Esophageal Cancer | Quality of Life and Dysphagia Following Palliative Stenting in Esophageal Cancer
Esophageal Cancer research study
What is the primary objective of this study?
This study consists of a prospective clinical trial which aims to evaluate the impact of stent insertion for palliation of malignant dysphagia. The main goal being to examine the number of days required following stenting in order to have significant improvement in dysphagia and the length of time that this baseline is maintained. Approximately 100 patients will be prospectively enrolled in this study. Patients with end stage inoperable esophageal cancer deemed candidates for intraluminal esophageal palliative stent insertion will be prospectively enrolled into the study. Patients with esophageal obstruction or stricture due to other benign causes, tumors obstructing the cervical esophagus, as well as patients with airway-esophageal fistulas will be excluded from the study. The investigators plan to evaluate the efficacy of intra-esophageal stent insertion to improve malignant dysphagia as a main factor affecting the quality of life in these patients.
Who is eligible to participate?
Inclusion Criteria: - All patients with end stage inoperable esophageal cancer deemed candidates for intraluminal esophageal palliative stent insertions. Exclusion Criteria: - Inability to consent for the study. - Patients less than 18 years old. - Patients with other benign causes of dysphagia and esophageal obstruction or stenosis. - Patients with malignant or benign airway - esophageal fistulas. - Patients with cervical esophageal cancer
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: June 2011
Completed Date: August 2019
Primary Outcome: improvement of dysphagia post stenting
Secondary Outcome: Quality of life post stenting
Study sponsors, principal investigator, and references
Principal Investigator: Moishe Liberman, MD, PhD
Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)