Comparing two techniques for removing certain colon and rectum tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the recurrence rates of Laterally Spreading Tumors - Granular Type (LST-G) in the colon and rectum after two different endoscopic removal techniques: Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD). EMR is a common method that may lead to higher local recurrence due to piecemeal resection, while ESD allows for complete removal in one piece, potentially reducing recurrence rates but requiring more skill and time. The study aims to determine which technique is more effective in preventing tumor recurrence in patients with LST-G lesions larger than 20mm. Participants will be monitored for recurrence rates post-procedure to assess the efficacy of each method.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Where it's running

• IRCCS Azienda Ospedaliero Universitaria di Bologna - Sant'Orsola Malpighi
  Bologna, Italy Recruiting
• Ente Ospedaliero Ospedali Galliera
  Genova, Italy Recruiting
• Università Vita Salute - IRCCS
  Milan, Italy Recruiting
• Ospedale Civile di Baggiovara
  Modena, Italy Recruiting
• Azienda USL IRCCS di Reggio Emilia
  Reggio Emilia, Italy Recruiting

Study contacts

• Principal investigator: Sassatelli Romano, MD — Azienda USL Reggio Emilia - IRCCS
• Study coordinator: Lucarini Matteo, MD
• Email: matteo.lucarini@ausl.re.it
• Phone: +39 0522 296423

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.