Recurrence Rate After Endoscopic Resection of , Laterally Spreading Tumor Granular Type (LST-G) of the Colon and Rectum: Endoscopic Mucosal Resection Vs. Endoscopic Submucosal Dissection

Last updated: February 7, 2025
Sponsor: Azienda Unita Sanitaria Locale Reggio Emilia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colorectal Cancer

Colon Cancer; Rectal Cancer

Rectal Cancer

Treatment

Endoscopic Submucosal Dissection (ESD)

Endoscopic Mucosal Resection (EMR)

Clinical Study ID

NCT06815406
104/2021/SPER/IRCCSRE
  • Ages > 18
  • All Genders

Study Summary

Colorectal cancer is one of the leading causes of cancer-related mortality worldwide. Early-stage non-polypoid neoplastic lesions, particularly Laterally Spreading Tumors - Granular Type (LST-G) larger than 20mm, require effective endoscopic removal to prevent malignant progression. The two primary techniques for resecting these lesions are Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD).

EMR is a widely used, minimally invasive technique that involves resecting the lesion with a diathermic snare after submucosal injection. While effective and safe, EMR often necessitates piecemeal resection, increasing the risk of local recurrence. In contrast, ESD, developed in Asia, allows for en bloc resection regardless of lesion size, ensuring more accurate histopathological assessment and lower recurrence rates. However, ESD requires greater technical expertise, has longer procedural times, and carries a higher risk of complications.

In Western clinical practice, EMR remains the standard treatment, whereas ESD is selectively performed in high-expertise centers. Given the lack of randomized controlled trials comparing EMR and ESD in Western populations, this study aims to provide robust clinical evidence to guide treatment decisions.

The primary objective of this study is to compare the recurrence/residual adenomatous tissue rate at 6 and 12 months between EMR and ESD in patients with LST-G lesions of the colon and rectum

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years.

  • Diagnosis of Laterally Spreading Tumor - Granular Type (LST-G) ≥ 20 mm in the colonor rectum with an indication for endoscopic resection.

  • Life expectancy > 10 years.

  • Ability to understand and sign the informed consent form, demonstratingcomprehension of the study and willingness to participate.

Exclusion

Exclusion Criteria:

  • Diagnosis of Laterally Spreading Tumor - Non-Granular Type (LST-NG).

  • Presence of depressed areas within the lesion.

  • Lesions located on a scar or anastomosis site.

  • Lesions classified as Kudo Vi or Vn pattern.

  • History of chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn'sdisease).

  • Diagnosis of hereditary polyposis syndromes (e.g., familial adenomatous polyposis,Lynch syndrome).

Study Design

Total Participants: 282
Treatment Group(s): 2
Primary Treatment: Endoscopic Submucosal Dissection (ESD)
Phase:
Study Start date:
November 17, 2021
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • IRCCS Azienda Ospedaliero Universitaria di Bologna - Sant'Orsola Malpighi

    Bologna,
    Italy

    Active - Recruiting

  • Ente Ospedaliero Ospedali Galliera

    Genova,
    Italy

    Active - Recruiting

  • Università Vita Salute - IRCCS

    Milano,
    Italy

    Active - Recruiting

  • Ospedale Civile di Baggiovara

    Modena,
    Italy

    Active - Recruiting

  • Azienda USL IRCCS di Reggio Emilia

    Reggio Emilia,
    Italy

    Active - Recruiting

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