BLI Based Adenoma Surveillance Strategy

NCT04111601 | Completed

• 1 other identifier: PHT/2019/30
• Study Type: observational
• Target: 217
• Locations: 1 country
• Sites: 1

Brief Summary

Bowel cancer is the third most common cancer in the UK. It develops through smaller growths in the bowel called polyps. Early recognition and removal of these polyps result in prevention of developing bowel cancer in an individual. However, not all polyps will lead to cancer, certain polyps are just growths of normal tissue and can be left in the bowel. We therefore need to know which polyps to remove and which ones to leave. One way of doing this is to have a better look at these polyps. This can be done by new technologies. One of them is called Blue Light Imaging (BLI). This is a new light source at the end of the camera which is activated by the push of a button. It will help us in looking at these polyps more closely. This helps us decide which polyps to remove and which ones are safe to leave as there is always a small risk in removing a polyp. It would also give us a better idea as to when to repeat the camera test if necessary (endoscopic surveillance). By reducing the number of polyps resected and sent to the pathology labs for diagnosis, the work load on the pathology department is also reduced and in the process, providing cost savings to the Trust, The study aims to see if using Blue Light during endoscopy helps us to identify and characterize small polyps better

Conditions

Colorectal Polyp

Outcome Measures

Primary Outcomes (1)

• Percentage of adenomas correctly identified with BLI

  Accuracy of BLI in optical diagnosis of small colorectal polyps

  12 months

Secondary Outcomes (1)

• Amount of money saved in GBP ( Cost savings)

  12 months

Interventions

Blue light imaging DEVICE

Advanced virtual chromoendoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients undergoing colonoscopy who fulfill eligibility criteria.

You may qualify if:

• \> 18 years of age Able to provide informed consent

You may not qualify if:

• History of polyposis syndrome History of Inflammatory bowel disease History of poor bowel prep

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead
• King's College Hospital NHS Trust: collaborator
• Luzerner Kantonsspital: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator
• University Medical Centre Ljubljana: collaborator
• Göteborg University: collaborator
• Humanitas Hospital, Italy: collaborator
• Nuovo Regina Margherita Hospital: collaborator
• MITERA Hospitals, Athens , Greece: collaborator

Study Sites (1)

Portsmouth Hospital NHS Trust

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

Study Officials

• Pradeep Z Bhandari, Prof

  Portsmouth Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: October 1, 2019
• Study Start: October 16, 2019
• Primary Completion: October 15, 2022
• Study Completion: October 15, 2022
• Last Updated: November 30, 2022

Record last verified: 2022-11

Locations

GB (1)