Surveillance Intervals After Piecemeal Resection of Non-pedunculated Colorectal Lesions ≥20mm
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Colonoscopy.
- Who it may be relevant to
- Registry conditions: Colorectal Neoplasms, Adenoma Colon, Colonic Polyps, Serrated Adenoma. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Surveillance Intervals After Piecemeal Resection of Non-pedunculated Colorectal Lesions ≥20mm: SCARFACE Clinical Trial
Overview
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.
Interventions
- Procedure Colonoscopy
Surveillance colonoscopy
Primary outcome measures
- Cumulative incidence of recurrence/residual tissue [Time frame: 12 months]
Secondary outcome measures (7)
- To compare the cumulative incidence of recurrence/residual tissue [Time frame: 48 months]
- To describe the characteristics of recurrences [Time frame: 48 months]
- To determine the complete endoscopic resection rate in patients who have experienced recurrence. [Time frame: 48 months]
- To analyze the incidence of complications arising from the endoscopic treatment of recurrences. [Time frame: 48 months]
- To determine the proportion of patients requiring surgery to treat recurrence or complications associated with it. [Time frame: 48 months]
- To assess the incidence of advanced colonic lesions or colorectal cancer [Time frame: 12 months]
- To assess the incidence of advanced colonic lesions or colorectal cancer [Time frame: 48 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06791616 · SCARFACE