RecruitingNot ApplicableNCT06070376

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

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.

Sponsor

Instituto do Cancer do Estado de São Paulo

Enrollment

34 participants

Start Date

Jun 26, 2023

Study Type

INTERVENTIONAL

Conditions

Esophageal Neoplasms Dysphagia

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two types of stents (small tubes placed in the esophagus) to relieve severe swallowing difficulty caused by advanced esophageal cancer. Researchers want to find out which stent — one that is fully covered or one that is partially covered — works better and is safer for patients. **You may be eligible if...** - You have advanced esophageal cancer (with or without ongoing chemo or radiation) - You have significant trouble swallowing (dysphagia score above 2) or an abnormal connection between the food pipe and airway - Your care team has recommended stent placement as a palliative option - You are 18 or older **You may NOT be eligible if...** - You are under 18 years old - The obstruction is caused by a cancer outside the esophagus - The narrowed area of the esophagus is very short (less than 30 mm) - You have already had an esophageal stent placed previously Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFully 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.

DEVICEPartially 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.