Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06070376

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

Led by Instituto do Cancer do Estado de São Paulo · Updated on 2025-05-01

34

Participants Needed

1

Research Sites

165 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Instituto do Câncer do Estado de São Paulo

São Paulo, São Paulo, Brazil, 01246-000

Actively Recruiting

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Research Team

F

Fauze Maluf-Filho, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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