Trials / Not Yet Recruiting

Not Yet RecruitingNCT06791616

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

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 746 (estimated)

Sponsor: Asociación Española de Gastroenterología · Academic / Other
Sex: All
Age: 18 Years – 85 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Colonoscopy	Surveillance colonoscopy

Timeline

Start date: 2025-03-01
Primary completion: 2027-05-31
Completion: 2030-05-31
First posted: 2025-01-24
Last updated: 2025-01-24

Source: ClinicalTrials.gov record NCT06791616. Inclusion in this directory is not an endorsement.