Colorectal NeoplasmsNCT06324097
Diagnostic Value of Endocytoscopy for Colorectal Lesions
An observational study of Colorectal Neoplasms, run by Hong Xu at 1 site in China.
Trial summary
Colorectal cancer (CRC) is the third most common malignancy and the second leading cause of cancer-related death worldwide. Colonoscopy is considered the preferred method of screening for colorectal cancer, and resection of colorectal lesions can significantly reduce the incidence and mortality of colorectal cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- endocytoscopy
- How many people
- 463 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 28 Feb 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The investigators analyzed only endoscopically or surgically resected colorectal lesions (hyperplastic polyps, adenomas and invasive cancers) that had been observed with EC-NBI and EC-stained by endoscopists before treatment that were ultimately performed histopathologic examination.
Who may be able to join
- colorectal lesions
Who cannot join
- non-epithelial tumors
- sessile serrated lesions
- inflammatory polyps
- juvenile polyps
- hamartomatous polyps
- a history of inflammatory bowel disease
- chemotherapy or radiation therapy for colorectal cancer
- lesions without clear EC images.
Trial locations and contacts
1 site in 1 country.
China1 site
the Department of Gastroenterology and Endoscopy Center, First Hospital of Jilin University
Changchun, Jilin, 130021
About this study
Official title: Diagnostic Value of Two Different Mode Endocytoscopy for Colorectal Lesions
Colorectal cancer (CRC) is the third most common malignancy and the second leading cause of cancer-related death worldwide. Colonoscopy is considered the preferred method of screening for colorectal cancer, and resection of colorectal lesions can significantly reduce the incidence and mortality of colorectal cancer. In order to improve the qualitative and quantitative diagnosis of colorectal lesions, many endoscopic techniques, such as image-enhanced endoscopy (IEE), including narrowband imaging (NBI), magnifying endoscopy, pigment endoscopy, confocal laser endoscopy, and endocytoscopy (EC) are applied clinically. The application of EC is intended to achieve the purpose of real-time histopathological endoscopic diagnosis without biopsy. Several studies have shown that EC is effective in identifying the nature of colorectal lesions and judging the depth of invasion in CRC. Based on the endoscopic diagnosis, the endoscopist can determine the treatment plan for the colorectal lesions. The latest EC is an integrated endoscope with a contact light microscopy system with a maximum magnification of 520 x. EC may demonstrate the atypical of gland structure and cells after staining (EC staining mode, along with the use of the EC-NBI mode. The endoscopic diagnosis of the EC staining mode is based on the EC classification (EC-C), used to predict the histopathological diagnosis of colorectal lesions. A prospective randomized trial showed that the diagnostic accuracy was 94.1% by EC-C. However, the diagnostic value of EC-C depends on the operator and may be influenced by the quality of the staining. Meanwhile, the high-quality staining process is time-consuming and tedious. Therefore, EC-NBI seems to be the first choice for EC diagnosis with the advantages of convenient operation and efficient diagnosis. EC-NBI can display the super-amplified surface microvessels of the lesion and provide pathological prediction according to the vessel classification (EC-V). EC-V achieved 99% diagnostic accuracy for hyperplastic polyps and 88.6% for invasive carcinoma. In EC examination, the investigators usually use EC-NBI and EC staining successively to diagnose colorectal lesions, which is believed to improve the diagnostic performance. However, the diagnostic value of increasing EC-staining after EC-NBI examination for predicting the pathological nature of colorectal lesions is still unclear. Therefore, this retrospective study aimed to evaluate the diagnostic value of two different modalities of cell endoscopy for colorectal lesions and to clarify whether additional EC staining after EC-NBI could improve the diagnostic performance of predicting the pathological diagnosis of colorectal lesions.
In the study, the investigators collect clinical information of colorectal lesions which were diagnosed by endoscopic diagnosis (including EC-NBI and EC-staining) and pathological diagnosis. Then, the investigators calculate the accuracy, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and high confidence diagnosis rate of EC-C and EC-V classification, respectively. Inter-and intra-observer agreement in the diagnosis of EC-C and EC-V will be calculated.
- Conditions
- Colorectal Neoplasms
- Being tested
- endocytoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endocytoscopyDiagnostic test
The colorectal lesions had been observed with EC-NBI and EC-stained by endoscopists before treatment that were ultimately performed histopathologic examination. The endocytoscopies (CF-H290ECI, Olympus, Tokyo, Japan) have a maximum magnification of ×520, focusing depth, 35 μm; field of view, 570 × 500μm. During EC-NBI , the endoscopist pushed the button of the endoscope to switch from white-light imaging to NBI and observed the lesion with full magnification. Finally, the endoscopist performed EC-stained mode diagnosis after staining the lesion surface with 1.0% methylene blue.
| Study group | Role | What they receive |
|---|---|---|
| colorectal lesion | Not described Receives: Diagnostic Test: endocytoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity
Measured: April 2024
specificity
Measured: April 2024
accuracy
Measured: April 2024
positive predictive value
Measured: April 2024
negative predictive value
Measured: April 2024
Secondary outcomes (2)
inter-observer agreement
Measured: April 2024
intra-observer agreement
Measured: April 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Apr 2024
- Primary completion31 Jan 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- 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
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hong Xu, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324097
- Sponsor's protocol ID
- 2024-623
- Status last verified
- May 2025
- First submitted
- 15 Mar 2024
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Two Different Mode Endocytoscopy for Colorectal Lesions
- ClinicalTrials.gov ID
- NCT06324097
- Acronym / sponsor ID
- 2024-623
- Conditions
- Colorectal Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Hong XuUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 21 Mar 2024 (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.
Colorectal cancer (CRC) is the third most common malignancy and the second leading cause of cancer-related death worldwide. Colonoscopy is considered the preferred method of screening for colorectal cancer, and resection of colorectal lesions can significantly reduce the incidence and mortality of colorectal cancer. In order to improve the qualitative and quantitative diagnosis of colorectal lesions, many endoscopic techniques, such as image-enhanced endoscopy (IEE), including narrowband imaging (NBI), magnifying endoscopy, pigment endoscopy, confocal laser endoscopy, and endocytoscopy (EC) are applied clinically. The application of EC is intended to achieve the purpose of real-time histopathological endoscopic diagnosis without biopsy. Several studies have shown that EC is effective in identifying the nature of colorectal lesions and judging the depth of invasion in CRC. Based on the endoscopic diagnosis, the endoscopist can determine the treatment plan for the colorectal lesions. The latest EC is an integrated endoscope with a contact light microscopy system with a maximum magnification of 520 x. EC may demonstrate the atypical of gland structure and cells after staining (EC staining mode, along with the use of the EC-NBI mode. The endoscopic diagnosis of the EC staining mode is based on the EC classification (EC-C), used to predict the histopathological diagnosis of colorectal lesions. A prospective randomized trial showed that the diagnostic accuracy was 94.1% by EC-C. However, the diagnostic value of EC-C depends on the operator and may be influenced by the quality of the staining. Meanwhile, the high-quality staining process is time-consuming and tedious. Therefore, EC-NBI seems to be the first choice for EC diagnosis with the advantages of convenient operation and efficient diagnosis. EC-NBI can display the super-amplified surface microvessels of the lesion and provide pathological prediction according to the vessel classification (EC-V). EC-V achieved 99% diagnostic accuracy for hyperplastic polyps and 88.6% for invasive carcinoma. In EC examination, the investigators usually use EC-NBI and EC staining successively to diagnose colorectal lesions, which is believed to improve the diagnostic performance. However, the diagnostic value of increasing EC-staining after EC-NBI examination for predicting the pathological nature of colorectal lesions is still unclear. Therefore, this retrospective study aimed to evaluate the diagnostic value of two different modalities of cell endoscopy for colorectal lesions and to clarify whether additional EC staining after EC-NBI could improve the diagnostic performance of predicting the pathological diagnosis of colorectal lesions.
In the study, the investigators collect clinical information of colorectal lesions which were diagnosed by endoscopic diagnosis (including EC-NBI and EC-staining) and pathological diagnosis. Then, the investigators calculate the accuracy, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and high confidence diagnosis rate of EC-C and EC-V classification, respectively. Inter-and intra-observer agreement in the diagnosis of EC-C and EC-V will be calculated.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| colorectal lesion | – | Diagnostic Test: endocytoscopy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The investigators analyzed only endoscopically or surgically resected colorectal lesions (hyperplastic polyps, adenomas and invasive cancers) that had been observed with EC-NBI and EC-stained by endoscopists before treatment that were ultimately performed histopathologic examination.
Key inclusion criteria (1 listed)
- colorectal lesions
Key exclusion criteria (8 listed)
- non-epithelial tumors
- sessile serrated lesions
- inflammatory polyps
- juvenile polyps
- hamartomatous polyps
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 |
|---|---|---|
| endocytoscopyThe colorectal lesions had been observed with EC-NBI and EC-stained by endoscopists before treatment that were ultimately performed histopathologic examination. The endocytoscopies (CF-H290ECI, Olympus, Tokyo, Japan) have a maximum magnification of ×520, focusing depth, 35 μm; field of view, 570 × 500μm. During EC-NBI , the endoscopist pushed the button of the endoscope to switch from white-light imaging to NBI and observed the lesion with full magnification. Finally, the endoscopist performed EC-stained mode diagnosis after staining the lesion surface with 1.0% methylene blue. | Diagnostic test | colorectal lesion |
Primary outcome
sensitivity
Time frame: April 2024
specificity
Time frame: April 2024
accuracy
Time frame: April 2024
positive predictive value
Time frame: April 2024
negative predictive value
Time frame: April 2024
2 secondary outcomes
inter-observer agreement
Time frame: April 2024
intra-observer agreement
Time frame: April 2024
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 14 May 2025.
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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. 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 Colorectal Neoplasms, run by Hong Xu 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 8 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 14 May 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?
sensitivity (time frame: April 2024). The study lists 5 primary outcomes in all. 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 14 May 2025.