Effectiveness of Cold Biopsy Forceps With Pre-lift for Complete Resection of Colonic Polyps ≤7mm in Size.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Histological complete resection rate (CRR) using a pre injection lift and cold forceps for polypectomy of polyps ≤7mm.
研究概览
简要总结
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.
详细描述
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
- Determine the histological complete resection rate (CRR) using a pre injection lift and cold forceps for polypectomy of polyps ≤7mm.
- 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.
- To determine the polyp retrieval rate of this method.
- To record any complications from this technique.
- 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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Patients will be excluded if:
- •They are under the age of
- •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.
- •There is a history of Inflammatory Bowel Disease
- •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.
- •Taking dual anti platelet therapy or pharmacological anti coagulation.
- •Bowel preparation is deemed poor by colonoscopist.
结局指标
主要结局
Histological complete resection rate (CRR) using a pre injection lift and cold forceps for polypectomy of polyps ≤7mm.
时间窗: Within one week of patients colonoscopy
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.
次要结局
- 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.(intraoperative during colonoscopy and analysed within one month of last patient recruitment)