Decreased morbidity of laparoscopic distal gastrectomy compared with open distal gastrectomy for stage I gastric cancer: Short-term outcomes from a multicenter randomized controlled trial (KLASS-01)

Wook Kim, Hyung Ho Kim, Sang Uk Han, Min Chan Kim, WooJin Hyung, Seung Wan Ryu, Gyu Seok Cho, Chan Young Kim, Han Kwang Yang, Do Joong Park, Kyo Young Song, Sang Il Lee, Seung Yub Ryu, Joo Ho Lee, Hyuk Joon Lee

Research output: Contribution to journalArticle

200 Citations (Scopus)

Abstract

Objective: To determine the safety of laparoscopy-assisted distal gastrectomy (LADG) compared with open distal gastrectomy (ODG) in patients with clinical stage I gastric cancer in Korea. Background: There is still a lack of large-scale, multicenter randomized trials regarding the safety of LADG. Methods: A large-scale, phase 3, multicenter, prospective randomized controlled trial was conducted. The primary end point was 5-year overall survival. Morbidity within 30 postoperative days and surgical mortality were compared to evaluate the safety of LADG as a secondary end point Results: A total of 1416 patients were randomly assigned to the LADG group (n=705) or the ODG group (n=711) between February 1, 2006, and August 31, 2010, and 1384 patients were analyzed for modified intention-to-treat analysis (ITT) and 1256 were eligible for per protocol (PP) analysis (644 and 612, respectively). In the PP analysis, 6 patients (0.9%) needed open conversion in the LADG group. The overall complication rate was significantly lower in the LADG group (LADG vs ODG; 13.0% vs 19.9%, P=0.001). In detail, the wound complication rate of the LADG group was significantly lower than that of the ODG group (3.1% vs 7.7%, P<0.001). The major intraabdominal complication (7.6% vs 10.3%, P=0.095) and mortality rates (0.6% vs 0.3%, P=0.687) were similar between the 2 groups. Modified ITT analysis showed similar results with PP analysis. Conclusions: LADG for patients with clinical stage I gastric cancer is safe and has a benefit of lower occurrence of wound complication compared with conventional ODG.

Original languageEnglish
Pages (from-to)28-35
Number of pages8
JournalAnnals of Surgery
Volume263
Issue number1
DOIs
Publication statusPublished - 2016 Jan 1

Fingerprint

Gastrectomy
Stomach Neoplasms
Randomized Controlled Trials
Morbidity
Laparoscopy
Intention to Treat Analysis
Safety
Mortality
Wounds and Injuries
Korea
Multicenter Studies

All Science Journal Classification (ASJC) codes

  • Surgery

Cite this

Kim, Wook ; Kim, Hyung Ho ; Han, Sang Uk ; Kim, Min Chan ; Hyung, WooJin ; Ryu, Seung Wan ; Cho, Gyu Seok ; Kim, Chan Young ; Yang, Han Kwang ; Park, Do Joong ; Song, Kyo Young ; Lee, Sang Il ; Ryu, Seung Yub ; Lee, Joo Ho ; Lee, Hyuk Joon. / Decreased morbidity of laparoscopic distal gastrectomy compared with open distal gastrectomy for stage I gastric cancer : Short-term outcomes from a multicenter randomized controlled trial (KLASS-01). In: Annals of Surgery. 2016 ; Vol. 263, No. 1. pp. 28-35.
@article{cf4ce9607bfb4824804fe4940b3c286b,
title = "Decreased morbidity of laparoscopic distal gastrectomy compared with open distal gastrectomy for stage I gastric cancer: Short-term outcomes from a multicenter randomized controlled trial (KLASS-01)",
abstract = "Objective: To determine the safety of laparoscopy-assisted distal gastrectomy (LADG) compared with open distal gastrectomy (ODG) in patients with clinical stage I gastric cancer in Korea. Background: There is still a lack of large-scale, multicenter randomized trials regarding the safety of LADG. Methods: A large-scale, phase 3, multicenter, prospective randomized controlled trial was conducted. The primary end point was 5-year overall survival. Morbidity within 30 postoperative days and surgical mortality were compared to evaluate the safety of LADG as a secondary end point Results: A total of 1416 patients were randomly assigned to the LADG group (n=705) or the ODG group (n=711) between February 1, 2006, and August 31, 2010, and 1384 patients were analyzed for modified intention-to-treat analysis (ITT) and 1256 were eligible for per protocol (PP) analysis (644 and 612, respectively). In the PP analysis, 6 patients (0.9{\%}) needed open conversion in the LADG group. The overall complication rate was significantly lower in the LADG group (LADG vs ODG; 13.0{\%} vs 19.9{\%}, P=0.001). In detail, the wound complication rate of the LADG group was significantly lower than that of the ODG group (3.1{\%} vs 7.7{\%}, P<0.001). The major intraabdominal complication (7.6{\%} vs 10.3{\%}, P=0.095) and mortality rates (0.6{\%} vs 0.3{\%}, P=0.687) were similar between the 2 groups. Modified ITT analysis showed similar results with PP analysis. Conclusions: LADG for patients with clinical stage I gastric cancer is safe and has a benefit of lower occurrence of wound complication compared with conventional ODG.",
author = "Wook Kim and Kim, {Hyung Ho} and Han, {Sang Uk} and Kim, {Min Chan} and WooJin Hyung and Ryu, {Seung Wan} and Cho, {Gyu Seok} and Kim, {Chan Young} and Yang, {Han Kwang} and Park, {Do Joong} and Song, {Kyo Young} and Lee, {Sang Il} and Ryu, {Seung Yub} and Lee, {Joo Ho} and Lee, {Hyuk Joon}",
year = "2016",
month = "1",
day = "1",
doi = "10.1097/SLA.0000000000001346",
language = "English",
volume = "263",
pages = "28--35",
journal = "Annals of Surgery",
issn = "0003-4932",
publisher = "Lippincott Williams and Wilkins",
number = "1",

}

Decreased morbidity of laparoscopic distal gastrectomy compared with open distal gastrectomy for stage I gastric cancer : Short-term outcomes from a multicenter randomized controlled trial (KLASS-01). / Kim, Wook; Kim, Hyung Ho; Han, Sang Uk; Kim, Min Chan; Hyung, WooJin; Ryu, Seung Wan; Cho, Gyu Seok; Kim, Chan Young; Yang, Han Kwang; Park, Do Joong; Song, Kyo Young; Lee, Sang Il; Ryu, Seung Yub; Lee, Joo Ho; Lee, Hyuk Joon.

In: Annals of Surgery, Vol. 263, No. 1, 01.01.2016, p. 28-35.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Decreased morbidity of laparoscopic distal gastrectomy compared with open distal gastrectomy for stage I gastric cancer

T2 - Short-term outcomes from a multicenter randomized controlled trial (KLASS-01)

AU - Kim, Wook

AU - Kim, Hyung Ho

AU - Han, Sang Uk

AU - Kim, Min Chan

AU - Hyung, WooJin

AU - Ryu, Seung Wan

AU - Cho, Gyu Seok

AU - Kim, Chan Young

AU - Yang, Han Kwang

AU - Park, Do Joong

AU - Song, Kyo Young

AU - Lee, Sang Il

AU - Ryu, Seung Yub

AU - Lee, Joo Ho

AU - Lee, Hyuk Joon

PY - 2016/1/1

Y1 - 2016/1/1

N2 - Objective: To determine the safety of laparoscopy-assisted distal gastrectomy (LADG) compared with open distal gastrectomy (ODG) in patients with clinical stage I gastric cancer in Korea. Background: There is still a lack of large-scale, multicenter randomized trials regarding the safety of LADG. Methods: A large-scale, phase 3, multicenter, prospective randomized controlled trial was conducted. The primary end point was 5-year overall survival. Morbidity within 30 postoperative days and surgical mortality were compared to evaluate the safety of LADG as a secondary end point Results: A total of 1416 patients were randomly assigned to the LADG group (n=705) or the ODG group (n=711) between February 1, 2006, and August 31, 2010, and 1384 patients were analyzed for modified intention-to-treat analysis (ITT) and 1256 were eligible for per protocol (PP) analysis (644 and 612, respectively). In the PP analysis, 6 patients (0.9%) needed open conversion in the LADG group. The overall complication rate was significantly lower in the LADG group (LADG vs ODG; 13.0% vs 19.9%, P=0.001). In detail, the wound complication rate of the LADG group was significantly lower than that of the ODG group (3.1% vs 7.7%, P<0.001). The major intraabdominal complication (7.6% vs 10.3%, P=0.095) and mortality rates (0.6% vs 0.3%, P=0.687) were similar between the 2 groups. Modified ITT analysis showed similar results with PP analysis. Conclusions: LADG for patients with clinical stage I gastric cancer is safe and has a benefit of lower occurrence of wound complication compared with conventional ODG.

AB - Objective: To determine the safety of laparoscopy-assisted distal gastrectomy (LADG) compared with open distal gastrectomy (ODG) in patients with clinical stage I gastric cancer in Korea. Background: There is still a lack of large-scale, multicenter randomized trials regarding the safety of LADG. Methods: A large-scale, phase 3, multicenter, prospective randomized controlled trial was conducted. The primary end point was 5-year overall survival. Morbidity within 30 postoperative days and surgical mortality were compared to evaluate the safety of LADG as a secondary end point Results: A total of 1416 patients were randomly assigned to the LADG group (n=705) or the ODG group (n=711) between February 1, 2006, and August 31, 2010, and 1384 patients were analyzed for modified intention-to-treat analysis (ITT) and 1256 were eligible for per protocol (PP) analysis (644 and 612, respectively). In the PP analysis, 6 patients (0.9%) needed open conversion in the LADG group. The overall complication rate was significantly lower in the LADG group (LADG vs ODG; 13.0% vs 19.9%, P=0.001). In detail, the wound complication rate of the LADG group was significantly lower than that of the ODG group (3.1% vs 7.7%, P<0.001). The major intraabdominal complication (7.6% vs 10.3%, P=0.095) and mortality rates (0.6% vs 0.3%, P=0.687) were similar between the 2 groups. Modified ITT analysis showed similar results with PP analysis. Conclusions: LADG for patients with clinical stage I gastric cancer is safe and has a benefit of lower occurrence of wound complication compared with conventional ODG.

UR - http://www.scopus.com/inward/record.url?scp=84953839656&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84953839656&partnerID=8YFLogxK

U2 - 10.1097/SLA.0000000000001346

DO - 10.1097/SLA.0000000000001346

M3 - Article

C2 - 26352529

AN - SCOPUS:84953839656

VL - 263

SP - 28

EP - 35

JO - Annals of Surgery

JF - Annals of Surgery

SN - 0003-4932

IS - 1

ER -