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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01283893
• Other study ID #: 4-2010-0637
• Status: Recruiting
• Phase: N/A
• First received: January 24, 2011
• Last updated: June 1, 2013
• Start date: December 2010
• Est. completion date: August 2013

Study information

• Verified date: June 2013
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)South Korea: Korean Laparoscopic Gastrointestinal Surgery Study Group (KLASS)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Cancer

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No