Comparing two techniques for removing certain colon and rectum tumors

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 )

This study is testing which of two techniques for removing certain colon and rectum tumors works better to prevent them from coming back in patients with larger lesions.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 282 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Azienda USL Reggio Emilia - IRCCS (other gov)
• Locations: 5 sites (Bologna and 4 other locations)
• Trial ID: NCT06815406 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with LST-G tumors larger than 20mm in the colon or rectum.

Not a fit: Patients with non-granular type tumors, certain lesion characteristics, or chronic inflammatory bowel diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with LST-G tumors, reducing the risk of cancer recurrence.

How similar studies have performed: Previous studies have shown promising results with ESD in reducing recurrence rates for similar lesions, indicating that this approach may be effective.

Eligibility criteria

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 this trial is running

Bologna and 4 other locations

• 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 - IRCCS di Reggio Emilia
• Study coordinator: Lucarini Matteo, MD

Conditions: Colorectal Cancer, Endoscopic Mucosal Resection, Endoscopic submucosal dissection, Laterally spreading tumors