Comparative Study Between (FC-SEMS) and (PC-SEMS) in the Palliation of Dysphagia Due to Malignant Neoplasm of Esophagus.
Launched by INSTITUTO DO CANCER DO ESTADO DE SÃO PAULO · Oct 4, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating two types of esophageal prostheses, known as fully covered self-expanding metal stents (FC-SEMS) and partially covered self-expanding metal stents (PC-SEMS), to help patients with esophageal cancer who are experiencing difficulty swallowing, also known as dysphagia. The goal is to see which type of prosthesis works better in relieving symptoms and to assess how often patients might need additional procedures after receiving the stent. This is particularly important for patients who may not be eligible for more aggressive treatments due to advanced stages of their cancer.
To be eligible for this study, participants should be adults aged 65 and older with advanced esophageal cancer, regardless of whether they are receiving chemotherapy or radiotherapy. They must have a significant swallowing problem or a specific type of complication related to their cancer. Throughout the trial, participants will have regular check-ins to monitor their symptoms and any side effects that may arise from the stent placement. This research aims to improve care for patients facing the challenges of esophageal cancer and enhance overall treatment strategies.
Gender
ALL
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).
About Instituto Do Cancer Do Estado De São Paulo
The Instituto do Câncer do Estado de São Paulo (ICESP) is a leading cancer research and treatment institution in Brazil, dedicated to advancing the understanding and management of cancer through innovative clinical trials and comprehensive patient care. As a prominent sponsor of clinical trials, ICESP focuses on developing cutting-edge therapies and improving treatment outcomes for cancer patients. With a commitment to scientific excellence and collaboration, the institute plays a pivotal role in contributing to national and international cancer research initiatives, ultimately striving to enhance the quality of life for individuals affected by cancer.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
São Paulo, , Brazil
Patients applied
Trial Officials
Fauze Maluf-Filho, PhD
Principal Investigator
Cancer Institute of the state of São Paulo (ICESP)
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported