NCT06791616

Surveillance Intervals After Piecemeal Resection of Non-pedunculated Colorectal Lesions ≥20mm

Not yet recruiting NA Last updated 24 January 2025

What this trial tests

NA trial testing Colonoscopy in Colorectal Neoplasms in 746 participants. Not yet recruiting.

Timeline

1 March 2025

Primary endpoint
31 May 2027

31 May 2030

Quick facts

Lead sponsor	Asociación Española de Gastroenterología
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	746
Start date	1 March 2025
Primary completion	31 May 2027
Estimated completion	31 May 2030

Drugs / interventions tested

• Colonoscopy

Conditions studied

• Colorectal Neoplasms — all drugs for Colorectal Neoplasms →
• Adenoma Colon — all drugs for Adenoma Colon →
• Colonic Polyps — all drugs for Colonic Polyps →
• Serrated Adenoma — all drugs for Serrated Adenoma →

Sponsor

Asociación Española de Gastroenterología

Who can join

Adults 18 to 85, any sex, with Colorectal Neoplasms or Adenoma Colon. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.