Standardization of D2 Lymphadenectomy and Surgical Quality Control: KLASS-02-QC
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ClinicalTrials.gov Identifier: NCT01283893 |
Recruitment Status
: Unknown
Verified June 2013 by Yonsei University.
Recruitment status was: Recruiting
First Posted
: January 26, 2011
Last Update Posted
: June 4, 2013
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Condition or disease | Intervention/treatment |
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Gastric Cancer | Procedure: Laparoscopic distal gastrectomy with D2 lymphadenectomy |
Study Type : | Observational |
Estimated Enrollment : | 160 participants |
Observational Model: | Case Control |
Time Perspective: | Prospective |
Official Title: | Standardization of D2 Lymphadenectomy and Surgical Quality Control for KLASS-02 Trial: KLASS-02-QC |
Study Start Date : | December 2010 |
Estimated Primary Completion Date : | August 2013 |
Estimated Study Completion Date : | August 2013 |

Group/Cohort | Intervention/treatment |
---|---|
Laparoscopy group
Laparoscopy group: patients who underwent laparoscopic distal gastrectomy with D2 lymphadenectomy
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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.
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Open group
Open group: patients who underwent open distal gastrectomy with D2 lymphadenectomy
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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.
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- Evaluation of operative procedure according to predetermined criteria [ Time Frame: 6 months ]
- 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)

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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01283893
Korea, Republic of | |
Severance Hospital | Recruiting |
Seoul, Korea, Republic of, 120-752 | |
Contact: Woo Jin Hyung, MD, Ph.D 82-2-2228-2129 wjhyung@yuhs.ac |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Yonsei University |
ClinicalTrials.gov Identifier: | NCT01283893 History of Changes |
Other Study ID Numbers: |
4-2010-0637 |
First Posted: | January 26, 2011 Key Record Dates |
Last Update Posted: | June 4, 2013 |
Last Verified: | June 2013 |
Additional relevant MeSH terms:
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |