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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Yonsei University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01283893
First received: January 24, 2011
Last updated: May 31, 2011
Last verified: January 2011
History of Changes
  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:

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: December 2011
Estimated Primary Completion Date: December 2011 (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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
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
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:

Responsible Party: Woo Jin Hyung / Associate Professor, Severance Hospital, Department of Surgery
ClinicalTrials.gov Identifier: NCT01283893     History of Changes
Other Study ID Numbers: 4-2010-0637
Study First Received: January 24, 2011
Last Updated: May 31, 2011
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 May 16, 2013