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Standardization of D2 Lymphadenectomy and Surgical Quality Control: KLASS-02-QC
Conditions
Gastric Cancer
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case Control, Time Perspective: Prospective
Intervention
Name: Laparoscopic distal gastrectomy with D2 lymphadenectomy
Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 20 Years
Gender: Both
Criteria: 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
- 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
Location
Severance Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Woo Jin Hyung, MD, Ph.D - 82-2-2228-2129 - wjhyung@yuhs.ac
Start Date
December 2010
Completion Date
August 2013
Sponsors
Yonsei University
Source
Yonsei University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page