Polyp Surface Pattern Recognition in the Identification of Neoplastic Polyps
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- The accuracy of predicted in-vivo polyp histology
Study Overview
Brief Summary
It is current practice to remove any polyps found during colonoscopy. This is because adenomatous polyps have the potential to turn into cancer. However, a proportion of polyps <10mm in size are hyperplastic, which cannot turn into cancer. Current practice requires these to be removed, as it is traditionally felt that they cannot be separated clinically from adenomas. This increases the risk of perforation and results in a significant cost in processing the samples. However, it has been suggested that it is possible to differentiate neoplastic from non neoplastic lesions using skills in polyp surface pattern recognition. If this is the case the investigators may be able to reduce the need for polypectomy The investigators believe that it is possible to tell the difference between polyps with cancerous potential and those that are harmless by assessment of surface patterns. This may enable us to improve the investigators clinical decisions when assessing polyps during colonoscopy, and reduce the number of unnecessary polypectomys being performed.
Detailed Description
Polyps are a common finding during colonoscopy. It is current practice to remove these lesions, as some have the potential to turn into cancer. However, not all polyps are the same. Polyps can be of three different types:
- Hyperplastic, which have negligible potential to turn into cancer and if left would cause no harm. These account for around one third of all small polyps encountered
- Adenomas, which can turn into cancer and should be removed
- Polyp cancers, which should be either biopsied or removed completely
The management pathway for polyps >10mm is very simple as they are either likely to be adenomas which need removal or cancers which need a biopsy and tattoo. There is a rare possibility of these big polyps being hyperplastic / serrated adenomas and given the risk of malignant transformation, they need removal as well.
It has been traditionally felt that hyperplastic polyps cannot be separated clinically from adenomas or polyp cancers by the endoscopist. It is for this reason that all polyps are removed. However, polypectomy increases the risk of perforation and results in a significant cost in processing the samples. Recently it has been suggested that it is possible to differentiate neoplastic from non neoplastic lesions in the colon using skills in polyp surface pattern recognition.
Kudo's pit pattern is an effective way of in-vivo prediction of histology and differentiating neoplastic from non neoplasic polyps. However, it was originally described using vial staining which is cumbersome, time consuming and is not possible to perform outside Japan due to lack of availability and fears of toxicity related to gentian violet. It does however produce excellent results when used for pit pattern recognition. (Hurlstone DP C. S., 2004) It works by irreversibly binding microbial DNA and directly inhibiting cell replication. (Wakelin LPG, 1981).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients found to have polyps up to 10 mm in size
Exclusion Criteria
- •Patient preference Clinicians judgement Obvious cancers Ulcerated polyps
Outcomes
Primary Outcomes
The accuracy of predicted in-vivo polyp histology
Time Frame: 9 months
Secondary Outcomes
- Sensitivity of Chromoendoscopy in predicting histology(9 months)
- Sensitivity of fujinon intelligent color enhancement (FICE) in predicting histology(9 months)
- Specificity of fujinon intelligent color enhancement (FICE) in predicting histology(9 months)
- • Sensitivity of white light endoscopy in predicting histology(9 months)
- specificity of white light endoscopy in predicting histology(9 months)
- Specificity of Chromoendoscopy in predicting histology(9 months)
- Whether one technique is superior(9 months)