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

• Conditions: Gastric Cancer
• Interventions: Procedure: Laparoscopic distal gastrectomy with D2 lymphadenectomy

• Registration Number: NCT01283893
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-01-25
• Study First Posted: 2011-01-26
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-01
• Last Update Posted: 2013-06-04
• Primary Completion: 2013-08
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Laparoscopy group	Laparoscopic distal gastrectomy with D2 lymphadenectomy	Laparoscopy group: patients who underwent laparoscopic distal gastrectomy with D2 lymphadenectomy
Open group	Laparoscopic distal gastrectomy with D2 lymphadenectomy	Open group: patients who underwent open distal gastrectomy with D2 lymphadenectomy

Primary Outcome Measures

Name	Time	Method
Evaluation of operative procedure according to predetermined criteria	6 months	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)

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of