An observational study in Gastric Cancer, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-06-04.
Sponsored by Yonsei University · Observational
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 160 is below the median of 274 across 670 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
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Gastric cancer patients
Exclusion Criteria:
Laparoscopy group: patients who underwent laparoscopic distal gastrectomy with D2 lymphadenectomy
Procedure: Laparoscopic distal gastrectomy with D2 lymphadenectomy
Open group: patients who underwent open distal gastrectomy with D2 lymphadenectomy
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.
Evaluation of operative procedure according to predetermined criteria
1. Video recording during the operation 2. Peer reviewer's evaluation according to predetermined criteria 3. Final approval by review committee Predetermined criteria: exact dissection of lymph node (LN) station satisfying each requirements (omentum, LN1, LN3, LN4sb, LN4d, LN5, LN6, LN7, LN8a, LN9, LN11p and LN12a)
Time frame: 6 months
This study is status unknown, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Yonsei University