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Trial Title:
Comparative Study Between (FC-SEMS) and (PC-SEMS) in the Palliation of Dysphagia Due to Malignant Neoplasm of Esophagus.
NCT ID:
NCT06070376
Condition:
Esophageal Neoplasms
Dysphagia
Conditions: Official terms:
Neoplasms
Esophageal Neoplasms
Deglutition Disorders
Conditions: Keywords:
Esophageal Neoplasms
Palliation of dysphagia
Esophageal stent
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Device
Intervention name:
Fully Covered Esophageal Prosthesis (FC-SEMS)
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.
Arm group label:
Group A
Intervention type:
Device
Intervention name:
Partially Covered Esophageal Prosthesis (PC-SEMS)
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.
Arm group label:
Group B
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.
Criteria for 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Instituto do Câncer do Estado de São Paulo
Address:
City:
São Paulo
Zip:
01246-000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Fauze Maluf-Filho, PhD
Phone:
+5511991919014
Email:
fauze.maluf@terra.com.br
Start date:
June 26, 2023
Completion date:
August 26, 2026
Lead sponsor:
Agency:
Instituto do Cancer do Estado de São Paulo
Agency class:
Other
Source:
Instituto do Cancer do Estado de São Paulo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06070376
