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

July 23, 2019 updated by: Parc de Salut Mar

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

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).

Study Overview

Status

Unknown

Conditions

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 Type

Interventional

Enrollment (Anticipated)

356

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital del Mar. Parc de Salut Mar
        • Contact:
      • Ciudad Real, Spain, 13005
        • Recruiting
        • Hospital General Universitario de Ciudad Real
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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
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.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 4, 2018

Primary Completion (ANTICIPATED)

December 30, 2019

Study Completion (ANTICIPATED)

December 30, 2019

Study Registration Dates

First Submitted

June 13, 2018

First Submitted That Met QC Criteria

June 13, 2018

First Posted (ACTUAL)

June 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 25, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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