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Clinical Outcomes of Endoscopic Resection for Treating WHYX Lesion

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ClinicalTrials.gov Identifier: NCT01451034
Recruitment Status : Completed
First Posted : October 13, 2011
Last Update Posted : October 13, 2011
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
WHYX Lesion Extremely Well Differentiated Intestinal-type Adenocarcinoma Procedure: WHYX cancer group Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 872 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Outcomes of Endoscopic Resection for Treating Extremely Well Differentiated Intestinal-type Adenocarcinoma (WHYX Lesion)
Study Start Date : January 2009
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: WHYX cancer group
WHYX cancer diagnosed by pathologic report
Procedure: WHYX cancer group
WHYX cancer diagnosed by pathologic report
Placebo Comparator: non-WHYX cancer group
all cancer except WHYX cancer diagnosed by pathologic report
Procedure: WHYX cancer group
WHYX cancer diagnosed by pathologic report


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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): NCT01451034


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
More Information

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01451034     History of Changes
Other Study ID Numbers: 2011-08-022
First Posted: October 13, 2011    Key Record Dates
Last Update Posted: October 13, 2011
Last Verified: October 2011

Keywords provided by Samsung Medical Center:
WHYX lesion
endoscopic resection
complete resection
complete resection rate
endoscopic feature
Average size discrepancy

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms