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

• ClinicalTrials.gov Identifier: NCT03567746
• Recruitment Status: Unknown
• First Posted: June 26, 2018
• Last Update Posted: July 25, 2019
• Sponsor: Parc de Salut Mar
• Information provided by (Responsible Party): Parc de Salut Mar

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Colonic Polyp	Procedure: Underwater EMR; Procedure: Conventional EMR	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 356 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: June 4, 2018
• Estimated Primary Completion Date: December 30, 2019
• Estimated Study Completion Date: December 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Procedure: Underwater EMR; Polypectomy is performed under full water emersion avoiding the use of submucosal injection.
Active Comparator: 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.	Procedure: 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.

Outcome Measures

Primary Outcome Measures :

1. Lesion recurrence rate [ Time Frame: 1 year ]
   Presence of polyp tissue at the same site as the original lesion (adenoma or sessile serrated polyp)

Secondary Outcome Measures :

1. Technical success rate [ Time Frame: 1 hour ]
   Complete removal of polypoid tissue during the procedure
2. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 1 year ]
   Incidence of Treatment-Emergent Adverse Events (delated hemorrhage, perforation, hospital admission)
3. En bloc Resection rate [ Time Frame: 1 hour ]
   Rate of endoscopic mucosal resection in one piece during the procedure
4. Procedure time [ Time Frame: 1 hour ]
   Time in minutes for the endoscopic mucosal resection
5. Number of fragments [ Time Frame: 1 hour ]
   Number of fragments of the endoscopic mucosal resection
6. Lesion size [ Time Frame: 1 hour ]
   Size of the lesion in millimeters
7. Thermal artecfacts [ Time Frame: 1 hour ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Joaquin Rodriguez, MD PhD; 926278000 ext 79114; joakinrodriguez@gmail.com

Contact: Marco A Alvarez-Gonzalez, MD PhD; marcoalgo@gmail.com

Locations

Spain

Hospital del Mar. Parc de Salut Mar; Recruiting

Barcelona, Spain, 08003

Contact: Marco A Alvarez-Gonzalez, MD PhD 0034 932483000 marcoalgo@gmail.com

Hospital General Universitario de Ciudad Real; Recruiting

Ciudad Real, Spain, 13005

Contact: Joaquin Rodriguez Sanchez, MD PhD joakinrodriguez@gmail.com

Sponsors and Collaborators

Parc de Salut Mar

More Information

• Responsible Party: Parc de Salut Mar
• ClinicalTrials.gov Identifier: NCT03567746
• Other Study ID Numbers: UEMR
• First Posted: June 26, 2018
• Last Update Posted: July 25, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Parc de Salut Mar:

Colonic Polyp; Endoscopic mucosal resection

Additional relevant MeSH terms:

Polyps; Colonic Polyps; Pathological Conditions, Anatomical; Intestinal Polyps