Standardized Implementation and Quality Assessment System for Confocal Enteroscopy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorShanghai Jiao Tong University School of Medicine

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

600 Participants
are grouped into 2 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