The Diagnosis of Invasive Depth of Early Rectal Cancer

NCT04222530 | Unknown

• 1 other identifier: V2.0/2019-10-21(NFEC-2019-232)
• Study Type: interventional
• Target: 81
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this clinical study is to compare the accuracy of linear endoscopic ultrasonography and magnified narrowband endoscopy in the diagnosis of invasive depth of early rectal cancer, and to provide more powerful evidence for the choice of surgical methods for early rectal cancer. Patients with early rectal cancer who will be examined by endoscopic ultrasonography or magnifying narrowband endoscopy in the department of gastroenterology and general surgery will be examined by linear endoscopic ultrasonography or magnifying narrowband endoscopy to examine the depth of invasion of early rectal cancer, and the results are compared with the postoperative pathological results of the patients as the gold standard. It provides strong evidence that the accuracy of linear endoscopic ultrasonography in judging the invasive depth of early colorectal cancer is not inferior to that of magnifying narrowband endoscopy.

Conditions

Early Rectal Cancer

Keywords

linear endoscopic ultrasonography; Magnifying narrowband endoscopy; Diagnostic accuracy

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

  The pathological T staging of rectal cancer was selected as the gold standard. The preoperative T staging diagnosis of linear endoscopic ultrasonography and magnifying narrowband endoscopy was compared with the final pathological diagnosis to calculate the diagnostic accuracy of the two methods.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Operating time

  through study completion, an average of 1 year

Study Arms (2)

Linear EUS

EXPERIMENTAL

patients underwent linear endoscopic ultrasonography followed by magnifying narrowband endoscopy

Diagnostic Test: Linear EUS first

ME-NBI

EXPERIMENTAL

patients underwent magnifying narrowband endoscopy followed by linear endoscopic ultrasonography

Diagnostic Test: ME-NBI first

Interventions

Linear EUS first DIAGNOSTIC_TEST

Linear endoscopic ultrasonography followed by magnifying narrow band endoscopy are used to determine the depth of invasion of early rectal cancer.

Linear EUS

ME-NBI first DIAGNOSTIC_TEST

Magnifying narrow band endoscopy followed by linear endoscopic ultrasonography are used to determine the depth of invasion of early rectal cancer.

ME-NBI

Eligibility Criteria

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

You may qualify if:

• Colonoscopic diagnosis of early rectal cancer, the longest diameter \>10mm.
• Age 18 Mel 80 years old;
• The subjects are willing to participate in this clinical trial and sign the relevant informed consent form.

You may not qualify if:

• The coagulation function of the subjects was abnormal and uncontrolled: international standardized ratio ((INR))\>2 or platelet count \<75000 platelets / μ L;
• Three months before entering the group, there were uncontrolled angina pectoris and / or myocardial infarction, congestive heart failure, lung (respiratory failure), kidney, pancreas, liver disease or other diseases were judged by the researchers to be unable to participate in the study.
• Pregnant woman

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Related Publications (1)

• Li L, He J, Hu H, Wang Y, Li W, Huang S, Rownoak J, Xu S, Xie F, Wang J, Mi W, Cai J, Ye Y, Liu S, Wang J, Li Y. Linear-Array Endoscopic Ultrasound and Narrow-Band Imaging Measure the Invasion Depth of Nonpedunculated Rectal Lesions With Comparable Accuracy Based on a Randomized Controlled Trial. Am J Gastroenterol. 2025 Mar 1;120(3):562-569. doi: 10.14309/ajg.0000000000002975. Epub 2024 Jul 25.

  PMID: 39051647 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Side Liu, Doctor

  Nanfang Hospital, Southern Medical University

  STUDY DIRECTOR

• Yue Li, Doctor

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yue Li, Doctor

CONTACT

8615975537291; liyue_1989919@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All the subjects who met the inclusion criteria were required to sign an informed consent form before joining the group, but they did not know their own grouping. The team of doctors is composed of four experienced endoscopes from the Department of Gastroenterology of Nanfang Hospital. Patients were randomly divided into group A (patients underwent linear endoscopic ultrasonography followed by magnifying narrowband endoscopy) and group B (patients underwent magnifying narrowband endoscopy first and then linear endoscopic ultrasonography). Different examination items are examined by randomly selected doctors, and the two doctors do not know the diagnosis of the other test. The examination results, examination time and complications were recorded in both groups. After examination, continue to follow up the patient's operation until the patient's surgical and pathological results are obtained.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a single-center randomized, self-controlled clinical trial. The subjects were selected according to the inclusion and exclusion criteria, and all subjects who met the inclusion criteria were required to sign an informed consent form before joining the group. The team of doctors is composed of four experienced endoscopes from the Department of Gastroenterology of Nanfang Hospital. Patients were randomly divided into group A (patients underwent linear endoscopic ultrasonography followed by magnifying narrowband endoscopy) and group B (patients underwent magnifying narrowband endoscopy first and then linear endoscopic ultrasonography). The examination results, examination time and complications were recorded in both groups. After examination, continue to follow up the patient's operation until the patient's surgical and pathological results are obtained.

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: January 10, 2020
• Study Start: January 28, 2020
• Primary Completion: June 20, 2022
• Study Completion: December 20, 2022
• Last Updated: January 10, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share