Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer

An interim report-a phase III multicenter, prospective, randomized trial (KLASS trial)

Hyung Ho Kim, WooJin Hyung, Gyu Seok Cho, Min Chan Kim, Sang Uk Han, Wook Kim, Seung Wan Ryu, Hyuk Joon Lee, Kyo Young Song

Research output: Contribution to journalArticle

510 Citations (Scopus)

Abstract

Objective: The aim of this study was to evaluate the safety of this trial with respect to morbidity and mortality. Summary Background Data: Laparoscopic-assisted distal gastrectomy (LADG) is rapidly gaining popularity. However, there is limited evidence regarding its oncologic safety. We therefore conducted a phase III multicenter, prospective, randomized study comparing LADG with open gastrectomy (ODG). Methods: Patient eligibility criteria were pathologically-proven adenocarcinoma, 20 to 80 years of age, preoperative stage I, no history of other cancer, chemotherapy, or radiotherapy. The primary end point was to determine whether there is a difference in overall survival between 2 groups. The morbidity and mortality were compared to evaluate the safety of this trial. The time was decided on the hypothesis that the morbidity of this trial was not significantly different from that of previous reports on open gastric cancer surgeries (17%-20%). This study is registered at ClinicalTrials.gov and carries the following ID number: NCT00452751. Results: A total of 342 patients were randomized (LADG, 179 patients; ODG, 161 patients) between January 1, 2006 and July 19, 2007. There were no significant differences between the 2 groups in age, gender, and comorbidities. The postoperative complication rates of the LADG and ODG groups were 10.5% (17/179) and 14.7% (24/163), respectively (P = 0.137). Reoperations were required in 3 cases each group. The postoperative mortality was 1.1% (2/179) and 0% (0/163) in the LADG and ODG groups (P = 0.497), respectively. Conclusion: There was no significance difference in the morbidity and mortality between the 2 groups. Therefore, we conclude that this trial is safe and is thus ongoing.

Original languageEnglish
Pages (from-to)417-420
Number of pages4
JournalAnnals of Surgery
Volume251
Issue number3
DOIs
Publication statusPublished - 2010 Mar 1

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Gastrectomy
Stomach Neoplasms
Morbidity
Mortality
Safety
Reoperation
Comorbidity
Adenocarcinoma
Radiotherapy
Age Groups
Prospective Studies
Drug Therapy
Survival
Neoplasms

All Science Journal Classification (ASJC) codes

  • Surgery

Cite this

Kim, Hyung Ho ; Hyung, WooJin ; Cho, Gyu Seok ; Kim, Min Chan ; Han, Sang Uk ; Kim, Wook ; Ryu, Seung Wan ; Lee, Hyuk Joon ; Song, Kyo Young. / Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer : An interim report-a phase III multicenter, prospective, randomized trial (KLASS trial). In: Annals of Surgery. 2010 ; Vol. 251, No. 3. pp. 417-420.
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abstract = "Objective: The aim of this study was to evaluate the safety of this trial with respect to morbidity and mortality. Summary Background Data: Laparoscopic-assisted distal gastrectomy (LADG) is rapidly gaining popularity. However, there is limited evidence regarding its oncologic safety. We therefore conducted a phase III multicenter, prospective, randomized study comparing LADG with open gastrectomy (ODG). Methods: Patient eligibility criteria were pathologically-proven adenocarcinoma, 20 to 80 years of age, preoperative stage I, no history of other cancer, chemotherapy, or radiotherapy. The primary end point was to determine whether there is a difference in overall survival between 2 groups. The morbidity and mortality were compared to evaluate the safety of this trial. The time was decided on the hypothesis that the morbidity of this trial was not significantly different from that of previous reports on open gastric cancer surgeries (17{\%}-20{\%}). This study is registered at ClinicalTrials.gov and carries the following ID number: NCT00452751. Results: A total of 342 patients were randomized (LADG, 179 patients; ODG, 161 patients) between January 1, 2006 and July 19, 2007. There were no significant differences between the 2 groups in age, gender, and comorbidities. The postoperative complication rates of the LADG and ODG groups were 10.5{\%} (17/179) and 14.7{\%} (24/163), respectively (P = 0.137). Reoperations were required in 3 cases each group. The postoperative mortality was 1.1{\%} (2/179) and 0{\%} (0/163) in the LADG and ODG groups (P = 0.497), respectively. Conclusion: There was no significance difference in the morbidity and mortality between the 2 groups. Therefore, we conclude that this trial is safe and is thus ongoing.",
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Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer : An interim report-a phase III multicenter, prospective, randomized trial (KLASS trial). / Kim, Hyung Ho; Hyung, WooJin; Cho, Gyu Seok; Kim, Min Chan; Han, Sang Uk; Kim, Wook; Ryu, Seung Wan; Lee, Hyuk Joon; Song, Kyo Young.

In: Annals of Surgery, Vol. 251, No. 3, 01.03.2010, p. 417-420.

Research output: Contribution to journalArticle

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T1 - Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer

T2 - An interim report-a phase III multicenter, prospective, randomized trial (KLASS trial)

AU - Kim, Hyung Ho

AU - Hyung, WooJin

AU - Cho, Gyu Seok

AU - Kim, Min Chan

AU - Han, Sang Uk

AU - Kim, Wook

AU - Ryu, Seung Wan

AU - Lee, Hyuk Joon

AU - Song, Kyo Young

PY - 2010/3/1

Y1 - 2010/3/1

N2 - Objective: The aim of this study was to evaluate the safety of this trial with respect to morbidity and mortality. Summary Background Data: Laparoscopic-assisted distal gastrectomy (LADG) is rapidly gaining popularity. However, there is limited evidence regarding its oncologic safety. We therefore conducted a phase III multicenter, prospective, randomized study comparing LADG with open gastrectomy (ODG). Methods: Patient eligibility criteria were pathologically-proven adenocarcinoma, 20 to 80 years of age, preoperative stage I, no history of other cancer, chemotherapy, or radiotherapy. The primary end point was to determine whether there is a difference in overall survival between 2 groups. The morbidity and mortality were compared to evaluate the safety of this trial. The time was decided on the hypothesis that the morbidity of this trial was not significantly different from that of previous reports on open gastric cancer surgeries (17%-20%). This study is registered at ClinicalTrials.gov and carries the following ID number: NCT00452751. Results: A total of 342 patients were randomized (LADG, 179 patients; ODG, 161 patients) between January 1, 2006 and July 19, 2007. There were no significant differences between the 2 groups in age, gender, and comorbidities. The postoperative complication rates of the LADG and ODG groups were 10.5% (17/179) and 14.7% (24/163), respectively (P = 0.137). Reoperations were required in 3 cases each group. The postoperative mortality was 1.1% (2/179) and 0% (0/163) in the LADG and ODG groups (P = 0.497), respectively. Conclusion: There was no significance difference in the morbidity and mortality between the 2 groups. Therefore, we conclude that this trial is safe and is thus ongoing.

AB - Objective: The aim of this study was to evaluate the safety of this trial with respect to morbidity and mortality. Summary Background Data: Laparoscopic-assisted distal gastrectomy (LADG) is rapidly gaining popularity. However, there is limited evidence regarding its oncologic safety. We therefore conducted a phase III multicenter, prospective, randomized study comparing LADG with open gastrectomy (ODG). Methods: Patient eligibility criteria were pathologically-proven adenocarcinoma, 20 to 80 years of age, preoperative stage I, no history of other cancer, chemotherapy, or radiotherapy. The primary end point was to determine whether there is a difference in overall survival between 2 groups. The morbidity and mortality were compared to evaluate the safety of this trial. The time was decided on the hypothesis that the morbidity of this trial was not significantly different from that of previous reports on open gastric cancer surgeries (17%-20%). This study is registered at ClinicalTrials.gov and carries the following ID number: NCT00452751. Results: A total of 342 patients were randomized (LADG, 179 patients; ODG, 161 patients) between January 1, 2006 and July 19, 2007. There were no significant differences between the 2 groups in age, gender, and comorbidities. The postoperative complication rates of the LADG and ODG groups were 10.5% (17/179) and 14.7% (24/163), respectively (P = 0.137). Reoperations were required in 3 cases each group. The postoperative mortality was 1.1% (2/179) and 0% (0/163) in the LADG and ODG groups (P = 0.497), respectively. Conclusion: There was no significance difference in the morbidity and mortality between the 2 groups. Therefore, we conclude that this trial is safe and is thus ongoing.

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