RecruitingNot ApplicableNCT06815406

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

Recurrence Rate After Endoscopic Resection of , Laterally Spreading Tumor Granular Type (LST-G) of the Colon and Rectum: Endoscopic Mucosal Resection (EMR) Vs. Endoscopic Submucosal Dissection (ESD): a Multicenter Randomized Controlled Trial ( ESD Vs EMR )

Sponsor

Azienda USL Reggio Emilia - IRCCS

Enrollment

282 participants

Start Date

Nov 17, 2021

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer

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

Min Age: 18 Years

Inclusion Criteria4

Age ≥ 18 years.
Diagnosis of Laterally Spreading Tumor - Granular Type (LST-G) ≥ 20 mm in the colon or rectum with an indication for endoscopic resection.
Life expectancy \> 10 years.
Ability to understand and sign the informed consent form, demonstrating comprehension of the study and willingness to participate.

Exclusion Criteria6

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's disease).
Diagnosis of hereditary polyposis syndromes (e.g., familial adenomatous polyposis, Lynch syndrome).

Interventions

PROCEDUREEndoscopic Mucosal Resection (EMR)

atients assigned to this arm will undergo Endoscopic Mucosal Resection (EMR), a standard endoscopic technique that involves the resection of colorectal Laterally Spreading Tumors - Granular type (LST-G) using a diathermic snare with submucosal injection. The procedure may be performed en bloc or in a piecemeal fashion, depending on lesion size and characteristics. EMR is widely accepted for lesions with low submucosal invasion risk but has a higher recurrence rate than ESD.

PROCEDUREEndoscopic Submucosal Dissection (ESD)

Patients assigned to this arm will undergo Endoscopic Submucosal Dissection (ESD), an advanced endoscopic technique that allows for en bloc resection of large colorectal Laterally Spreading Tumors - Granular type (LST-G). The procedure involves the use of specialized knives to dissect the submucosal layer, ensuring complete resection with histologically clear margins (R0 resection). ESD has been associated with lower recurrence rates but requires a high level of expertise, longer procedural times, and carries a higher risk of complications.