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

Purpose

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	Intervention
Gastric Cancer	Procedure: Laparoscopic distal gastrectomy with D2 lymphadenectomy


Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Standardization of D2 Lymphadenectomy and Surgical Quality Control for KLASS-02 Trial: KLASS-02-QC

Resource links provided by NLM:

MedlinePlus related topics: Stomach Cancer

Genetic and Rare Diseases Information Center resources: Stomach Cancer

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:

Evaluation of operative procedure according to predetermined criteria [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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)


Estimated Enrollment:	160
Study Start Date:	December 2010
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.
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.

Groups/Cohorts

Assigned Interventions

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.

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.

Eligibility


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

Study Population

Gastric cancer patients

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283893

Locations


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

Sponsors and Collaborators

Yonsei University

More Information

Publications:

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hur H, Lee HY, Lee HJ, Kim MC, Hyung WJ, Park YK, Kim W, Han SU. Efficacy of laparoscopic subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer: the protocol of the KLASS-02 multicenter randomized controlled clinical trial. BMC Cancer. 2015 May 5;15:355. doi: 10.1186/s12885-015-1365-z.

Kim HI, Hur H, Kim YN, Lee HJ, Kim MC, Han SU, Hyung WJ. Standardization of D2 lymphadenectomy and surgical quality control (KLASS-02-QC): a prospective, observational, multicenter study [NCT01283893]. BMC Cancer. 2014 Mar 19;14:209. doi: 10.1186/1471-2407-14-209.


Responsible Party:	Yonsei University
ClinicalTrials.gov Identifier:	NCT01283893 History of Changes
Other Study ID Numbers:	4-2010-0637
Study First Received:	January 24, 2011
Last Updated:	June 1, 2013
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA) South Korea: Korean Laparoscopic Gastrointestinal Surgery Study Group (KLASS)

Additional relevant MeSH terms:


Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site	Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases

ClinicalTrials.gov processed this record on September 23, 2016