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

NCT ID: NCT06070376

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-26
• Study Completion Date: 2026-08-26

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.

Conditions

Esophageal Neoplasms; Dysphagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A

placement of the esophageal prostheses fully covered in the palliative treatment of malignant esophageal obstructions.

Group Type: ACTIVE_COMPARATOR

Fully Covered Esophageal Prosthesis (FC-SEMS)

Intervention Type: DEVICE

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.

Group B

placement of the partially covered esophageal prostheses in the palliative treatment of malignant esophageal obstructions.

Group Type: ACTIVE_COMPARATOR

Partially Covered Esophageal Prosthesis (PC-SEMS)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Fauze Maluf Filho

MD, PhD, FASGE

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fauze Maluf-Filho, PhD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute of the state of São Paulo (ICESP)

Locations

Instituto do Câncer do Estado de São Paulo

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Fauze Maluf-Filho, PhD

Role: CONTACT

fauze.maluf@terra.com.br

+5511991919014

Facility Contacts

Fauze Maluf-Filho, PhD

Role: primary

fauze.maluf@terra.com.br

+5511991919014

Other Identifiers

NP3080/22

Identifier Type: -

Identifier Source: org_study_id