Differentiation of Tubular Adenoma and Colonic Innominate Groove Under EC Endoscopy

NCT06076369 | Recruiting DMC

• 1 other identifier: 130025
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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).

Conditions

Endocytoscopy

Keywords

tubular adenoma; IIIL duct opening; colonic innominate groove

Outcome Measures

Primary Outcomes (1)

• Proportion of opening length to field of view

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

  10 minutes after the observation of Endocytoscopy

Secondary Outcomes (1)

• Observation of anatomical location

  10 minutes after the observation of Endocytoscopy

Other Outcomes (2)

• Morphology of IIIL type glandular opening and unnamed sulcus opening

  10 minutes after the observation of Endocytoscopy

• Distribution characteristics of glandular opening

  10 minutes after the observation of Endocytoscopy

Study Arms (2)

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

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.

Interventions

The tubular adenoma group 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.

Also known as: the colonic innominate groove group

The tubular adenoma group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Suffering from hereditary polyposis or inflammatory bowel disease, severe intestinal inflammation, or difficulty recognizing normal intestinal mucosa;
• \. History of methylene blue allergy;
• \. Patients who have participated or are currently participating in other clinical trials within the first 4 weeks of enrollment;

Sponsors & Collaborators

• Jilin University: lead

Study Sites (1)

the First Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

Central Study Contacts

Hong Xu, professor

CONTACT

18844097668; 18844097668@163.com

Dong Yang, doctor

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisted Investigator

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: October 10, 2023
• Study Start: March 26, 2024
• Primary Completion: September 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)