About this trial
Confocal technology, hailed as "optical biopsy," enables real-time cellular-level histological examination of mucosal surfaces. Its integration with double-balloon enteroscopy significantly enhances the clinical feasibility of targeted biopsy, early diagnosis, and endoscopic staging for small bowel diseases such as inflammatory bowel disease. Currently, confocal endoscopy is primarily applied to upper and lower gastrointestinal tract diseases, leaving small bowel pathologies largely unexplored. Consequently, establishing a diagnostic framework for small bowel tumors and non-neoplastic lesions using confocal enteroscopy, alongside developing quality assessment standards for its operational procedures, is of paramount importance.
Eligibility criteria
Qualifiers
Aged 18-70 years and scheduled to undergo small-bowel endoscopy.
Able to provide written informed consent and willing to participate in the study.
Certified gastroenterologists with an intermediate (or higher) professional title.
Disqualifiers
Poor general condition, severe hepatic or renal insufficiency, or inability to tolerate complete endoscopic examination.
Known hypersensitivity to any study-related agents (fluorescein sodium, polyethylene glycol, lidocaine mucilage).
Currently enrolled in another clinical trial.
Never perform endoscopic procedures.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Shanghai Jiao Tong University School of Medicine
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Collaborator
Huashan Hospital
Collaborator
RenJi Hospital
Collaborator
Ruijin Hospital
Collaborator
Kashgar Second People's Hospital
Collaborator
Ningbo Hangzhou Bay Hospital
Collaborator