Colorectal Cancer, Colorectal Neoplasms, Colorectal Polyp
Conditions
Keywords
Colonoscopy, Fluorescence guided surgery
Brief summary
This is a feasibility study investigating the use of a fluorescently conjugated lectin to identify colorectal dysplasia and cancer during colonoscopy and surgery.
Interventions
DRUGFluorescent Lectin Application
Fluorescein conjugated wisteria floribunda (a lectin).
Sponsors
University of Oxford
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant is willing and able to give informed consent for participation in the study. * Male or female, aged 18 years or above * Participants undergoing endoscopic procedures including colonoscopy and flexible sigmoidoscopy or transanal endoscopic microsurgery (TEMS), including robotic assisted TEMS * In the investigator's opinion, is able and willing to comply with all study requirements
Exclusion criteria
* Participant who is unable to unwilling to give informed consent * Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. If there is an uncertainty regarding whether a woman could be pregnant, then they will be excluded from the study * Participants with known egg allergies, ovalbumin allergy and soya allergies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Signal to background ratios of identified colonic lesions under white light and under fluorescence | During procedure | This outcome measure compares the fluorescence signal of lesions identified during colonoscopy. |
| Number of dysplastic and cancerous lesions identified under white light and under fluorescence | During procedure | Number of lesions identified under white light colonoscopy will be compared to the number of lesions identified under fluorescence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of dysplastic and cancerous lesions identified under white light and fluorescence in different subgroups | 12 months | Assessment of subgroups including ulcerative colitis, lesions suspicious of sessile serrated adenomas / traditional serrated adenomas |
| Resection margin of of lesions undergoing TEMS resection under white light and under fluorescence. | 12 months | Planned resection margins will be compared under white light and under fluorescence. R0/R1 resection rates will be assessed post operatively. |
Countries
United Kingdom
Outcome results
None listed