Comparison of Second Forward View Examination and Conventional Withdrawal Examination in the Right Colon on Polyp Detection in Screening and Surveillance Colonoscopies: A Randomized Controlled Study (SFVRC Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,011
- 试验地点
- 3
- 主要终点
- Per-patient ADR in the right colon in each group.
研究概览
简要总结
It is estimated that there are about 1.4 million patients with colorectal cancer (CRC) worldwide, with a rising trend in CRC incidence in many Asian Pacific countries. In Hong Kong, colorectal cancer ranks first in cancer incidence and second in cancer mortality based on data from 2013.
CRC is one of the most preventable cancers because its development in general follows an adenoma-carcinoma sequence. Adenomas are considered precursor lesions for CRC.
While early detection and removal of colorectal adenoma by screening colonoscopy with polypectomy reduce CRC incidence and mortality, interval cancers (cancers that develop after a colonoscopy and before the next scheduled colonoscopy) may still occur and were reported to account for up to 10.5% of CRC. The protective effect of colonoscopy against cancer in the right colon has not been consistently demonstrated. Interval CRC has been associated with proximal colon location, small lesion, flat lesion, missed lesion, inadequate examination, incomplete resection of lesion, tumor biology, and low adenoma detection rate (ADR).
High ADR (eg, ≥ 20%) has been associated with a reduced risk of interval CRC. Methods that can improve polyp detection in the right colon such as retroflexed examination of the right colon, second forward view examination of the right colon, use of colonic fold flattening device, colonoscope with an increased field of view may potentially reduce the risk of interval CRC, but data is still limited. Performance of a second forward view (SFV) examination of the right colon may be the easiest and safest from a practical standpoint when compared to other options (eg, additional training is often needed for retroflexed examination of the right colon since there may be a potentially higher risk of perforation in endoscopists not familiar with the technique, additional equipment is needed when using a colonic fold flattening device, or a colonoscope with an increased field of view).
Our current study aims to determine whether a routine SFV examination in the right colon can lead to an increase in adenoma / polyp detection when compared to conventional withdrawal examination in the right colon in both male and female patients undergoing screening and surveillance colonoscopies.
详细描述
It is estimated that there are about 1.4 million patients with colorectal cancer (CRC) worldwide, with a rising trend in CRC incidence in many Asian Pacific countries. In Hong Kong, colorectal cancer ranks first in cancer incidence and second in cancer mortality based on data from 2013.
CRC is one of the most preventable cancers because its development in general follows an adenoma-carcinoma sequence. Adenomas are considered precursor lesions for CRC.
While early detection and removal of colorectal adenoma by screening colonoscopy with polypectomy reduce CRC incidence and mortality, interval cancers (cancers that develop after a colonoscopy and before the next scheduled colonoscopy) may still occur and were reported to account for up to 10.5% of CRC. The protective effect of colonoscopy against cancer in the right colon has not been consistently demonstrated. Interval CRC has been associated with proximal colon location, small lesion, flat lesion, missed lesion, inadequate examination, incomplete resection of lesion, tumor biology, and low adenoma detection rate (ADR).
High ADR (eg, ≥ 20%) has been associated with a reduced risk of interval CRC. Methods that can improve polyp detection in the right colon such as retroflexed examination of the right colon, second forward view examination of the right colon, use of colonic fold flattening device, colonoscope with an increased field of view may potentially reduce the risk of interval CRC, but data is still limited. Performance of a second forward view (SFV) examination of the right colon may be the easiest and safest from a practical standpoint when compared to other options (eg, additional training is often needed for retroflexed examination of the right colon since there may be a potentially higher risk of perforation in endoscopists not familiar with the technique, additional equipment is needed when using a colonic fold flattening device, or a colonoscope with an increased field of view).
Our current study aims to determine whether a routine SFV examination in the right colon can lead to an increase in adenoma / polyp detection when compared to conventional withdrawal examination in the right colon in both male and female patients undergoing screening and surveillance colonoscopies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing colonoscopy for CRC screening or polyp surveillance
- •Age 50 - 75 years
- •Written informed consent available
排除标准
- •Contraindications for endoscopy due to comorbidities
- •Unable to provide written informed consent
- •Personal history of prior resection of any portion of the colon, familial polyposis syndrome, inflammatory bowel disease
- •Patients with incomplete colonoscopy (i.e, inability to achieve cecal intubation), a Boston Bowel Preparation Scale (BBPS) score of 0 in either right colon, transverse colon, or left colon at the time of colonoscopy
- •Known history of coagulopathy and thrombocytopenia
- •Pregnant patients
研究组 & 干预措施
Second forward view exam
During withdrawal, the colonoscope will be advanced to the cecum again when hepatic flexure was reached the first time, where a second forward view (SFV) examination of the right colon will be performed.
干预措施: Second forward view (SFV) examination of the right colon (Diagnostic Test)
Conventional withdrawal exam
No intervention additional to the conventional withdrawal examination during withdrawal
结局指标
主要结局
Per-patient ADR in the right colon in each group.
时间窗: 24 months
For the SFV group, it is defined as the number of patients with at least 1 adenoma identified in the right colon on either the first or second examination of the right colon divided by the total number of patients in the SFV group. Thus, if a patient has at least 1 adenoma detected on both the first examination and the second examination of the right colon, then this patient will be counted once only. For the conventional group, it is defined as the number of patients with at least 1 adenoma identified in the right colon on the conventional withdrawal examination of the right colon divided by the total number of patients in the conventional withdrawal group.
次要结局
- Total number of polyps found on the first and second examinations of the right colon in the SFV group, and that on the examination of the right colon in the conventional group(24 months)
- The number of patients with at least 1 additional adenoma detected in right colon in the SFV group(24 months)
- Adverse events during colonoscopy and up to 30 days post colonoscopy(24 months)
- Increase in per-patient ADR in the right colon in the SFV group.(24 months)
- Overall ADR for the entire colon in each group.(24 months)
- Total number of adenomas found on the first and second examinations of the right colon in the SFV group, and that on the examination of the right colon in the conventional group(24 months)
研究者
Raymond Shing Yan Tang
Clinical Professional Consultant
Chinese University of Hong Kong