NCT05877456

Brief 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 (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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
10mo left

Started Mar 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Mar 2023Mar 2027

Study Start

First participant enrolled

March 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2027

Last Updated

June 20, 2024

Status Verified

June 1, 2024

Enrollment Period

4 years

First QC Date

May 17, 2023

Last Update Submit

June 18, 2024

Conditions

Keywords

colonoscopypolypectomyquality in endoscopy

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 1 year

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Endoscopists of varying abilities and grades Adult patients undergoing a polypectomy who agree to participate

You may qualify if:

  • Endoscopists of varying abilities and grades
  • Adult patients undergoing a polypectomy who agree to participate

You may not qualify if:

  • Patients \<18 y

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

uz Gent

Ghent, Gent, 9000, Belgium

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2023

First Posted

May 26, 2023

Study Start

March 1, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 2, 2027

Last Updated

June 20, 2024

Record last verified: 2024-06

Locations