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NCT06815406Recruiting

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 )

Source: ClinicalTrials.gov · Last updated 6 May 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Interventional
Enrollment
282 (estimated)
First submitted
4 Feb 2025
Start date
18 Nov 2021
Primary completion date
Jun 2026
Lead sponsor
Azienda USL Reggio Emilia - IRCCS
NCT number
NCT06815406

What you commit to

  • Study type: Interventional
  • Planned participants: 282
  • From 18 Nov 2021 to the primary completion date, Jun 2026
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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).

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IRCCS Azienda Ospedaliero Universitaria di Bologna - Sant'Orsola Malpighi
Coordinator of this site? Confirm its status
BolognaItalyRecruiting
Ente Ospedaliero Ospedali Galliera
Coordinator of this site? Confirm its status
GenovaItalyRecruiting
Università Vita Salute - IRCCS
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Ospedale Civile di Baggiovara
Coordinator of this site? Confirm its status
ModenaItalyRecruiting
Azienda USL IRCCS di Reggio Emilia
Coordinator of this site? Confirm its status
Reggio EmiliaItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.