Colonic Polyp
Conditions
Keywords
Colonic Polyp, Endoscopic mucosal resection
Brief summary
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).
Detailed description
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.
Interventions
PROCEDUREUnderwater EMR
Polypectomy is performed under full water emersion avoiding the use of submucosal injection.
PROCEDUREConventional EMR
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.
Sponsors
Parc de Salut Mar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Consecutive patients aged \>18 years, diagnosed with a large (\>=20 mm) non-pedunculated colonic polyp, who consent to endoscopic mucosal resection of the polyp and willing to participate in this study.
Exclusion criteria
* Polyps showing signs of deep submucosal invasion * Inflamatory bowel disease with signs of activity * Known or suspected pregnancy * Patients unable or unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lesion recurrence rate | 1 year | Presence of polyp tissue at the same site as the original lesion (adenoma or sessile serrated polyp) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 1 year | Incidence of Treatment-Emergent Adverse Events (delated hemorrhage, perforation, hospital admission) |
| En bloc Resection rate | 1 hour | Rate of endoscopic mucosal resection in one piece during the procedure |
| Procedure time | 1 hour | Time in minutes for the endoscopic mucosal resection |
| Technical success rate | 1 hour | Complete removal of polypoid tissue during the procedure |
| Lesion size | 1 hour | Size of the lesion in millimeters |
| Thermal artecfacts | 1 hour | — |
| Number of fragments | 1 hour | Number of fragments of the endoscopic mucosal resection |
Countries
Spain
Contacts
Primary ContactJoaquin Rodriguez, MD PhD
Backup ContactMarco A Alvarez-Gonzalez, MD PhD
Outcome results
None listed