Clinical Outcomes of Endoscopic Resection for Treating WHYX Lesion

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT01451034

First received: September 28, 2011

Last updated: October 12, 2011

Last verified: October 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	September 28, 2011
Last Updated Date	October 12, 2011
Start Date ^ICMJE	January 2009
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 12, 2011)	complete resection rate [ Time Frame: 6 months after endoscopical resection ] [ Designated as safety issue: No ] Complete resection was defined to have all of the following features: 1. grossly en bloc resection, 2. Tumor-free lateral and vertical resection margins, 3. No lymphovascular invasion, and 5. A depth of submucosal tumor invasion of less than 500 micrometers.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01451034 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Clinical Outcomes of Endoscopic Resection for Treating WHYX Lesion
Official Title ^ICMJE	Clinical Outcomes of Endoscopic Resection for Treating Extremely Well Differentiated Intestinal-type Adenocarcinoma (WHYX Lesion)
Brief Summary	Endoscopically, WHYX cancers demonstrated a vague extent of tumor spread due to pale color changes in both the background atrophic and metaplastic gastric mucosa. However, the clinical outcomes of WHYX cancers after endoscopic resection are unknown. The aim of this study was to evaluate clinical outcomes of WHYX cancers after endoscopic resection.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	WHYX Lesion Extremely Well Differentiated Intestinal-type Adenocarcinoma
Intervention ^ICMJE	Procedure: WHYX cancer group WHYX cancer diagnosed by pathologic report
Study Arm (s)	Active Comparator: WHYX cancer group WHYX cancer diagnosed by pathologic report Intervention: Procedure: WHYX cancer group Placebo Comparator: non-WHYX cancer group all cancer except WHYX cancer diagnosed by pathologic report Intervention: Procedure: WHYX cancer group
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	872
Completion Date	December 2010
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: From January 2009 to December 2010 enrolled 872 patients with EGC Exclusion Criteria: EGC with regional lymph node metastasis in radiologic finding endoscopically suspicious submucosal invasion
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01451034
Other Study ID Numbers ^ICMJE	2011-08-022
Has Data Monitoring Committee	Yes
Responsible Party	Samsung Medical Center
Study Sponsor ^ICMJE	Samsung Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Samsung Medical Center
Verification Date	October 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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