Optical Diagnosis With vs. Without Three-Dimensional Imaging for Small and Diminutive Colorectal Polyps: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 458
- 试验地点
- 1
- 主要终点
- endoscopic diagnostic accuracy of polyps and adenomas
研究概览
简要总结
This study investigated whether adding a three-dimensional (3D) imaging view during colonoscopy helps doctors classify small colon polyps more accurately than standard colonoscopy without 3D. Polyps are small growths in the colon that may develop into cancer over time. When doctors remove polyps, they often examine them closely during the procedure to judge how likely they are to be precancerous-a process called optical diagnosis.
In this study, two approaches to optical diagnosis were compared: diagnosis using standard colonoscopy without 3D, and diagnosis using the same colonoscopy with additional 3D imaging. Both groups used the same classification systems (JNET and WASP) to identify polyp type; the only difference was whether 3D imaging was used. The main question was whether adding 3D improves the agreement between the doctor's diagnosis during colonoscopy and the final laboratory diagnosis of the removed polyp. The study also collected safety information.
Participants were randomly assigned to one of the two groups, like flipping a coin. Regardless of group, all participants underwent an initial colonoscopy to detect polyps, a second colonoscopy to remove polyps and perform optical diagnosis, and a follow-up period of up to 30 days to monitor for side effects. The study included adults with at least one colon polyp smaller than 10 mm that did not require a more advanced type of removal called ESD.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥18 years;
- •Underwent non-3D white-light colonoscopy with at least one colorectal polyp identified;
- •Endoscopically estimated polyp size <10 mm;
- •No indication for endoscopic submucosal dissection (ESD);
- •Scheduled for inpatient polypectomy;
- •Provided written informed consent.
排除标准
- •History of any polypectomy;
- •History of colorectal surgery;
- •Inflammatory bowel disease (Crohn's disease or ulcerative colitis);
- •Hereditary polyposis syndromes;
- •Concurrent colorectal cancer;
- •Contraindications to colonoscopy (e.g., severe cardiopulmonary insufficiency);
- •Coagulopathy or failure to discontinue antithrombotic agents;
- •Inability to cooperate with procedures;
- •Pregnancy or lactation;
- •Refusal to participate or inability to give informed consent.
研究组 & 干预措施
3D imaging arm
Participants will undergo inpatient colonoscopy with polypectomy (CSP, CFP, or EMR) using standard high-definition colonoscopy with additional 3D imaging assistance. Optical diagnosis will be based on the JNET classification, with additional WASP features applied for JNET Type 1 lesions, integrating 3D visualization.
干预措施: Optical diagnosis based on JNET classification with WASP features plus 3D imaging assistance (Diagnostic Test)
non-3D group
Participants will undergo inpatient colonoscopy with polypectomy (CSP, CFP, or EMR) using standard high-definition colonoscopy. Optical diagnosis will be based on the JNET classification, with additional WASP features applied for JNET Type 1 lesions, without 3D assistance.
干预措施: Optical diagnosis based on JNET classification with WASP features (no 3D assistance) (Diagnostic Test)
结局指标
主要结局
endoscopic diagnostic accuracy of polyps and adenomas
时间窗: 1-7 days after polypectomy
The overall proportion of correct classifications by endoscopy compared to the gold standard (pathology) in lesion level
Overall diagnostic concordance of endoscopic polyp classification
时间窗: 1-7 days after polypectomy
The overall proportion of correct classifications by endoscopy (3D vs. non-3D) compared to the gold standard (pathology) at the lesion level, across all polyp types.
次要结局
- Adenoma detection rate (ADR)(1-7 days after polypectomy)
- Polyp detection rate (PDR)(1-7 days after polypectomy)
- the accuracy of lession size evaluation(1-7 days after polypectomy)
- The colonoscopy-relevant adverse events(1-30 days after polypectomy)
- Modified high-risk adenoma (mHRA) detection rate(1-7 days after polypectomy)
- Clinically relevant serrated polyp detection rate(1-7 days after polypectomy)
- early colorectal cancer detection rate(1-7 days after polypectomy)
- the accuracy of the evaluation of invasion depth(1-7 days after polypectomy)
- the confidence of endoscopy diagnosis(during endoscopy diagnosis before polypectomy by the endoscopists)
- Diagnostic confidence(During the endoscopic procedure, immediately after optical diagnosis)
- Diagnostic concordance for adenomas and sessile serrated lesions (SSLs)(1-7 days after polypectomy)
- Diagnostic concordance for identifying patients requiring surveillance(1-7 days after polypectomy)
- Diagnostic characteristics (sensitivity, specificity, PPV, NPV) for adenomas and SSLs(1-7 days after polypectomy)
研究者
Zhiguo Liu
associate professor
Xijing Hospital of Digestive Diseases