Standardized Implementation and Quality Assessment System for Confocal Enteroscopy

NCT07363291 | Recruiting

• 1 other identifier: KY2024-200-B
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Confocal Enteroscopy; Quality Assessment System; Standardized Implementation

Keywords

Confocal Enteroscopy; Standardized Implementation; Quality Assessment System

Outcome Measures

Primary Outcomes (1)

• procedural success rate

  the proportion of examinations in which confocal enteroscopy was successfully completed

  14 days

Secondary Outcomes (2)

• diagnostic accuracy

  14 days

• complication rate

  14 days

Study Arms (2)

Confocal Enteroscopy group

Record the performance under CLE

Conventional enteroscopy group

Record the performance under Enteroscopy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: collaborator
• Renji Hospital Anhui Hospital: collaborator
• Ruijin Hospital: collaborator
• Ningbo Hangzhou Bay Hospital: collaborator
• Shanghai Jiao Tong University School of Medicine: lead
• Shanghai Zhongshan Hospital: collaborator
• Huashan Hospital: collaborator
• Kashgar Second People's Hospital: collaborator

Study Sites (8)

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

Central Study Contacts

Xiaobo Li, MD. PhD

CONTACT

13901631056; lxb_1969@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: January 23, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 23, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)