Does Cap Assisted Colonoscopy Improve Detection of Adenomatous Polyps? (CAP Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,148
- 试验地点
- 4
- 主要终点
- Mean Number of Adenomas
研究概览
简要总结
Effectiveness of screening colonoscopy in cancer prevention relies on the detection and removal of adenomatous polyps. However, a substantial rate of adenomas is missed during a colonoscopy. It has been estimated that two thirds of missed adenomas are located on the proximal aspect of colonic folds. Attaching a transparent cap to the tip of a colonoscope may allow examination of the proximal aspect of colonic folds, and some early studies have suggested an increased polyp and adenoma detection using this technology. However, the studies have in part substantial methodological limitations (e.g. missing polyp histology, single endoscopist study, polyps not removed at the time of detection). Therefore, at this point it is unclear whether cap assisted colonoscopy may improve adenoma detection. The objective of this study is to evaluate whether cap assisted colonoscopy improves adenoma detection.
The investigators propose a two-center multiple endoscopists randomized controlled trial. Patients will be randomized to cap assisted colonoscopy or standard high definition white light colonoscopy. The cap is a 4mm commercially available transparent cap that is attached to the tip of the colonoscopy. Primary outcome measure is the adenoma detection rate (mean number of adenoma per patient). The investigators will assess and adjust for possible variables that can affect adenoma detection, including withdrawal time and quality of colon preparation. As a secondary outcome of interest the investigators will evaluate a possible learning curve effect among all endoscopists (a minimum of six) new to this method. In addition the investigators will evaluate whether cap assisted endoscopy improves real time prediction of polyp histology.
详细描述
All patients who present for a colonoscopy and meet inclusion and exclusion criteria will be asked to participate (see inclusion and exclusion criteria). All patients will undergo a regular bowel preparation with polyethylene glycol lavage (based on current standard of care) until clear rectal fluid is evacuated. Patients will be randomized to one of two groups:
- Standard colonoscopy, or
- Cap assisted colonoscopy. All colonoscopies will be performed using state of the art high-definition wide angle colonoscopy. The transparent cap, which is attached to the tip of the colonoscope, has a 4mm margin extending beyond the tip of the colonoscope. All patients will undergo a careful endoscopic examination. A timer will provide feedback on the time of insertion and the withdrawal time. Detected polyps will be assessed with standard white light and narrow band imaging to predict polyp histology (adenoma versus no adenoma), then resected and sent for histological evaluation according to standard of care. At least 8 experienced endoscopists at the participating centers will participate. Each endoscopist will perform at least 50 cap assisted colonoscopies as part of the study. Each endoscopist will be asked to complete a survey after 10 and after 50 cap assisted colonoscopies.
Patients will be randomized in blocks of four allocated to each examiner. The order of randomization will be computer generated. Information on randomization will be contained in sealed envelopes assigned to each examiner and individually opened immediately before the procedure after a patient's All participating endoscopist will fill out a questionnaire regarding the use of cap assistance colonoscopy after the initial 10 cap assisted colonoscopies and after at least 50 cap assisted cap colonoscopies. Endoscopists will also undergo a training session with respect to real time polyp diagnosis before study commencement and after each 20 colonoscopies enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any patient ≥ 50 years old and < 85 years old who presents for a colonoscopy with a potential for polyp resection and who does not meet any of the exclusion criteria mentioned below will be asked to participate
- •Exclusion criteria:
- •Patients with known inflammatory bowel disease or active colitis
- •Patients with familial adenomatous polyposis or other genetic syndromes that are associated with a high number of colonic polyps
- •Patients who are receiving an emergency colonoscopy
- •Poor general health (ASA class > 3)
- •Patients on coumadin at the time of the procedure or with a coagulopathy and an elevated INR ≥ 1.5, or platelets < 50
- •Patients who do not consent
排除标准
- 未提供
研究组 & 干预措施
Standard colonoscopy
Cap assisted colonoscopy
A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
干预措施: Colonoscopy Cap (Device)
结局指标
主要结局
Mean Number of Adenomas
时间窗: duration of colonoscopy
Mean number of adenomas per patient in each group.
次要结局
- Advanced Adenoma Detection Rate(duration of colonoscopy)
- Quality of Bowel Preparation(duration of colonoscopy)
- Withdrawal Time(time of colonoscope withdrawal)
- Ease of Terminal Ileum Intubation(during colonoscopy)
- Real Time Prediction of Polyp Histology(duration of colonoscopy)
- Adenoma Detection Rate(duration of colonoscopy)
研究者
Dr. Heiko Pohl
PI
White River Junction Veterans Affairs Medical Center