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.
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.
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.
Parallel
Colonoscopy
Procedure/SurgerySurveillance colonoscopy
Cumulative incidence of recurrence/residual tissue
To compare the cumulative incidence of recurrence/residual tissue
To describe the characteristics of recurrences
To determine the complete endoscopic resection rate in patients who have experienced recurrence.
To analyze the incidence of complications arising from the endoscopic treatment of recurrences.
Click on the lead sponsor to view all of their trials.
Asociación Española de Gastroenterología
Lead sponsor
Instituto de Investigación Sanitaria y Biomédica de Alicante
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
