Colorectal AdenomaGPATNCT05877456
Validation of the Global Polypectomy Assessment Tool (GPAT)
An observational study of Colorectal Adenoma and Colorectal Polyp, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Colorectal polypectomy is offten incompletely performed with high variability between endoscopists, resulting in interval cancer or repeated procedures. Current available scoring systems for polypectomy technique are lacking in different areas so the investigators developed the Global Polypectomy Assessment Tool… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Adenoma, Colorectal Polyp, Colo-rectal Cancer
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2023to 2 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Endoscopists of varying abilities and grades Adult patients undergoing a polypectomy who agree to participate
Who may be able to join
- Endoscopists of varying abilities and grades
- Adult patients undergoing a polypectomy who agree to participate
Who cannot join
- Endoscopist does not consent to inclusion
- Patient does not consent to inclusion
- Patients <18 y
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Validation of the Global Polypectomy Assessment Tool (GPAT) - a Novel Online Assessment Tool for Any Colorectal Polypectomy
Colorectal polypectomy is offten incompletely performed with high variability between endoscopists, resulting in interval cancer or repeated procedures. Current available scoring systems for polypectomy technique are lacking in different areas so the investigators developed the Global Polypectomy Assessment Tool (GPAT) which is an online video-based assessment tool for any colorectal polypectomy.
The goal of the study is to assess the validity of GPAT through demonstrating the inter-rater agreement (Fleiss Kappa (κ)). GPAT has 20 items, contains evidence-based statements to aid interpretation, calculates an overall quality score and a complexity score.
Read the detailed description
Colorectal cancer (CRC) 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). This is linked with a significant and increasing annual economic cost1.
Screening for polyps is mostly done by performing a colonoscopy, which is considered the golden standard for screening and removal of polyps and has been proven to reduce the global colorectal cancer burden significantly2,3. Endoscopic removal of polyps is preferred because of its efficiency, cost-effectiveness and safety in comparison to surgery4.
Incomplete polyp resection may contribute significantly to the development of so called 'interval cancers'5,6. These comprise up to 6% of newly diagnosed CRC cases and occur during the 6 - 36 month period following complete colonoscopy. Incompetent removal of polyps leads to higher recurrence rates, more hospitalizations and the use of standard surgery which has greater risks and is costlier7. Using the appropriate technique, depending on the size and aspect of the polyps, reduces recurrence-rates significantly and should therefore be pursued.
There is currently very little known about training for polypectomy. An international consensus on quality metrics of polypectomy still doesn't exist since the criteria for what makes a well-performed polypectomy have still not been identified. Many of the current endoscopists have never even received any training in polypectomy. A 3.4-fold difference in resection rates was found between gastroenterologist who knew they were being observed by using the Direct Observation of Polypectomy Skills competency score (DOPyS)8,9. This stresses the need for a standardized international training program. In countries where guidelines are available, not all endoscopy-trainers are aware of them nor do they apply them for evaluation of their trainees, even though it has been proven to augment a trainee's skills when he/she's given a report card10,11.
Attempts to develop score systems have already been made but each has its own restrictions. The DOPyS score system lacks in certain areas: it does not take the difficulty of the procedure into account and demands training of the assessor to make it reliable. The fact that a training is needed for DOPyS is a factor that's holding it back for international use. Procedure numbers and current quality indicators (including adenoma detection rate or withdrawal time) are not sufficient to account for good clinical competence12. So current tools are difficult to use, not accessible to all and are using outdated and debunked quality metrics. Therefore a new tool with new quality metrics should be easily accessible, easy to use and preferably have excellent interobserver reliability (even without training the assessor). For evaluation of polyps <1cm, which are the most frequent ones, many categories of the DOPyS were non-applicable.
With training moving away from a numbers-based competency, and current score systems lacking in different aspects, the identification of quality metrics for polypectomy and implementation of them into a new score-system, has become more and more pressing.
This led to the development of a new score system: the Global Polypectomy Assessment Tool (GPAT), by Tate et al. This score-system has been established based upon the Delphi technique13 what enforces the content-validity of this score-system. For its development, an online questionnaire was sent to 11 international experts in the field of EMR (Endoscopic Mucosal Resection). These experts were chosen because of their international recognition for performing outstanding polypectomies. The tool has 16 categories. Each category has several questions and generates a score. Depending on which questions are relevant to the polypectomy that the participants are assessing, more or less points can be gained. If the polypectomy is more difficult, the difficulty-score will rise and subsequently, there will be more points to be scored. This way the scoring system adapts to the difficulty of the polypectomy. This is important since no two polypectomies are the same and therefore different scoring-criteria are relevant depending on the polyp. This is a major difference in comparison to the DOPyS which does not adapt to the difficulty of the procedure.
Two scores are generated by this tool. The first score provides an indication on the quality of the polypectomy. The second score gives an indication on the difficulty of the polypectomy based upon the difference between the complexity of the assessed procedure and the maximum possible complexity. If some categories or questions are not relevant, it does not affect the score. The number of questions per category differs as well as the possible answers for each question. The score-system is web-based.
This scoring system was already validated using standardized videos of colorectal polypectomy and in a real-life endoscopy setting by this research group. In this study the investigators will correlate GPAT scores to key performance indicators for colonoscopy and polypectomy including caecal intubation rate, caecal photography score, withdrawal time, sedation usage, intra- and post-procedural bleeding, perforation and rate of recurrence. Through this comparison the investigators can assess whether an increase in GPAT scores correlates to a better patient outcome after polypectomy.
- Conditions
- Colorectal Adenoma, Colorectal Polyp, Colo-rectal Cancer
- Keywords
- colonoscopy, polypectomy, quality in endoscopy
- Medical subject headings
- Colonic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate the GPAT (global polypectomy assesment tool) scoring tool for polypectomy using key performance indicators.
Two scores are generated by this tool. The first score provides an indication on the quality of the polypectomy. This comprises of 6 domains: global competencies, injection, snare placement, safety checks, defect assessment, accessory techniques. The second score gives an indication on the difficulty of the polypectomy based upon the difference between the complexity of the assessed procedure and the maximum possible complexity (Size, morphology, site, access and 4 plus criteria: Size > 40mm, non granular morfology, non lifting polyp/previously attempted, ileocaecal valve, diverticular or appendiceal orifice involvement). If some categories or questions are not relevant, it does not affect the score. The number of questions per category differs as well as the possible answers for each question. The score-system is web-based.
The maximum score for the first part of the tool is 105. For the indication on the difficulty of the polypectomy the maximum score is 17.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start1 Mar 2023
- Primary completion1 Mar 2027 (estimated)
- Study completion2 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 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
- NCT05877456
- Sponsor's protocol ID
- ONZ-2022-0597
- Acronym
- GPAT
- Status last verified
- Jun 2024
- First submitted
- 17 May 2023
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Publications
Smeets S, Argenziano ME, De Crem AC, Desomer L, Anderson J, Bhandari P, Boskoski I, Bugajski M, Bourke MJ, Debels L, Heitman SJ, Kashida H, Lee RRT, Lyutakov I, Rivero-Sanchez L, Schoonjans C, Thomas-Gibson S, Thorlacius H, Fuccio L, Tham TC, Bisschops R, Tate DJ. Validation of the GPAT - the Global Polypectomy Assessment Tool: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy. 2025 May;57(5):555-566. doi: 10.1055/a-2541-4028. Epub 2025 Mar 14.
PubMed 40086890
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Global Polypectomy Assessment Tool (GPAT) - a Novel Online Assessment Tool for Any Colorectal Polypectomy
- ClinicalTrials.gov ID
- NCT05877456
- Acronym / sponsor ID
- GPAT / ONZ-2022-0597
- Conditions
- Colorectal Adenoma, Colorectal Polyp, Colo-rectal Cancer
- Keywords
- colonoscopy, polypectomy, quality in endoscopy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 2 Mar 2027 (estimated)
- First posted
- 26 May 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.
Colorectal polypectomy is offten incompletely performed with high variability between endoscopists, resulting in interval cancer or repeated procedures. Current available scoring systems for polypectomy technique are lacking in different areas so the investigators developed the Global Polypectomy Assessment Tool (GPAT) which is an online video-based assessment tool for any colorectal polypectomy.
The goal of the study is to assess the validity of GPAT through demonstrating the inter-rater agreement (Fleiss Kappa (κ)). GPAT has 20 items, contains evidence-based statements to aid interpretation, calculates an overall quality score and a complexity score.
Detailed description
Colorectal cancer (CRC) 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). This is linked with a significant and increasing annual economic cost1.
Screening for polyps is mostly done by performing a colonoscopy, which is considered the golden standard for screening and removal of polyps and has been proven to reduce the global colorectal cancer burden significantly2,3. Endoscopic removal of polyps is preferred because of its efficiency, cost-effectiveness and safety in comparison to surgery4.
Incomplete polyp resection may contribute significantly to the development of so called 'interval cancers'5,6. These comprise up to 6% of newly diagnosed CRC cases and occur during the 6 - 36 month period following complete colonoscopy. Incompetent removal of polyps leads to higher recurrence rates, more hospitalizations and the use of standard surgery which has greater risks and is costlier7. Using the appropriate technique, depending on the size and aspect of the polyps, reduces recurrence-rates significantly and should therefore be pursued.
There is currently very little known about training for polypectomy. An international consensus on quality metrics of polypectomy still doesn't exist since the criteria for what makes a well-performed polypectomy have still not been identified. Many of the current endoscopists have never even received any training in polypectomy. A 3.4-fold difference in resection rates was found between gastroenterologist who knew they were being observed by using the Direct Observation of Polypectomy Skills competency score (DOPyS)8,9. This stresses the need for a standardized international training program. In countries where guidelines are available, not all endoscopy-trainers are aware of them nor do they apply them for evaluation of their trainees, even though it has been proven to augment a trainee's skills when he/she's given a report card10,11.
Attempts to develop score systems have already been made but each has its own restrictions. The DOPyS score system lacks in certain areas: it does not take the difficulty of the procedure into account and demands training of the assessor to make it reliable. The fact that a training is needed for DOPyS is a factor that's holding it back for international use. Procedure numbers and current quality indicators (including adenoma detection rate or withdrawal time) are not sufficient to account for good clinical competence12. So current tools are difficult to use, not accessible to all and are using outdated and debunked quality metrics. Therefore a new tool with new quality metrics should be easily accessible, easy to use and preferably have excellent interobserver reliability (even without training the assessor). For evaluation of polyps <1cm, which are the most frequent ones, many categories of the DOPyS were non-applicable.
With training moving away from a numbers-based competency, and current score systems lacking in different aspects, the identification of quality metrics for polypectomy and implementation of them into a new score-system, has become more and more pressing.
This led to the development of a new score system: the Global Polypectomy Assessment Tool (GPAT), by Tate et al. This score-system has been established based upon the Delphi technique13 what enforces the content-validity of this score-system. For its development, an online questionnaire was sent to 11 international experts in the field of EMR (Endoscopic Mucosal Resection). These experts were chosen because of their international recognition for performing outstanding polypectomies. The tool has 16 categories. Each category has several questions and generates a score. Depending on which questions are relevant to the polypectomy that the participants are assessing, more or less points can be gained. If the polypectomy is more difficult, the difficulty-score will rise and subsequently, there will be more points to be scored. This way the scoring system adapts to the difficulty of the polypectomy. This is important since no two polypectomies are the same and therefore different scoring-criteria are relevant depending on the polyp. This is a major difference in comparison to the DOPyS which does not adapt to the difficulty of the procedure.
Two scores are generated by this tool. The first score provides an indication on the quality of the polypectomy. The second score gives an indication on the difficulty of the polypectomy based upon the difference between the complexity of the assessed procedure and the maximum possible complexity. If some categories or questions are not relevant, it does not affect the score. The number of questions per category differs as well as the possible answers for each question. The score-system is web-based.
This scoring system was already validated using standardized videos of colorectal polypectomy and in a real-life endoscopy setting by this research group. In this study the investigators will correlate GPAT scores to key performance indicators for colonoscopy and polypectomy including caecal intubation rate, caecal photography score, withdrawal time, sedation usage, intra- and post-procedural bleeding, perforation and rate of recurrence. Through this comparison the investigators can assess whether an increase in GPAT scores correlates to a better patient outcome after polypectomy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Endoscopists of varying abilities and grades Adult patients undergoing a polypectomy who agree to participate
Key inclusion criteria (2 listed)
- Endoscopists of varying abilities and grades
- Adult patients undergoing a polypectomy who agree to participate
Key exclusion criteria (3 listed)
- Endoscopist does not consent to inclusion
- Patient does not consent to inclusion
- Patients <18 y
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To validate the GPAT (global polypectomy assesment tool) scoring tool for polypectomy using key performance indicators.
Time frame: up to 1 year
Two scores are generated by this tool. The first score provides an indication on the quality of the polypectomy. This comprises of 6 domains: global competencies, injection, snare placement, safety checks, defect assessment, accessory techniques. The second score gives an indication on the difficulty of the polypectomy based upon the difference between the complexity of the assessed procedure and the maximum possible complexity (Size, morphology, site, access and 4 plus criteria: Size > 40mm, non granular morfology, non lifting polyp/previously attempted, ileocaecal valve, diverticular or appendiceal orifice involvement). If some categories or questions are not relevant, it does not affect the score. The number of questions per category differs as well as the possible answers for each question. The score-system is web-based. The maximum score for the first part of the tool is 105. For the indication on the difficulty of the polypectomy the maximum score is 17.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Derived from this study: PubMed 40086890Smeets S, Argenziano ME, De Crem AC, Desomer L, Anderson J, Bhandari P, Boskoski I, Bugajski M, Bourke MJ, Debels L, Heitman SJ, Kashida H, Lee RRT, Lyutakov I, Rivero-Sanchez L, Schoonjans C, Thomas-Gibson S, Thorlacius H, Fuccio L, Tham TC, Bisschops R, Tate DJ. Validation of the GPAT - the Global Polypectomy Assessment Tool: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy. 2025 May;57(5):555-566. doi: 10.1055/a-2541-4028. Epub 2025 Mar 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Adenoma and 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 3 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: enrolling by invitation, as of the sponsor's last update on 20 Jun 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 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?
This study is still under way. Results are not available in the source record yet.
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?
To validate the GPAT (global polypectomy assesment tool) scoring tool for polypectomy using key performance indicators. (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05877456, which also lists 1 linked publication.
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 20 Jun 2024.