Underwater EMR vs. Conventional EMR for Large Non-pedunculated Colonic Polyp

Not Applicable

• Conditions: Colonic Polyp
• Interventions: Procedure: Underwater EMR; Procedure: Conventional EMR

• Registration Number: NCT03567746
• Lead Sponsor: Parc de Salut Mar

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.

Study Timeline

• Study Start: 2018-06-04
• Study First Submitted: 2018-06-13
• Study First Submitted QC: 2018-06-13
• Study First Posted: 2018-06-26
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-25
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 356

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Underwater EMR	Underwater EMR	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	Conventional EMR	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.

Primary Outcome Measures

Name	Time	Method
Lesion recurrence rate	1 year	Presence of polyp tissue at the same site as the original lesion (adenoma or sessile serrated polyp)

Secondary Outcome Measures

Name	Time	Method
Technical success rate	1 hour	Complete removal of polypoid tissue during the procedure
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
Number of fragments	1 hour	Number of fragments of the endoscopic mucosal resection
Lesion size	1 hour	Size of the lesion in millimeters
Thermal artecfacts	1 hour

Trial Locations

Locations (2)

Hospital del Mar. Parc de Salut Mar; 🇪🇸 Barcelona, Spain

Hospital General Universitario de Ciudad Real; 🇪🇸 Ciudad Real, Spain