NCT06791616Not yet recruiting
Surveillance Intervals After Piecemeal Resection of Non-pedunculated Colorectal Lesions ≥20mm
Evaluation of Surveillance Intervals After Piecemeal Resection of Non-pedunculated Colorectal Lesions ≥20mm: SCARFACE Clinical Trial
Source: ClinicalTrials.gov · Last updated 24 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 746 (estimated)
- First submitted
- 19 Jan 2025
- Start date
- Mar 2025
- Primary completion date
- May 2027
- Lead sponsor
- Asociación Española de Gastroenterología
- Diseases
- Colorectal cancer
- NCT number
- NCT06791616
What you commit to
- Study type: Interventional
- Planned participants: 746
- From Mar 2025 to the primary completion date, May 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Resection performed using a cold snare technique due to the high risk of recurrence.
- 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.
Other illness
- Histology of the lesion showing malignancy: colorectal cancer with submucosal invasion, regardless of invasion depth in microns.
- Personal history of colorectal cancer.
- Hereditary cancer syndromes (e.g., adenomatous or serrated polyposis syndromes, Lynch syndrome, etc.).
- Inflammatory bowel disease.
- Ongoing cytotoxic treatment or radiotherapy for a malignant disease.
Other
- Absence of information regarding the grade of dysplasia of the index lesion.
- Severe comorbidities with reduced life expectancy.
- Pregnancy.
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.