Evaluation of Surveillance Intervals After Piecemeal Resection of Non-pedunculated Colorectal Lesions ≥20mm: SCARFACE Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 746
- 主要终点
- Cumulative incidence of recurrence/residual tissue
研究概览
简要总结
Intensive endoscopic surveillance following piecemeal resection of non-pedunculated colorectal lesions (NPCL) ≥20 mm is the current standard of care, given the high recurrence rate of these lesions (15-30%). However, most recurrences are detected at 12 months, are small and unifocal, and can be easily resected endoscopically. Furthermore, thermal margin ablation has demonstrated a reduction in recurrence rates to 5-6%, highlighting the need to optimize current surveillance protocols, which are costly, invasive, and impose a significant clinical burden.
The multicenter SCARFACE clinical trial aims to evaluate whether a reduced surveillance protocol (at 12 and 48 months) is non-inferior to the standard protocol (at 6, 12, and 48 months) in terms of recurrence rates, using a predefined non-inferiority margin. This non-inferiority design aims to determine if the reduced protocol maintains acceptable efficacy while reducing clinical workload and minimizing risks and discomfort associated with intensive follow-up.
Patients will be randomized in a 1:1 ratio into the two surveillance protocols, with an estimated sample size of 746 lesions. The primary objective is to compare the cumulative incidence of recurrence at 12 months. Secondary objectives include characterizing recurrences, assessing complications associated with endoscopic treatments and evaluating the incidence of advanced colorectal lesions. The findings of this study are expected to directly impact clinical guidelines and routine practice, optimizing resource utilization and improving patient quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a single non-pedunculated colorectal lesion (NPCL) ≥20 mm that has been resected piecemeal and treated with thermal ablation (using snare tip or argon plasma) at the margins as prophylaxis against recurrence, and who are awaiting the initiation of specific endoscopic follow-up.
- •Complete colonoscopy with adequate or excellent bowel preparation performed within the last 6 months prior to the resection of the index lesion.
- •Signed informed consent.
排除标准
- •Resection performed using a cold snare technique due to the high risk of recurrence.
- •Histology of the lesion showing malignancy: colorectal cancer with submucosal invasion, regardless of invasion depth in microns.
- •Absence of information regarding the grade of dysplasia of the index lesion.
- •Personal history of colorectal cancer.
- •Incomplete endoscopic resection of the index lesion or any other polyps present in the patient.
- •When the endoscopist performing the index colonoscopy expresses doubts about whether the resection was complete.
- •Index lesion with prior attempted resection.
- •Hereditary cancer syndromes (e.g., adenomatous or serrated polyposis syndromes, Lynch syndrome, etc.).
- •Inflammatory bowel disease.
- •Severe comorbidities with reduced life expectancy.
- •Pregnancy.
- •Ongoing cytotoxic treatment or radiotherapy for a malignant disease.
研究组 & 干预措施
Reduced surveillance interval
Surveillance colonoscopies at 12 and 48 months
干预措施: Colonoscopy (Procedure)
Standard surveillance interval
Surveillance colonoscopies at 6, 12 and 48 months
干预措施: Colonoscopy (Procedure)
结局指标
主要结局
Cumulative incidence of recurrence/residual tissue
时间窗: 12 months
次要结局
- To describe the characteristics of recurrences(48 months)
- To compare the cumulative incidence of recurrence/residual tissue(48 months)
- To assess the incidence of advanced colonic lesions or colorectal cancer(48 months)
- To determine the proportion of patients requiring surgery to treat recurrence or complications associated with it.(48 months)
- To determine the complete endoscopic resection rate in patients who have experienced recurrence.(48 months)
- To analyze the incidence of complications arising from the endoscopic treatment of recurrences.(48 months)
- To assess the incidence of advanced colonic lesions or colorectal cancer(12 months)