Colorectal PolypNCT05660317
Assessment of Endoscopic Tip Control Using a Novel Score Based on the Snare Tip Soft Coagulation of Polypectomy Margin Defects
An observational study of Colorectal Polyp, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Colorectal cancer is the third most common malignancy worldwide and the second leading cause of cancer related death with approximately 880 792 deaths every year (9,2% of the global yearly 9.6 million cancer deaths). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Polyp
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2022to 1 Oct 2024
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Endoscopists: all endoscopist (varying experience) performing polypectomy at the University Hospital of Ghent, Belgium (UZ Gent) Patients: all patients undergoing endoscopic mucosal resection of colorectal polyps
Who may be able to join
- Endoscopists who perform endoscopic mucosal resections (EMR) at the University Hospital of Ghent, Belgium (UZ Gent)
- Patients, > 18 years of age, referred for EMR needing snare tip soft coagulation of the defect margins.
Who cannot join
- Endoscopists who do not consent to the study
- Patients who do not consent to the study
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Gent
Ghent, 9000
David Tate, 003293321072, david.tate@uzgent.be
Lynn Debels
About this study
Official title: Tip Control Assessment to Determine the Accuracy of Snare Tip Soft Coagulation to the Margin of Defects After EMR Predicts Polypectomy Experience and Procedural Difficulty
Colorectal cancer is the third most common malignancy worldwide and the second leading cause of cancer related death with approximately 880 792 deaths every year (9,2% of the global yearly 9.6 million cancer deaths). Screening for polyps is done by colonoscopy, which is considered the gold standard for screening and removal of polyps and has been proven to reduce the global colorectal cancer burden significantly. Endoscopic removal of polyps is preferred because of its efficiency, cost-effectiveness, and safety in comparison to surgery.
Endoscopic tip control is a fundamental component of high quality endoscopy. Endoscopic procedures are complex processes where cognitive processing and motoric output need to be perfectly aligned. This is reflected in endoscopic tip control. It is indispensable in every step of endoscopy: during insertion of the endoscope, where the tip of the endoscope needs to reach the caecum/terminal ileum/duodenum, without discomfort for the patient if under light sedation, during withdrawal of the endoscope in order not to miss any lesions, and also during every endoscopic treatment whether it is a simple polypectomy or a complex therapeutic procedure performed by expert endoscopists.
Read more
However, there is currently no tool available to assess endoscopic tip control. And very little is known about educating it.
The investigators developed a new, web-based scoring system to assess tip control. The intent of this study is to validate this novel tool so it can be used to assess endoscopists and evaluate their progress when training in endoscopy.
This study takes place at the University Hospital Ghent, which is a tertiary care center for gastrointestinal endoscopy. The investigators will validate the tool in this study, through assessment of endoscopists of varying experience while they use a technique of snare tip soft coagulation on the margin of a polypectomy defect. This technique has proven its use in preventing recurrence after polypectomy. The technique uses the tip of a snare (used to resect polyps) to deliver thermal energy to the margin of a polypectomy, also called margin ablation. Thermal energy is applied by a hit on a pedal (operated with the foot), every hit needs to be exactly on the margin of the defect (not in the defect, not on normal mucosa around the defect). This requires a very steady and controlled handling of the endoscope and is an ideal technique to assess endoscopist's tip control. The score system will calculate the accuracy (number of correct hits over number of wrong hits) of tip control per second.
- Conditions
- Colorectal Polyp
- Being tested
- Tip control score
- Keywords
- Endoscopy, Training, Polypectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tip control scoreOther
Scoring of endoscopist's tip control performing snare tip soft coagulation to the margins of a endoscopic mucosal resection (EMR) defect
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopists' accuracy of tip control using a novel scoring system.
Assessment of the tip control accuracy of endoscopists with varying experience using a novel scoring system.
The scoring system reports accuracy of tip control: correct hits/total hits (range of accuracy 0-100% with 0% no correct hits, and 100% best possible accuracy) and correct hits per second, where a high score demonstrates good accuracy in short period of time (participants is good en fast).
Measured: Through study completion, an average of 1 year (no intervention, the participant gets scored with every margin ablation he does)
Secondary outcomes (1)
Assessment of quality parameters of the novel tip control scoring system.
Assess if the scoring system is user friendly and assess if it is feasable to use it in an endoscopy setting.
- questions: was this score easy to use?
- did you find it useful?
- you feel we can improve? how? (free text box)
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Sep 2022
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660317
- Sponsor's protocol ID
- ONZ-2022-0178
- Status last verified
- Nov 2023
- First submitted
- 2 Dec 2022
- Last updated
- 21 Nov 2023
- 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 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tip Control Assessment to Determine the Accuracy of Snare Tip Soft Coagulation to the Margin of Defects After EMR Predicts Polypectomy Experience and Procedural Difficulty
- ClinicalTrials.gov ID
- NCT05660317
- Acronym / sponsor ID
- ONZ-2022-0178
- Conditions
- Colorectal Polyp
- Keywords
- Endoscopy, Training, Polypectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 21 Dec 2022 (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.
Colorectal cancer is the third most common malignancy worldwide and the second leading cause of cancer related death with approximately 880 792 deaths every year (9,2% of the global yearly 9.6 million cancer deaths). Screening for polyps is done by colonoscopy, which is considered the gold standard for screening and removal of polyps and has been proven to reduce the global colorectal cancer burden significantly. Endoscopic removal of polyps is preferred because of its efficiency, cost-effectiveness, and safety in comparison to surgery.
Endoscopic tip control is a fundamental component of high quality endoscopy. Endoscopic procedures are complex processes where cognitive processing and motoric output need to be perfectly aligned. This is reflected in endoscopic tip control. It is indispensable in every step of endoscopy: during insertion of the endoscope, where the tip of the endoscope needs to reach the caecum/terminal ileum/duodenum, without discomfort for the patient if under light sedation, during withdrawal of the endoscope in order not to miss any lesions, and also during every endoscopic treatment whether it is a simple polypectomy or a complex therapeutic procedure performed by expert endoscopists.
However, there is currently no tool available to assess endoscopic tip control. And very little is known about educating it.
The investigators developed a new, web-based scoring system to assess tip control. The intent of this study is to validate this novel tool so it can be used to assess endoscopists and evaluate their progress when training in endoscopy.
This study takes place at the University Hospital Ghent, which is a tertiary care center for gastrointestinal endoscopy. The investigators will validate the tool in this study, through assessment of endoscopists of varying experience while they use a technique of snare tip soft coagulation on the margin of a polypectomy defect. This technique has proven its use in preventing recurrence after polypectomy. The technique uses the tip of a snare (used to resect polyps) to deliver thermal energy to the margin of a polypectomy, also called margin ablation. Thermal energy is applied by a hit on a pedal (operated with the foot), every hit needs to be exactly on the margin of the defect (not in the defect, not on normal mucosa around the defect). This requires a very steady and controlled handling of the endoscope and is an ideal technique to assess endoscopist's tip control. The score system will calculate the accuracy (number of correct hits over number of wrong hits) of tip control per second.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Endoscopists: all endoscopist (varying experience) performing polypectomy at the University Hospital of Ghent, Belgium (UZ Gent) Patients: all patients undergoing endoscopic mucosal resection of colorectal polyps
Key inclusion criteria (2 listed)
- Endoscopists who perform endoscopic mucosal resections (EMR) at the University Hospital of Ghent, Belgium (UZ Gent)
- Patients, > 18 years of age, referred for EMR needing snare tip soft coagulation of the defect margins.
Key exclusion criteria (2 listed)
- Endoscopists who do not consent to the study
- Patients who do not consent to the study
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 |
|---|---|---|
| Tip control scoreScoring of endoscopist's tip control performing snare tip soft coagulation to the margins of a endoscopic mucosal resection (EMR) defect | Other | – |
Primary outcome
Endoscopists' accuracy of tip control using a novel scoring system.
Time frame: Through study completion, an average of 1 year (no intervention, the participant gets scored with every margin ablation he does)
Assessment of the tip control accuracy of endoscopists with varying experience using a novel scoring system. The scoring system reports accuracy of tip control: correct hits/total hits (range of accuracy 0-100% with 0% no correct hits, and 100% best possible accuracy) and correct hits per second, where a high score demonstrates good accuracy in short period of time (participants is good en fast).
1 secondary outcome
Assessment of quality parameters of the novel tip control scoring system.
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Polyp, run by University Hospital, Ghent at 1 site in Belgium.
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 2 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 21 Nov 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 Belgium. 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?
Endoscopists' accuracy of tip control using a novel scoring system. (time frame: Through study completion, an average of 1 year (no intervention, the participant gets scored with every margin ablation he does)). 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 21 Nov 2023.