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Study on safety of laparoscopic total gastrectomy for clinical stage I gastric cancer: the protocol of the CLASS02-01 multicenter randomized controlled clinical trial.

ABSTRACT: BACKGROUND:The safety of laparoscopic total gastrectomy (LTG) for the treatment of gastric cancer remains lack of clinical evidence. The Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group recently launched a multicenter randomized clinical trial (CLASS02-01) to compare the safety of LTG for clinical stage I gastric cancer with the conventional open total gastrectomy (OTG). METHODS:This CLASS02-01 trial is a prospective, multicenter, randomized, controlled, open, and non-inferiority trial. Two hundred patients who met the inclusion criteria and did not accord with the exclusion criteria will be randomly divided into LTG group (n?=?100) and OTG group (n?=?100). The primary purpose of this study is to evaluate the early operative morbidity and mortality of LTG compared with OTG for clinical stage I gastric adenocarcinoma. The second purpose is to evaluate the recovery course and compare the postoperative hospital stay of the patients enrolled in this study. DISCUSSION:This CLASS02-01 trial is the first prospective randomized two-arm controlled study to determine the safety of LTG compared with OTG. Through this trial, we hope to show that experienced surgeons can safely perform LTG with lymphadenectomy for gastric cancer. TRIAL REGISTRATION:ClinicalTrials.gov ID: NCT03007550 . December 30, 2016.

SUBMITTER: He H

PROVIDER: S-EPMC6171153 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Study on safety of laparoscopic total gastrectomy for clinical stage I gastric cancer: the protocol of the CLASS02-01 multicenter randomized controlled clinical trial.

He Hongyong H Li Haojie H Su Xiangqian X Li Ziyu Z Yu Peiwu P Huang Hua H Huang Changming C Ye Jianxin J Li Yong Y Suo Jian J Yu Jiren J Li Guoxin G Xu Zekuan Z Zhao Gang G Cao Hui H Hu Jiankun J Du Xiaohui X Liu Fenglin F Sun Yihong Y

BMC cancer 20181003 1

<h4>Background</h4>The safety of laparoscopic total gastrectomy (LTG) for the treatment of gastric cancer remains lack of clinical evidence. The Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group recently launched a multicenter randomized clinical trial (CLASS02-01) to compare the safety of LTG for clinical stage I gastric cancer with the conventional open total gastrectomy (OTG).<h4>Methods</h4>This CLASS02-01 trial is a prospective, multicenter, randomized, controlled, open, and ...[more]

PMID: 30285673

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Project description:ImportanceThe safety of laparoscopic total gastrectomy (LTG) for the treatment of gastric cancer remains uncertain given the lack of high-level clinical evidence.ObjectiveTo compare the safety of LTG for clinical stage I gastric cancer with that of conventional open total gastrectomy (OTG).Design, setting, and participantsThe Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group CLASS02 study was a prospective, multicenter, open-label, noninferiority, randomized clinical trial that compared the safety of LTG vs OTG with lymphadenectomy for patients with clinical stage I gastric cancer. From January 2017 to September 2018, a total of 227 patients were enrolled. Final follow-up was in October 2018.InterventionsEligible patients were randomized to LTG (n = 113) or OTG (n = 114) by an interactive web response system.Main outcomes and measuresThe primary outcome was the morbidity and mortality within 30 days following surgeries between LTG and OTG with a noninferiority margin of 10%. The secondary outcomes were recovery courses and postoperative hospital stays.ResultsA total of 214 patients were analyzed for morbidity and mortality (105 patients in the LTG group and 109 patients in the OTG group). The mean (SD) age was 59.8 (9.4) years in the LTG group and 59.4 (9.2) years in the OTG group, and most were male (LTG group, 75 of 105 [71.4%]; OTG group, 80 of 109 [73.4%]). The overall morbidity and mortality rates were not significantly different between the groups (rate difference, -1.1%; 95% CI, -11.8% to 9.6%). Intraoperative complications occurred in 3 patients (2.9%) in the LTG group and 4 patients (3.7%) in the OTG group (rate difference, -0.8%; 95% CI, -6.5% to 4.9%). In addition, there was no significant difference in the overall postoperative complication rate of 18.1% in the LTG group and 17.4% in the OTG group (rate difference, 0.7%; 95% CI, -9.6% to 11.0%). One patient in the LTG group died from intra-abdominal bleeding secondary to splenic artery hemorrhage. However, there was no significant difference in mortality between the LTG group and the OTG group (rate difference, 1.0%; 95% CI, -2.5% to 5.2%), and the distribution of complication severity was similar between the 2 groups.Conclusions and relevanceThe results of the CLASS02 trial showed that the safety of LTG with lymphadenectomy by experienced surgeons for clinical stage I gastric cancer was comparable to that of OTG.Trial registrationClinicalTrials.gov Identifier: NCT03007550.

Project description:ImportanceLaparoscopic distal gastrectomy is gaining popularity over open distal gastrectomy for gastric cancer because of better early postoperative outcomes. However, to our knowledge, no studies have proved whether laparoscopic distal gastrectomy is oncologically equivalent to open distal gastrectomy.ObjectiveTo examine whether the long-term survival among patients with stage I gastric cancer undergoing laparoscopic distal gastrectomy is noninferior to that among patients undergoing open distal gastrectomy.DesignThe Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) group, which includes 15 surgeons from 13 institutes, conducted a phase 3, multicenter, open-label, noninferiority, prospective randomized clinical trial (KLASS-01) of patients with histologically proven, preoperative clinical stage I gastric adenocarcinoma from January 5, 2006, to August 23, 2010. Survival and recurrence status of the patients was determined in December 2016.InterventionsPatients were randomly assigned (1:1) to laparoscopic distal gastrectomy (n = 705) or open distal gastrectomy (n = 711). Of these patients, 85 received a surgical approach opposite the one to which they were randomized (63 randomized to the open surgery group and 22 to the laparoscopic group).Main outcomes and measuresDifference in 5-year overall survival between the laparoscopic and open distal gastrectomy groups. The noninferiority margin was prespecified as -5% (corresponding hazard ratio of 1.54), with an assumed survival of 90% after 5 years in the open surgery group.ResultsAmong the 1416 patients (mean [SD] age, 57.3 [11.1] years; 940 [66.4%] male) included in the study, the 5-year overall survival rates were 94.2% in the laparoscopic group and 93.3% in the open surgery group (log-rank P = .64). Intention-to-treat analysis confirmed the noninferiority of the laparoscopic approach compared with the open approach (difference, 0.9 percentage points; 1-sided 97.5% CI, -1.6 to infinity). The 5-year cancer-specific survival rates were similar between the 2 groups (97.1% in the laparoscopic group and 97.2% in the open surgery group, log-rank P = .91; difference, -0.03 percentage points; 1-sided 97.5% CI, -1.8 to infinity). Per-protocol analysis results were consistent with the intention-to-treat results for overall and cancer-specific survival rates.Conclusions and relevanceThe KLASS-01 trial revealed similar overall and cancer-specific survival rates between patients receiving laparoscopic and open distal gastrectomy. Laparoscopic distal gastrectomy is an oncologically safe alternative to open surgery for stage I gastric cancer.Trial registrationClinicalTrials.gov identifier: NCT00452751.

Project description:BackgroundGastric cancer is the third most common cause of cancer-related deaths and has the fifth highest incidence worldwide, especially in eastern Asia, central and Eastern Europe, and South America. Currently, surgery is the only curative treatment for gastric cancer; however, there is an increasing trend toward laparoscopic radical gastrectomy. Early oral feeding (EOF) has been shown to benefit clinical outcomes compared with open gastrectomy under conditions of enhanced recovery after surgery. There are a lack of guidelines and evidence for the safety and feasibility of EOF in patients undergoing laparoscopic radical gastrectomy. Thus, a prospective randomized trial is warranted.Methods/designThe EOF after total laparoscopic radical gastrectomy (SOFTLY) study is a single-center, parallel-arm, non-inferiority randomized controlled trial which will enroll 200 patients who are pathologically diagnosed with gastric cancer and undergo laparoscopic radical gastrectomy. The primary endpoint, incidence of anastomotic leakage, is based on 1.9% in the control group in the CLASS-01 study. The patients will be randomized (1:1) into two groups: the EOF group will receive a clear liquid diet on post-operative day 1 (POD1) and the delayed oral feeding (DOF) group will receive a clear liquid diet on post-operative day 4 (POD4). The demographic and pathologic characteristics will be recorded. Total and oral nutritional intake, general data, total serum protein, serum albumin, blood glucose, and temperature will be recorded before surgery and at the time of hospitalization. Adverse events will also be recorded. The occurrence of post-operative fistulas, including anastomotic leakage, will be recorded as the main severe post-operative adverse event and represent the primary endpoint.DiscussionThe safety and feasibility of EOF after gastrectomy has not been established. The SOFTLY trial will be the first randomized controlled trial involving total laparoscopic radical gastrectomy, in which the EOF group (POD1) will be compared with the DOF group (POD4). The results of the SOFTLY trial will provide data on the safety and feasibility of EOF after total laparoscopic radical gastrectomy.Trial registrationChinese Clinical Trial Registry, ChiCTR-IOR-15007660 . Registered on 28 December 2015. The study has full ethical and institutional approval.

Project description:ImportanceIt is not clear whether laparoscopic and open distal gastrectomy produce similar outcomes among patients with locally advanced gastric cancer. Data from a multicenter, randomized clinical trial (Chinese Laparoscopic Gastrointestinal Surgical Study [CLASS]-01) showed that laparoscopic distal gastrectomy did not result in inferior disease-free survival at 3 years compared with open distal gastrectomy.ObjectiveTo report 5-year overall survival data from the CLASS-01 trial of laparoscopic vs open distal gastrectomy among patients with locally advanced gastric cancer.Design, setting, and patientsThis was a noninferiority, open-label, randomized clinical trial conducted at 14 centers in China. A total of 1056 eligible patients with clinical stage T2, T3, or T4a gastric cancer without bulky nodes or distant metastases were enrolled from September 12, 2012, to December 3, 2014. Final follow-up was on December 31, 2019.InterventionsParticipants were randomized in a 1:1 ratio after stratification by site, age, cancer stage, and histologic features to undergo either laparoscopic distal gastrectomy (n = 528) or open distal gastrectomy (n = 528) with D2 lymphadenectomy.Main outcomes and measuresThe 5-year overall survival rates were updated to compare laparoscopic distal gastrectomy with open distal gastrectomy. All analyses were performed on an intention-to-treat basis. In addition, per-protocol and as-treated analyses were performed for overall survival.ResultsData from 1039 patients (726 men [69.9%]; mean [SD] age, 56.2 [10.7] years) who received curative therapy were analyzed. At 5 years, the overall survival rates were 72.6% in the laparoscopic distal gastrectomy group and 76.3% in the open distal gastrectomy group (log-rank P = .19; hazard ratio, 1.17; 95% CI, 0.93-1.48; P = .19). After comparison for competing risk events, gastric cancer-related deaths (hazard ratio, 1.14; 95% CI, 0.87-1.49; P = .34) and deaths from other causes (hazard ratio, 1.23; 95% CI, 0.74-2.05; P = .42) did not differ significantly between groups. Overall rates of survival did not differ significantly between groups with each tumor stage.Conclusions and relevanceThis study found that laparoscopic distal gastrectomy with D2 lymphadenectomy performed by experienced surgeons in high-volume specialized institutions resulted in similar 5-year overall survival compared with open distal gastrectomy among patients with locally advanced gastric cancer.Trial registrationClinicalTrials.gov Identifier: NCT01609309.

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Study on safety of laparoscopic total gastrectomy for clinical stage I gastric cancer: the protocol of the CLASS02-01 multicenter randomized controlled clinical trial.

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Study on safety of laparoscopic total gastrectomy for clinical stage I gastric cancer: the protocol of the CLASS02-01 multicenter randomized controlled clinical trial.

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