Comparison of Diagnostic Accuracies of Various Endoscopic Examination Techniques

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03109938

Collaborator

(none)

340

Enrollment

Location

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

340 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2016

Anticipated Primary Completion Date :

Oct 1, 2020

Anticipated Study Completion Date :

Oct 1, 2021

Outcome Measures

Primary Outcome Measures

Diagnostic Accuracies [one week]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangdong Provincial Key Laboratory of Gastroenterology,Department of Gastroenterology	Guangzhou	Guangdong	China	510515

Sponsors and Collaborators

Nanfang Hospital of Southern Medical University

Investigators

Principal Investigator: Baoping Wu, Guangdong Provincial Key Laboratory of Gastroenterology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nanfang Hospital of Southern Medical University

ClinicalTrials.gov Identifier:

NCT03109938

Other Study ID Numbers:

LST2016

First Posted:

Apr 12, 2017

Last Update Posted:

Aug 20, 2019

Last Verified:

Aug 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Aug 20, 2019