Standardized Implementation and Quality Assessment System for Confocal Enteroscopy

January 15, 2026 updated by: Xiaobo Li, Shanghai Jiao Tong University School of Medicine
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This project intends to establish a multi-center cohort comprising 200 confocal small-bowel endoscopy cases plus 400 gastrointestinal control cases, equally split into two arms: an exploratory arm and a validation arm. Controls will be selected according to the research objective: for neoplastic lesions, normal-appearing small bowel, colonic adenomas, and early gastric adenocarcinoma; for non-neoplastic lesions, normal-appearing small bowel, colonic segments involved by IBD, and gastric segments involved by IBD.

Main inclusion: patients with suspected small-bowel disease who require endoscopy for lesion characterization, including but not limited to clinically suspected active or quiescent small-bowel Crohn's disease with or without complications, unclassified IBD such as CMUSE, hereditary small-bowel neoplastic syndromes (e.g. Peutz-Jeghers), and small-bowel lymphomas that need endoscopy plus histology.

During single- or double-balloon enteroscopy, areas endoscopically suspected and adjacent normal mucosa will be examined with confocal laser endomicroscopy (CLE). Conventional enteroscopic and CLE findings will be summarized; CLE variables will include, but are not limited to, mucosal-barrier assessment (epithelial gap score, cell-shedding score, Watson score), inflammatory activity based on crypt architecture, ENHANCE mucosal-healing score, and will be augmented by AI image-recognition systems (Yingnuo™ & Xiaohua-Tanying™).

Using the exploratory arm, parameters that show statistically significant contribution to diagnosis by integrating endoscopic and comprehensive clinical diagnosis will be identified to build a new confocal enteroscopy-based model for small-bowel IBD, which will then be tested in the validation arm for sensitivity, specificity, AUC, etc. The auxiliary role of AI in lesion recognition will also be evaluated.

In parallel, quality-control (QC) indicators will be developed from the clinical-use cohort. Key indicators include: procedural-success rate (proportion of completed confocal enteroscopies), diagnostic accuracy (concordance with pathology or gold standard, including AI-induced drift), adverse-event rate, and image-quality score.

Contributions to QC of the entire workflow-pre-procedure (scope model, CLE mode setting, patient risk/anesthesia assessment, demographics), intra-procedure (insertion/withdrawal time, time to lesion, scope posture, completeness of CLE parameters, bowel preparation), and post-procedure (specimen handling, recovery, observation time, prophylactic antibiotics)-will be quantified by logistic regression to identify high-impact factors and build a scientific QC system. This system will be applied to the validation arm for feasibility and accuracy, and regular internal audits will be conducted for continuous improvement.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Confocal Enteroscopy group
Record the performance under CLE
Conventional enteroscopy group
Record the performance under Enteroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
procedural success rate
Time Frame: 14 days
the proportion of examinations in which confocal enteroscopy was successfully completed
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diagnostic accuracy
Time Frame: 14 days
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
14 days
complication rate
Time Frame: 14 days
the number of cases in which complications occur after the examination
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Collaborators

Shanghai Zhongshan Hospital
Huashan Hospital
Ruijin Hospital
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Ningbo Hangzhou Bay Hospital
Renji Hospital Anhui Hospital
Kashgar Second People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

October 1, 2025

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KY2024-200-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Confocal Enteroscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe