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.

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.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Neoplasms; Dysphagia
• Intervention / Treatment: Device: Fully Covered Esophageal Prosthesis (FC-SEMS); Device: Partially Covered Esophageal Prosthesis (PC-SEMS)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fauze Maluf-Filho, PhD; Phone Number: +5511991919014; Email: fauze.maluf@terra.com.br

Study Locations

• Brazil
  • São Paulo, Brazil, 01246-000
    • Recruiting
    • Instituto do Cancer do Estado de Sao Paulo
    • Contact: Fauze Maluf-Filho, PhD; Phone Number: +5511991919014; Email: fauze.maluf@terra.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; placement of the esophageal prostheses fully covered in the palliative treatment of malignant esophageal obstructions.	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.
Active Comparator: Group B; placement of the partially covered esophageal prostheses in the palliative treatment of malignant esophageal obstructions.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reinterventions	Number of reinterventions after the procedure.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events and patency time of the prostheses	Number of adverse events	2 years
Patency time of the prostheses.	Days without need a new prothesis or procedure	2 years

Collaborators and Investigators

• Sponsor: Instituto do Cancer do Estado de São Paulo
• Investigators: Principal Investigator: Fauze Maluf-Filho, PhD, Cancer Institute of the state of São Paulo (ICESP)

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2023
• Primary Completion (Estimated): February 26, 2026
• Study Completion (Estimated): August 26, 2026

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Esophageal Neoplasms; Esophageal stent; Palliation of dysphagia
• Additional Relevant MeSH Terms: Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Neoplasms; Esophageal Neoplasms; Deglutition Disorders
• Other Study ID Numbers: NP3080/22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No