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

NCT06070376 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-05-01

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • Instituto do Cancer do Estado de São Paulo

    lead OTHER

Principal Investigators

  • Fauze Maluf-Filho, PhD · Cancer Institute of the state of São Paulo (ICESP)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-26
Primary Completion
2026-02-26
Completion
2026-08-26

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06070376 on ClinicalTrials.gov