Colorectal Polyps Clinical Trial
Official title:
Effectiveness of Cold Biopsy Forceps With Pre-lift for Complete Resection of Colonic Polyps ≤7mm in Size.
Verified date | April 2017 |
Source | Gloucestershire Hospitals NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 propose a study
to evaluate the effectiveness, safety and costs of this method.
Status | Completed |
Enrollment | 64 |
Est. completion date | September 25, 2015 |
Est. primary completion date | September 25, 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Patients from Cheltenham General Hospital and Royal Gloucestershire Hospitals that have been scheduled for colonoscopy through our outpatient clinics or inpatient consult service will be prospectively recruited prior to their Colonoscopy. Exclusion Criteria: - Patients will be excluded if: 1. They are under the age of 18. 2. They do not have capacity to consent for the Colonoscopy as determined at the time of procedural admission by the trained admitting endoscopy nurse. If a patient is deemed to lack capacity by the referring doctor or admitting nurse this will also be assessed by the colonoscopist. Both the colonoscopist and admitting nurses have been trained to assess capacity,that is whether a persons mind is affected at the time of the procedure in such a way that they are unable to make a decision. There are multiple reasons as to why an individuals brain or mind may be altered such as medications, mental illness or dementia. 3. There is a history of Inflammatory Bowel Disease 4. Identified coagulopathy with PT>1.4 or thrombocytopenia with Platelets <80 on any bloods collected within routine clinical practice within the past 4 weeks. This will not be an additional procedure and these bloods are routinely taken on patients where coagulopathy or thrombocytopenia is a concern such as patients on long term Warfarin or with chronic liver disease. These patients are identified by Endoscopy nursing staff in pre assessment work up. Routine haematology is not taken as part of a standard assessment for outpatient endoscopy. 5. Taking dual anti platelet therapy or pharmacological anti coagulation. 6. Bowel preparation is deemed poor by colonoscopist. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Cheltenham General Hospital | Cheltenham | Gloucestershire |
Lead Sponsor | Collaborator |
---|---|
Gloucestershire Hospitals NHS Foundation Trust | Olympus |
United Kingdom,
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* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The polyp retrieval rate of this method. | Complete polyp retrieval is if all polyp tissue is successfully retrieved at the time of colonoscopy. Occasionally tissue may be dislodged from forceps and be misplaced within colon fluid and residue. | intraoperative during patient colonoscopy and analysed within one month of last patients recruitment. | |
Other | Immediate or delayed complications from this technique. | Common complications of polypectomy include bleeding, both immediate and delayed. Immediate bleeds will occur at the time of the colonoscopy and will be considered significant if endoscopic therapy is required to treat. Delayed bleeds will usually be within a week of the index procedure and will present as per rectal bleeding or haematochezia. This will only be determined to be related to the procedure if a repeat colonoscopy is performed and the bleeding site is assessed to be from a polypectomy site included in the study. Perforation of the colon would usually be determined during the colonoscopy, often at the time of polypectomy at the polypectomy site. A delayed perforation is also possible usually within 48 hours of the procedure and is often determined with computer tomography (CT) scan. | intraoperative and after one week. | |
Other | An overall comparison of this polypectomy method compared to other methods used for diminutive and small polyps. | A direct comparison of CRR, number of biopsies for visual eradication, time taken for procedure, polyp retrieval rate and complication rate to other techniques primarily cold snare and cold forceps without a pre-lift. | 2 months post completion of recruitment. | |
Primary | Histological complete resection rate (CRR) using a pre injection lift and cold forceps for polypectomy of polyps =7mm. | 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. | Within one week of patients colonoscopy | |
Secondary | 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. | Researcher will record time from pre injection till end of visual eradication of polyp. | intraoperative during colonoscopy and analysed within one month of last patient recruitment |
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