Back to resultsClinical Outcomes of Endoscopic Resection for Treating WHYX Lesion
Primary Purpose
WHYX Lesion, Extremely Well Differentiated Intestinal-type Adenocarcinoma
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
WHYX cancer group
Sponsored by
About this trial
This is an interventional treatment trial for WHYX Lesion focused on measuring WHYX lesion, endoscopic resection, complete resection, complete resection rate, endoscopic feature, Average size discrepancy
Eligibility Criteria
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
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
WHYX cancer group
non-WHYX cancer group
Arm Description
WHYX cancer diagnosed by pathologic report
all cancer except WHYX cancer diagnosed by pathologic report
Outcomes
Primary Outcome Measures
complete resection rate
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01451034
First Posted
September 28, 2011
Last Updated
October 12, 2011
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01451034
Brief Title
Clinical Outcomes of Endoscopic Resection for Treating WHYX Lesion
Official Title
Clinical Outcomes of Endoscopic Resection for Treating Extremely Well Differentiated Intestinal-type Adenocarcinoma (WHYX Lesion)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
WHYX Lesion, Extremely Well Differentiated Intestinal-type Adenocarcinoma
Keywords
WHYX lesion, endoscopic resection, complete resection, complete resection rate, endoscopic feature, Average size discrepancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
872 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WHYX cancer group
Arm Type
Active Comparator
Arm Description
WHYX cancer diagnosed by pathologic report
Arm Title
non-WHYX cancer group
Arm Type
Placebo Comparator
Arm Description
all cancer except WHYX cancer diagnosed by pathologic report
Intervention Type
Procedure
Intervention Name(s)
WHYX cancer group
Intervention Description
WHYX cancer diagnosed by pathologic report
Primary Outcome Measure Information:
Title
complete resection rate
Description
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.
Time Frame
6 months after endoscopical resection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Clinical Outcomes of Endoscopic Resection for Treating WHYX Lesion
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