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Differentiation of Tubular Adenoma and Colonic Innominate Groove Under EC Endoscopy

Differentiation of Tubular Adenoma IIIL Duct Opening and Colonic Innominate Groove Under EC Endoscopy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06076369
Enrollment
96
Registered
2023-10-10
Start date
2024-03-26
Completion date
2024-12-30
Last updated
2024-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endocytoscopy

Keywords

tubular adenoma, IIIL duct opening, colonic innominate groove

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).

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.

Interventions

PROCEDUREThe 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.

Sponsors

Jilin University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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; 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;

Design outcomes

Primary

MeasureTime frameDescription
Proportion of opening length to field of view10 minutes after the observation of Endocytoscopy(more than 1 field of view is calculated as 1.0)

Secondary

MeasureTime frameDescription
Observation of anatomical location10 minutes after the observation of EndocytoscopyThe anatomical site (ileocecal region, ascending colon, hepatic flexure, transverse colon, Colonic splenic region, descending colon, sigmoid colon, rectum)

Other

MeasureTime frameDescription
Morphology of IIIL type glandular opening and unnamed sulcus opening10 minutes after the observation of EndocytoscopyMorphology of IIIL type glandular opening and unnamed sulcus opening after methylene blue staining.Linear or circular pit pattern.
Distribution characteristics of glandular opening10 minutes after the observation of EndocytoscopyMagnified 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?

Countries

China

Contacts

Primary ContactHong Xu, professor
18844097668@163.com18844097668
Backup ContactDong Yang, doctor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026