NCT06070376Recruiting
Comparative Study Between (FC-SEMS) and (PC-SEMS) in the Palliation of Dysphagia Due to Malignant Neoplasm of Esophagus.
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.
Source: ClinicalTrials.gov · Last updated 17 Jul 2026
Brief summary (registry, in English)
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, associated or not with weight loss. Unfortunately, due to asymptomatic presentation in the early stages, more than half of patients are diagnosed in advanced stages of the disease, becoming ineligible for treatment with curative intent. In this sense, chemotherapy and radiotherapy are the pillars of palliative treatment, often regressing the injury and improving symptoms. However, some patients persist with dysphagia. In this scenario, esophageal prostheses are one of the main tools in the palliative treatment of esophageal cancer dysphagia, obtaining rapid and lasting relief of dysphagia. This study aims to compare fully covered (FC-SEMS) and partially covered (PC-SEMS) esophageal prostheses in this context, evaluating the number of reinterventions in each group, as well as the occurrence of adverse events. However, it is expected that with the data obtained it is possible to develop clearer and more effective protocols in the palliation of malignant dysphagia of esophageal stenosis.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- First submitted
- 27 Sept 2023
- Start date
- 26 Jun 2023
- Primary completion date
- 26 Feb 2027
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06070376
What you commit to
- Study type: Interventional
- Planned participants: 34
- From 26 Jun 2023 to the primary completion date, 26 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with esophageal prosthesis;
Other
- Patients under 18 years;
- Extraesophageal neoplasms;
- Lesions with longitudinal extension less than 30 mm;
- Tumors easily transposed to standard endoscope (9.8mm).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto do Câncer do Estado de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.