Clinical Outcomes of Endoscopic Resection for Treating WHYX Lesion

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01451034
• Collaborator: (none)
• Enrollment: 872
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 38

Study Details

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
• 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: Jan 1, 2009
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

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 [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	135-710

Sponsors and Collaborators

• Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT01451034
• Other Study ID Numbers: 2011-08-022
• First Posted: Oct 13, 2011
• Last Update Posted: Oct 13, 2011
• Last Verified: Oct 1, 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

Study Results

No Results Posted as of Oct 13, 2011