Efficacy of laparoscopic subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer: The protocol of the KLASS-02 multicenter randomized controlled clinical trial

Hoon Hur, Hyun Yong Lee, Hyuk Joon Lee, Min Chan Kim, WooJin Hyung, Young Kyu Park, Wook Kim, Sang Uk Han

Research output: Contribution to journalArticle

50 Citations (Scopus)

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 3years. 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.

Original languageEnglish
Article number355
JournalBMC cancer
Volume15
Issue number1
DOIs
Publication statusPublished - 2015 May 5

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Gastrectomy
Lymph Node Excision
Stomach Neoplasms
Randomized Controlled Trials
Clinical Trials
Lymph Nodes
Laparoscopy
Neoplasm Metastasis
Postoperative Hemorrhage
Peer Review
Survival
Stomach
Arteries
Quality of Life
Research Personnel
Morbidity
Recurrence
Muscles
Mortality
Neoplasms

All Science Journal Classification (ASJC) codes

  • Oncology
  • Genetics
  • Cancer Research

Cite this

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title = "Efficacy of laparoscopic subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer: The protocol of the KLASS-02 multicenter randomized controlled clinical trial",
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 3years. 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.",
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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. / Hur, Hoon; Lee, Hyun Yong; Lee, Hyuk Joon; Kim, Min Chan; Hyung, WooJin; Park, Young Kyu; Kim, Wook; Han, Sang Uk.

In: BMC cancer, Vol. 15, No. 1, 355, 05.05.2015.

Research output: Contribution to journalArticle

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T1 - Efficacy of laparoscopic subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer

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AU - Hur, Hoon

AU - Lee, Hyun Yong

AU - Lee, Hyuk Joon

AU - Kim, Min Chan

AU - Hyung, WooJin

AU - Park, Young Kyu

AU - Kim, Wook

AU - Han, Sang Uk

PY - 2015/5/5

Y1 - 2015/5/5

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