Comparing two types of esophageal stents for treating swallowing difficulties in cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.