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

Colonic Polyp Clinical Trial

Official title:

Efficacy and Safety of Underwater Endoscopic Mucosal Resection Versus Conventional Endoscopic Mucosal Resection for the Treatment of Large Non-pedunculated Colonic Lesions. Multicentric Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03567746
• Other study ID #: UEMR
• Status: Recruiting
• Phase: N/A
• Start date: June 4, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: July 2019
• Source: Parc de Salut Mar
• Contact: Joaquin Rodriguez, MD PhD
• Phone: 926278000
• Email: joakinrodriguez[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 356
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps
• Polyps

Intervention

Procedure:
• Underwater EMR
Polypectomy is performed under full water emersion avoiding the use of submucosal injection.
• Conventional 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.

Locations

Country	Name	City	State
Spain	Hospital del Mar. Parc de Salut Mar	Barcelona
Spain	Hospital General Universitario de Ciudad Real	Ciudad Real

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lesion recurrence rate	Presence of polyp tissue at the same site as the original lesion (adenoma or sessile serrated polyp)	1 year
Secondary	Technical success rate	Complete removal of polypoid tissue during the procedure	1 hour
Secondary	Incidence of Treatment-Emergent Adverse Events	Incidence of Treatment-Emergent Adverse Events (delated hemorrhage, perforation, hospital admission)	1 year
Secondary	En bloc Resection rate	Rate of endoscopic mucosal resection in one piece during the procedure	1 hour
Secondary	Procedure time	Time in minutes for the endoscopic mucosal resection	1 hour
Secondary	Number of fragments	Number of fragments of the endoscopic mucosal resection	1 hour
Secondary	Lesion size	Size of the lesion in millimeters	1 hour
Secondary	Thermal artecfacts		1 hour