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

Study Overview
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Brief Summary
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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.

Official Title
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Standardization of D2 Lymphadenectomy and Surgical Quality Control for KLASS-02 Trial: KLASS-02-QC

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: Laparoscopic distal gastrectomy with D2 lymphadenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have documented diagnosis of gastric cancer Patients receiving laparoscopic gastric cancer surgery without preoperative evidence of serosal invasion and distant lymph node metastasis as determined by evaluation of preoperative CT-scan, upper endoscopy, or endoscopic ultrasound. Patients undergoing gastric cancer surgery without plans for combined operations, such as resection of another organ for another primary disease. Patients who have received comprehensive explanation about the planned study, understand and accept all the terms of the study and willingly give consent to participate in all the required elements of the study Exclusion Criteria: Patients without mental competence Patients who are illiterate Patients who are pregnant Patients < 20 and > 80 years old

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Laparoscopy group<br>Laparoscopy group: patients who underwent laparoscopic distal gastrectomy with D2 lymphadenectomy | Procedure: Laparoscopic distal gastrectomy with D2 lymphadenectomy<br>* 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.<br>|
| Open group<br>Open group: patients who underwent open distal gastrectomy with D2 lymphadenectomy | Procedure: Laparoscopic distal gastrectomy with D2 lymphadenectomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of operative procedure according to predetermined criteria | Video recording during the operation Peer reviewer's evaluation according to predetermined criteria 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) | 6 months |