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

NCT06791616 | Not Yet Recruiting DMC

• 1 other identifier: SCARFACE
• Study Type: interventional
• Target: 746
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Neoplasms; Adenoma Colon; Colonic Polyps; Serrated Adenoma; Endoscopic Mucosal Resection; Non-pedunculated Lesions; Thermal Ablation; Recurrence

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of recurrence/residual tissue

  12 months

Secondary Outcomes (7)

• 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

Study Arms (2)

Reduced surveillance interval

EXPERIMENTAL

Surveillance colonoscopies at 12 and 48 months

Procedure: Colonoscopy

Standard surveillance interval

PLACEBO COMPARATOR

Surveillance colonoscopies at 6, 12 and 48 months

Procedure: Colonoscopy

Interventions

Colonoscopy PROCEDURE

Surveillance colonoscopy

Reduced surveillance interval; Standard surveillance interval

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asociación Española de Gastroenterología: lead
• Instituto de Investigación Sanitaria y Biomédica de Alicante: collaborator

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Polyps; Recurrence

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Rodrigo Jover, MD, PhD

CONTACT

+34-965913952; rodrigojover@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: January 24, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2030
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share