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

Not Applicable

Recruiting

• Conditions: Dysphagia; Esophageal Neoplasms
• Interventions: Device: Fully Covered Esophageal Prosthesis (FC-SEMS); Device: Partially Covered Esophageal Prosthesis (PC-SEMS)

• Registration Number: NCT06070376
• Lead Sponsor: Instituto do Cancer do Estado de São Paulo

Brief 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.

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 Timeline

• Study Start: 2023-06-26
• Study First Submitted: 2023-09-27
• Study First Submitted QC: 2023-10-04
• Study First Posted: 2023-10-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-02-26
• Study Completion: 2026-08-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Fully Covered Esophageal Prosthesis (FC-SEMS)	placement of the esophageal prostheses fully covered in the palliative treatment of malignant esophageal obstructions.
Group B	Partially Covered Esophageal Prosthesis (PC-SEMS)	placement of the partially covered esophageal prostheses in the palliative treatment of malignant esophageal obstructions.

Primary Outcome Measures

Name	Time	Method
Reinterventions	2 years	Number of reinterventions after the procedure.

Secondary Outcome Measures

Name	Time	Method
Patency time of the prostheses.	2 years	Days without need a new prothesis or procedure
Adverse events and patency time of the prostheses	2 years	Number of adverse events

Trial Locations

Locations (1)

Instituto do Câncer do Estado de São Paulo; 🇧🇷 São Paulo, Brazil