Differentiation of Tubular Adenoma and Colonic Innominate Groove Under EC Endoscopy

Sponsor
Jilin University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06076369
Collaborator
(none)
96
1
8
12

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: The tubular adenoma group

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

Study Type:
Observational
Anticipated Enrollment :
96 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Differentiation of Tubular Adenoma IIIL Duct Opening and Colonic Innominate Groove Under EC Endoscopy
Anticipated Study Start Date :
Sep 30, 2023
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
May 30, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

Procedure: 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.
Other Names:
  • the colonic innominate groove 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.

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of opening length to field of view [10 minutes after the observation of Endocytoscopy]

      (more than 1 field of view is calculated as 1.0)

    Secondary Outcome Measures

    1. Observation of anatomical location [10 minutes after the observation of Endocytoscopy]

      The anatomical site (ileocecal region, ascending colon, hepatic flexure, transverse colon, Colonic splenic region, descending colon, sigmoid colon, rectum)

    Other Outcome Measures

    1. Morphology of IIIL type glandular opening and unnamed sulcus opening [10 minutes after the observation of Endocytoscopy]

      Morphology of IIIL type glandular opening and unnamed sulcus opening after methylene blue staining.Linear or circular pit pattern.

    2. Distribution characteristics of glandular opening [10 minutes after the observation of Endocytoscopy]

      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, and distribution characteristics of glandular duct openings. Regular or irregular?

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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;
    1. History of methylene blue allergy;

    2. Patients who have participated or are currently participating in other clinical trials within the first 4 weeks of enrollment;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 the First Hospital of Jilin University Chang chun Ji Lin China 130021

    Sponsors and Collaborators

    • Jilin University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dong Yang, Assisted Investigator, Jilin University
    ClinicalTrials.gov Identifier:
    NCT06076369
    Other Study ID Numbers:
    • 130025
    First Posted:
    Oct 10, 2023
    Last Update Posted:
    Oct 10, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dong Yang, Assisted Investigator, Jilin University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 10, 2023