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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Recurrence; Colorectal Neoplasms; Colonic Polyps; Adenoma Colon; Thermal Ablation; Endoscopic Mucosal Resection; Serrated Adenoma; Non-pedunculated Lesions
• Intervention / Treatment: Procedure: Colonoscopy

• Study Type: Interventional
• Enrollment (Estimated): 746
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rodrigo Jover, MD, PhD; Phone Number: +34-965913952; Email: rodrigojover@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reduced surveillance interval; Surveillance colonoscopies at 12 and 48 months	Procedure: Colonoscopy; Surveillance colonoscopy
Placebo Comparator: Standard surveillance interval; Surveillance colonoscopies at 6, 12 and 48 months	Procedure: Colonoscopy; Surveillance colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative incidence of recurrence/residual tissue	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
To compare the cumulative incidence of recurrence/residual tissue	48 months
To describe the characteristics of recurrences	48 months
To determine the complete endoscopic resection rate in patients who have experienced recurrence.	48 months
To analyze the incidence of complications arising from the endoscopic treatment of recurrences.	48 months
To determine the proportion of patients requiring surgery to treat recurrence or complications associated with it.	48 months
To assess the incidence of advanced colonic lesions or colorectal cancer	12 months
To assess the incidence of advanced colonic lesions or colorectal cancer	48 months

Collaborators and Investigators

• Sponsor: Asociación Española de Gastroenterología
• Collaborators: Instituto de Investigación Sanitaria y Biomédica de Alicante

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2030

Study Registration Dates

• First Submitted: January 19, 2025
• First Submitted That Met QC Criteria: January 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 19, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Pathological Conditions, Anatomical; Disease Attributes; Intestinal Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplasms, Glandular and Epithelial; Colonic Diseases; Polyps; Intestinal Polyps; Recurrence; Colorectal Neoplasms; Adenoma; Colonic Polyps
• Other Study ID Numbers: SCARFACE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No