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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto do Cancer do Estado de São Paulo

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients under 18 years;

Extraesophageal neoplasms;

Lesions with longitudinal extension less than 30 mm;

Previous treatment with esophageal prosthesis;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fully Covered Esophageal Prosthesis (FC-SEMS)

    Device

    The placement of the Fully Covered Esophageal Prosthesis (FC-SEMS) will be performed under sedation or general anesthesia supervised by the anesthesiologist at the endoscopy service of the Cancer Institute of the State of São Paulo (ICESP). The tests will be performed under radioscopic control. The tests will be performed on an outpatient basis, and hospitalization may occur in case of clinical need.

  • Partially Covered Esophageal Prosthesis (PC-SEMS)

    Device

    The placement of the Partially Covered Esophageal Prosthesis (PC-SEMS) will be performed under sedation or general anesthesia supervised by the anesthesiologist at the endoscopy service of the Cancer Institute of the State of São Paulo (ICESP). The tests will be performed under radioscopic control. The tests will be performed on an outpatient basis, and hospitalization may occur in case of clinical need.

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: Group AActive comparator 1 intervention
Group B: Group BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Reinterventions

Number of reinterventions after the procedure.

Time frame
2 years

Secondary outcomes

1

Adverse events and patency time of the prostheses

Number of adverse events

Time frame
2 years
2

Patency time of the prostheses.

Days without need a new prothesis or procedure

Time frame
2 years

Other outcomes

Sponsors and contacts

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