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Trial Title:
Standardization of D2 Lymphadenectomy and Surgical Quality Control: KLASS-02-QC
NCT ID:
NCT01283893
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Laparoscopic distal gastrectomy with D2 lymphadenectomy
Description:
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.
Arm group label:
Laparoscopy group
Arm group label:
Open group
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.
Criteria for eligibility:
Study pop:
Gastric cancer patients
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Severance Hospital
Address:
City:
Seoul
Zip:
120-752
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Woo Jin Hyung, MD, Ph.D
Phone:
82-2-2228-2129
Email:
wjhyung@yuhs.ac
Start date:
December 2010
Completion date:
August 2013
Lead sponsor:
Agency:
Yonsei University
Agency class:
Other
Source:
Yonsei University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01283893
