EndocytoscopyNCT06076369
Differentiation of Tubular Adenoma and Colonic Innominate Groove Under EC Endoscopy
An observational study of Endocytoscopy, run by Jilin University at 1 site in China.
Trial summary
This study is to analyze the characteristics of the IIIL opening of the duct in tubular adenoma and the colonic innominate groove under EC endoscopy, in order to improve the ability to tell lesions and the colonic innominate groove under EC endoscopy (Endocytoscopy). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Endocytoscopy
- What is being tested?
- The tubular adenoma group
- Type of treatment
- Surgery or procedure
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2024to 30 Dec 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cases of colorectal polyps discovered in our hospital and undergoing EC endoscopic examination.
Who may be able to join
- Cases of colorectal polyps discovered in our hospital and undergoing EC endoscopic examination.
Who cannot join
- 1.Suffering from hereditary polyposis or inflammatory bowel disease, severe intestinal inflammation, or difficulty recognizing normal intestinal mucosa;
- 2. History of methylene blue allergy;
- 3. Patients who have participated or are currently participating in other clinical trials within the first 4 weeks of enrollment;
Trial locations and contacts
1 site in 1 country.
Dong Yang, doctor contact
China1 site, 1 recruiting
- Recruiting
the First Hospital of Jilin University
Changchun, Jilin, 130021
Dong Yang, Master
About this study
Official title: Differentiation of Tubular Adenoma IIIL Duct Opening and Colonic Innominate Groove Under EC Endoscopy
This study is to analyze the characteristics of the IIIL opening of the duct in tubular adenoma and the colonic innominate groove under EC endoscopy, in order to improve the ability to tell lesions and the colonic innominate groove under EC endoscopy (Endocytoscopy).
Read the detailed description
This is a prospective cohort study. The recruitment time for all participants will be 4 months. The tubular adenoma group and the colonic innominate groove group will be paired in a 1:2 ratio, with 32 lesions of tubular adenoma and 64 adjacent innominate groove. It is expected that there will be 32 cases and a total of 96 observation subjects. Analyze and compare the characteristics of the opening of the IIIL duct in tubular adenomas and the colonic innominate groove under EC endoscopy, in order to summarize and differentiate them.
- Conditions
- Endocytoscopy
- Being tested
- The tubular adenoma group
- Keywords
- tubular adenoma, IIIL duct opening, colonic innominate groove
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The tubular adenoma groupProcedure or surgery
Also called the colonic innominate groove group
Biopsy or removal of polyps for pathological examination. Collect baseline data such as gender, age, BMI, etc. If the pathology confirms a pure tubular adenoma, the observed object will be included in the group for final comparative analysis.
| Study group | Role | What they receive |
|---|---|---|
| The tubular adenoma group | The anatomical site was determined, and the size and morphology of the polyps were observed. The classification of the microvascular ECV of the polyps and its adjacent normal mucosal microvascular ECV (white light+NBI) was observed, and methylene blue staining was used to approach and magnify the glandular duct opening to observe the IIIL type (pit pattern). Magnified to the maximum magnification of EC endoscopy to the clearest cell level (approximately 520 times), and observed the morphology of the opening of the IIIL type glandular duct and the opening of the colonic innominate groove, including the morphology of cell cytoplasm and nucleus, proportion of opening length to field of view (more than 1 field of view is calculated as 1.0), and ratio of maximum to minimum opening diameter; Distribution characteristics of glandular duct openings. Receives: Procedure: The tubular adenoma group | |
| the colonic innominate groove group | The methylene blue staining area of the normal mucosa adjacent to the polyp was observed to identify the colonic innominate groove.Magnified to the maximum magnification of EC endoscopy to the clearest cell level (approximately 520 times), and observed the morphology of the opening of the IIIL type glandular duct and the opening of the colonic innominate groove, including the morphology of cell cytoplasm and nucleus, proportion of opening length to field of view (more than 1 field of view is calculated as 1.0), and ratio of maximum to minimum opening diameter; Distribution characteristics of glandular duct openings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of opening length to field of view
(more than 1 field of view is calculated as 1.0)
Measured: 10 minutes after the observation of Endocytoscopy
Secondary outcomes (1)
Observation of anatomical location
The anatomical site (ileocecal region, ascending colon, hepatic flexure, transverse colon, Colonic splenic region, descending colon, sigmoid colon, rectum)
Measured: 10 minutes after the observation of Endocytoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start26 Mar 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndocytoscopyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Yang, Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076369
- Sponsor's protocol ID
- 130025
- Status last verified
- Apr 2024
- First submitted
- 23 Aug 2023
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differentiation of Tubular Adenoma IIIL Duct Opening and Colonic Innominate Groove Under EC Endoscopy
- ClinicalTrials.gov ID
- NCT06076369
- Acronym / sponsor ID
- 130025
- Conditions
- Endocytoscopy
- Keywords
- tubular adenoma, IIIL duct opening, colonic innominate groove
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Jilin UniversityUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 10 Oct 2023 (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.
This study is to analyze the characteristics of the IIIL opening of the duct in tubular adenoma and the colonic innominate groove under EC endoscopy, in order to improve the ability to tell lesions and the colonic innominate groove under EC endoscopy (Endocytoscopy).
Detailed description
This is a prospective cohort study. The recruitment time for all participants will be 4 months. The tubular adenoma group and the colonic innominate groove group will be paired in a 1:2 ratio, with 32 lesions of tubular adenoma and 64 adjacent innominate groove. It is expected that there will be 32 cases and a total of 96 observation subjects. Analyze and compare the characteristics of the opening of the IIIL duct in tubular adenomas and the colonic innominate groove under EC endoscopy, in order to summarize and differentiate them.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The tubular adenoma group | – | Procedure: The tubular adenoma groupThe anatomical site was determined, and the size and morphology of the polyps were observed. The classification of the microvascular ECV of the polyps and its adjacent normal mucosal microvascular ECV (white light+NBI) was observed, and methylene blue staining was used to approach and magnify the glandular duct opening to observe the IIIL type (pit pattern). Magnified to the maximum magnification of EC endoscopy to the clearest cell level (approximately 520 times), and observed the morphology of the opening of the IIIL type glandular duct and the opening of the colonic innominate groove, including the morphology of cell cytoplasm and nucleus, proportion of opening length to field of view (more than 1 field of view is calculated as 1.0), and ratio of maximum to minimum opening diameter; Distribution characteristics of glandular duct openings. |
| the colonic innominate groove group | – | –The methylene blue staining area of the normal mucosa adjacent to the polyp was observed to identify the colonic innominate groove.Magnified to the maximum magnification of EC endoscopy to the clearest cell level (approximately 520 times), and observed the morphology of the opening of the IIIL type glandular duct and the opening of the colonic innominate groove, including the morphology of cell cytoplasm and nucleus, proportion of opening length to field of view (more than 1 field of view is calculated as 1.0), and ratio of maximum to minimum opening diameter; Distribution characteristics of glandular duct openings. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cases of colorectal polyps discovered in our hospital and undergoing EC endoscopic examination.
Key inclusion criteria (1 listed)
- Cases of colorectal polyps discovered in our hospital and undergoing EC endoscopic examination.
Key exclusion criteria (3 listed)
- 1.Suffering from hereditary polyposis or inflammatory bowel disease, severe intestinal inflammation, or difficulty recognizing normal intestinal mucosa;
- 2. History of methylene blue allergy;
- 3. Patients who have participated or are currently participating in other clinical trials within the first 4 weeks of enrollment;
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 |
|---|---|---|
| The tubular adenoma groupAlso: the colonic innominate groove groupBiopsy or removal of polyps for pathological examination. Collect baseline data such as gender, age, BMI, etc. If the pathology confirms a pure tubular adenoma, the observed object will be included in the group for final comparative analysis. | Procedure or surgery | The tubular adenoma group |
Primary outcome
Proportion of opening length to field of view
Time frame: 10 minutes after the observation of Endocytoscopy
(more than 1 field of view is calculated as 1.0)
1 secondary outcome
Observation of anatomical location
Time frame: 10 minutes after the observation of Endocytoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- 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. This study is not recruiting at the moment.
Dong Yang, doctor contact
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 Endocytoscopy, run by Jilin University 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: status not confirmed, as of the sponsor's last update on 12 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong Xu, professor (18844097668, 18844097668@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of opening length to field of view (time frame: 10 minutes after the observation of Endocytoscopy). 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 12 Apr 2024.