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

Parc de Salut Mar

Status: Unknown

Conditions: Colonic Polyp

Treatments: Procedure: Conventional EMR; Procedure: Underwater EMR

Study type: Interventional

Funder types: Other

Identifiers

NCT03567746

UEMR

Details and patient eligibility

About

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).

Full 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.

Enrollment: 356 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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356 participants in 2 patient groups

Underwater EMR

Experimental group

Description:

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

Treatment:

Procedure: Underwater EMR

Conventional EMR

Active Comparator group

Description:

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.

Treatment:

Procedure: Conventional EMR