Can Pan-Colonic Chromoendoscopy (PCC) Improve Adenoma Detection Rate in FIT-Positive-Patients: A Randomized Study
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- To evaluate the adenoma detection rate between pan-colonic chromoendoscopy and white light colonoscopy
研究概览
简要总结
Colonoscopy is the technique of choice for evaluation of patients with positive fecal occult blood (FIT). Identification of polyps and their removal has been shown to decrease colorectal cancer incidence rates and mortality. Many endoscopic imaging technologies and devices have been developed to increase adenoma detection (ADR) during screening colonoscopies. They vary in the way they work, and some of the technologies are costly and not widely available. Studies has shown the simple to use pan-colonic chromoendoscopy can improve ADR compared to standard colonoscopy. However, there is little evidence on the utility of pan-colonic chromoendoscopy in asymptomatic individuals undergoing colonoscopy after a positive FIT test. In this randomized study, the investigators aim to compare the utility of chromoendoscopy and high-definition white-light endoscopy in asymptomatic individuals undergoing colonoscopy after a positive FIT test
详细描述
Eligible subjects with positive screening FIT test referred to the Department of Gastroenterology, Singapore General Hospital will be approached and recruited. The included patients will be randomised to either a) Group A- Chromoendoscopy or b) Group B- high definition white light based evaluation.
Hypothesis:
The investigators hypothesize that application of non-absorbable dye during colonoscopy would enhance the mucosal contrast, delineate the border and surface patterns by accumulating in the innominate grooves and, thereby, enhance the detection of adenoma during colonoscopy
Procedure:
Pan-colonic chromoendoscopy and high-definition white light endoscopy will be performed by five experienced endoscopist, and hospital sedation guidelines will be followed. The colonoscopy will be performed using Olympus (CF-HQ190) or Fujifilm (EC-590) colonoscopies. Indigo carmine dye will be used for pan-colonic chromoendoscopy. Two ampules of Indigo carmine (0.8%, 5ml/ampule) will be dissolved in 250 ml of water and sprayed through the waterjet channel by using the auxiliary foot pump upon reaching the caecum.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 50 years
- •Positive stool FIT test or FOBT test
排除标准
- •Known inflammatory bowel disease
- •Known polyposis syndromes
- •Previous history of colon cancer and surgical resection
- •Overt gastrointestinal bleeding
- •Stool FIT or FOBT test performed during hospitalization
- •Inadequate bowel preparation (Boston Bowel Preparation score <6 or <2 for each colonic segment)
- •Poor patient tolerance to the procedure
- •Pregnancy
- •Concurrent intake of anticoagulants and thienopyridines (e.g., Clopidogrel), where these drugs cannot be suspended for the adequate duration before colonoscopy
- •Patient with known history of hypersensitivity to Indigo carmine dye
结局指标
主要结局
To evaluate the adenoma detection rate between pan-colonic chromoendoscopy and white light colonoscopy
时间窗: 2 years
次要结局
- Flat lesion detection rate(2 years)
- Serrated adenoma detection rate(2 years)
- Advanced adenoma detection rate white light colonoscopy(2 years)
- Withdrawal time comparison(2 years)