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.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Brazil
Instituto do Câncer do Estado de São Paulo
RECRUITING
São Paulo
Contact Information
Primary
Fauze Maluf-Filho, PhD
fauze.maluf@terra.com.br
+5511991919014
Time Frame
Start Date: 2023-06-26
Estimated Completion Date: 2026-08-26
Participants
Target number of participants: 34
Treatments
Active_comparator: Group A
placement of the esophageal prostheses fully covered in the palliative treatment of malignant esophageal obstructions.
Active_comparator: Group B
placement of the partially covered esophageal prostheses in the palliative treatment of malignant esophageal obstructions.
Sponsors
Leads: Instituto do Cancer do Estado de São Paulo

This content was sourced from clinicaltrials.gov