Standard approach and quality system for confocal enteroscopy

Standardized Implementation and Quality Assessment System for Confocal Enteroscopy

This project will test whether using confocal laser endomicroscopy during balloon enteroscopy can improve diagnosis and help set quality standards for people with suspected small-bowel disease.

Quick facts

• Study type: Observational
• Enrollment: 600 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai Jiao Tong University School of Medicine (Academic / other)
• Locations: 8 sites (Hefei, Anhui and 7 other locations)
• Trial ID: NCT07363291 on ClinicalTrials.gov

What this trial studies

This multi-center observational project will collect 200 confocal small-bowel enteroscopy cases and 400 gastrointestinal control cases split into exploratory and validation arms. During single- or double-balloon enteroscopy, areas of suspected lesions and adjacent normal mucosa will be examined with confocal laser endomicroscopy (CLE) alongside conventional enteroscopic assessment and histology. CLE features will include mucosal-barrier metrics, inflammatory and mucosal-healing scores, and will be analyzed with AI image-recognition tools to identify diagnostic patterns. The exploratory arm will derive candidate diagnostic parameters and quality metrics, which the validation arm will then test for reproducibility across centers and operators.

Who should consider this trial

Good fit: Adults aged 18–70 who are scheduled for small-bowel endoscopy to characterize suspected small-bowel disease (for example suspected Crohn's disease, unclassified IBD, hereditary small-bowel neoplasia syndromes, or suspected small-bowel lymphoma) are ideal candidates.

Not a fit: People who cannot tolerate complete endoscopy, have severe hepatic or renal failure, known hypersensitivity to required agents, are outside the age range, or are otherwise unable to undergo the procedure are unlikely to benefit.

Why it matters

Potential benefit: If successful, this work could enable faster, more accurate small-bowel diagnoses and reduce unnecessary biopsies or delayed treatment by giving doctors clearer real-time cellular information and standardized quality procedures.

How similar studies have performed: Confocal laser endomicroscopy has demonstrated clinical value for upper and lower gastrointestinal lesions, but its application to small-bowel pathology is largely novel and less well studied.

Eligibility criteria

Inclusion Criteria:

* 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.

Have completed formal training and passed competency assessments in gastroscopy, colonoscopy, and small-bowel endoscopy.

-Willing to participate and able to provide written informed consent.

Exclusion Criteria:

* 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.
* Endoscopic procedure or image-reading volume \< 100 cases in the past 2 years.
* Medical license revoked or currently suspended for any reason.

Where this trial is running

Hefei, Anhui and 7 other locations

• Renji Hospital Anhui Hospital — Hefei, Anhui, China (Recruiting)
• Ningbo Hangzhou Bay Hospital — Ningbo, Zhejiang, China (Recruiting)
• Kashgar Second People's Hospital — Kashgar, China (Recruiting)
• Huashan Hospital, Fudan University — Shanghai, China (Recruiting)
• Renji Hospital — Shanghai, China (Recruiting)
• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)
• Shanghai Sixth People's Hospital — Shanghai, China (Recruiting)
• Zhongshan Hospital, Fudan University — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Xiaobo Li, MD. PhD

Conditions Confocal Enteroscopy; Quality Assessment System; Standardized Implementation