Impact of Using Hybrid-ESD+ and LiftUp® as Injectable on en Bloc/R0 Rate in Colorectal Adenomas Between 2 and 3 cm.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 18
- 主要终点
- R0 resection rate of non pedunculated colorectal polyps between 2 and 3cm using hybrid ESD+
研究概览
简要总结
This study examines whether the use of Hybrid-ESD+ with LiftUp (Injection solution) results in a higher en bloc and/or R0 rate for non pedunculated colorectal adenomas between 2 and 3 cm than described in the literature for conventional EMR.
详细描述
There are several options for endoscopic polypectomy of polyps between 2-3 cm, all of which have their advantages and disadvantages and none of which has yet become the established standard procedure.
Conventional EMR has the disadvantage of more frequent residuals and/or recurrences due to lack of en bloc resection, while ESD has the disadvantage of being more complex and complications more likely.
A possible alternative is the use of hybrid ESD+ with LiftUp subcutaneous injection. The method with the LiftUp gel forming a stable gel cushion under the lesion, in combination with the circular circumcision of the mucosa at this site and the AWC for the current loop and the grasper, could achieve a better en bloc resection rate with a low complication rate than other procedures mentioned above.
The higher effectiveness in terms of recurrences and complications could subsequently result in a reduction of endoscopic or surgical re-interventions.
In this study, non-pedunculated colorectal polyps between 2 and 3cm in size are resected using ESD+ method and lift up as an injection solution.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-pedunculated lesion in the colorectum (epithelial lesion, 2-3 cm).
- •Ablation medically indicated and possible (coagulation, etc. - as determined by the center)
排除标准
- •Age < 18 years
- •Pedunculated lesion (Paris0-Ip)
- •Size of the lesion <2cm or >3cm
- •Pregnant and breastfeeding women
- •Patient not capable of informed consent / consent not possible
- •Bioptic evidence of a carcinoma / high probability of the presence of a carcinoma
- •Non-lifting sign / known recurrence after previous therapy
- •Impassable stenosis in the colon / rectum
- •Patients with compelling need for therapeutic anticoagulation or dual antiplatelet therapy that cannot be discontinued for resection
- •As per contraindications from the AWC & LiftUp Instructions for Use:
- •The AWC is not to be used if flexible-endoscopic procedures are contraindicated.
- •The LiftUp gel should not be used when flexible endoscopic procedures are contraindicated, especially in combination with submucosal endoscopic resection (EMR) or endoscopic submucosal dissection (ESD) injectables.
- •LiftUp gel should not be used in patients with known sensitivity to any of the ingredients.
结局指标
主要结局
R0 resection rate of non pedunculated colorectal polyps between 2 and 3cm using hybrid ESD+
时间窗: after 14 days
In how many cases a complete R0 resection (basal and lateral margin) is found on pathologic examination
次要结局
- Recurrence rate(6 months)
- Procedural parameters - Intervention duration(1 day)
- Procedural parameters - Cleanliness of the colon(1 day)
- Polyp morphology(1 day)
- Complication rate (perforations, bleeding)(up to 4 weeks)
- Localization of polyp(1 day)
- Polyp size(1 day)
- Polyp histology(7 days)
- Duration of hospital stay(up to 4 weeks)