Clinical trial · Interventional
Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for Colorectal Laterally Spreading 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.
NCT04593407CI-TRIAL-00087167intERsectionactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms, Colorectal | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic mucosal resection (EMR) | Procedure | — | UNRESOLVED |
| Endoscopic submucosal dissection (ESD) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Endoscopic Mucosal Resection (EMR):
- description
- Piecemeal EMR is a conventional endoscopic resection technique. A submucosal injection of a large volume of a solution (normal saline or other) with or without dilute epinephrine (1/10,000) with or without indigo carmine is performed. Then, sequential piecemeal resection is performed with use of a combination of stiff-type snares. At the end of the procedure when macroscopically visible adenoma has been totally resected, a snare tip soft coagulation (STSC) of the margin of the scar is performed to eliminate non visible residual neoplastic tissue. This procedure is quicker and safer than ESD but led to more recurrent disease (around 20% with the standard technique but recently reduced to 5% after the introduction of STSC)
- interventionNames
- Procedure: Endoscopic mucosal resection (EMR)
- type
- EXPERIMENTAL
- label
- : Endoscopic Submucosal Dissection (ESD):
- description
- ESD is a newer resection technique that allows en bloc resection for large LSLs. A submucosal injection is also needed but, in this case, different endo-knives are used to achieve the resection instead of diathermic snares. The en bloc resection allows a more precise pathological analysis and the risk of recurrence is lower (\<2%) when margins are tumor-free.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (26)
- BACKGROUNDBurgess NG, Hourigan LF, Zanati SA, Brown GJ, Singh R, Williams SJ, Raftopoulos SC, Ormonde D, Moss A, Byth K, Mahajan H, McLeod D, Bourke MJ. Risk Stratification for Covert Invasive Cancer Among Patients Referred for Colonic Endoscopic Mucosal Resection: A Large Multicenter Cohort. Gastroenterology. 2017 Sep;153(3):732-742.e1. doi: 10.1053/j.gastro.2017.05.047. Epub 2017 Jun 2. PMID 28583826
- BACKGROUNDUraoka T, Saito Y, Matsuda T, Ikehara H, Gotoda T, Saito D, Fujii T. Endoscopic indications for endoscopic mucosal resection of laterally spreading tumours in the colorectum. Gut. 2006 Nov;55(11):1592-7. doi: 10.1136/gut.2005.087452. Epub 2006 May 8. PMID 16682427
- BACKGROUNDMoss A, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Burgess NG, Sonson R, Byth K, Bourke MJ. Long-term adenoma recurrence following wide-field endoscopic mucosal resection (WF-EMR) for advanced colonic mucosal neoplasia is infrequent: results and risk factors in 1000 cases from the Australian Colonic EMR (ACE) study. Gut. 2015 Jan;64(1):57-65. doi: 10.1136/gutjnl-2013-305516. Epub 2014 Jul 1. PMID 24986245
- BACKGROUNDAlbeniz E, Pellise M, Gimeno-Garcia AZ, Lucendo AJ, Alonso-Aguirre PA, Herreros de Tejada A, Alvarez MA, Fraile M, Herraiz Bayod M, Lopez Roses L, Martinez Ares D, Ono A, Parra Blanco A, Redondo E, Sanchez-Yague A, Soto S, Diaz-Tasende J, Montes Diaz M, Rodriguez-Tellez M, Garcia O, Zuniga Ripa A, Hernandez Conde M, Alberca de Las Parras F, Gargallo CJ, Saperas E, Munoz Navas M, Gordillo J, Ramos Zabala F, Echevarria JM, Bustamante M, Gonzalez-Haba M, Gonzalez-Huix F, Gonzalez-Suarez B, Vila Costas JJ, Guarner Argente C, Mugica F, Cobian J, Rodriguez Sanchez J, Lopez Viedma B, Pin N, Marin Gabriel JC, Nogales O, de la Pena J, Navajas Leon FJ, Leon Brito H, Remedios D, Esteban JM, Barquero D, Martinez Cara JG, Martinez Alcala F, Fernandez-Urien I, Valdivielso E. Clinical guidelines for endoscopic mucosal resection of non-pedunculated colorectal lesions. Rev Esp Enferm Dig. 2018 Mar;110(3):179-194. doi: 10.17235/reed.2018.5086/2017. PMID 29421912
- BACKGROUNDYang D, Othman M, Draganov PV. Endoscopic Mucosal Resection vs Endoscopic Submucosal Dissection For Barrett's Esophagus and Colorectal Neoplasia. Clin Gastroenterol Hepatol. 2019 May;17(6):1019-1028. doi: 10.1016/j.cgh.2018.09.030. Epub 2018 Sep 26.