Early Gastric CancerpCLENCT07507071
Comparison of the Sensitivity of pCLE and Pathological Biopsy for Gastric Mucosal Lesions
An observational study of Early Gastric Cancer, run by Changhai Hospital at 1 site in China.
Trial summary
The pathological biopsy of gastric lesions, performed prior to endoscopic submucosal dissection (ESD), is crucial for differentiating the pathological nature of the lesions and guiding treatment decisions. However, due to the impact of biopsy sampling, the sensitivity of the pathological biopsy is not optimal. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Early Gastric Cancer
- What is being tested?
- Probe-based Confocal Laser Endomicroscopy and Pathological biopsy
- How many people
- 169 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2026to 15 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population primarily consisted of patients who had undergone both preoperative pathological biopsy and pCLE examination and then received endoscopic submucosal dissection (ESD) treatment. As both pathological biopsy and pCLE struggle to achieve a perfect diagnosis, this study employed the pathological diagnosis obtained via ESD surgery as the gold standard to compare the sensitivity, specificity, and accuracy of pathological biopsy and pCLE in diagnosing early gastric cancer.
Who may be able to join
- All patients aged 18-75 who underwent pCLE examination and received ESD treatmen.
Who cannot join
- lack of pre-ESD pathological biopsy results, and ESD pathology indicated advanced gastric cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Naval Medical University
Shanghai
Yu Bai, MD, +86 (021)-31161236, md.baiyu@foxmail.com
Peng Pan, +8618721828503, panpeng211@126.com
About this study
Official title: Comparison of the Sensitivity of Probe-Based Confocal Laser Endomicroscopy and Pathological Biopsy for Gastric Mucosal Lesions
The pathological biopsy of gastric lesions, performed prior to endoscopic submucosal dissection (ESD), is crucial for differentiating the pathological nature of the lesions and guiding treatment decisions. However, due to the impact of biopsy sampling, the sensitivity of the pathological biopsy is not optimal.
The probe - based confocal laser endomicroscopy (pCLE) technique enables the real - time display of high-resolution microscopic images of the mucosal layer (with an amplification factor of up to 1000 times) through a slender optical fiber probe that can pass through the standard endoscope's working channel. It is an optical biopsy technique and has unique value in determining the pathological nature of gastric lesions.
Read more
As the Digestive Endoscopy Center of Shanghai Changhai Hospital is a national-level pCLE application demonstration center, it has prospectively collected numerous cases of pCLE examinations of gastric mucosal lesions.
The main purpose of this study is to retrospectively analyze these cases and compare the sensitivity and specificity of pathological biopsy and pCLE in differentiating the pathological nature of gastric mucosal lesions.
Read the detailed description
In this study, the pathological results of ESD or surgical resection of large specimens were used as the gold standard. The sensitivity of preoperative confocal endomicroscopy examination and pathological biopsy for gastric mucosal cancerous lesions was compared. The study adopted a retrospective approach and invited three experts to conduct offline blind diagnoses of the confocal endoscopy images respectively. First, two experts independently diagnosed all the cases. For those cases with inconsistent diagnosis results, a third expert was then consulted for a final determination. Although it was a retrospective study, the cases included in the research were all prospectively and continuously included in a demonstration project.
- Conditions
- Early Gastric Cancer
- Being tested
- Probe-based Confocal Laser Endomicroscopy, Pathological biopsy
- Keywords
- Pathological biopsy, Early gastric cancer, High-grade intraepithelial neoplasia, Probe-based confocal Laser endomicroscopy, Endoscopic submucosal dissection
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probe-based Confocal Laser EndomicroscopyDiagnostic test
Also called Optical biopsy
Description: 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. All patients scheduled for endoscopic submucosal dissection (ESD) of gastric lesions must undergo probe-based confocal laser endomicroscopy (pCLE) prior to the ESD procedure.
Pathological biopsyDiagnostic test
A pathological biopsy is a medical procedure that involves the removal of a small sample of tissue or cells from the body for microscopic examination. It is a crucial diagnostic tool used to identify diseases, particularly cancer, infections, inflammatory conditions, and other abnormalities.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity, also known as True Positive Rate (TPR), refers to the proportion of patients with early gastric cancer that can be correctly identified by a certain diagnostic technique. High sensitivity means that this detection method can minimize the risk of missed diagnoses to the greatest extent and is applicable for disease screening (such as infectious diseases and early cancer screening).
Measured: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for sensitivity calculation.
Secondary outcomes (4)
Specificity
Specificity refers to the ability of a diagnostic test to accurately identify individuals without early gastric cancer (true negative, TN), namely, the proportion of individuals who are actually healthy and test negative.
Measured: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for specific calculations.
Accuracy
Accuracy refers to a comprehensive indicator that measures the ability of a medical test or diagnostic method to correctly distinguish between early gastric cancer and non - cancerous lesions. It is the ratio of the sum of true positives and true negatives to the total test population.
Measured: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for the calculation of accuracy.
Positive Predictive Value (PPV)
PPV is an important indicator in diagnostic tests, used to assess the probability that a subject actually has early gastric cancer when the test result is positive. Here is a detailed explanation.
Measured: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for sensitivity calculation.
Nnegative predictive value (NPV)
The definition of NPV is the probability that a lesion diagnosed as a non-cancerous lesion is actually non-cancerous.
Measured: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for sensitivity calculation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start30 Mar 2026 (estimated)
- Primary completion10 Apr 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early 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 crossover
- Time perspective
- Retrospective
- Enrolment
- 169 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507071
- Sponsor's protocol ID
- pCLE vs. Pathological Biopsy
- Acronym
- pCLE
- Status last verified
- Mar 2026
- First submitted
- 27 Jan 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data that support the findings of this study are available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Sensitivity of Probe-Based Confocal Laser Endomicroscopy and Pathological Biopsy for Gastric Mucosal Lesions
- ClinicalTrials.gov ID
- NCT07507071
- Acronym / sponsor ID
- pCLE / pCLE vs. Pathological Biopsy
- Conditions
- Early Gastric Cancer
- Keywords
- Pathological biopsy, Early gastric cancer, High-grade intraepithelial neoplasia, Probe-based confocal Laser endomicroscopy, Endoscopic submucosal dissection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 169 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 10 Apr 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 2 Apr 2026 (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.
The pathological biopsy of gastric lesions, performed prior to endoscopic submucosal dissection (ESD), is crucial for differentiating the pathological nature of the lesions and guiding treatment decisions. However, due to the impact of biopsy sampling, the sensitivity of the pathological biopsy is not optimal.
The probe - based confocal laser endomicroscopy (pCLE) technique enables the real - time display of high-resolution microscopic images of the mucosal layer (with an amplification factor of up to 1000 times) through a slender optical fiber probe that can pass through the standard endoscope's working channel. It is an optical biopsy technique and has unique value in determining the pathological nature of gastric lesions.
As the Digestive Endoscopy Center of Shanghai Changhai Hospital is a national-level pCLE application demonstration center, it has prospectively collected numerous cases of pCLE examinations of gastric mucosal lesions.
The main purpose of this study is to retrospectively analyze these cases and compare the sensitivity and specificity of pathological biopsy and pCLE in differentiating the pathological nature of gastric mucosal lesions.
Detailed description
In this study, the pathological results of ESD or surgical resection of large specimens were used as the gold standard. The sensitivity of preoperative confocal endomicroscopy examination and pathological biopsy for gastric mucosal cancerous lesions was compared. The study adopted a retrospective approach and invited three experts to conduct offline blind diagnoses of the confocal endoscopy images respectively. First, two experts independently diagnosed all the cases. For those cases with inconsistent diagnosis results, a third expert was then consulted for a final determination. Although it was a retrospective study, the cases included in the research were all prospectively and continuously included in a demonstration project.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population primarily consisted of patients who had undergone both preoperative pathological biopsy and pCLE examination and then received endoscopic submucosal dissection (ESD) treatment. As both pathological biopsy and pCLE struggle to achieve a perfect diagnosis, this study employed the pathological diagnosis obtained via ESD surgery as the gold standard to compare the sensitivity, specificity, and accuracy of pathological biopsy and pCLE in diagnosing early gastric cancer.
Key inclusion criteria (1 listed)
- All patients aged 18-75 who underwent pCLE examination and received ESD treatmen.
Key exclusion criteria (1 listed)
- lack of pre-ESD pathological biopsy results, and ESD pathology indicated advanced gastric cancer.
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 EndomicroscopyAlso: Optical biopsyDescription: 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. All patients scheduled for endoscopic submucosal dissection (ESD) of gastric lesions must undergo probe-based confocal laser endomicroscopy (pCLE) prior to the ESD procedure. | Diagnostic test | – |
| Pathological biopsyA pathological biopsy is a medical procedure that involves the removal of a small sample of tissue or cells from the body for microscopic examination. It is a crucial diagnostic tool used to identify diseases, particularly cancer, infections, inflammatory conditions, and other abnormalities. | Diagnostic test | – |
Primary outcome
Sensitivity
Time frame: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for sensitivity calculation.
Sensitivity, also known as True Positive Rate (TPR), refers to the proportion of patients with early gastric cancer that can be correctly identified by a certain diagnostic technique. High sensitivity means that this detection method can minimize the risk of missed diagnoses to the greatest extent and is applicable for disease screening (such as infectious diseases and early cancer screening).
4 secondary outcomes
Specificity
Time frame: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for specific calculations.
Accuracy
Time frame: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for the calculation of accuracy.
Positive Predictive Value (PPV)
Time frame: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for sensitivity calculation.
Nnegative predictive value (NPV)
Time frame: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for sensitivity calculation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: Undecided. The data that support the findings of this study are available from the corresponding author upon reasonable request.
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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.
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 Early Gastric Cancer, 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 1 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: opening soon, as of the sponsor's last update on 2 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhaoshen Li, Ph.D (+8618936364880, li.zhaoshen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for sensitivity calculation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.