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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2014 by Jeongmin Choi, Seoul National University Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01832246
First Posted: April 16, 2013
Last Update Posted: November 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jeongmin Choi, Seoul National University Hospital
  Purpose
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.

Condition
Gastric Tumor Early Gastric Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Jeongmin Choi, Seoul National University Hospital:

Primary Outcome Measures:
  • diagnostic accuracy between endoscopic ultrasonographic staging and conventional endoscopic staging [ Time Frame: up to 2.5 years (end of study, December 2014) ]

Estimated Enrollment: 560
Study Start Date: December 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with early gastric adenocarcinoma is prospectively enrolled at Seoul National University Hospital.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832246


Contacts
Contact: Jeongmin Choi, M.D. 82-2-2072-7209 doct00@hanmail.net

Locations
Korea, Republic of
Division of Gastroenterology, Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of, 110-744
Contact: Jeongmin Choi, M.D.    82-2-2072-7209    doct00@hanmail.net   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Director: Sang Gyun Kim, M.D. Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine
Principal Investigator: Jeongmin Choi, M.D. Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine
  More Information

Responsible Party: Jeongmin Choi, professor, Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01832246     History of Changes
Other Study ID Numbers: 20122012
First Submitted: July 4, 2012
First Posted: April 16, 2013
Last Update Posted: November 18, 2014
Last Verified: November 2014

Keywords provided by Jeongmin Choi, Seoul National University Hospital:
endoscopy
endosonography
stomach cancer
tumor staging

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases