Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for Colorectal Latera
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
| Condition(s) | Neoplasms, Colorectal |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Lead sponsor | José Carlos Marín Gabriel |
| Locations | Madrid, Spain |
| Start date | 2020-11-03 |
| NCT ID | NCT04593407 |
| Official listing | https://clinicaltrials.gov/study/NCT04593407 |