Colon PolypNCT06073561
Underwater Endoscopic Mucosal Resection
A study testing learning curve of Underwater mucosectomy in people with Colon Polyp and Adenoma Colon, run by Instituto Portugues Oncologia de Lisboa Francisco Gentil at 1 site in Portugal.
Trial summary
The global aim of this multi-centric study is to assess the learning curve of U-EMR by an endoscopist skilled in C-EMR aiming to assess the application in real world and check the rate of complete EMR and adverse events related to the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Polyp, Adenoma Colon
- What is being tested?
- learning curve of Underwater mucosectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jan 2024to 31 Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 years-old or older with at least one large (>10 and <30 mm) non pedunculated polyp
- Agreement with study's procedures, having signed the informed consent for the study and EMR, prior to the procedure
Who cannot join
- Previous attempted resection
- Lesion located at ileo-cecal valve or appendiceal orifice
- Fully circumferential lesion
- Pedunculated polyps (Paris classification type Ip) and ulcerated depression lesions (Paris classification type III)
- Surface pattern suggestive of deep invasion (ex: narrow-band imaging (NBI) International Colorectal Endoscopic (NICE) classification type 3 criteria, Kudo V or equivalent)
- Invasive cancer at EMR specimen
- Inflammatory bowel disease
- Familial polyposis syndrome
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Instituto Português de Oncologia de Lisboa Francisco Gentil
Lisbon, 1099-023
Luis Correia Gomes, MD
About this study
Official title: Underwater Endoscopic Mucosal Resection a Learning Curve Study
The global aim of this multi-centric study is to assess the learning curve of U-EMR by an endoscopist skilled in C-EMR aiming to assess the application in real world and check the rate of complete EMR and adverse events related to the procedure.
Read the detailed description
Conventional Endoscopic mucosal resection (C-EMR) is currently the standard therapy for the removal of large colon polyps. The procedure consists on the injection of fluids into the submucosa layer below the lesion with the intention to create a cushion to separate it from the muscular layer and avoid its damage and consequently perforation and thermal injury. There are some drawbacks about this technique such us fibrotic polyps, difficult location (areas behind the fold and appendicular orifice) and recurrence rate which without ablation techniques could reach 30%.
Underwater endoscopic mucosal resection (U-EMR) has been first described in 2012 by Binmoeller et al [10] and the main difference to C-EMR was the absence of need the submucosal injection. This would be possible because when the lumen is filled with water, the mucosal and the submucosal layer tend to float while the muscularis propria maintains its circular shape even in the presence of peristalsis. Recent data as shown not only a lower rate of recurrence but also a lower procedure time and R0 resections with no difference in adverse events.
Therefore, the global aim of this multi-centric study is to assess the learning curve of U-EMR by an endoscopist skilled in C-EMR aiming to assess the application in real world and check the rate of complete EMR and adverse events related to the procedure.
- Conditions
- Colon Polyp, Adenoma Colon
- Being tested
- learning curve of Underwater mucosectomy
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
learning curve of Underwater mucosectomyOther
Patients will be submitted to underwater mucosectomy (U-EMR)
| Study group | Role | What they receive |
|---|---|---|
| Underwater mucosectomy | Experimental | Every colonoscopy should be performed with a high definition colonoscope, such as Olympus series Q185 or Q190 with virtual chromoendoscopy by NBI (Olympus Inc., Tokyo, Japan) or Fujifilm EC-760R-V/L or EC-760Z-V/L with virtual chromoendoscopy by LBI (Fujifilm Group, Japan).
A study investigator or a senior endoscopy fellow under their direct supervision should perform all procedures.
The U-EMR procedure should include the following steps: CO2 should be completely removed, and the bowel lumen filled with normal saline using a water jet pump (OFP-2, Olympus Medical System or similar) until the lesion is totally immersed in water. The lesion and 2-3 mm of normal surrounding mucosa should be resected using electrocauterization (VIO 200D Endocut Q Effect 3; ERBE Electromedizin, Tübingen, Germany). Receives: Other: learning curve of Underwater mucosectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
learning curve of the application of U-EMR by endoscopists skilled in C-EMR
evaluate the learning curve of the application of U-EMR by endoscopists skilled in C-EMR after an online course about U-EMR technique.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Jan 2024
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- Not applicable
- Intervention model
- Single group
- Model description
- Every patient will be selected do underwater emr group.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Portugues Oncologia de Lisboa Francisco Gentil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luís Correia Gomes, Instituto Portugues Oncologia de Lisboa Francisco Gentil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073561
- Sponsor's protocol ID
- UIC/1593
- Status last verified
- Apr 2024
- First submitted
- 4 Oct 2023
- Last updated
- 30 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Underwater Endoscopic Mucosal Resection a Learning Curve Study
- ClinicalTrials.gov ID
- NCT06073561
- Acronym / sponsor ID
- UIC/1593
- Conditions
- Colon Polyp, Adenoma Colon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Instituto Portugues Oncologia de Lisboa Francisco GentilUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 10 Oct 2023 (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.
The global aim of this multi-centric study is to assess the learning curve of U-EMR by an endoscopist skilled in C-EMR aiming to assess the application in real world and check the rate of complete EMR and adverse events related to the procedure.
Detailed description
Conventional Endoscopic mucosal resection (C-EMR) is currently the standard therapy for the removal of large colon polyps. The procedure consists on the injection of fluids into the submucosa layer below the lesion with the intention to create a cushion to separate it from the muscular layer and avoid its damage and consequently perforation and thermal injury. There are some drawbacks about this technique such us fibrotic polyps, difficult location (areas behind the fold and appendicular orifice) and recurrence rate which without ablation techniques could reach 30%.
Underwater endoscopic mucosal resection (U-EMR) has been first described in 2012 by Binmoeller et al [10] and the main difference to C-EMR was the absence of need the submucosal injection. This would be possible because when the lumen is filled with water, the mucosal and the submucosal layer tend to float while the muscularis propria maintains its circular shape even in the presence of peristalsis. Recent data as shown not only a lower rate of recurrence but also a lower procedure time and R0 resections with no difference in adverse events.
Therefore, the global aim of this multi-centric study is to assess the learning curve of U-EMR by an endoscopist skilled in C-EMR aiming to assess the application in real world and check the rate of complete EMR and adverse events related to the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Every patient will be selected do underwater emr group.
| Arm | Type | Receives |
|---|---|---|
| Underwater mucosectomy | Experimental | Other: learning curve of Underwater mucosectomyEvery colonoscopy should be performed with a high definition colonoscope, such as Olympus series Q185 or Q190 with virtual chromoendoscopy by NBI (Olympus Inc., Tokyo, Japan) or Fujifilm EC-760R-V/L or EC-760Z-V/L with virtual chromoendoscopy by LBI (Fujifilm Group, Japan). A study investigator or a senior endoscopy fellow under their direct supervision should perform all procedures. The U-EMR procedure should include the following steps: CO2 should be completely removed, and the bowel lumen filled with normal saline using a water jet pump (OFP-2, Olympus Medical System or similar) until the lesion is totally immersed in water. The lesion and 2-3 mm of normal surrounding mucosa should be resected using electrocauterization (VIO 200D Endocut Q Effect 3; ERBE Electromedizin, Tübingen, Germany). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 18 years-old or older with at least one large (>10 and <30 mm) non pedunculated polyp
- Agreement with study's procedures, having signed the informed consent for the study and EMR, prior to the procedure
Key exclusion criteria (8 listed)
- Previous attempted resection
- Lesion located at ileo-cecal valve or appendiceal orifice
- Fully circumferential lesion
- Pedunculated polyps (Paris classification type Ip) and ulcerated depression lesions (Paris classification type III)
- Surface pattern suggestive of deep invasion (ex: narrow-band imaging (NBI) International Colorectal Endoscopic (NICE) classification type 3 criteria, Kudo V or equivalent)
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 |
|---|---|---|
| learning curve of Underwater mucosectomyPatients will be submitted to underwater mucosectomy (U-EMR) | Other | Underwater mucosectomy |
Primary outcome
learning curve of the application of U-EMR by endoscopists skilled in C-EMR
Time frame: 6 months
evaluate the learning curve of the application of U-EMR by endoscopists skilled in C-EMR after an online course about U-EMR technique.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing learning curve of Underwater mucosectomy in people with Colon Polyp and Adenoma Colon, run by Instituto Portugues Oncologia de Lisboa Francisco Gentil at 1 site in Portugal.
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 2 inclusion and 8 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 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. 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 Luís Correia Gomes, MD (+351914534888, luisfilipe.gomes@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
learning curve of the application of U-EMR by endoscopists skilled in C-EMR (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2024.