Colonic PolypNCT03567746
Underwater EMR vs. Conventional EMR for Large Non-pedunculated Colonic Polyp
A study testing Underwater EMR and Conventional EMR in people with Colonic Polyp, run by Parc de Salut Mar at 2 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colonic Polyp
- What is being tested?
- Underwater EMR and Conventional EMR
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 2 sitesSpain
- Study dates
- 4 Jun 2018to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Marco A Alvarez-Gonzalez, MD PhD contact
Spain2 sites, 2 recruiting
- Recruiting
Hospital del Mar. Parc de Salut Mar
Barcelona, 08003
Marco A Alvarez-Gonzalez, MD PhD, 0034 932483000, marcoalgo@gmail.com
- Recruiting
Hospital General Universitario de Ciudad Real
Ciudad Real, 13005
Joaquin Rodriguez Sanchez, MD PhD, joakinrodriguez@gmail.com
About this study
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
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).
Read the 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.
- Conditions
- Colonic Polyp
- Being tested
- Underwater EMR, Conventional EMR
- Keywords
- Colonic Polyp, Endoscopic mucosal resection
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Underwater EMRProcedure or surgery
Polypectomy is performed under full water emersion avoiding the use of submucosal injection.
Conventional EMRProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Underwater EMR | Experimental | 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 Receives: Procedure: Underwater EMR |
| Conventional EMR | Active comparator | 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. Receives: Procedure: Conventional EMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion recurrence rate
Presence of polyp tissue at the same site as the original lesion (adenoma or sessile serrated polyp)
Measured: 1 year
Secondary outcomes (7)
Technical success rate
Complete removal of polypoid tissue during the procedure
Measured: 1 hour
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events (delated hemorrhage, perforation, hospital admission)
Measured: 1 year
En bloc Resection rate
Rate of endoscopic mucosal resection in one piece during the procedure
Measured: 1 hour
Procedure time
Time in minutes for the endoscopic mucosal resection
Measured: 1 hour
Number of fragments
Number of fragments of the endoscopic mucosal resection
Measured: 1 hour
Lesion size
Size of the lesion in millimeters
Measured: 1 hour
Thermal artecfacts
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start4 Jun 2018
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic PolypStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567746
- Sponsor's protocol ID
- UEMR
- Status last verified
- Jul 2019
- First submitted
- 13 Jun 2018
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodriguez Sanchez J, Alvarez-Gonzalez MA, Pellise M, Coto-Ugarte D, Uchima H, Aranda-Hernandez J, Santiago Garcia J, Marin-Gabriel JC, Riu Pons F, Nogales O, Carreno Macian R, Herreros-de-Tejada A, Hernandez L, Patron GO, Rodriguez-Tellez M, Redondo-Cerezo E, Sanchez Alonso M, Daca M, Valdivielso-Cortazar E, Alvarez Delgado A, Enguita M, Montori S, Albeniz E. Underwater versus conventional EMR of large nonpedunculated colorectal lesions: a multicenter randomized controlled trial. Gastrointest Endosc. 2023 May;97(5):941-951.e2. doi: 10.1016/j.gie.2022.12.013. Epub 2022 Dec 23.
PubMed 36572129
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03567746
- Acronym / sponsor ID
- UEMR
- Conditions
- Colonic Polyp
- Keywords
- Colonic Polyp, Endoscopic mucosal resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Underwater EMR | Experimental | Procedure: Underwater EMRThe 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 |
| Conventional EMR | Active comparator | Procedure: Conventional EMRThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Underwater EMRPolypectomy is performed under full water emersion avoiding the use of submucosal injection. | Procedure or surgery | Underwater EMR |
| Conventional EMRIt 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. | Procedure or surgery | Conventional EMR |
Primary outcome
Lesion recurrence rate
Time frame: 1 year
Presence of polyp tissue at the same site as the original lesion (adenoma or sessile serrated polyp)
7 secondary outcomes
Technical success rate
Time frame: 1 hour
Incidence of Treatment-Emergent Adverse Events
Time frame: 1 year
En bloc Resection rate
Time frame: 1 hour
Procedure time
Time frame: 1 hour
Number of fragments
Time frame: 1 hour
Lesion size
Time frame: 1 hour
Thermal artecfacts
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
- Derived from this study: PubMed 36572129Rodriguez Sanchez J, Alvarez-Gonzalez MA, Pellise M, Coto-Ugarte D, Uchima H, Aranda-Hernandez J, Santiago Garcia J, Marin-Gabriel JC, Riu Pons F, Nogales O, Carreno Macian R, Herreros-de-Tejada A, Hernandez L, Patron GO, Rodriguez-Tellez M, Redondo-Cerezo E, Sanchez Alonso M, Daca M, Valdivielso-Cortazar E, Alvarez Delgado A, Enguita M, Montori S, Albeniz E. Underwater versus conventional EMR of large nonpedunculated colorectal lesions: a multicenter randomized controlled trial. Gastrointest Endosc. 2023 May;97(5):941-951.e2. doi: 10.1016/j.gie.2022.12.013. Epub 2022 Dec 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco A Alvarez-Gonzalez, MD PhD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Underwater EMR and Conventional EMR in people with Colonic Polyp, run by Parc de Salut Mar at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joaquin Rodriguez, MD PhD (926278000 ext. 79114, joakinrodriguez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion recurrence rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03567746, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2019; AzTrials last refreshed its copy on 6 Nov 2026.