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

Dysphagia Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06070376
• Other study ID #: NP3080/22
• Status: Recruiting
• Phase: N/A
• Start date: June 26, 2023
• Est. completion date: August 26, 2026

Study information

• Verified date: February 2024
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: Fauze Maluf-Filho, PhD
• Phone: +5511991919014
• Email: fauze.maluf[@]terra.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: August 26, 2026
• Est. primary completion date: February 26, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Esophageal Neoplasms
• Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Instituto do Câncer do Estado de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reinterventions	Number of reinterventions after the procedure.	2 years
Secondary	Adverse events and patency time of the prostheses	Number of adverse events	2 years
Secondary	Patency time of the prostheses.	Days without need a new prothesis or procedure	2 years