The Cap-Assisted Resection Margin Assessment (CARMA) Technique After Polyp Resection: a Prospective Feasibility Study of a "Novel" Approach to Reduce Polyp Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Rate of achieving a clear resection margin using the CARMA technique
研究概览
简要总结
Colonoscopic removal of polyps is an important and well-established tool in the prevention of colorectal cancers. However, high polyp recurrence rates after endoscopic resection, with resultant development of interval cancers, remains a problem; this most commonly stems from unrecognised incomplete polyp resection. Thus, a standardised endoscopic technique is needed that will allow endoscopists to consistently achieve a clear margin of resection. The investigators believe the Cap Assisted Resection Margin Assessment (CARMA) technique will address this problem. This novel technique focuses on a standardised assessment of the resection margin after endoscopic polypectomy utilising available standard high-definition video endoscopes with imaging features including narrow band imaging (NBI) and magnification endoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with colonic polyps will be considered following below criteria
- •Inclusion Criteria:
- •any polypectomy (though only a maximum of two polyps from one individual participant)
排除标准
- •polyps less than 10mm which were resected under endoscopic view with a definite > 1mm clear margin
- •scar site recurrence polyps
- •polyps with endoscopic evidence of invasion
- •pedunculated polyps
- •pseudopolyps
- •participants who will not be available for follow up endoscopy
结局指标
主要结局
Rate of achieving a clear resection margin using the CARMA technique
时间窗: Established during index procedure
次要结局
- Frequency of residual polyp without CARMA assessment(Established during index procedure)
- Sensitivity and specificity of the CARMA technique for residual polyp detection(Established during index procedure)
- Incomplete resection rate with use of the CARMA technique in polyps > 10mm with cold snare(Established during index procedure)
- Residual polyp rate after CARMA technique with hot snare(Established during index procedure)
- Residual polyp rate after CARMA technique with cold snare(Established during index procedure)
- Incomplete resection rate with use of CARMA technique(Established during index procedure)
- Incomplete resection rate with use of the CARMA technique in polyps > 10mm with hot snare(Established during index procedure)
- Time required for application of the CARMA technique with < 10mm(Established during index procedure)
- Time required for application of the CARMA technique with > 10mm(Established during index procedure)
- Polyp recurrence rate for < 10mm polyps(Established during surveillance procedure (following national guidelines - between 6 months to 5 years))
- Polyp recurrence rate for > 10mm polyps(Established during surveillance procedure (following national guidelines - between 6 months to 5 years))
研究者
Alexander Huelsen
Interventional Gastroenterologist, Principal Investigator
Princess Alexandra Hospital, Brisbane, Australia