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To analyse the efficacy and safety of two standard methods of endoscopic mucosal resection (EMR) for large non-pedunculated colorectal polyps, the investigators will compare submucosal injection-assisted endoscopic mucosal resection (SEMR) versus underwater endoscopic mucosal resection, without submucosal injection (UEMR).
Underwater endoscopic mucosal resection (UEMR) emerges as a variant of traditional resection, in which a submucosal cushion formation is not necessary. This technique was described in 2012 by Kenneth Binmoeller based on the physical floating effect of colonic mucous membrane by filling the colonic lumen using water instead of air. This "floating effect" conditions the natural separation of the colonic wall layers, allowing the distension of the submucosal space without the need to inject substances into it. On the other hand, performing resection in liquid medium conditions could drive the benefit of heat dissipation caused by the current, which would reduces thermal damage caused to the tissues.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Underwater EMR | Experimental | The patients randomized in this arm will be treated by endoscopic resection assisted by the filling of the colonic lumen using water instead of air and avoiding the formation of a submucosal cushion |
|
| Conventional EMR | Active Comparator | The patients randomized in this arm will be treated by endoscopic resection following the traditional technique. It means, by assistance of selective submucosal saline injection to create a submucosal cushion below the polyp. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Underwater EMR | Procedure | Polypectomy is performed under full water emersion avoiding the use of submucosal injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lesion recurrence rate | Presence of polyp tissue at the same site as the original lesion (adenoma or sessile serrated polyp) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | Complete removal of polypoid tissue during the procedure | 1 hour |
| Incidence of Treatment-Emergent Adverse Events | Incidence of Treatment-Emergent Adverse Events (delated hemorrhage, perforation, hospital admission) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joaquin Rodriguez, MD PhD | Contact | 926278000 | 79114 | joakinrodriguez@gmail.com |
| Marco A Alvarez-Gonzalez, MD PhD | Contact | marcoalgo@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Mar. Parc de Salut Mar | Recruiting | Barcelona | 08003 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36572129 | Derived | Rodriguez Sanchez J, Alvarez-Gonzalez MA, Pellise M, Coto-Ugarte D, Uchima H, Aranda-Hernandez J, Santiago Garcia J, Marin-Gabriel JC, Riu Pons F, Nogales O, Carreno Macian R, Herreros-de-Tejada A, Hernandez L, Patron GO, Rodriguez-Tellez M, Redondo-Cerezo E, Sanchez Alonso M, Daca M, Valdivielso-Cortazar E, Alvarez Delgado A, Enguita M, Montori S, Albeniz E. Underwater versus conventional EMR of large nonpedunculated colorectal lesions: a multicenter randomized controlled trial. Gastrointest Endosc. 2023 May;97(5):941-951.e2. doi: 10.1016/j.gie.2022.12.013. Epub 2022 Dec 23. |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Conventional EMR | Procedure | It will be performed in a 2-step procedure. First the formation of a submucosal injection underneath the polyp to create a submucosal safety cushion. Then EMR is performed with a polipectomy snare. |
|
| 1 year |
| En bloc Resection rate | Rate of endoscopic mucosal resection in one piece during the procedure | 1 hour |
| Procedure time | Time in minutes for the endoscopic mucosal resection | 1 hour |
| Number of fragments | Number of fragments of the endoscopic mucosal resection | 1 hour |
| Lesion size | Size of the lesion in millimeters | 1 hour |
| Thermal artecfacts | 1 hour |
| Hospital General Universitario de Ciudad Real | Recruiting | Ciudad Real | 13005 | Spain |
|