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NCT01832246 Clinical Trial

Endoscopic Ultrasonographic Staging and Conventional Endoscopic Staging for Depth of Invasion for Early Gastric Cancer

Early Gastric Cancer Clinical Trial

Official title:
Prospective Study of Endoscopic Ultrasonographic Staging and Conventional Endoscopic Staging for Depth of Invasion and Endoscopic Tumor Size Estimation for Early Gastric Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01832246
Other study ID # 20122012
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 4, 2012
Last updated November 17, 2014
Start date December 2014
Est. completion date December 2015

Study information
Verified date November 2014
Source Seoul National University Hospital
Contact Jeongmin Choi, M.D.
Phone 82-2-2072-7209
Email doct00@hanmail.net
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

The accurate prediction of depth of tumor invasion in early gastric cancer is essential for the proper selection of candidates for endoscopic resection. Conventional endoscopy and endoscopic ultrasonography have been useful diagnostic method for depth of invasion in early gastric cancer. However, there has been no prospective comparative study on the accuracy between the 2 methods. Therefore, the investigators prospectively compare the accuracy between the 2 methods regarding prediction of depth of invasion.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 560
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients with early gastric adenocarcinoma undergo both endoscopic staging and endoscopic ultrasonographic staging for depth of invasion

Exclusion Criteria:

- patients had previously received neoadjuvant chemotherapy or chemoradiotherapy

- patients with obviously advanced gastric cancer by endoscopy

- the evidence of distant metastasis or extensive adjacent organ invasion on abdominal CT scan

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Division of Gastroenterology, Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary diagnostic accuracy between endoscopic ultrasonographic staging and conventional endoscopic staging up to 2.5 years (end of study, December 2014) No
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