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.
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.
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.
Parallel
Endoscopic mucosal resection (EMR)
Procedure/SurgeryEndoscopic mucosal resection (EMR) is an endoscopic resection technique that allows the removal of large colorectal lesions using a conventional "lift-and-cut" procedure or an underwater technique
Endoscopic submucosal dissection (ESD)
Procedure/SurgeryEndoscopic submucosal dissection (ESD) is an endoscopic procedure that allows dissection of larger colorectal lesions in one piece using endoknives. The procedure is technically more difficult, much more time-consuming than EMR, mandates multiday hospital admission and has an increased risk of perforation.
Percentage of surgical referral after treatment
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En bloc resection rate
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R0 resection rate
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Duration of the procedure
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Percentage of curative resection rates without surgery
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Click on the lead sponsor to view all of their trials.
José Carlos Marín Gabriel
Lead sponsor
Hospital Universitario 12 de Octubre
Sponsor institution
Spanish Society of Digestive Endoscopy
Collaborator
