Clinical trial NCT06791616: Surveillance Intervals After Piecemeal Resection of Non-pedunculated Colorectal Lesions ≥20mm
Official title: Evaluation of Surveillance Intervals After Piecemeal Resection of Non-pedunculated Colorectal Lesions ≥20mm: SCARFACE Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Neoplasms
Adenoma Colon
Colonic Polyps
Serrated Adenoma
Endoscopic Mucosal Resection
Non-pedunculated Lesions
Thermal Ablation
Recurrence
Lead sponsor: Asociación Española de Gastroenterología
Sponsor class: OTHER
Collaborators: name: Instituto de Investigación Sanitaria y Biomédica de Alicante
First posted: 2025-01-24
Enrollment: 746
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


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.

Primary outcomes:
measure: Cumulative incidence of recurrence/residual tissue
timeFrame: 12 months
Secondary outcomes:
measure: To compare the cumulative incidence of recurrence/residual tissue
timeFrame: 48 months
measure: To describe the characteristics of recurrences
timeFrame: 48 months
measure: To determine the complete endoscopic resection rate in patients who have experienced recurrence.
timeFrame: 48 months
measure: To analyze the incidence of complications arising from the endoscopic treatment of recurrences.
timeFrame: 48 months
measure: To determine the proportion of patients requiring surgery to treat recurrence or complications associated with it.
timeFrame: 48 months
measure: To assess the incidence of advanced colonic lesions or colorectal cancer
timeFrame: 12 months
measure: To assess the incidence of advanced colonic lesions or colorectal cancer
timeFrame: 48 months
Other outcomes:
Locations:
Study officials:
References: