跳至主要内容
临床试验/NCT05660317
NCT05660317招募中不适用

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

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Endoscopists' accuracy of tip control using a novel scoring system.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Endoscopists who do not consent to the study
  • Patients who do not consent to the study

结局指标

主要结局

Endoscopists' accuracy of tip control using a novel scoring system.

时间窗: 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).

次要结局

  • Assessment of quality parameters of the novel tip control scoring system.(Through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验