Clinical Trial: Effectiveness of Cold Biopsy Forceps With Pre-lift for Complete Resection of Colonic Polyps ≤7mm in Size

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Effectiveness of Cold Biopsy Forceps With Pre-lift for Complete Resection of Colonic Polyps ≤7mm in Size.

Brief Summary:

There is no consensus method for removal of diminutive (5mm) to small(6-9mm) colorectal polyps at colonoscopy. Neither the European Society of Gastrointestinal Endoscopy or the American Society of Gastrointestinal Endoscopy have guidelines for the removal of these polyps, despite the fact that around 90% of lesions removed by polypectomy at colonoscopy are diminutive to small.

Multiple techniques are used for polyp removal, especially diminutive lesions. These include either forceps, both hot and cold, as well as snare with electrocautery or cold snare. Forceps utilises shearing force to grasp tissue and remove it, with the hot method passing a current through the grasper to essentially burn tissue. Snare is the use of a small metal loop placed and tightened at the base of polyps to cut through the tissue either straight away in a cold method or with electrocautery where a small current is passed through the loop to assist cutting through tissue. Surveys of Colonoscopists and Gastroenterologists in Australia and the United States show that the choice of method used for diminutive to small polyps is highly variable with cold snaring marginally favoured.Studies into polypectomy techniques are limited and it is clear that additional data and the review of polypectomy methods needs to be undertaken in order determine the optimal method for the removal of diminutive and small colorectal polyps.

A technique is used at the Gloucestershire National Health Service (NHS) trust involving a submucosal pre injection with a standard solution then the use of cold forceps for removal of polyps ≤7mm. This appears to be both very safe and highly effective method for the removal of these lesions compared to other techniques. No formal published studies have been completed to evaluate this method at national and international levels. We

Detailed Summary:

Hypothesis A pre injection and cold forceps technique for removal of polyps ≤ 7mm is safe and results in retrieval rates >98% with complete histological resection >90% of the time.

Objectives

1. Determine the histological complete resection rate (CRR) using a pre injection lift and cold forceps for polypectomy of polyps ≤7mm.
2. Determine the number of bites required for complete visual resection of these polyps and the time taken from the beginning of pre injection needle insertion till complete resection.
3. To determine the polyp retrieval rate of this method.
4. To record any complications from this technique.
5. To compare the CRR, number of biopsies for visual eradication, time taken, polyp retrieval rate and complication rate of this method to cold forceps alone and cold snare from previous studies.

Methods

Participants:

Sample size 150 polyps, anticipated to be captured in between 75 and 100 patients based on an average of 2 polyps per patient. There is no published data on this polypectomy technique and there is limited data on other diminutive to small polypectomy techniques. Other comparative published studies looking at polypectomy techniques for diminutive to small polyps have had polyp numbers between fifty four and one hundred and seventeen.The sample size of 150 polyps is an approximation based on the fact that it is an achievable figure within the scope of the project and local clinical service which should yield a relatively narrow confidence interval.

Gastrointestinal pathologist will assess histology of polyp resected then assess the polypectomy site rim that was resected at EMR for any evidence of residual polyp that was not visible to the colonoscopist.