Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for Colorectal Laterally Spreading Lesions.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorJosé Carlos Marín Gabriel

About this trial

EMR and ESD are both effective and safe and are associated with a very low risk of procedure related mortality when performed for colorectal laterally spreading lesions (LSL).

Some kind of LSLs have a low risk of submucosal invasive carcinoma (SMIC) or these foci are found in well demarcated areas of the tumor. This is the case of the non-granular flat elevated (LSN-NG-FE) and the LSLs-G mixed subtypes.

The investigators aim to assess if piecemeal EMR (the older technique) for LSLs-G mixed type \> 30 mm and LSLs-NG FE type \> 20 mm is not inferior to ESD (the new treatment) for the need of additional surgery in the mid-term.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Endoscopic mucosal resection (EMR)
  • Endoscopic submucosal dissection (ESD)

Treatment groups

376 Participants
are divided into 2 treatment groups

Sponsors and collaborators

José Carlos Marín Gabriel

Lead sponsor

Hospital Universitario 12 de Octubre

Sponsor institution

Spanish Society of Digestive Endoscopy

Collaborator