Comparing two types of esophageal stents for treating swallowing difficulties in cancer patients
Comparative Study Between Fully Covered Esophageal Prosthesis (FC-SEMS) and Partially Covered Esophageal Prosthesis (PC-SEMS) in the Palliation of Dysphagia Due to Malignant Neoplasm of Esophagus.
This study is testing whether fully covered or partially covered esophageal stents can help cancer patients with swallowing difficulties feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto do Cancer do Estado de São Paulo Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT06070376 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of fully covered esophageal stents (FC-SEMS) versus partially covered esophageal stents (PC-SEMS) in alleviating dysphagia caused by advanced esophageal cancer. Patients with significant swallowing difficulties will be randomly assigned to receive one of the two types of stents, and their outcomes will be monitored for the need for reinterventions and any adverse events. The placement of the stents will be performed under sedation or general anesthesia in an outpatient setting, ensuring patient safety and comfort. This prospective study aims to provide insights into the best palliative care options for patients suffering from esophageal neoplasms.
Who should consider this trial
Good fit: Ideal candidates include adults with advanced esophageal cancer experiencing severe swallowing difficulties.
Not a fit: Patients under 18 years or those with specific types of esophageal lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for patients suffering from dysphagia due to esophageal cancer.
How similar studies have performed: Previous studies have shown promising results with esophageal stenting for dysphagia, indicating that this approach is both viable and beneficial.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
São Paulo, São Paulo
- Instituto do Câncer do Estado de São Paulo — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Fauze Maluf-Filho, PhD — Cancer Institute of the state of São Paulo (ICESP)
- Study coordinator: Fauze Maluf-Filho, PhD
- Email: fauze.maluf@terra.com.br
- Phone: +5511991919014
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.