Colorectal PolypNCT03859479
Cold Snare Polypectomy of Non-pedunculated Colorectal Adenomas
A study testing Cold snare polypectomy and Hot snare polypectomy in people with Colorectal Polyp, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
Trial summary
A prospective randomised controlled trial of cold vs hot snare polypectomy of non-pedunculated colorectal adenomas. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Colorectal Polyp
- What is being tested?
- Cold snare polypectomy and Hot snare polypectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteRussia
- Study dates
- 20 Jan 2019to 31 Aug 2021
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with non-pedunculated colorectal adenomas who had provided written informed consent
Who cannot join
- known coagulopathy.
- polyposis of the alimentary tract.
- inflammatory bowel disease.
- malignant polyps.
- associated diseases in the stage of decompensation
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
State Scientific Centre of Coloproctology
Moscow, 123423
Stanislav Chernyshov, MD, +74991992554, stchernyshov@gmail.com
About this study
Official title: A Prospective Randomized Controlled Trial of Cold Snare Polypectomy vs. Conventional Polypectomy for Non-pedunculated Colorectal Adenomas
A prospective randomised controlled trial of cold vs hot snare polypectomy of non-pedunculated colorectal adenomas.
Read the detailed description
Diagnostic colonoscopy will be performed in all patients. If a polyp, appropriate for inclusion criteria, is identified, an endoscopic polypectomy will be assigned. All eligible polyps will be randomly assigned (1:1) to endoscopic polypectomy with either the cold snare resection or hot snare resection (control group). Randomization will be stratified using random numbers. After resection, the marginal mucosa will be carefully observed with used of magnification and image enhancement (near focus imaging or narrow band imaging) for determine residual tissue. The time period when the snare will be entered in the bowel lumen and until a polyp will be retrieved will be recorded by a stopwatch.
All polyps will be retrieved for morphological examination to estimate R0/R1resetion. After polypectomy all patients will be observed for 3-4 days in-hospital to diagnose and eliminate complications (delayed bleeding and perforations). All patients will have a control colonoscopy 6 months after polypectomy to investigate long-term results.
- Conditions
- Colorectal Polyp
- Being tested
- Cold snare polypectomy, Hot snare polypectomy
- Keywords
- Cold snare polypectomy, Hot snare polypectomy, Сolorectal polyps, Endoscopic treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold snare polypectomyProcedure or surgery
After a target polyp was identified, it should be placed at the comfortable position. Then the snare will be opened and encircled the polyp without air aspiration. Then, the snare will be captured the polyp with at least 1-2 mm of surrounding normal tissue. The polyp will be guillotined and would not be lifted or tented until complete closure is achieved. After resection, the mucosal defect the marginal mucosa was carefully observed, with used of magnification and image enhancement. If residual polyp tissue was recognised, additional removal using the cold snare technique or biopsy forceps will be performed. If a submucosal injection prior to snaring was necessary it will be permitted. After polypectomy all patients will be observed for 3-4 days in-hospital
Hot snare polypectomyProcedure or surgery
After a target polyp was identified, it should be placed at the comfortable position. Then the polyp with minimal normal tissue will be captured by the snare. The ensnared polyp should be tented away from the colonic wall and removed by one the types of electric currents. After resection, the mucosal defect will be washed thoroughly and the marginal mucosa was carefully observed, with used of magnification and image enhancement, such as near focus imaging or narrow band imaging. If a submucosal injection prior to snaring was necessary it would be permitted. If residual polyp tissue was recognised, additional removal using coagulation or biopsy forceps will be performed. After polypectomy all patients will be observed for 3-4 days in-hospital
| Study group | Role | What they receive |
|---|---|---|
| Cold snare polypectomy | Experimental | After a target polyp was identified, it should be placed at the comfortable position. Then the snare will be opened and encircled the polyp without air aspiration. Then, the snare will be captured the polyp with at least 1-2 mm of surrounding normal tissue. The polyp will be guillotined and would not be lifted or tented until complete closure is achieved. After resection, the mucosal defect the marginal mucosa was carefully observed, with used of magnification and image enhancement. If residual polyp tissue was recognised, additional removal using the cold snare technique or biopsy forceps will be performed. If a submucosal injection prior to snaring was necessary it will be permitted. After polypectomy all patients will be observed for 3-4 days in-hospital Receives: Procedure: Cold snare polypectomy |
| Hot snare polypectomy | Active comparator | After a target polyp was identified, it should be placed at the comfortable position. Then the polyp with minimal normal tissue will be captured by the snare. The ensnared polyp should be tented away from the colonic wall and removed by one the types of electric currents. After resection, the mucosal defect will be washed thoroughly and the marginal mucosa was carefully observed, with used of magnification and image enhancement, such as near focus imaging or narrow band imaging. If a submucosal injection prior to snaring was necessary it would be permitted. If residual polyp tissue was recognised, additional removal using coagulation or biopsy forceps will be performed. After polypectomy all patients will be observed for 3-4 days in-hospital Receives: Procedure: Hot snare polypectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
Measured: 14 days
Complete resection rate
Measured: 1 day
Secondary outcomes (6)
Incidence of local recurrence
Measured: 6 months
The immediate bleeding or immediate perforation rate after polypectomy
Measured: 1 day
Complication rate
Measured: 14 days
Use of submucosal injection
Measured: 1 day
Polyp retrieval rate
Measured: 1 day
The procedure time
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start20 Jan 2019
- Primary completion30 Aug 2021 (estimated)
- Study completion31 Aug 2021 (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.
- 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
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian Federation
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859479
- Sponsor's protocol ID
- 122
- Status last verified
- Mar 2019
- First submitted
- 28 Feb 2019
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- 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 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Cold Snare Polypectomy vs. Conventional Polypectomy for Non-pedunculated Colorectal Adenomas
- ClinicalTrials.gov ID
- NCT03859479
- Acronym / sponsor ID
- 122
- Conditions
- Colorectal Polyp
- Keywords
- Cold snare polypectomy, Hot snare polypectomy, Сolorectal polyps, Endoscopic treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian FederationOther government
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 1 Mar 2019 (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 randomised controlled trial of cold vs hot snare polypectomy of non-pedunculated colorectal adenomas.
Detailed description
Diagnostic colonoscopy will be performed in all patients. If a polyp, appropriate for inclusion criteria, is identified, an endoscopic polypectomy will be assigned. All eligible polyps will be randomly assigned (1:1) to endoscopic polypectomy with either the cold snare resection or hot snare resection (control group). Randomization will be stratified using random numbers. After resection, the marginal mucosa will be carefully observed with used of magnification and image enhancement (near focus imaging or narrow band imaging) for determine residual tissue. The time period when the snare will be entered in the bowel lumen and until a polyp will be retrieved will be recorded by a stopwatch.
All polyps will be retrieved for morphological examination to estimate R0/R1resetion. After polypectomy all patients will be observed for 3-4 days in-hospital to diagnose and eliminate complications (delayed bleeding and perforations). All patients will have a control colonoscopy 6 months after polypectomy to investigate long-term results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold snare polypectomy | Experimental | Procedure: Cold snare polypectomyAfter a target polyp was identified, it should be placed at the comfortable position. Then the snare will be opened and encircled the polyp without air aspiration. Then, the snare will be captured the polyp with at least 1-2 mm of surrounding normal tissue. The polyp will be guillotined and would not be lifted or tented until complete closure is achieved. After resection, the mucosal defect the marginal mucosa was carefully observed, with used of magnification and image enhancement. If residual polyp tissue was recognised, additional removal using the cold snare technique or biopsy forceps will be performed. If a submucosal injection prior to snaring was necessary it will be permitted. After polypectomy all patients will be observed for 3-4 days in-hospital |
| Hot snare polypectomy | Active comparator | Procedure: Hot snare polypectomyAfter a target polyp was identified, it should be placed at the comfortable position. Then the polyp with minimal normal tissue will be captured by the snare. The ensnared polyp should be tented away from the colonic wall and removed by one the types of electric currents. After resection, the mucosal defect will be washed thoroughly and the marginal mucosa was carefully observed, with used of magnification and image enhancement, such as near focus imaging or narrow band imaging. If a submucosal injection prior to snaring was necessary it would be permitted. If residual polyp tissue was recognised, additional removal using coagulation or biopsy forceps will be performed. After polypectomy all patients will be observed for 3-4 days in-hospital |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with non-pedunculated colorectal adenomas who had provided written informed consent
Key exclusion criteria (5 listed)
- known coagulopathy.
- polyposis of the alimentary tract.
- inflammatory bowel disease.
- malignant polyps.
- associated diseases in the stage of decompensation
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 |
|---|---|---|
| Cold snare polypectomyAfter a target polyp was identified, it should be placed at the comfortable position. Then the snare will be opened and encircled the polyp without air aspiration. Then, the snare will be captured the polyp with at least 1-2 mm of surrounding normal tissue. The polyp will be guillotined and would not be lifted or tented until complete closure is achieved. After resection, the mucosal defect the marginal mucosa was carefully observed, with used of magnification and image enhancement. If residual polyp tissue was recognised, additional removal using the cold snare technique or biopsy forceps will be performed. If a submucosal injection prior to snaring was necessary it will be permitted. After polypectomy all patients will be observed for 3-4 days in-hospital | Procedure or surgery | Cold snare polypectomy |
| Hot snare polypectomyAfter a target polyp was identified, it should be placed at the comfortable position. Then the polyp with minimal normal tissue will be captured by the snare. The ensnared polyp should be tented away from the colonic wall and removed by one the types of electric currents. After resection, the mucosal defect will be washed thoroughly and the marginal mucosa was carefully observed, with used of magnification and image enhancement, such as near focus imaging or narrow band imaging. If a submucosal injection prior to snaring was necessary it would be permitted. If residual polyp tissue was recognised, additional removal using coagulation or biopsy forceps will be performed. After polypectomy all patients will be observed for 3-4 days in-hospital | Procedure or surgery | Hot snare polypectomy |
Primary outcome
R0 resection rate
Time frame: 14 days
Complete resection rate
Time frame: 1 day
6 secondary outcomes
Incidence of local recurrence
Time frame: 6 months
The immediate bleeding or immediate perforation rate after polypectomy
Time frame: 1 day
Complication rate
Time frame: 14 days
Use of submucosal injection
Time frame: 1 day
Polyp retrieval rate
Time frame: 1 day
The procedure time
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Colorectal Polyp
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Colonic Neoplasms
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
RecruitingObservational study
Malignant Polyp Registry
Malignant Colorectal Polyp, Colorectal Cancer
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
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 Cold snare polypectomy and Hot snare polypectomy in people with Colorectal Polyp, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
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: status not confirmed, as of the sponsor's last update on 6 Mar 2019. 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 Russia. 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?
R0 resection rate (time frame: 14 days). 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 6 Mar 2019; AzTrials last refreshed its copy on 7 Nov 2026.