Optical Diagnosis Versus Laser Measurement of Polyps' Size During Colonoscopy and Implications for Surveillance (Polyp Size Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 3
- 主要终点
- Cohens' Kappa coefficient
研究概览
简要总结
Recent updates of the guidelines on polyp surveillance of the American Society of Gastrointestinal Endoscopy (ASGE) and European Society of Gastrointestinal Endoscopy (ESGE) increasingly focus on size of polyps as an important indicator of malignant transformation to colorectal cancer (CRC). However, the interobserver variability in polyp size assessment between optical diagnosis of endoscopists and pathologists is considerable. This may lead to incorrect surveillance intervals in patients at risk for developing colorectal cancer, which may increase the risk of post-colonoscopy CRC (PCCRC). This study aims to assess the precision of a new laser-based measurement system (AccuMeasure, VTM Technologies Ltd.) for polyps during colonoscopy.
详细描述
Objective
The main objective is to compare the precision of polyp size measurement by AccuMeasure to biopsy forceps assisted measurement. Secondary objectives are to assess: Time needed for measurement and learning curve, endoscopists advised surveillance intervals based on both measurement methods, and safety.
Study design: Multicenter, randomized, parallel group, endoscopist blinded study, including the measurement of 138 polyps during standard colonoscopy. With a polyp detection rate of approximately 40%1, this results in up to 345 patients/colonoscopies to be included. Enrollment will conclude once 138 polyps are included in the study.
Study population: All adult patients with screening or surveillance colonoscopies will be asked for informed consent. Polyps smaller than 25mm found during colonoscopy are considered eligible for inclusion. Up to 3 polyps per patient can be included in this study.
Intervention: Optical assessment will be performed upon identification of the polyp. Then, measurement with AccuMeasure and biopsy forceps will be performed in a randomized order. The endoscopist will remain blinded to the AccuMeasure measurement outcomes, to avoid a learning effect that could influence subsequent measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
盲法说明
the endoscopist will remain blinded to the AccuMeasure measurement outcomes, to avoid a learning effect that could influence subsequent measurements. Even so, all pathologist assessments will be done independent of the study allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Adult patients (>18 years)
- •Scheduled for screening, surveillance, or diagnostic colonoscopy
- •Polyps of all forms ≤ 25mm as assessed by the endoscopist
排除标准
- •• Therapeutic colonoscopy;
- •Inflammatory bowel disease (IBD);
- •American Society of Anesthesiologists (ASA) score of >3;
- •Inadequately corrected anticoagulation disorder or anticoagulation medication use;
- •Inability to provide informed consent;
- •Inadequate bowel preparation (Boston bowel preparation scale score [BBPS] <2 per segment);
- •No polyps identified during colonoscopy or only small (<5mm) hyperplastic rectal polyps;
- •Intraprocedural complications, not caused by the study device.
研究组 & 干预措施
Accumeasure last
Optical polyp size assessment, followed by biopsy forceps and then AccuMeasure measurement
干预措施: AccuMeasure (Device)
AccuMeasure first
optical assessment, followed by AccuMeasure measurement and then biopsy forceps assisted assessment (2)
干预措施: AccuMeasure (Device)
结局指标
主要结局
Cohens' Kappa coefficient
时间窗: at colonoscopy
interobserver agreement between AccuMeasure and biopsy forceps assisted measurement
次要结局
- Number of Participants with adverse events up to 30 days post colonoscopy(30 days post colonoscopy)
- Absolute size differences(at colonoscopy)
- Time for measurement(at colonoscopy)
- Endoscopist advised surveillance interval(At colonoscopy)