Developing a Standardized Quality and Use System for Confocal Enteroscopy in Small-Bowel Disease Diagnosis

What this Trial Is About

Researchers are investigating the use of confocal technology, also known as optical biopsy, combined with double-balloon enteroscopy to improve real-time cellular-level examination of the small bowel. This study aims to establish a diagnostic framework for small bowel tumors and non-neoplastic lesions, as confocal endoscopy is currently used mainly for upper and lower gastrointestinal tract diseases. The project is focused on developing a quality assessment system for confocal enteroscopy procedures to enhance early diagnosis and staging of small bowel diseases such as inflammatory bowel disease and hereditary neoplastic syndromes. This project will create a multi-center cohort with 200 confocal small-bowel endoscopy cases and 400 gastrointestinal control cases divided equally into exploratory and validation arms. Patients with suspected small-bowel diseases who require endoscopy will be included. During single- or double-balloon enteroscopy, suspected areas and adjacent normal mucosa will be examined with confocal laser endomicroscopy CLE, and conventional enteroscopic findings will be recorded. CLE will assess various mucosal and inflammatory activity scores, supported by AI image-recognition systems. The exploratory arm will identify diagnostic parameters to build a new confocal enteroscopy model for small-bowel inflammatory bowel disease, which will then be tested in the validation arm. Quality-control indicators covering pre-, intra-, and post-procedure phases will also be developed and validated. Participants will undergo confocal small-bowel endoscopy with data collection on procedural success, diagnostic accuracy, complication rates, and image quality. The study will assess factors impacting quality control throughout the workflow, including preparation, procedure timing, scope handling, specimen management, and recovery. Regular audits will ensure continuous improvement. The primary outcome is procedural success rate within 14 days, with secondary outcomes including diagnostic accuracy and complication rates. The study will last until June 2028, involving adult participants aged 18 to 70 years.

Standardized Implementation and Quality Assessment System for Confocal Enteroscopy