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Efficacy of laparoscopic subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer: the protocol of the KLASS-02 multicenter randomized controlled clinical trial
- Source :
- BMC Cancer
- Publication Year :
- 2015
- Publisher :
- Springer Science and Business Media LLC, 2015.
-
Abstract
- Background: Despite the well-described benefits of laparoscopic surgery such as lower operative blood loss and enhanced postoperative recovery in gastric cancer surgery, the application of laparoscopic surgery in patients with locally advanced gastric cancer (AGC) remains elusive owing to a lack of clinical evidence. Recently, the Korean Laparoscopic Surgical Society Group launched a new multicenter randomized clinical trial (RCT) to compare laparoscopic and open D2 lymphadenectomy for patients with locally AGC. Here, we introduce the protocol of this clinical trial. Methods/design: This trial is an investigator-initiated, randomized, controlled, parallel group, non-inferiority trial. Gastric cancer patients diagnosed with primary tumors that have invaded into the muscle propria and not into an adjacent organ (cT2–cT4a) in preoperative studies are recruited. Another criterion for recruitment is no lymph node metastasis or limited perigastric lymph node (including lymph nodes around the left gastric artery) metastasis. A total 1,050 patients in both groups are required to statistically show non-inferiority of the laparoscopic approach with respect to the primary end-point, relapse-free survival of 3 years. Secondary outcomes include postoperative morbidity and mortality, postoperative recovery, quality of life, and overall survival. Surgeons who are validated through peer-review of their surgery videos can participate in this clinical trial. Discussion: This clinical trial was designed to maintain the principles of a surgical clinical trial with internal validity for participating surgeons. Through the KLASS-02 RCT, we hope to show the efficacy of laparoscopic D2 lymphadenectomy in AGC patients compared with the open procedure. Trial registration: ClinicalTrial.gov, NCT01456598.
- Subjects :
- Laparoscopic surgery
Cancer Research
medicine.medical_specialty
Advanced gastric cancer
Left gastric artery
medicine.medical_treatment
law.invention
Metastasis
Study Protocol
Randomized controlled trial
Gastrectomy
Stomach Neoplasms
law
Surgical oncology
medicine.artery
Genetics
medicine
Humans
Multicenter Studies as Topic
Laparoscopy
Randomized Controlled Trials as Topic
medicine.diagnostic_test
business.industry
General surgery
D2 lymphadenectomy
medicine.disease
Surgery
Clinical trial
Treatment Outcome
Oncology
Lymphatic Metastasis
Sample Size
Gastric neoplasm
Lymph Node Excision
business
Subjects
Details
- ISSN :
- 14712407 and 01456598
- Volume :
- 15
- Database :
- OpenAIRE
- Journal :
- BMC Cancer
- Accession number :
- edsair.doi.dedup.....5b78b5e2218a83ac5e13da9c8474ce06