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NCT Number: NCT06791616

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

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.

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Key information

Conditions

Colorectal Neoplasms Adenoma Colon Colonic Diseases Colonic Polyps Digestive System Diseases Digestive System Neoplasms Disease Attributes Endoscopic Mucosal Resection Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Site Non-pedunculated Lesions Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Rectal Diseases Recurrence Serrated Adenoma Thermal Ablation

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

colonoscopy

Procedure

Surveillance colonoscopy

Primary outcomes

  1. Cumulative incidence of recurrence/residual tissue

    Time frame: 12 months

Secondary outcomes

  1. To compare the cumulative incidence of recurrence/residual tissue

    Time frame: 48 months

  2. To describe the characteristics of recurrences

    Time frame: 48 months

  3. To determine the complete endoscopic resection rate in patients who have experienced recurrence.

    Time frame: 48 months

  4. To analyze the incidence of complications arising from the endoscopic treatment of recurrences.

    Time frame: 48 months

  5. To determine the proportion of patients requiring surgery to treat recurrence or complications associated with it.

    Time frame: 48 months

  6. To assess the incidence of advanced colonic lesions or colorectal cancer

    Time frame: 12 months

  7. To assess the incidence of advanced colonic lesions or colorectal cancer

    Time frame: 48 months

Study contacts

Contact information is provided by the study sponsor or research team.

Rodrigo Jover, MD, PhD

CONTACT

[email protected]

+34-965913952

Sponsors and collaborators

Lead sponsor

Asociación Española de Gastroenterología

Other

Collaborators

  • Instituto de Investigación Sanitaria y Biomédica de Alicante

Registry information

Official study title

Evaluation of Surveillance Intervals After Piecemeal Resection of Non-pedunculated Colorectal Lesions ≥20mm: SCARFACE Clinical Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Jan 24, 2025
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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