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

NCT06070376 | Recruiting DMC

• 1 other identifier: NP3080/22
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Neoplasms; Dysphagia

Keywords

Esophageal Neoplasms; Palliation of dysphagia; Esophageal stent

Outcome Measures

Primary Outcomes (1)

• Reinterventions

  Number of reinterventions after the procedure.

  2 years

Secondary Outcomes (2)

• Adverse events and patency time of the prostheses

  2 years

• Patency time of the prostheses.

  2 years

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Device: Fully Covered Esophageal Prosthesis (FC-SEMS)

Group B

ACTIVE COMPARATOR

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

Device: Partially Covered Esophageal Prosthesis (PC-SEMS)

Interventions

Fully Covered Esophageal Prosthesis (FC-SEMS) 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 A

Partially Covered Esophageal Prosthesis (PC-SEMS) 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.

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

Instituto do Câncer do Estado de São Paulo

São Paulo, São Paulo, 01246-000, Brazil

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Deglutition Disorders

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Fauze Maluf-Filho, PhD

  Cancer Institute of the state of São Paulo (ICESP)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fauze Maluf-Filho, PhD

CONTACT

+5511991919014; fauze.maluf@terra.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, FASGE

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 6, 2023
• Study Start: June 26, 2023
• Primary Completion: February 26, 2026
• Study Completion (Estimated): August 26, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

BR (1)