Esophageal Cancer
Conditions
Keywords
metastatic, obstructing
Brief summary
The main goal of this trial is to assess whether it's feasible to conduct a larger, full-scale study comparing the use of gastrostomy (g-tubes) and stents in patients with unresectable cancer of the stomach and/or esophagus, and to evaluate their impact on patients' quality of life. Additional objectives include examining the rates of complications, the need for additional treatments, and the total number of hospital days over a three-month period.
Interventions
PROCEDUREGastrostomy Tube
Feeding gastrostomy tube insertion
DEVICESelf Expanding Metal esophageal Stent
Fully covered SEMS in the esophagus
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a single centre, prospective, feasibility randomized controlled clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 years of age and older who present with an obstructing metastatic or unresectable gastroesophageal cancer.
Exclusion criteria
* Patients under the age of 18 years. * Prior Esophageal Stent or gastrostomy tube
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FACT-E | 3 months | • Change in FACT-E scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 3 months | • The rates of grade 1 to 5 complications as per the TSQIC |
| Crossover | 3 months | Rate of crossover from initial intervention to comparator arm |
Countries
Canada
Contacts
Primary ContactSamantha So, MSc
Backup ContactDeb Lewis, BSc
Outcome results
None listed