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

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).

Study Overview

• Status: Recruiting
• Conditions: Endocytoscopy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 96

Contacts and Locations

• Study Contact: Name: Dong Yang, doctor
• Study Contact Backup: Name: Hong Xu, professor; Phone Number: 18844097668; Email: 18844097668@163.com

Study Locations

• China
  • Ji Lin
    • Chang chun, Ji Lin, China, 130021
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: Dong Yang, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observation of anatomical location	The anatomical site (ileocecal region, ascending colon, hepatic flexure, transverse colon, Colonic splenic region, descending colon, sigmoid colon, rectum)	10 minutes after the observation of Endocytoscopy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphology of IIIL type glandular opening and unnamed sulcus opening	Morphology of IIIL type glandular opening and unnamed sulcus opening after methylene blue staining.Linear or circular pit pattern.	10 minutes after the observation of Endocytoscopy
Distribution characteristics of glandular opening	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？	10 minutes after the observation of Endocytoscopy

Collaborators and Investigators

• Sponsor: Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: tubular adenoma; IIIL duct opening; colonic innominate groove
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: 130025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No