Assessment of Endoscopic Tip Control Using a Novel Score Based on the Snare Tip Soft Coagulation of Polypectomy Margin Defects

Colorectal Polyp Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05660317
• Other study ID #: ONZ-2022-0178
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: November 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Endoscopists who do not consent to the study

• Patients who do not consent to the study

Related Conditions & MeSH terms

• Colorectal Polyp

Intervention

Other:
• Tip control score
Scoring of endoscopist's tip control performing snare tip soft coagulation to the margins of a endoscopic mucosal resection (EMR) defect

Locations

Country	Name	City	State
Belgium	UZ Gent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Through study completion, an average of 1 year (no intervention, the participant gets scored with every margin ablation he does)
Secondary	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)	Through study completion, an average of 1 year