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
  Purpose

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 Intervention Phase
WHYX Lesion
Extremely Well Differentiated Intestinal-type Adenocarcinoma
Procedure: WHYX cancer group
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Outcomes of Endoscopic Resection for Treating Extremely Well Differentiated Intestinal-type Adenocarcinoma (WHYX Lesion)

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • 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.


Enrollment: 872
Study Start Date: January 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01451034

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

No publications provided

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01451034     History of Changes
Other Study ID Numbers: 2011-08-022
Study First Received: September 28, 2011
Last Updated: October 12, 2011
Health Authority: South Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014