Gastric Cancer (Diagnosis)NCT07088744
Comparison of the Sensitivity of pCLE and Pathological Biopsy Before ESD
An observational study of Gastric Cancer (Diagnosis) and Gastric High-grade Intraepithelial Neoplasia, run by Changhai Hospital at 4 sites in China.
Trial summary
Pathological biopsy before endoscopic submucosal dissection (ESD) the gastric lesion plays an important role in differentiating the pathological nature of the lesion and guiding treatment decisions. However, due to the influence of the materials used, the sensitivity of pathological biopsy is not satisfactory. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer (Diagnosis), Gastric High-grade Intraepithelial Neoplasia, Gastric Low-grade Intraepithelial Neoplasia
- What is being tested?
- Probe-based Confocal Laser Endomicroscopy and Pathological biopsy
- How many people
- 169 participants
- Where
- 4 sitesChina
- Study dates
- 30 Jul 2025to 15 Sep 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The absolute indications for curative endoscopic resection (ESD) include moderately and well-differentiated, nonulcerated, mucosal lesions that are ≤2 cm in size. Other relative (expanded) indications for gastric endoscopic submucosal dissection include moderately and well-differentiated superficial cancers that are >2 cm, lesions ≤3 cm with ulceration or that contain early submucosal invasion, and poorly differentiated superficial cancers ≤2 cm in size.
Who may be able to join
- patients aged 18 to 85 years who were scheduled for endoscopic submucosal dissection due to early-stage gastric cancer were consecutively enrolled.
Who cannot join
- Severe cardiac or pulmonary dysfunction, impaired renal function, coagulopathy, pregnancy or lactation, allergy to fluorescein, and inability to provide informed consent.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
West China Hospital of Sichuan University
Chengdu, Sichuan
Wenjuan Yang, MD, +8618980608063, yangwenjuan19860@163.com
Guangxi Zhuang Autonomous Region People's Hospital
Nanning, Guangxi, 200433
Wenhua Zhang, MD, +86189789802299, zwh_159@163.com
The First Affiliated Hospital of Naval Medical University
Shanghai
Yu Bai, MD, +86 (021)-31161236, md.baiyu@foxmail.com
Northern Theater Command Hospital
Shenyang, Liaoning
Wen Jia, MD, +8617614308587, 17614308587@163.com
About this study
Official title: Comparison of the Sensitivity of Probe-based Confocal Laser Endomicroscopy and Pathological Biopsy Before Endoscopic Submucosal Dissection
Pathological biopsy before endoscopic submucosal dissection (ESD) the gastric lesion plays an important role in differentiating the pathological nature of the lesion and guiding treatment decisions. However, due to the influence of the materials used, the sensitivity of pathological biopsy is not satisfactory. Confocal Laser Endomicroscopy (CLE) is a technology that integrates a confocal microscope into an endoscope. It enables the acquisition of high-resolution microscopic images of the mucosal layer in real-time (with a magnification of up to 1000 times), and it is an optical biopsy technique. It has unique value in the determination of the pathological nature of gastric lesions. The main purpose of this study is to compare the sensitivity of pathological biopsy and CLE in differentiating the pathological nature of gastric lesions.
- Conditions
- Gastric Cancer (Diagnosis), Gastric High-grade Intraepithelial Neoplasia, Gastric Low-grade Intraepithelial Neoplasia, Gastritis
- Being tested
- Probe-based Confocal Laser Endomicroscopy, Pathological biopsy
- Keywords
- Confocal Laser Endomicroscopy, pathological biopsy
- Medical subject headings
- Stomach Neoplasms, Disease, Gastritis
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
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 the true positive rate (TPR), refers to the proportion of individuals in the actual patient group that a diagnostic test can correctly identify as positive (i.e., accurately detect cases). High sensitivity means that this detection method can minimize the risk of missed diagnosis to the greatest extent and is suitable for screening diseases (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 (2)
Accuracy
Accuracy refers to a comprehensive indicator that measures the ability of a medical test or diagnostic method to correctly distinguish between the target disease (such as being ill or not ill). 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.
Specificity
Specificity refers to the ability of a diagnostic test to correctly identify individuals who do not have the disease (true negative, TN), that is, the proportion of people who are actually not ill and have a negative test result.
Measured: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for specific calculations.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start30 Jul 2025 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (Diagnosis)Studies 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
- 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
- NCT07088744
- Sponsor's protocol ID
- Optical biopsy-CLE
- Status last verified
- Jul 2025
- First submitted
- 19 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. 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 Before Endoscopic Submucosal Dissection
- ClinicalTrials.gov ID
- NCT07088744
- Acronym / sponsor ID
- Optical biopsy-CLE
- Conditions
- Gastric Cancer (Diagnosis), Gastric High-grade Intraepithelial Neoplasia, Gastric Low-grade Intraepithelial Neoplasia, Gastritis
- Keywords
- Confocal Laser Endomicroscopy, pathological biopsy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 169 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 30 Jul 2025 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 28 Jul 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.
Pathological biopsy before endoscopic submucosal dissection (ESD) the gastric lesion plays an important role in differentiating the pathological nature of the lesion and guiding treatment decisions. However, due to the influence of the materials used, the sensitivity of pathological biopsy is not satisfactory. Confocal Laser Endomicroscopy (CLE) is a technology that integrates a confocal microscope into an endoscope. It enables the acquisition of high-resolution microscopic images of the mucosal layer in real-time (with a magnification of up to 1000 times), and it is an optical biopsy technique. It has unique value in the determination of the pathological nature of gastric lesions. The main purpose of this study is to compare the sensitivity of pathological biopsy and CLE in differentiating the pathological nature of gastric lesions.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The absolute indications for curative endoscopic resection (ESD) include moderately and well-differentiated, nonulcerated, mucosal lesions that are ≤2 cm in size. Other relative (expanded) indications for gastric endoscopic submucosal dissection include moderately and well-differentiated superficial cancers that are >2 cm, lesions ≤3 cm with ulceration or that contain early submucosal invasion, and poorly differentiated superficial cancers ≤2 cm in size.
Key inclusion criteria (1 listed)
- patients aged 18 to 85 years who were scheduled for endoscopic submucosal dissection due to early-stage gastric cancer were consecutively enrolled.
Key exclusion criteria (1 listed)
- Severe cardiac or pulmonary dysfunction, impaired renal function, coagulopathy, pregnancy or lactation, allergy to fluorescein, and inability to provide informed consent.
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 EndomicroscopyConfocal 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 the true positive rate (TPR), refers to the proportion of individuals in the actual patient group that a diagnostic test can correctly identify as positive (i.e., accurately detect cases). High sensitivity means that this detection method can minimize the risk of missed diagnosis to the greatest extent and is suitable for screening diseases (such as infectious diseases and early cancer screening).
2 secondary outcomes
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.
Specificity
Time frame: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for specific calculations.
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 28 Jul 2025.
- Individual participant dataSharing planned: No
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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.
4 sites 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 (Diagnosis) and Gastric High-grade Intraepithelial Neoplasia, run by Changhai Hospital at 4 sites 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 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 (+8618721828503, 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 28 Jul 2025.