Safety Of Laparoscopic Total Gastrectomy Research Articles

Morbidity and Mortality of Laparoscopic vs Open Total Gastrectomy for Clinical Stage I Gastric Cancer

The safety of laparoscopic total gastrectomy (LTG) for the treatment of gastric cancer remains uncertain given the lack of high-level clinical evidence. To compare the safety of LTG for clinical stage I gastric cancer with that of conventional open total gastrectomy (OTG). The 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. Eligible patients were randomized to LTG (n = 113) or OTG (n = 114) by an interactive web response system. The 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. A 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. The 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. ClinicalTrials.gov Identifier: NCT03007550.

Laparoscopic versus open total gastrectomy for clinical stage I gastric cancer: Morbidity and mortality results from a prospective randomized multicenter controlled trial (CLASS02).

378 Background: The safety of laparoscopic total gastrectomy (LTG) for the treatment of gastric cancer remains lack of clinical evidence. The aim of this study was to compare the safety of LTG for clinical stage I gastric cancer with the conventional open total gastrectomy (OTG). Methods: From January 2017 to September 2018, a total of 227 patients with clinical stage T1N0-1M0/T2N0M0 gastric cancer were enrolled in this clinical trial and randomly assigned to Laparoscopic Gastrectomy group (LG, n=113) or Open Gastrectomy group (OG, n=114). The morbidity and mortality within 30 days following surgery, the recovery course, and the postoperative hospital stay between LG group (n=105) and OG group (n=109) were compared. Clavien-Dindo classification system was used to stratify surgical complications. Results: The overall morbidity rate was not significantly different in each group (LG group: 19.05%; OG group: 20.18%; Rate difference [RD]: -1.14%, 95%CI, -11.75%-9.58%). Intraoperative complications occurred in 3 (2.86%) patients in LG group and 4 (3.67%) patients in OG group (RD: -0.81%, 95%CI, -6.52%-4.85%). In addition, there was no significant difference in the overall postoperative complication rate of 18.10% in LG group and 17.43% in OG group (RD: 0.66%, 95%CI, -9.61%-11.01%). Each subtypes of postoperative complication were not significantly different between groups. One patient in LG group died of intra-abdominal bleeding from splenic artery, and there was no significant difference in mortality between LG group and OG group (RD: 0.95%, 95%CI, -2.54%-5.20%). The distribution of severity was similar between the two groups. Conclusions: Experienced surgeons can safely perform LTG with lymphadenectomy for clinical stage I gastric cancer. Clinical trial information: NCT03007550.

Safety of laparoscopic total gastrectomy with splenectomy for upper third advanced gastric cancer.

139 Background: In patients with locally advanced gastric cancer, total gastrectomy with splenectomy (TGS) is sometimes indicated when a tumor directly infiltrates the spleen or obvious splenic hilar lymph node metastasis exists. However, this procedure is technically demanding and can cause potentially fatal postoperative pancreas-related complications. TGS has increasingly been performed laparoscopically, particularly in East Asia. However, the number of reports regarding laparoscopic TGS (LTGS) is limited, and thus the feasibility of LTGS remains unclear. Methods: The present study included 68 patients with upper-third advanced gastric cancer who underwent LTGS or conventional open TGS (OTGS) between 2012 and 2018. Clinicopathological characteristics and surgical outcomes were retrospectively reviewed and compared between the groups. Results: There were no significant differences in sex, age, tumor size, cN factor, or cStage. cT4 was less frequently included in the LTGS group (21.4 vs 79.6 %, P < 0.01). In the LTGS group, operating time was longer (332 vs 247 min, P < 0.01) and blood loss was less (38 vs 598 ml, P < 0.01). Incidence of Clavien-Dindo grade 3 or higher complication (0 vs 24.1 %, P = 0.05) and median postoperative hospital stay (9 vs 11 days, P = 0.03) were significantly difference between the groups. The median number of harvested No. 10 and No.11d lymph nodes was equivalent between the groups. Conclusions: LTGS can be a safe procedure provided an experienced surgical team performs the surgery. Oncological safety remains unclear, and needs to be confirmed in future trials.

Study on safety of laparoscopic total gastrectomy for clinical stage I gastric cancer: the protocol of the CLASS02\u201301 multicenter randomized controlled clinical trial

BackgroundThe 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).MethodsThis 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.DiscussionThis 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 registrationClinicalTrials.gov ID: NCT03007550. December 30, 2016.

Clinical research status of laparoscopic total gastrectomy in China

Many retrospective and cohort studies have shown that laparoscopic total gastrectomy(LTG) has advantages of less trauma, quicker recovery and better incision than open total gastrectomy, and is not inferior to laparotomy in safety and the short- and long-term outcomes, so it has been widely applied. However there is still a lack of high level evidence-based basis. At present, several prospective multicenter clinical studies are being carried out in China, Japan and South Korea which have high incidence of gastric cancer to demonstrate the safety and feasibility of LTG and evaluate its long-term outcomes as well. A multicenter randomized controlled clinical trial comparing the safety of laparoscopic and open radical gastrectomy(CLASS-02 Research) conducted by Professor Sun Yihong, Zhongshan Hospital of Fudan University, is under way. The subjects of this study were the patients with clinical stage I(, the lesion locating in the gastric body, gastric fundus, or the esophagogastric junction (not involving the cardia dentate line), who were expected to be treated with total gastrectomy. The primary outcome measures were early operative morbidity and mortality and the secondary outcome measures were early postoperative recovery course and postoperative hospital stay. It is believed that results of the study will provide a high level evidence-based basis for the safety of LTG. The ongoing JCOG-1401 study in Japan aims to assess the feasibility and safety of LTG and LAPG for the treatment of early gastric cancer. LTG (Roux-en-Y reconstruction) or LAPG (double-tract or jejunal interposition reconstruction) will be performed in patients with clinical stage I( gastric cancer in this study. The primary endpoint of the study is the incidence of anastomotic leakage, and the secondary endpoints are proportion of patients converted to open surgery, the time to the first flatus, analgesic requirement, postoperative body temperature, the overall survival and relapse-free survival. The follow-up time is at least 5 years, and the results will also effectively evaluate the long-term efficacy of LTG and LAPG in the treatment for early gastric cancer. No.10 lymph nodes dissection of D2 total gastrectomy is a major difficulty in LTG. Japanese JCOG-0110 study has showed that for proximal gastric cancer patients without involvement of the greater curvature of the stomach, routine splenectomy for No.10 lymph nodes dissection is not recommended. In this regard, Professor Huang Changming, Union Hospital of Fujian Medical University, led the ongoing CLASS-04 study to evaluate the safety, feasibility and clinical efficacy of laparoscopic No.10 lymph node dissection with spleen preservation for patients with locally advanced gastric cancer locating in the upper part of the stomach. The ongoing CLASS-02 and JCOG-1401 studies will answer whether LTG is suitable for the treatment of early gastric cancer. We believe that in the absence of high level evidence-based basis, LTG should be applied cautiously to advanced gastric cancer, and LTG for early gastric cancer patients should also be operated by experienced surgeons.

Risk factors associated with early postoperative complications following laparoscopic total gastrectomy: Experience from the Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) group.

e15544 Background: The incidence rate of proximal gastric cancer has been rising steadily, and laparoscopic total gastrectomy (LTG) has been widely adopted. However, the safety of LTG still lacks solid evidence to prove. The aim of this study was to evaluate morbidity and mortality of LTG, and determine the risk factors associated with early postoperative complications. Methods: A retrospective multicenter study was carried out in China, and medical records of 109 gastric cancer patients receiving LTG during September 2014 and June 2016 were retrieved from the database. Patient characteristics, surgical outcomes, and postoperative morbidities and mortalities were analyzed. Results: Morbidity and mortality rates were 22.0% and 0% respectively. Pulmonary infection (13.8%, n = 15) was the most common complication. Most complications were grade II (15.5%, n = 17) according to the Clavien-Dindo classification. Multivariable analysis identified comorbidity, type of reconstruction method (TLTG) were independent risk factors of early postoperative complications. Comorbidity was the only independent risk factor of complications graded more than II. Diabetes mellitus was found correlated with surgical complication in subgroup analysis. Conclusions: LTG is safe and technically feasible in treating gastric cancer. Careful selection of patients without comorbidity and applying laparoscopy-assisted total gastrectomy instead of totally laparoscopic total gastrectomy may decrease postoperative complications.

Laparoscopic Total Gastrectomy for Gastric Cancer

Laparoscopic total gastrectomy (LTG) has been more widely performed in the last decade because of improvements in the techniques and safety of laparoscopic distal gastrectomy. However, due to its technical difficulty, there are still concerns regarding the safety of LTG. Meta-analyses have shown that LTG is technically feasible, safe, and may offer advantages over open total gastrectomy for treatment of gastric cancer. Various methods of performing esophagojejunostomy have been developed in an effort to decrease the rate of anastomosis-related complications, and have ultimately improved the safety and acceptance of LTG. However, there is still a lack of level-one evidence in support of LTG. Conduct of large-scale, randomized clinical trials will be needed in order to verify the safety and efficacy of LTG. Therefore, we reviewed the current status and some of the controversies surrounding LTG.

Laparoscopic versus Open Total Gastrectomy for Gastric Cancer: An Updated Meta-Analysis

ObjectiveTo expand the current knowledge on the feasibility and safety of laparoscopic total gastrectomy (LTG) for gastric cancer in comparison with open total gastrectomy (OTG).BackgroundAdditional studies comparing laparoscopic versus open total gastric resection have been published, and it is necessary to update the meta-analysis of this subject.MethodsOriginal articles compared LTG and OTG for gastric cancer, which published in English from January 1990 to July 2013 were searched in PubMed, Embase, and Web of Knowledge by two reviewers independently. Operative time, blood loss, harvested lymph nodes, proximal resection margin, analgesic medication, first flatus day, first oral intake, postoperative hospital stay, postoperative complications, hospital mortality, 5-year overall survival (OS) and disease-free survival (DFS) were compared using STATA version 10.1.Results17 studies were selected in this analysis, which included a total of 2313 patients (955 in LTG and 1358 in OTG). LTG showed longer operative time, less blood loss, fewer analgesic uses, earlier passage of flatus, quicker resumption of oral intake, earlier hospital discharge, and reduced postoperative morbidity. The number of harvested lymph nodes, proximal resection margin, hospital mortality, 5-year OS and DFS were similar.ConclusionLTG had the benefits of less blood loss, less postoperative pain, quicker bowel function recovery, shorter hospital stay and lower postoperative morbidity, at the price of longer operative time. There were no statistical differences in lymph node dissection, resection margin, hospital mortality, and long-term outcomes, which indicated the similar oncological safety with OTG. A positive trend was indicated towards LTG. So LTG can be performed as an alternative to OTG by the experienced surgeons in high-volume centers. Whereas, due to the relative small sample size of long-term outcomes and lack of randomized control trials, more studies are required.

Laparoscopic versus open total gastrectomy with D2 dissection for gastric cancer: a meta-analysis

To elucidate the feasibility and safety of laparoscopic total gastrectomy with D2 dissection (LTGD2) for gastric cancer in comparison with open total gastrectomy with D2 dissection (OTGD2). More surgeons have chosen laparoscopic total gastrectomy as an alternative to open total gastrectomy. But no meta-analysis has been performed to evaluate the value of LTGD2. Original articles compared LTGD2 and OTGD2 for gastric cancer, which published in English from January 1990 to March 2013 were searched in PubMed, Embase, and Web of Knowledge by two reviewers independently. Operative time, blood loss, harvested lymph nodes, analgesic medication, first flatus day, postoperative hospital stay, postoperative complications, and hospital mortality were compared using STATA version 10.1. 8 studies were selected in this analysis. A total of 1,498 patients were included (559 in LTG and 939 in OTG). LTGD2 showed longer operative time (WMD 39.29; 95 % CI 20.52, 58.06; P < 0.001), less blood loss (WMD -157.94; 95 % CI -245.25 -70.62; P < 0.001), fewer analgesic requirements (WMD -2.01; 95 % CI -3.10, -0.93; P < 0.001), earlier passage of flatus (WMD -0.73; 95 % CI -1.19, -0.27; P = 0.002), earlier hospital discharge (WMD -2.69; 95 % CI -3.42, -1.97; P < 0.001), and reduced postoperative morbidity (RR 0.70; 95 % CI 0.50, 0.98; P = 0.035). The number of harvested lymph nodes (WMD 0.27; 95 % CI -1.43, 1.98; P = 0.752) and hospital mortality rate (RR 0.57; 95 % CI 0.11, 3.09; P = 0.513) were similar. LTGD2 was associated with less blood loss, less postoperative pain, quicker bowel function recovery, shorter hospital stay, and reduced postoperative morbidity, at the expense of longer operative time. No statistical differences were observed in lymph node dissection, and hospital mortality, which indicated the similar ability of lymph nodes clearance and short-term outcomes with OTGD2. A positive trend was indicated toward LTGD2. So we encourage the experienced surgeons to achieve LTGD2 instead of OTGD2. Whereas, due to non-randomized control trails and lack of long-term outcomes, more studies are required.

Comparison of Short-Term Surgical Outcomes Between Laparoscopic and Open Total Gastrectomy for Gastric Carcinoma: Case-Control Study Using Propensity Score Matching Method

To evaluate the technical feasibility and safety of laparoscopic total gastrectomy (LTG) for gastric carcinoma, this study compared short-term surgical outcomes between LTG and open total gastrectomy (OTG) using the propensity score matching method. After generating propensity scores given the covariates of age, sex, body mass index, comorbidity, American Society of Anesthesiologists (ASA) score, operators, and tumor stage, 122 patients with LTG were matched to 122 OTG patients using the nearest available score matching. Operative outcomes and hospital courses were compared in the matched groups and in the subgroups by the extent of lymph node dissection (LND). The 2 study groups were well balanced with respect to the baseline characteristics of the propensity score derivation model. In the analysis of overall patients, the LTG group showed significantly longer operating time (289 vs 203 min, p < 0.001), but postoperative outcomes, including hospital stay, morbidity, and mortality, were similar in the 2 groups. In the subgroup with D1 + ß LND (perigastric nodes + Nos. 7, 8a, 9, 11p), the LTG group showed no significant differences in hospital stay, morbidity, and mortality from the OTG group. However, in the subgroup with D2 LND (perigastric nodes + Nos. 7, 8a, 9, 10, 11p, 11d, 12a), the LTG group showed significantly increased morbidity (52.6% vs 21.0%, p = 0.007) and tendency toward increased length of hospital stay and mortality as compared with the OTG group. Laparoscopic total gastrectomy is a safe and feasible technique for treatment of upper gastric carcinoma. However, LTG with D2 LND for upper gastric cancer may increase the operative risk and requires considerable experience in laparoscopic surgery.

Laparoscopic total gastrectomy in gastric cancer*

BACKGROUND: The aim of this retrospective study was to investigate the feasibility and safety of laparoscopic total gastrectomy in gastric cancer. METHODS: From 01/2008 to 09/2011 laparoscopic total gastrectomy was performed in 11 patients with gastric carcinoma. RESULTS: All patients had histopathologically diagnosed gastric cancer according to UICC-TNM classification: pT1 (n = 2), pT2 (n = 3), pT3 (n = 3), pT4 (n = 2), one case without histopathological malignancy in the postoperative specimen. Mean age was 69 years, mean BMI 25 and the average tumour size was 4.6 (1–10) cm. In every case R0-resection could be obtained, the amount of resected lymph nodes (25 mean) was oncologically reasonable. Conversion to open surgery was performed in two patients. Operation time was long compared to experiences in open surgery, 374 (290–465) min. There was no mortality and complication rate was acceptable. Postoperative stay was 18 days mean. CONCLUSIONS: Based on our experience laparoscopic total gastrectomy is a feasible option for treating gastric carcinomas. R0-resection in all cases and the amount of resected lymph nodes demonstrate adherence to oncologic principles.