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

This trial does not accept healthy volunteers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

600 Participants
are grouped into 2 trial groups
Group A: Confocal Enteroscopy group
Group B: Conventional enteroscopy group

Trial outcomes

Primary outcomes

1

procedural success rate

the proportion of examinations in which confocal enteroscopy was successfully completed

Time frame
14 days

Secondary outcomes

1

diagnostic accuracy

the proportion of clinical findings that are consistent with pathology or other gold-standard diagnoses, and the impact of AI-induced bias on this concordance

Time frame
14 days
2

complication rate

the number of cases in which complications occur after the examination

Time frame
14 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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