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Standardization of D2 Lymphadenectomy and Surgical Quality Control: KLASS-02-QC

NCT01283893 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2013-06-04

No results posted yet for this study

Summary

Gastric cancer is one of the most common cancers in Korea. Having achieved excellent long-term survival for early gastric cancer patients, there is a growing interest in improving the quality of life of these patients without compromising their prognosis. Laparoscopic surgery for early gastric cancer have been found to be safe and feasible with superior short-term outcomes. Although laparoscopic gastrectomy with D2 lymphadenectomy is being performed for patients with locally advanced gastric cancer; the completeness of the D2 lymphadenectomy during laparoscopic surgery has not been evaluate and no standardized procedure exists. To conduct a clinical trial comparing laparoscopic D2 lymphadenectomy to the open approach, quality control of D2 lymphadenectomy procedure is necessary.

Conditions

Interventions

PROCEDURE

Laparoscopic distal gastrectomy with D2 lymphadenectomy

The commonly practice laparoscopic surgery for gastric cancer involves a partial omentectomy+D1+b lymphadenectomy which includes the dissection of Lymph node stations 1, 3, 4, 5, 6, 7, 8a, 9; however, when performing a D2 lymph node dissection, a total omentectomy plus LN1, 3, 4, 5, 6, 7, 8a, 9, 12a retrieval will be completed. The same total omentectomy+D2 lymphadenectomy will also be performed by the open method.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01283893 on ClinicalTrials.gov