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BLI Based Adenoma Surveillance Strategy

BLI Based Adenoma Surveillance Strategy: BLAST Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04111601
Acronym
BLAST
Enrollment
217
Registered
2019-10-01
Start date
2019-10-16
Completion date
2022-10-15
Last updated
2022-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Polyp

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

Detailed description

Advanced endoscopic imaging can facilitate the characterisation of neoplastic and non-neoplastic polyps. Accurate identification of small non-neoplastic polyps (e.g. rectosigmoid hyperplastic polyps) that do not harbour malignant potential can lead to future implementation of a 'resect and discard' or 'diagnose and leave' strategy. However, there is insufficient evidence that endoscopists are able to attain high enough levels of optical diagnostic performance in-vivo in order to implement this strategy safely. Blue Light Imaging (BLI) is a new enhanced imaging technology that enhances mucosal surface and vessel patterns. A specific BLI classification was recently developed to enable better characterisation of colorectal polyps (BLI Adenoma Serrated International Classification - BASIC). The use of this technology with the appropriate classification to enhance its performance has not yet been tested in clinical settings of polyp surveillance and screening colonoscopy amongst general endoscopists. BLAST is a multicentre prospective observational study which will compare BLI optical diagnosis with histological assessment (as a reference standard) for patients with small polyps (\<10mm) identified at colonoscopy.

Interventions

DEVICEBlue light imaging

Advanced virtual chromoendoscopy

Sponsors

King's College Hospital NHS Trust
CollaboratorOTHER
Luzerner Kantonsspital
CollaboratorOTHER
Catharina Ziekenhuis Eindhoven
CollaboratorOTHER
University Medical Centre Ljubljana
CollaboratorOTHER
Göteborg University
CollaboratorOTHER
Humanitas Hospital, Italy
CollaboratorOTHER
Nuovo Regina Margherita Hospital
CollaboratorOTHER
MITERA Hospitals, Athens , Greece
CollaboratorUNKNOWN
Portsmouth Hospitals NHS Trust
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of adenomas correctly identified with BLI12 monthsAccuracy of BLI in optical diagnosis of small colorectal polyps

Secondary

MeasureTime frameDescription
Amount of money saved in GBP ( Cost savings)12 monthsEconomic implications of replacing histological diagnosis with optical diagnosis

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026