Standardization of D2 Lymphadenectomy and Surgical Quality Control: KLASS-02-QC
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Laparoscopy group Laparoscopy group: patients who underwent laparoscopic 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.
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| Open group 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.
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Outcome Measures
Primary Outcome Measures
- Evaluation of operative procedure according to predetermined criteria [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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients must have documented diagnosis of gastric cancer
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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.
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Patients undergoing gastric cancer surgery without plans for combined operations, such as resection of another organ for another primary disease.
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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:
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Patients without mental competence
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Patients who are illiterate
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Patients who are pregnant
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Patients < 20 and > 80 years old
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Severance Hospital | Seoul | Korea, Republic of | 120-752 |
Sponsors and Collaborators
- Yonsei University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Kim HH, Hyung WJ, Cho GS, Kim MC, Han SU, Kim W, Ryu SW, Lee HJ, Song KY. Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report--a phase III multicenter, prospective, randomized Trial (KLASS Trial). Ann Surg. 2010 Mar;251(3):417-20. doi: 10.1097/SLA.0b013e3181cc8f6b.
- Kitano S, Shiraishi N, Fujii K, Yasuda K, Inomata M, Adachi Y. A randomized controlled trial comparing open vs laparoscopy-assisted distal gastrectomy for the treatment of early gastric cancer: an interim report. Surgery. 2002 Jan;131(1 Suppl):S306-11.
- Song KY, Kim SN, Park CH. Laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for gastric cancer: technical and oncologic aspects. Surg Endosc. 2008 Mar;22(3):655-9.
- Tokunaga M, Hiki N, Fukunaga T, Nohara K, Katayama H, Akashi Y, Ohyama S, Yamaguchi T. Laparoscopy-assisted distal gastrectomy with D2 lymph node dissection following standardization--a preliminary study. J Gastrointest Surg. 2009 Jun;13(6):1058-63. doi: 10.1007/s11605-009-0840-8. Epub 2009 Mar 7.
- 4-2010-0637