Status:
RECRUITING
Comparative Study Between (FC-SEMS) and (PC-SEMS) in the Palliation of Dysphagia Due to Malignant Neoplasm of Esophagus.
Lead Sponsor:
Instituto do Cancer do Estado de São Paulo
Conditions:
Esophageal Neoplasms
Dysphagia
Eligibility:
All Genders
18+ years
Phase:
NA
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, associat...
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 gene...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 26 2026
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06070376
Start Date
June 26 2023
End Date
August 26 2026
Last Update
May 1 2025
Active Locations (1)
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1
Instituto do Câncer do Estado de São Paulo
São Paulo, São Paulo, Brazil, 01246-000