Actively Recruiting
Comparing Fully Covered and Partially Covered Esophageal Stents to Relieve Swallowing Difficulties in Esophageal Cancer Patients
Led by Instituto do Cancer do Estado de São Paulo · Updated on 2026-07-17
34
Participants Needed
1
Research Sites
25 weeks
Total Duration
AI-Summary
What this Trial Is About
Esophageal cancer is the seventh most common cancer globally, often diagnosed late when curative treatment is not possible. This trial evaluates two types of esophageal prostheses, fully covered FC-SEMS and partially covered PC-SEMS, used to relieve swallowing difficulties caused by advanced esophageal cancer. The study aims to compare the number of reinterventions and adverse events between these devices to improve palliative care protocols for malignant esophageal narrowing. Participants will receive either the fully covered or partially covered esophageal prosthesis, placed under sedation or general anesthesia with anesthesiologist supervision at a specialized cancer institute. The procedure is guided by radioscopy and usually done on an outpatient basis, although hospitalization may occur if clinically necessary. The study is prospective, randomized, and compares these two device types in parallel groups. During the study, participants will be monitored for up to two years to track the need for additional procedures, occurrence of adverse events, and how long the prostheses remain open and functional. Tests and evaluations will occur under radioscopic control, with ongoing assessment of swallowing symptoms and device patency. The total participation duration can extend to two years, ensuring thorough observation of outcomes and safety in managing dysphagia due to esophageal cancer.
CONDITIONS
Brief Title
Comparative Study Between (FC-SEMS) and (PC-SEMS) in the Palliation of Dysphagia Due to Malignant Neoplasm of Esophagus.
Research Team
F
Fauze Maluf-Filho, PhD
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