Comparative Study Between Fully Covered and Partially Covered Esophageal Prostheses in the Palliation of Dysphagia Due to Malignant Esophageal Neoplasm

What this Trial Is About

Esophageal cancer is a common cancer worldwide, often diagnosed late when curative treatment is not possible. This research aims to compare two types of esophageal prostheses, fully covered (FC-SEMS) and partially covered (PC-SEMS), used to relieve swallowing difficulties caused by malignant esophageal narrowing. The study intends to find out which prosthesis results in fewer reinterventions and fewer complications, helping develop better treatment protocols for symptom relief in advanced esophageal cancer. The study is a prospective, randomized trial where participants will receive either a fully covered or a partially covered esophageal prosthesis. Placement of these devices will be done under sedation or general anesthesia with anesthesiologist supervision, using imaging guidance. The procedures are outpatient but may require hospitalization if needed. The two groups will be compared mainly on the number of reinterventions over two years, along with the time the prostheses remain open and any adverse events. Participants will undergo placement of the esophageal prosthesis at a cancer institute under controlled conditions. Researchers will monitor patients for up to two years, assessing how long the prostheses remain functional and recording any complications or additional treatments needed. The study will include tests performed with imaging, and patient symptoms will be evaluated to measure relief. This long-term follow-up will help understand the durability and safety of each prosthesis type in managing malignant dysphagia.

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