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

Primary Purpose

Esophageal Neoplasms, Dysphagia

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Fully Covered Esophageal Prosthesis (FC-SEMS)
Partially Covered Esophageal Prosthesis (PC-SEMS)
Sponsored by
Instituto do Cancer do Estado de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Neoplasms focused on measuring Esophageal Neoplasms, Palliation of dysphagia, Esophageal stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Instituto do Câncer do Estado de São PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Reinterventions
Number of reinterventions after the procedure.

Secondary Outcome Measures

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

Full Information

First Posted
September 27, 2023
Last Updated
October 4, 2023
Sponsor
Instituto do Cancer do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT06070376
Brief Title
Comparative Study Between (FC-SEMS) and (PC-SEMS) in the Palliation of Dysphagia Due to Malignant Neoplasm of Esophagus.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2023 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
June 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto do Cancer do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasms, Dysphagia
Keywords
Esophageal Neoplasms, Palliation of dysphagia, Esophageal stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
placement of the esophageal prostheses fully covered in the palliative treatment of malignant esophageal obstructions.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
placement of the partially covered esophageal prostheses in the palliative treatment of malignant esophageal obstructions.
Intervention Type
Device
Intervention Name(s)
Fully Covered Esophageal Prosthesis (FC-SEMS)
Intervention Description
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
Intervention Name(s)
Partially Covered Esophageal Prosthesis (PC-SEMS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reinterventions
Description
Number of reinterventions after the procedure.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Adverse events and patency time of the prostheses
Description
Number of adverse events
Time Frame
2 years
Title
Patency time of the prostheses.
Description
Days without need a new prothesis or procedure
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fauze Maluf-Filho, PhD
Phone
+5511991919014
Email
fauze.maluf@terra.com.br
Facility Information:
Facility Name
Instituto do Câncer do Estado de São Paulo
City
São Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fauze Maluf-Filho, PhD
Phone
+5511991919014
Email
fauze.maluf@terra.com.br

12. IPD Sharing Statement

Learn more about this trial

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

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