]

Критерии участия

Критерии включения

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.