Gastric CancerNCT06981819
Establishment and Effectiveness Evaluation of a Training System for Confocal Laser Endomicroscopy
An observational study of Gastric Cancer and Gastric High-grade Intraepithelial Neoplasia, run by Changhai Hospital at 1 site in China.
Trial summary
Gastrointestinal endoscopy is a vital method for screening and diagnosing gastric cancer. It aids in identifying the tumor's location within the stomach and its macroscopic type, and allows biopsy for histological confirmation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastric Cancer, Gastric High-grade Intraepithelial Neoplasia, Gastric Low-grade Intraepithelial Neoplasia
- What is being tested?
- Probe-based Confocal Laser Endomicroscopy by Experts, magnifying endoscopy with blue laser imaging and Probe-based Confocal Laser Endomicroscopy by trainees
- How many people
- 147 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 2025to 13 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The use of detailed endoscopic examination includes the following scenarios: routine endoscopic examination suspected early cancer but the biopsy pathology only indicated precancerous lesions, preoperative examination for early upper gastrointestinal cancer endoscopic resection, follow-up after endoscopic resection of early upper gastrointestinal cancer and precancerous lesions, follow-up after partial gastrectomy for advanced gastric cancer.
Who may be able to join
- atients aged 18 to 85 years who were scheduled for detailed endoscopic examination at the First Affiliated Hospital of Naval Medical University were consecutively enrolled.
Who cannot join
- nwillingness to undergo CLE examination
- hypersensitivity to sodium fluorescein
- hepatic or renal insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishment and Effectiveness Evaluation of a Training System for Confocal Laser Endomicroscopy in Diagnosing Gastric Neoplastic Lesions: A Prospective Diagnostic Study
Gastrointestinal endoscopy is a vital method for screening and diagnosing gastric cancer. It aids in identifying the tumor's location within the stomach and its macroscopic type, and allows biopsy for histological confirmation. Moreover, suspicious lesions can be further examined using specialized endoscopic techniques such as magnifying endoscopy (ME) combined with electronic staining, chromoendoscopy, confocal laser endomicroscopy (CLE) and fluorescence endoscopy. ME combined with electronic staining has been confirmed to achieve excellent diagnostic accuracy in distinguishing between noncancerous and cancerous lesions. However, ME is technically challenging, and gastric magnifying endoscopy involves various evaluation criteria such as the vessel plus surface classification system and Kudo's pit pattern classification, leading to a steep learning curve.
Confocal Laser Endomicroscopy (CLE) is an advanced in vivo imaging technique that combines confocal microscopy with endoscopy, enabling real-time, microscopic visualization of tissues at a cellular level during endoscopic procedures. Despite having been available for approximately 20 years, and its accuracy in diagnosing gastric neoplastic lesions having been confirmed by several studies, the clinical application of CLE is not widespread, and there is a lack of relevant standards to guide the training of CLE endoscopists. To train more CLE endoscopists, we organized CLE training courses. We also evaluated the training's effectiveness and try to explore the Influencing factors of learning curve.
- Conditions
- Gastric Cancer, Gastric High-grade Intraepithelial Neoplasia, Gastric Low-grade Intraepithelial Neoplasia, Gastritis
- Being tested
- Probe-based Confocal Laser Endomicroscopy by Experts, magnifying endoscopy with blue laser imaging, Probe-based Confocal Laser Endomicroscopy by trainees
- Keywords
- Confocal Laser Endomicroscopy, Gastric Neoplastic Lesions
- Medical subject headings
- Stomach Neoplasms, Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probe-based Confocal Laser Endomicroscopy by ExpertsDiagnostic test
Also called pCLE by Experts
Confocal Laser Endomicroscopy (CLE) is an advanced in vivo imaging technique that combines confocal microscopy with endoscopy, enabling real-time, microscopic visualization of tissues at a cellular level during endoscopic procedures. Probe-based CLE (pCLE) can enter the stomach cavity through the biopsy channel of the endoscope and observe the gastric mucosa. To generate diagnostic results of pCLE, two pCLE experts dignosed independent. Any discrepancies are then resolved by a third expert.
magnifying endoscopy with blue laser imagingDiagnostic test
Also called ME-BLI
Magnifying Endoscopy with Blue Laser Imaging (ME-BLI) is an advanced endoscopic imaging technique that combines high-resolution magnification with laser-enhanced visualization to improve the detection and characterization of gastrointestinal (GI) mucosal lesions. Developed by Fujifilm, BLI utilizes specific laser wavelengths to enhance surface and vascular patterns, making it particularly useful for diagnosing early-stage cancers and precancerous conditions in the stomach, colon, and esophagus. To generate diagnostic results of ME-BLI, two ME-BLI experts dignosed independent. Any discrepancies are then resolved by a third expert.
Probe-based Confocal Laser Endomicroscopy by traineesDiagnostic test
Also called pCLE by trainees
Confocal Laser Endomicroscopy (CLE) is an advanced in vivo imaging technique that combines confocal microscopy with endoscopy, enabling real-time, microscopic visualization of tissues at a cellular level during endoscopic procedures. Probe-based CLE (pCLE) can enter the stomach cavity through the biopsy channel of the endoscope and observe the gastric mucosa. The diagnosis results of CLE trainees are generated by each trainee themselves.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy
Diagnostic accuracy in the research refers to the ability of diagnostic tests to correctly identify gastric cancerous or noncancerous lesions. gastric cancerous lesions included gastric high-grade intraepithelial neoplasia (HGIN), and gastric cancer. The calculation method for diagnostic accuracy is the percentage of cases where the diagnostic results are consistent with the pathological results out of the total number of cases.
Measured: From enrollment to obtaining the pathological results at 2 weeks
Secondary outcomes (2)
Other diagnostic performance outcomes
Other diagnostic performance outcomes included diagnostic sensitivity, specificity, positive predictive value and negative predictive value.
Measured: From enrollment to obtaining the pathological results at 2 weeks
Kappa value
The Kappa value was used to evaluate the reliability or agreement between two diagnostic methods or two diagnostic results. In this study, the pathological results were used as the gold standard. The pCLE diagnosis results of each trainee were compared for consistency with the expert's pCLE results as well as the expert's ME-BLI diagnosis results using the Kapper value. The pCLE results and the ME-BLI diagnosis results provided by the experts also need to be compared for consistency using the Kapper value.
Measured: From the completion of the diagnosis of all cases to the end of calculating the Kapper value at one week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start2 Jun 2025
- Primary completion31 Oct 2025
- Study completion13 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China Biotechnology Development Center
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981819
- Sponsor's protocol ID
- CLE Training
- Status last verified
- Dec 2025
- First submitted
- 13 May 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pan P, Gao J, Zhang Y, Pan JY, Zhang WH, Wang NN, Zhao JL, Dong ZX, Xiao ZH, Jin ZD, Li ZS, Bai Y. Establishment and Evaluation of a Probe-Based Confocal Laser Endomicroscopy Training System for Gastric Cancerous Lesions Diagnosis: Evidence From a National Training Program. Clin Transl Gastroenterol. 2026 Jul 27. doi: 10.14309/ctg.0000000000001074. Online ahead of print.
PubMed 42508426
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Effectiveness Evaluation of a Training System for Confocal Laser Endomicroscopy in Diagnosing Gastric Neoplastic Lesions: A Prospective Diagnostic Study
- ClinicalTrials.gov ID
- NCT06981819
- Acronym / sponsor ID
- CLE Training
- Conditions
- Gastric Cancer, Gastric High-grade Intraepithelial Neoplasia, Gastric Low-grade Intraepithelial Neoplasia, Gastritis
- Keywords
- Confocal Laser Endomicroscopy, Gastric Neoplastic Lesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- China Biotechnology Development Center
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 13 Nov 2025 (actual)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastrointestinal endoscopy is a vital method for screening and diagnosing gastric cancer. It aids in identifying the tumor's location within the stomach and its macroscopic type, and allows biopsy for histological confirmation. Moreover, suspicious lesions can be further examined using specialized endoscopic techniques such as magnifying endoscopy (ME) combined with electronic staining, chromoendoscopy, confocal laser endomicroscopy (CLE) and fluorescence endoscopy. ME combined with electronic staining has been confirmed to achieve excellent diagnostic accuracy in distinguishing between noncancerous and cancerous lesions. However, ME is technically challenging, and gastric magnifying endoscopy involves various evaluation criteria such as the vessel plus surface classification system and Kudo's pit pattern classification, leading to a steep learning curve.
Confocal Laser Endomicroscopy (CLE) is an advanced in vivo imaging technique that combines confocal microscopy with endoscopy, enabling real-time, microscopic visualization of tissues at a cellular level during endoscopic procedures. Despite having been available for approximately 20 years, and its accuracy in diagnosing gastric neoplastic lesions having been confirmed by several studies, the clinical application of CLE is not widespread, and there is a lack of relevant standards to guide the training of CLE endoscopists. To train more CLE endoscopists, we organized CLE training courses. We also evaluated the training's effectiveness and try to explore the Influencing factors of learning curve.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The use of detailed endoscopic examination includes the following scenarios: routine endoscopic examination suspected early cancer but the biopsy pathology only indicated precancerous lesions, preoperative examination for early upper gastrointestinal cancer endoscopic resection, follow-up after endoscopic resection of early upper gastrointestinal cancer and precancerous lesions, follow-up after partial gastrectomy for advanced gastric cancer.
Key inclusion criteria (1 listed)
- atients aged 18 to 85 years who were scheduled for detailed endoscopic examination at the First Affiliated Hospital of Naval Medical University were consecutively enrolled.
Key exclusion criteria (3 listed)
- nwillingness to undergo CLE examination
- hypersensitivity to sodium fluorescein
- hepatic or renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probe-based Confocal Laser Endomicroscopy by ExpertsAlso: pCLE by ExpertsConfocal Laser Endomicroscopy (CLE) is an advanced in vivo imaging technique that combines confocal microscopy with endoscopy, enabling real-time, microscopic visualization of tissues at a cellular level during endoscopic procedures. Probe-based CLE (pCLE) can enter the stomach cavity through the biopsy channel of the endoscope and observe the gastric mucosa. To generate diagnostic results of pCLE, two pCLE experts dignosed independent. Any discrepancies are then resolved by a third expert. | Diagnostic test | – |
| magnifying endoscopy with blue laser imagingAlso: ME-BLIMagnifying Endoscopy with Blue Laser Imaging (ME-BLI) is an advanced endoscopic imaging technique that combines high-resolution magnification with laser-enhanced visualization to improve the detection and characterization of gastrointestinal (GI) mucosal lesions. Developed by Fujifilm, BLI utilizes specific laser wavelengths to enhance surface and vascular patterns, making it particularly useful for diagnosing early-stage cancers and precancerous conditions in the stomach, colon, and esophagus. To generate diagnostic results of ME-BLI, two ME-BLI experts dignosed independent. Any discrepancies are then resolved by a third expert. | Diagnostic test | – |
| Probe-based Confocal Laser Endomicroscopy by traineesAlso: pCLE by traineesConfocal Laser Endomicroscopy (CLE) is an advanced in vivo imaging technique that combines confocal microscopy with endoscopy, enabling real-time, microscopic visualization of tissues at a cellular level during endoscopic procedures. Probe-based CLE (pCLE) can enter the stomach cavity through the biopsy channel of the endoscope and observe the gastric mucosa. The diagnosis results of CLE trainees are generated by each trainee themselves. | Diagnostic test | – |
Primary outcome
Diagnostic Accuracy
Time frame: From enrollment to obtaining the pathological results at 2 weeks
Diagnostic accuracy in the research refers to the ability of diagnostic tests to correctly identify gastric cancerous or noncancerous lesions. gastric cancerous lesions included gastric high-grade intraepithelial neoplasia (HGIN), and gastric cancer. The calculation method for diagnostic accuracy is the percentage of cases where the diagnostic results are consistent with the pathological results out of the total number of cases.
2 secondary outcomes
Other diagnostic performance outcomes
Time frame: From enrollment to obtaining the pathological results at 2 weeks
Kappa value
Time frame: From the completion of the diagnosis of all cases to the end of calculating the Kapper value at one week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Derived from this study: PubMed 42508426Pan P, Gao J, Zhang Y, Pan JY, Zhang WH, Wang NN, Zhao JL, Dong ZX, Xiao ZH, Jin ZD, Li ZS, Bai Y. Establishment and Evaluation of a Probe-Based Confocal Laser Endomicroscopy Training System for Gastric Cancerous Lesions Diagnosis: Evidence From a National Training Program. Clin Transl Gastroenterol. 2026 Jul 27. doi: 10.14309/ctg.0000000000001074. Online ahead of print.
- Individual participant dataSharing planned: Undecided
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Gastric High-grade Intraepithelial Neoplasia, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy (time frame: From enrollment to obtaining the pathological results at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06981819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.