Differentiation of Tubular Adenoma and Colonic Innominate Groove Under EC Endoscopy

NCT ID: NCT06076369

Last Updated: 2024-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-26

Study Completion Date

2024-12-30

Brief Summary

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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

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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

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Endocytoscopy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

The tubular adenoma group

Intervention Type PROCEDURE

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.

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.

No interventions assigned to this group

Interventions

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The tubular adenoma 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.

Intervention Type PROCEDURE

Other Intervention Names

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the colonic innominate groove group

Eligibility Criteria

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Inclusion Criteria

* Cases of colorectal polyps discovered in our hospital and undergoing EC endoscopic examination.

Exclusion Criteria

* 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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jilin University

OTHER

Sponsor Role lead

Responsible Party

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Dong Yang

Assisted Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the First Hospital of Jilin University

Changchun, Jilin, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hong Xu, professor

Role: CONTACT

18844097668

Dong Yang, doctor

Role: CONTACT

Facility Contacts

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Dong Yang, Master

Role: primary

Other Identifiers

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130025

Identifier Type: -

Identifier Source: org_study_id

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