Prospective randomized controlled trial (phase III) to comparing laparoscopic distal gastrectomy with open distal gastrectomy for gastric adenocarcinoma (KLASS 01).
Ontology highlight
ABSTRACT:
SUBMITTER: Kim HH
PROVIDER: S-EPMC3566471 | biostudies-literature | 2013 Feb
REPOSITORIES: biostudies-literature
Similar Datasets
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.
| S-EPMC6459124 | biostudies-literature
Project description:ImportanceThe long-term safety of laparoscopic distal gastrectomy for locally advanced gastric cancer (AGC) remains uncertain given the lack of 5-year follow-up results.ObjectiveTo compare the 5-year follow-up results in patients with clinically AGC enrolled in the Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS)-02 randomized clinical trial who underwent laparoscopic or open distal gastrectomy.Design, setting, and participantsThe KLASS-02, a multicenter randomized clinical trial, showed that laparoscopic surgery was noninferior to open surgery for patients with locally AGC. The present study assessed the 5-year follow-up results, including 5-year overall survival (OS) and relapse-free survival (RFS) rates and long-term complications, in patients enrolled in KLASS-02. From November 21, 2011, to April 29, 2015, patients aged 20 to 80 years diagnosed preoperatively with locally AGC were enrolled. Final follow-up was on June 15, 2021. Data were analyzed June 24 to September 9, 2021.InterventionsPatients were treated with R0 resection either by laparoscopic gastrectomy or open gastrectomy as the full analysis set of the KLASS-02 trial.Main outcomes and measuresFive-year OS and RFS rates, recurrence patterns, and long-term surgical complications were evaluated.ResultsThis study enrolled a total of 1050 patients. A total of 974 patients were treated with R0 resection; 492 (50.5%) in the laparoscopic gastrectomy group (mean [SD] age, 59.8 [11.0] years; 351 men [71.3%]) and 482 (49.5%) in the open gastrectomy group (mean [SD] age, 59.4 [11.5] years; 335 men [69.5%]). In patients who underwent laparoscopic and open distal gastrectomy, the 5-year OS (88.9% vs 88.7%) and RFS (79.5% vs 81.1%) rates did not differ significantly. The most common types of recurrence were peritoneal carcinomatosis (73 of 173 [42.1%]), hematogenous metastases (36 of 173 [20.8%]), and locoregional recurrence (23 of 173 [13.2%]), with no between-group differences in types of recurrence at each cancer stage. The correlation between 3-year RFS and 5-year OS at the individual level was highest in patients with stage III gastric cancer (ρ = 0.720). The late complication rate was significantly lower in the laparoscopic than in the open surgery group (32 of 492 [6.5%] vs 53 of 482 [11.0%]). The most common type of complication in both groups was intestinal obstruction (13 of 492 [2.6%] vs 24 of 482 [5.0%]).Conclusions and relevanceThe 5-year outcomes of the KLASS-02 trial support the 3-year results, which is the noninferiority of laparoscopic surgery compared with open gastrectomy for locally AGC. The laparoscopic approach can be recommended in patients with locally AGC to achieve the benefit of low incidence of late complications.Trial registrationClinicalTrials.gov Identifier: NCT01456598.
| S-EPMC9301593 | biostudies-literature
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.
| S-EPMC8529527 | biostudies-literature
Project description:BackgroundLaparoscopic subtotal gastrectomy (LSG) for cancer is associated with good perioperative outcomes and superior quality of life compared with the open approach, albeit at higher cost. An economic evaluation was conducted to compare the two approaches.MethodsA cost-effectiveness analysis between LSG and open subtotal gastrectomy (OSG) for gastric cancer was performed using a decision-tree cohort model with a healthcare system perspective and a 12-month time horizon. Model inputs were informed by a meta-analysis of relevant literature, with costs represented in 2016 Canadian dollars (CAD) and outcomes measured in quality-adjusted life-years (QALYs). A secondary analysis was conducted using inputs extracted solely from European and North American studies. Deterministic (DSA) and probabilistic (PSA) sensitivity analyses were performed.ResultsIn the base-case model, costs of LSG were $935 (€565) greater than those of OSG, with an incremental gain of 0·050 QALYs, resulting in an incremental cost-effectiveness ratio of $18 846 (€11 398) per additional QALY gained from LSG. In the DSA, results were most sensitive to changes in postoperative utility, operating theatre and equipment costs, as well as duration of surgery and hospital stay. PSA showed that the likelihood of LSG being cost-effective at willingness-to-pay thresholds of $50 000 (€30 240) per QALY and $100 000 (€60 480) per QALY was 64 and 68 per cent respectively. Secondary analysis using European and North American clinical inputs resulted in LSG being dominant (cheaper and more effective) over OSG, largely due to reduced length of stay after LSG.ConclusionIn this decision analysis model, LSG was cost-effective compared with OSG for gastric cancer.
| S-EPMC7528510 | biostudies-literature
Project description:BackgroundKLASS (the Korean Laparoendoscopic Gastrointestinal Surgery Study) is a time-honored study group that has established laparoscopic surgery for gastrointestinal disease in Korea and has performed some important studies for the rationale of laparoscopic gastrointestinal surgery. A multi-center RCT (randomized controlled trial) to compare the quality of life (QOL) of patients undergoing totally laparoscopic distal gastrectomy (TLDG) and laparoscopy-assisted distal gastrectomy (LADG) for gastric cancer, named as KLASS 07, has been currently prepared in Korea.MethodsPatients diagnosed as gastric cancer, with clinical stage IA (T1N0M0) or IB (T1N1M0 / T2N0M0) according to the 7th edition of the Americal Joint Committee on Cancer System, were randomized to receive either TLDG or LADG. For surgical quality control, the surgeons participating in this trial had to have performed at least 50 gastrectomies and at least 30 gastrectomies annually (regardless of open or laparoscopic surgery for gastric cancer). The patients who are allocated to TLDG group undergo intracorporeal anastomosis and those who are assigned to LADG undergo extracorporeal anastomosis for gastrointestinal reconstruction.DiscussionThirty-one surgeons from 26 institutions were engaged in this trial. The primary endpoint is 30-day morbidity, and secondary endpoint is QOL assessed by the questionnaire score. The KLASS 07 trial is the first multi-center RCT to investigate whether there are significant and quantifiable differences between the QOL of TLDG and LADG. The findings from this trial are expected to be the critical clues for designing the detailed procedures during laparoscopic surgery for gastric cancer.Trial registrationThe protocol of KLASS 07 (CKLASS 01) was registered in http://register.clinicaltrials.gov as NCT03393182 (Date of registration: January 2nd, 2018.).
| S-EPMC6407283 | biostudies-literature
Project description:BACKGROUND:Compared with open gastrectomy (OG), laparoscopic gastrectomy (LG) for gastric cancer has achieved rapid development and popularities in the past decades. However, lack of comprehensive analysis in long-term oncological outcomes such as recurrence and mortality hinder its full support as a valid procedure. Therefore, there are still debates on whether one of these options is superior. AIM:To evaluate the primary and secondary outcomes of laparoscopic versus open gastrectomy for gastric cancer patients METHODS: Two authors independently extracted study data. Risk ratio (RR) with 95% confidence interval (CI) was calculated for binary outcomes, mean difference (MD) or the standardized mean difference (SMD) with 95% CI for continuous outcomes, and the hazard ratio (HR) for time-to-event outcomes. Review Manager 5.3 and STATA software were used for the meta-analysis. RESULTS:Seventeen randomized controlled trials (RCTs) involving 5204 participants were included in this meta-analysis. There were no differences in the primary outcomes including the number of lymph nodes harvested during operation, severe complications, short-term and long-term recurrence, and mortality. As for secondary outcomes, compared with the OG group, longer operative time was required for patients in the LG group (MD?=?58.80?min, 95% CI?=?[45.80, 71.81], P?<?0.001), but there were less intraoperative blood loss (MD?=?-?54.93?ml, 95% CI?=?[-?81.60, -?28.26], P?<?0.001), less analgesic administration (frequency: MD?=?-?1.73, 95% CI?=?[-?2.21, -?1.24], P?<?0.001; duration: MD?=?-?1.26?days, 95% CI?=?[-?1.40, -?1.12], P?<?0.001), shorter hospital stay (MD?=?-?1.37?days, 95% CI?=?[-?2.05, -?0.70], P?<?0.001), shorter time to first flatus (MD?=?-?0.58?days, 95% CI?=?[-?0.79, -?0.37], P?<?0.001), ambulation (MD?=?-?0.50?days, 95% CI?=?[-?0.90, -?0.09], P?=?0.02) and oral intake (MD?=?-?0.64?days, 95% CI?=?[-?1.24, -?0.03], P?<?0.04), and less total complications (RR?=?0.81, 95% CI?=?[0.71, 0.93], P?=?0.003) in the OG group. There was no difference in blood transfusions (number, quantity) between these two groups. Subgroup analysis, sensitivity analysis, and the adjustment of Duval's trim and fill methods for publication bias did not change the conclusions. CONCLUSION:LG was comparable to OG in the primary outcomes and had some advantages in secondary outcomes for gastric cancer patients. LG is superior to OG for gastric cancer patients.
| S-EPMC6986035 | biostudies-literature
Project description:ImportanceLaparoscopic distal gastrectomy is accepted as a more effective approach to conventional open distal gastrectomy for early-stage gastric cancer. However, efficacy for locally advanced gastric cancer remains uncertain.ObjectiveTo compare 3-year disease-free survival for patients with locally advanced gastric cancer after laparoscopic distal gastrectomy or open distal gastrectomy.Design, setting, and patientsThe study was a noninferiority, open-label, randomized clinical trial 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 2012 to December 2014. Final follow-up was on December 31, 2017.InterventionsParticipants were randomized in a 1:1 ratio after stratification by site, age, cancer stage, and histology to undergo either laparoscopic distal gastrectomy (n = 528) or open distal gastrectomy (n = 528) with D2 lymphadenectomy.Main outcomes and measuresThe primary end point was 3-year disease-free survival with a noninferiority margin of -10% to compare laparoscopic distal gastrectomy with open distal gastrectomy. Secondary end points of 3-year overall survival and recurrence patterns were tested for superiority.ResultsAmong 1056 patients, 1039 (98.4%; mean age, 56.2 years; 313 [30.1%] women) had surgery (laparoscopic distal gastrectomy [n=519] vs open distal gastrectomy [n=520]), and 999 (94.6%) completed the study. Three-year disease-free survival rate was 76.5% in the laparoscopic distal gastrectomy group and 77.8% in the open distal gastrectomy group, absolute difference of -1.3% and a 1-sided 97.5% CI of -6.5% to ∞, not crossing the prespecified noninferiority margin. Three-year overall survival rate (laparoscopic distal gastrectomy vs open distal gastrectomy: 83.1% vs 85.2%; adjusted hazard ratio, 1.19; 95% CI, 0.87 to 1.64; P = .28) and cumulative incidence of recurrence over the 3-year period (laparoscopic distal gastrectomy vs open distal gastrectomy: 18.8% vs 16.5%; subhazard ratio, 1.15; 95% CI, 0.86 to 1.54; P = .35) did not significantly differ between laparoscopic distal gastrectomy and open distal gastrectomy groups.Conclusions and relevanceAmong patients with a preoperative clinical stage indicating locally advanced gastric cancer, laparoscopic distal gastrectomy, compared with open distal gastrectomy, did not result in inferior disease-free survival at 3 years.Trial registrationClinicalTrials.gov Identifier: NCT01609309.
| S-EPMC6547120 | biostudies-literature
Project description:PurposeConventional straight-shaped laparoscopic surgical instruments have limitations that, unlike robotic surgery, the wrist joint cannot be used. This study aimed to analyze the short-term safety and feasibility of ArtiSential (Livsmed), a new articulating laparoscopic instrument, which obviates the limitations of conventional laparoscopic surgery and allows the wrist joint to be used freely over 360° as in robotic surgery.MethodsThe study included patients who underwent conventional laparoscopy or laparoscopy with the ArtiSential instrument. Patients who underwent laparoscopic gastrectomy for primary gastric adenocarcinoma in our institution were retrospectively reviewed. The groups were propensity score matched in a 11 ratio. Primary endpoint was incidence of early postoperative complication (postoperative 30-day morbidity and mortality) and secondary endpoints were operative outcomes.ResultsA total of 327 patients (147 of the conventional group and 180 of the ArtiSential group) were propensity score matched. After propensity score matching was performed, each group comprised of 122 patients. Both groups were comparable with regard to operation time, estimated blood loss, number of retrieved lymph nodes, and length of hospital stay. The ArtiSential group had a faster time to a fluid diet (2.6 ± 1.3 days vs. 2.3 ± 0.6 days, p = 0.015). There was no statistically significant difference in early postoperative complications between the two groups (the conventional group, 23.0%; the ArtiSential group, 26.2%; p = 0.656).ConclusionThe current study showed that the use of ArtiSential is a safe and feasible option without increasing operation time, length of hospital stay, and intraoperative bleeding.
| S-EPMC8966001 | biostudies-literature
Project description:BackgroundReduced-port laparoscopic gastrectomy is currently widely performed for patients with gastric cancer. However, its safety in obese patients has not yet been verified. This is the first study on reduced-port laparoscopic distal gastrectomy (RpLDG) in obese patients with gastric cancer. This study aimed to evaluate the short-term surgical outcomes and investigate the feasibility and safety of RpLDG in obese patients with gastric carcinoma.Material and methodsA total of 271 gastric cancer patients who underwent RpLDG at our institution were divided into two groups: non-obese [body mass index (BMI) <30 kg/m2, n = 251; NOG] and obese (BMI ≥30 kg/m2, n = 20; OG). The mean age of the enrolled patients was 64.8 ± 11.4 years, with 72.0% being men and 28.0% women. Operative details and short-term surgical outcomes, including hospital course and postoperative complications, were compared by retrospectively reviewing the medical records.ResultsNo significant difference in operation time was found between the NOG and OG (205.9 ± 40.0 vs. 211.3 ± 37.3 minutes, P = 0.563). Other operative outcomes in the OG, including estimated blood loss (54.1 ± 86.1 vs. 54.0 ± 39.0 mL, P = 0.995) and retrieved lymph nodes (36.2 ± 16.4 vs. 35.5 ± 18.2, P = 0.875), were not inferior to those in the NOG. There were also no statistical differences in short-term surgical outcomes, including the incidence of surgical complications (13.9% vs. 10.0%, P = 1).ConclusionRpLDG can be performed safely in obese gastric cancer patients by an experienced surgeon. It should be considered a feasible alternative to conventional port distal gastrectomy.
| S-EPMC8341504 | biostudies-literature
Project description:IntroductionCurrent guidelines recommend open gastrectomy with D2 lymph node dissection and adjuvant chemotherapy as the standard treatment for advanced gastric cancer. However, the prognosis is not satisfactory. Perioperative chemotherapy has been proposed to improve survival. Although still in debate, the efficacy of laparoscopic distal gastrectomy (LDG) in patients with advanced gastric cancer has been demonstrated in a few trials. Therefore, LDG after neoadjuvant chemotherapy can be a candidate for future standard treatment on advanced distal gastric cancer. We propose a randomised phase II trial to compare LDG and open distal gastrectomy (ODG) after neoadjuvant chemotherapy for advanced gastric cancer.Methods and analysisTo test the efficacy and safety, a randomised, open-label, single-centre, phase II trial was designed to evaluate the non-inferiority of LDG compared with ODG after neoadjuvant chemotherapy, with 3-year recurrence-free survival as the primary endpoint. The chosen critical value of a non-inferiority margin was an increase of <8%. The study started in 2015 and enrolled 96 patients according to a prior sample size calculation. Intention-to-treat and per-protocol approach will be used for efficacy analysis, and as-treated analysis will be applied for safety analysis. The survival curves will be constructed as time-to-event plots using the Kaplan-Meier method and compared using log-rank tests and Cox proportional hazards model. All statistical analyses will be conducted in standard statistical software with a significance level of 0.05.Ethics and disseminationThis study was approved by the Peking University Cancer Hospital Ethics Committee. The results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT02404753; Pre-results.
| S-EPMC6089315 | biostudies-literature