Colon Cancer, Gastric Cancer
Conditions
Keywords
Gastric cancer, colon cancer, EMR, biopsy, bariatric surgery
Brief summary
This is a study to determine how the viscosity (thickness) of an FDA approved gel affects the ease in which endoscopic mucosal resections (EMR) can be performed.
Detailed description
This is a study to determine how the viscosity (thickness) of an FDA approved gel made by Cook medical affects the ease in which endoscopic mucosal resections (EMR) - a type of endoscopic surgery performed for localised cancer - can be performed when the gel is injected submucosally. The lifting characteristics of the gel will be assessed by height and diameter and ease with which the subsequent EMR dissection can be performed. These characteristics would be assessed on excised human stomachs and colon, which are harvested during routine sleeve gastrectomy surgeries or colectomies, in an ex-vivo manner.
Interventions
DRUGCook Medical EMR Gel
Cook Medical EMR Gel will be injected submucosally into ex-vivo gastric or colonic tissue specimens
Sponsors
Antonios Likourezos
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Pts undergoing sleeve gastrectomy * Pts undergoing colectomy
Exclusion criteria
* Unable to give or understand consent * All of the excised tissue will be needed for diagnostic purposes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lift Efficacy | 1 hour | Lifting characteristics which would be measured by height of the mucosa after submucosal gel injection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dissection Adequacy | 1 hour | Dissection adequacy which would be measured by time which the gel stays within the tissues. Anything less than one hour will be considered failure. |
Countries
United States
Outcome results
None listed