Comparison of Diagnostic Accuracies of Various Endoscopic Examination Techniques

Comparison of Diagnostic Accuracies of Various Endoscopic Examination Techniques for Evaluating the Invasion Depth of Lateral Spreading Tumours (LST).

Endoscopic diagnosis of lateral spreading tumours (LST) with submucosal invasion is important in guiding the treatment strategy. The use of advanced imaging is not standard clinical practice in China. A clinical trial is now under way comparing the accuracy of narrow band imaging (NBI), endoscopic ultrasonography (EUS) and magnifying chromoendoscopy (MCE) for the diagnosis of LST with submucosal invasion.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer

Detailed Description

Endoscopic diagnosis of lateral spreading tumours (LST) with submucosal invasion is important in guiding the treatment strategy. The use of advanced imaging is not standard clinical practice in China. A clinical trial is now under way comparing the accuracy of narrow band imaging (NBI), endoscopic ultrasonography (EUS) and magnifying chromoendoscopy (MCE) for the diagnosis of LST with submucosal invasion.The final histologic diagnosis was used as the true diagnosis in the present study. By comparing the consistency of histologic diagnosis and preoperative evaluation,the diagnostic accuracies of various endoscopic examination techniques(narrow band imaging , endoscopic ultrasonography , and magnifying chromoendoscopy) was calculated respectively.

• Study Type: Observational
• Enrollment (Anticipated): 340

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Guangdong Provincial Key Laboratory of Gastroenterology,Department of Gastroenterology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with endoscopic diagnosis of lateral spreading tumours

Description

Inclusion Criteria:

- patients older than 18 years and Less than 65 years patients with endoscopic diagnosis of lateral spreading tumours signed informed consent

Exclusion Criteria:

- patients with serious heart, brain, lung, kidney complications patients with intestinal obstruction previous therapy for colorectal cancer women in gestational and lactational period taking anticoagulants or antiplatelet medications. based on the evaluations of physicians, the patient's condition is not suitable for the clinical trial

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Accuracies	The final histologic diagnosis was used as the true diagnosis in the present study. By comparing the consistency of histologic diagnosis and preoperative evaluation,the diagnostic accuracies of various endoscopic examination techniques(narrow band imaging , endoscopic ultrasonography , and magnifying chromoendoscopy) was calculated respectively.	one week

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Investigators: Principal Investigator: Baoping Wu, Guangdong Provincial Key Laboratory of Gastroenterology

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 18, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: LST2016

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