RecruitingNCT07363291

Standardized Implementation and Quality Assessment System for Confocal Enteroscopy


Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

600 participants

Start Date

Jun 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria5

  • 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 Criteria6

  • 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.

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Locations(8)

Renji Hospital Anhui Hospital

Hefei, Anhui, China

Ningbo Hangzhou Bay Hospital

Ningbo, Zhejiang, China

Kashgar Second People's Hospital

Kashgar, China

Huashan Hospital, Fudan University

Shanghai, China

Renji Hospital

Shanghai, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Shanghai Sixth People's Hospital

Shanghai, China

Zhongshan Hospital, Fudan University

Shanghai, China

View Full Details on ClinicalTrials.gov

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NCT07363291