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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01283893
First received: January 24, 2011
Last updated: June 1, 2013
Last verified: June 2013

January 24, 2011
June 1, 2013
December 2010
August 2013   (final data collection date for primary outcome measure)
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)

Same as current
Complete list of historical versions of study NCT01283893 on ClinicalTrials.gov Archive Site
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Standardization of D2 Lymphadenectomy and Surgical Quality Control: KLASS-02-QC
Standardization of D2 Lymphadenectomy and Surgical Quality Control for KLASS-02 Trial: KLASS-02-QC

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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Gastric cancer patients

Gastric Cancer
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.
  • Laparoscopy group
    Laparoscopy group: patients who underwent laparoscopic distal gastrectomy with D2 lymphadenectomy
    Intervention: Procedure: Laparoscopic distal gastrectomy with D2 lymphadenectomy
  • Open group
    Open group: patients who underwent open distal gastrectomy with D2 lymphadenectomy
    Intervention: Procedure: Laparoscopic distal gastrectomy with D2 lymphadenectomy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Korea, Republic of
 
NCT01283893
4-2010-0637
Yes
Yonsei University
Yonsei University
Not Provided
Not Provided
Yonsei University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP