- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03567746
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
Intervention / Treatment
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
- Name: Joaquin Rodriguez, MD PhD
- Phone Number: 79114 926278000
- Email: joakinrodriguez@gmail.com
Study Contact Backup
- Name: Marco A Alvarez-Gonzalez, MD PhD
- Email: marcoalgo@gmail.com
Study Locations
-
-
-
Barcelona, Spain, 08003
- Recruiting
- Hospital del Mar. Parc de Salut Mar
-
Contact:
- Marco A Alvarez-Gonzalez, MD PhD
- Phone Number: 0034 932483000
- Email: marcoalgo@gmail.com
-
Ciudad Real, Spain, 13005
- Recruiting
- Hospital General Universitario de Ciudad Real
-
Contact:
- Joaquin Rodriguez Sanchez, MD PhD
- Email: joakinrodriguez@gmail.com
-
-
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- UEMR
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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