BLI Based Adenoma Surveillance Strategy

NCT ID: NCT04111601

Last Updated: 2022-11-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 217 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-16
• Study Completion Date: 2022-10-15

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.

Conditions

Colorectal Polyp

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Blue light imaging

Advanced virtual chromoendoscopy

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

King's College Hospital NHS Trust

OTHER

Sponsor Role: collaborator

Luzerner Kantonsspital

OTHER

Sponsor Role: collaborator

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role: collaborator

University Medical Centre Ljubljana

OTHER

Sponsor Role: collaborator

Göteborg University

OTHER

Sponsor Role: collaborator

Humanitas Hospital, Italy

OTHER

Sponsor Role: collaborator

Nuovo Regina Margherita Hospital

OTHER

Sponsor Role: collaborator

MITERA Hospitals, Athens , Greece

UNKNOWN

Sponsor Role: collaborator

Portsmouth Hospitals NHS Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pradeep Z Bhandari, Prof

Role: PRINCIPAL_INVESTIGATOR

Portsmouth Hospitals NHS Trust

Locations

Portsmouth Hospital NHS Trust

Portsmouth, Hampshire, United Kingdom

Countries

United Kingdom

Other Identifiers

PHT/2019/30

Identifier Type: -

Identifier Source: org_study_id