Colorectal PolypNCT05825664
Underwater Versus Conventional Endoscopic Mucosal Resection in the Treatment of Non-pedunculated Colorectal Polyps
A study testing Endoscopic resection in people with Colorectal Polyp and Colorectal Neoplasms, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
A prospective, randomized, controlled study to compare the efficacy and safety of underwater endoscopic mucosal resection and conventional endoscopic mucosal resection in removal of non-pedunculated colorectal polyps Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Polyp, Colorectal Neoplasms
- What is being tested?
- Endoscopic resection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteVietnam
- Study dates
- 7 Apr 2023to 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
- Non-pedunculated polyps of 10 mm or more in size
- Type 1 or 2 according to NBI International Colorectal Endoscopy (NICE) classification
- Patients must sign an informed consent form prior to registration in study
Who cannot join
- Lesions with signs of deep invasion (hard, friable tissue, poor mobility, positive "non-lifting" sign)
- Type 3 according to NICE classification
- Colorectal cancer
- Patients with unstable chronic disease (melitus diabetes, hypertension, heart failure, kidney failure, liver failure, chronic obstructive pulmonary disease)
- Hemostasis disorder (INR > 1.5; platelets < 100000/mm3)
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
University of Medicine and Pharmacy at Ho Chi Minh city
Ho Chi Minh City, 700000
Quang D Le, MD, +84985938040, quangledinh@ump.edu.vn
About this study
Official title: Comparison of the Efficiency and Safety of Underwater Endoscopic Mucosal Resection and Conventional Endoscopic Mucosal Resection in the Treatment of Non-pedunculated Colorectal Polyps
A prospective, randomized, controlled study to compare the efficacy and safety of underwater endoscopic mucosal resection and conventional endoscopic mucosal resection in removal of non-pedunculated colorectal polyps
Read the detailed description
- Patients are undergone colonoscopy at the Endoscopy department of Ho Chi Minh City University Medical Center.
- Randomize patients with non-pedunculated polyp of 10mm or larger in size into 2 interventional groups based on Random function of Statistical Package for the Social Sciences (SPSS) 20.0, including (1) Group 1: Underwater endoscopic mucosal resection (UEMR) and (2) Group 2: Conventional endoscopic mucosal resection (CEMR).
- The time of local recurrence assessment depends on the histopathology of polyps. Polyps with low grade dysplasia are followed up at 6 months, while polyps with high grade dysplasia are followed at 3 months.
- Collecting variables which consist of primary and secodary outcomes.
- Conditions
- Colorectal Polyp, Colorectal Neoplasms
- Being tested
- Endoscopic resection
- Keywords
- colorectal polyp, underwater endoscopic mucosal resection, conventional endoscopic mucosal resection
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic resectionProcedure or surgery
Group 1: Polyps are resected by UEMR Group 2: Polyps are resected by CEMR
| Study group | Role | What they receive |
|---|---|---|
| Underwater endoscopic mucosal resection | Experimental | Intervention: Non-pedunculated polyps will be removed by underwater endoscopic mucosal resection. The UEMR procedure included the following: (1) complete deflation of the colorectal lumen; (2) total immersion of the lesion in normal saline using a mechanical water pump; (3) snaring the lesion and the surrounding mucosa; and (4) resection using electrocautery. Receives: Procedure: Endoscopic resection |
| Conventional endoscopic mucosal resection | Active comparator | Intervention: Non-pedunculated polyps will be removed by conventional endoscopic mucosal resection. The CEMR procedure included the following: (1) needle injection of normal saline into the submucosa; (2) entrapment of the mucosal protrusion with a snare; and (3) resection applying the same electrocautery setting as was used for UEMR. Receives: Procedure: Endoscopic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
en bloc resection
Rate of en bloc resection for non-pedunculated colorectal polyps of 10 mm or more
Measured: immediately after the procedure
Curative rate
Curative rate for non-pedunculated colorectal polyps of 10 mm or more
Measured: through study completion, an average of 6 months
Secondary outcomes (3)
Complication rate
Rate of complications including bleeding, perforation
Measured: up to 2 weeks
Local recurrence rate
Rate of local recurrence
Measured: 6 months
Procedure time
Time for complete resection of polyps
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start7 Apr 2023
- Primary completion31 Dec 2023 (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 Colorectal PolypStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Le Dinh Quang, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825664
- Sponsor's protocol ID
- 001
- Status last verified
- Apr 2023
- First submitted
- 7 Apr 2023
- Last updated
- 24 Apr 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 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficiency and Safety of Underwater Endoscopic Mucosal Resection and Conventional Endoscopic Mucosal Resection in the Treatment of Non-pedunculated Colorectal Polyps
- ClinicalTrials.gov ID
- NCT05825664
- Acronym / sponsor ID
- 001
- Conditions
- Colorectal Polyp, Colorectal Neoplasms
- Keywords
- colorectal polyp, underwater endoscopic mucosal resection, conventional endoscopic mucosal resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 24 Apr 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.
A prospective, randomized, controlled study to compare the efficacy and safety of underwater endoscopic mucosal resection and conventional endoscopic mucosal resection in removal of non-pedunculated colorectal polyps
Detailed description
- Patients are undergone colonoscopy at the Endoscopy department of Ho Chi Minh City University Medical Center.
- Randomize patients with non-pedunculated polyp of 10mm or larger in size into 2 interventional groups based on Random function of Statistical Package for the Social Sciences (SPSS) 20.0, including (1) Group 1: Underwater endoscopic mucosal resection (UEMR) and (2) Group 2: Conventional endoscopic mucosal resection (CEMR).
- The time of local recurrence assessment depends on the histopathology of polyps. Polyps with low grade dysplasia are followed up at 6 months, while polyps with high grade dysplasia are followed at 3 months.
- Collecting variables which consist of primary and secodary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Underwater endoscopic mucosal resection | Experimental | Procedure: Endoscopic resectionIntervention: Non-pedunculated polyps will be removed by underwater endoscopic mucosal resection. The UEMR procedure included the following: (1) complete deflation of the colorectal lumen; (2) total immersion of the lesion in normal saline using a mechanical water pump; (3) snaring the lesion and the surrounding mucosa; and (4) resection using electrocautery. |
| Conventional endoscopic mucosal resection | Active comparator | Procedure: Endoscopic resectionIntervention: Non-pedunculated polyps will be removed by conventional endoscopic mucosal resection. The CEMR procedure included the following: (1) needle injection of normal saline into the submucosa; (2) entrapment of the mucosal protrusion with a snare; and (3) resection applying the same electrocautery setting as was used for UEMR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Non-pedunculated polyps of 10 mm or more in size
- Type 1 or 2 according to NBI International Colorectal Endoscopy (NICE) classification
- Patients must sign an informed consent form prior to registration in study
Key exclusion criteria (5 listed)
- Lesions with signs of deep invasion (hard, friable tissue, poor mobility, positive "non-lifting" sign)
- Type 3 according to NICE classification
- Colorectal cancer
- Patients with unstable chronic disease (melitus diabetes, hypertension, heart failure, kidney failure, liver failure, chronic obstructive pulmonary disease)
- Hemostasis disorder (INR > 1.5; platelets < 100000/mm3)
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 |
|---|---|---|
| Endoscopic resectionGroup 1: Polyps are resected by UEMR Group 2: Polyps are resected by CEMR | Procedure or surgery | Conventional endoscopic mucosal resection, Underwater endoscopic mucosal resection |
Primary outcome
en bloc resection
Time frame: immediately after the procedure
Rate of en bloc resection for non-pedunculated colorectal polyps of 10 mm or more
Curative rate
Time frame: through study completion, an average of 6 months
Curative rate for non-pedunculated colorectal polyps of 10 mm or more
3 secondary outcomes
Complication rate
Time frame: up to 2 weeks
Local recurrence rate
Time frame: 6 months
Procedure time
Time frame: during the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- 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.
University of Medicine and Pharmacy at Ho Chi Minh city
Ho Chi Minh City, Vietnam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic resection in people with Colorectal Polyp and Colorectal Neoplasms, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
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 4 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: status not confirmed, as of the sponsor's last update on 24 Apr 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 Vietnam. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
en bloc resection (time frame: immediately after the procedure). The study lists 2 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 24 Apr 2023.