Clinical Outcomes of Endoscopic Resection for Treating WHYX Lesion
October 12, 2011 updated by: Samsung Medical Center
Clinical Outcomes of Endoscopic Resection for Treating Extremely Well Differentiated Intestinal-type Adenocarcinoma (WHYX Lesion)
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
872
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: WHYX cancer group
WHYX cancer diagnosed by pathologic report
|
WHYX cancer diagnosed by pathologic report
|
|
Placebo Comparator: non-WHYX cancer group
all cancer except WHYX cancer diagnosed by pathologic report
|
WHYX cancer diagnosed by pathologic report
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
complete resection rate
Time Frame: 6 months after endoscopical resection
|
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.
|
6 months after endoscopical resection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
September 28, 2011
First Submitted That Met QC Criteria
October 12, 2011
First Posted (Estimate)
October 13, 2011
Study Record Updates
Last Update Posted (Estimate)
October 13, 2011
Last Update Submitted That Met QC Criteria
October 12, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-08-022
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.