AdenomaNCT03021135
Conventional Endoscopic Mucosal Resection vs Underwater Resection for Colorectal Non-pedunculated Colorectal Lesions
A study testing Conventional Endoscopic Mucosal Resection and Underwater Endoscopic Mucosal Resection in people with Adenoma and Colorectal Neoplasms, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
Randomized, comparative and prospective study between Conventional Endoscopic Mucosal Resection for the removal of flat or sessile colorectal lesions without previous attempt to resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenoma, Colorectal Neoplasms
- What is being tested?
- Conventional Endoscopic Mucosal Resection and Underwater Endoscopic Mucosal Resection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Jun 2018to 19 Jan 2022
- 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
- Patients age >18 years with sessile or flat Colorectal Lesions (measuring between 10 and 40mm), who consent to this study
Who cannot join
- Patients who refuse to participate in the study.
- Patients with pedunculated, depressed or mixed lesions.
- Patients with lesions smaller than 10 mm or larger than 40 mm.
- Patients with lesions that are inflammatory, neuroendocrine or stromal at the pathology.
- Patients with lesions that were submitted to prior attempt to endoscopic resection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conventional Endoscopic Mucosal Resection (With Submucosal Injection) Versus Underwater Endoscopic Mucosal Resection (Without Submucosal Injection) for Colorectal Non-pedunculated Colorectal Lesions
Randomized, comparative and prospective study between Conventional Endoscopic Mucosal Resection for the removal of flat or sessile colorectal lesions without previous attempt to resection.
Read the detailed description
This prospective randomized trial was conducted in 2 academic services: Instituto do Câncer do Estado de São Paulo and Centro de Diagnóstico em Gastroenterologia, both linked to the University of São Paulo. The clinical study was performed in accordance to the Declaration of Helsinki.
- Conditions
- Adenoma, Colorectal Neoplasms
- Being tested
- Conventional Endoscopic Mucosal Resection, Underwater Endoscopic Mucosal Resection
- Medical subject headings
- Adenoma, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Endoscopic Mucosal ResectionProcedure or surgery
Also called EMR
Conventional Endoscopic Mucosal Resection
Underwater Endoscopic Mucosal ResectionProcedure or surgery
Also called U-EMR
Underwater Endoscopic Mucosal Resection
| Study group | Role | What they receive |
|---|---|---|
| Conventional Mucosal Resection | Active comparator | C-EMR will be made with saline injection with the indigo carmine. Receives: Procedure: Conventional Endoscopic Mucosal Resection |
| Underwater Mucosal Resection | Experimental | UW-EMR will be made after the complete filling of lumen with water. Receives: Procedure: Underwater Endoscopic Mucosal Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success rate
Measured: three years
Safety (incidence of complications);
Measured: three years
Local recurrence.
Measured: Four years
Secondary outcomes (3)
Resection rate en bloc
Measured: three years
Time of resection
Measured: Three years
Sydney resection ratio (characterized by the following equation - lesion size in millimeters
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study start7 Jun 2018
- Primary completion19 Jan 2022
- Study completion19 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomaStudies 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
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Sponsor
- Investigators
- Luciano Lenz, PhD, Principal investigator, Cancer Institute of the state of São Paulo (ICESP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021135
- Sponsor's protocol ID
- NP 941/16
- Status last verified
- Apr 2022
- First submitted
- 4 Nov 2016
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Endoscopic Mucosal Resection (With Submucosal Injection) Versus Underwater Endoscopic Mucosal Resection (Without Submucosal Injection) for Colorectal Non-pedunculated Colorectal Lesions
- ClinicalTrials.gov ID
- NCT03021135
- Acronym / sponsor ID
- NP 941/16
- Conditions
- Adenoma, Colorectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 19 Jan 2022 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 13 Jan 2017 (estimated)
- 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.
Randomized, comparative and prospective study between Conventional Endoscopic Mucosal Resection for the removal of flat or sessile colorectal lesions without previous attempt to resection.
Detailed description
This prospective randomized trial was conducted in 2 academic services: Instituto do Câncer do Estado de São Paulo and Centro de Diagnóstico em Gastroenterologia, both linked to the University of São Paulo. The clinical study was performed in accordance to the Declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Mucosal Resection | Active comparator | Procedure: Conventional Endoscopic Mucosal ResectionC-EMR will be made with saline injection with the indigo carmine. |
| Underwater Mucosal Resection | Experimental | Procedure: Underwater Endoscopic Mucosal ResectionUW-EMR will be made after the complete filling of lumen with water. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients age >18 years with sessile or flat Colorectal Lesions (measuring between 10 and 40mm), who consent to this study
Key exclusion criteria (5 listed)
- Patients who refuse to participate in the study.
- Patients with pedunculated, depressed or mixed lesions.
- Patients with lesions smaller than 10 mm or larger than 40 mm.
- Patients with lesions that are inflammatory, neuroendocrine or stromal at the pathology.
- Patients with lesions that were submitted to prior attempt to endoscopic resection.
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 |
|---|---|---|
| Conventional Endoscopic Mucosal ResectionAlso: EMRConventional Endoscopic Mucosal Resection | Procedure or surgery | Conventional Mucosal Resection |
| Underwater Endoscopic Mucosal ResectionAlso: U-EMRUnderwater Endoscopic Mucosal Resection | Procedure or surgery | Underwater Mucosal Resection |
Primary outcome
Technical success rate
Time frame: three years
Safety (incidence of complications);
Time frame: three years
Local recurrence.
Time frame: Four years
3 secondary outcomes
Resection rate en bloc
Time frame: three years
Time of resection
Time frame: Three years
Sydney resection ratio (characterized by the following equation - lesion size in millimeters
Time frame: Three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- ResultsLink provided by the sponsor.
- 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.
Luciano Lenz, PhD principal investigator
Cancer Institute of the state of São Paulo (ICESP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Endoscopic Mucosal Resection and Underwater Endoscopic Mucosal Resection in people with Adenoma and Colorectal Neoplasms, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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 5 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: finished, as of the sponsor's last update on 5 Jul 2023. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success rate (time frame: three years). The study lists 3 primary outcomes in all. 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 5 Jul 2023.