Comparing two methods for removing colorectal lesions

Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for Laterally Spreading Lesions Non Granular-Flat Elevated Type (LSL-NG-FE) ≥ 20 mm and LSLs-Granular Mixed Type ≥ 30 mm. A Randomized, Non-inferiority Trial.

This study is testing whether an older method or a newer method for removing certain larger colorectal lesions works better for adults who haven't been treated for them before.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 376 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Hospital Universitario 12 de Octubre (other)
• Locations: 1 site (Madrid)
• Trial ID: NCT04593407 on ClinicalTrials.gov

What this trial studies

This study compares the effectiveness of endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) for treating colorectal laterally spreading lesions (LSLs). It focuses on specific types of LSLs that are larger than certain sizes and evaluates whether the older EMR technique is as effective as the newer ESD method in preventing the need for additional surgery. The study involves adult patients who have not previously received treatment for these lesions and requires a complete colonoscopy prior to participation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with specific types of colorectal lesions that meet size criteria and have not been previously treated.

Not a fit: Patients with multiple lesions or those who have previously received treatment for their lesions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with a less invasive treatment option for colorectal lesions while maintaining effective outcomes.

How similar studies have performed: Previous studies have shown that both EMR and ESD are effective for colorectal lesions, but this specific comparison is less commonly tested in Western populations.

Eligibility criteria

Inclusion Criteria:

* Adults (at least 18 years old).
* LSL-NG FE type ≥ 20mm or LST-G mixed type ≥30mm who have not been previously treated or received submucosal injection, regardless of their location in the colon.
* LSL-NG FE type ≥ 20mm or LST-G mixed type ≥30mm WITHOUT a demarcated area
* The patient must have undergone a complete colonoscopy, reaching the cecum, to detect possible synchronous lesion. If this procedure has not been done previously, it will be performed prior to the inclusion of the patient in the study.
* Patients able to fill in questionnaires written in Spanish or English.

Exclusion Criteria:

* Contra-indication to colonoscopy.
* Contra-indication to general anesthesia.
* Inability to stop antiplatelet agents and anti-coagulant according to the European Society of Gastro-Intestinal Endoscopy guidelines.
* Patients with \> 1 lesion meeting the inclusion criteria.
* LSL-NG FE type ≥ 20mm or LST-G ≥30mm mixed type that have been previously treated (Recurrence or residual lesion after previous endoscopic or surgical treatment).
* LSL-NG FE type ≥ 20mm or LST-G ≥30mm mixed type with previous submucosal injection, even if a resection attempt with a snare was not finally performed.
* Lesions with suspicion of deep submucosal invasive carcinoma: depression or invasive pit-pattern (Vi within a demarcated area or Vn).
* Submucosal mass like elevation within a LSL-NG FE type.
* LSLs having a previous biopsy or tattooing. Previous biopsies of the lesion should only be allowed if LSL-G mixed type \> 30 mm and samples were taken out of the flat area.
* LSL-G with a Buddha like deformation (Polyp on polyp)
* LSL involving a surgical anastomosis.
* LSL involving the appendicular orifice.
* LSL involving the terminal ileum.
* Patient's refusal to participate in the study
* Presence of inflammatory bowel disease
* Pregnant or lactating women.
* Hereditary colorectal cancer syndrome or hereditary polyposis.
* Patient under legal protection and or deprived of liberty by judicial or administrative decision.
* Patient already participating in an interventional clinical research protocol
* Patient who cannot be followed for the duration of the study.
* Inability to sign the informed consent of the study.

Where this trial is running

Madrid

• Hospital Universitario "12 de Octubre" — Madrid, Spain (RECRUITING)

Study contacts

• Study coordinator: José C. Marín-Gabriel, Assoc. Prof.

Conditions: Neoplasms, Colorectal, Colonic Polyps, large laterally spreading lesion, colonic adenoma, Endoscopic submucosal dissection, Endoscopic Mucosal Resection, Adenoma, Polyps