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).
TL;DR: 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.
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.Method
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TL;DR: It is found that hybrid minimally invasive esophagectomy resulted in a lower incidence of intraoperative and postoperative major complications, specifically pulmonary complications, than open esophageal cancer, without compromising overall and disease‐free survival over a period of 3 years.
Abstract: Background Postoperative complications, especially pulmonary complications, affect more than half the patients who undergo open esophagectomy for esophageal cancer. Whether hybrid minimall...
431 citations
Southern Medical University1, Fujian Medical University2, Fudan University3, Peking University4, Shanghai Jiao Tong University5, Sichuan University6, Harbin Medical University7, Jilin University8, Huazhong University of Science and Technology9, Fourth Military Medical University10, Sun Yat-sen University11
TL;DR: Among 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.
Abstract: Importance Laparoscopic 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. Objective To compare 3-year disease-free survival for patients with locally advanced gastric cancer after laparoscopic distal gastrectomy or open distal gastrectomy. Design, Setting, and Patients The 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. Interventions Participants 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 Measures The 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. Results Among 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 Relevance Among 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 Registration ClinicalTrials.gov Identifier:NCT01609309
417 citations
Seoul National University Bundang Hospital1, Ajou University2, Dong-a University3, Catholic University of Korea4, New Generation University College5, Keimyung University6, Soonchunhyang University7, Chonbuk National University8, Chungnam National University9, Chonnam National University10, Ewha Womans University11, Yonsei University12
TL;DR: The KLASS-01 trial revealed similar overall and cancer-specific survival rates between patients receiving laparoscopic and open distal gastrectomy, and confirmed Laparoscopic distal Gastrointestinal Surgery is an oncologically safe alternative to open surgery for stage I gastric cancer.
Abstract: Importance Laparoscopic 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. Objective To 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. Design The 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. Interventions Patients 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 Measures Difference 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. Results Among 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-rankP = .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-rankP = .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 Relevance The 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 Registration ClinicalTrials.gov identifier:NCT00452751
290 citations
TL;DR: This trial confirmed that LADG was as safe as ODG in terms of adverse events and short-term clinical outcomes, and may be an alternative procedure in clinical IA/IB gastric cancer if the noninferiority of L ADG in Terms of RFS is confirmed.
Abstract: No confirmatory randomized controlled trials (RCTs) have evaluated the efficacy of laparoscopy-assisted distal gastrectomy (LADG) compared with open distal gastrectomy (ODG). We performed an RCT to confirm that LADG is not inferior to ODG in efficacy. We conducted a multi-institutional RCT. Eligibility criteria included histologically proven gastric adenocarcinoma in the middle or lower third of the stomach, clinical stage I tumor. Patients were preoperatively randomized to ODG or LADG. This study is now in the follow-up stage. The primary endpoint is relapse-free survival (RFS) and the primary analysis is planned in 2018. Here, we compared the surgical outcomes of the two groups. This trial was registered at the UMIN Clinical Trials Registry as UMIN000003319. Between March 2010 and November 2013, 921 patients (LADG 462, ODG 459) were enrolled from 33 institutions. Operative time was longer in LADG than in ODG (median 278 vs. 194 min, p < 0.001), while blood loss was smaller (median 38 vs. 115 ml, p < 0.001). There was no difference in the overall proportion with in-hospital grade 3–4 surgical complications (3.3 %: LADG, 3.7 %: ODG). The proportion of patients with elevated serum AST/ALT was higher in LADG than in ODG (16.4 vs. 5.3 %, p < 0.001). There was no operation-related death in either arm. This trial confirmed that LADG was as safe as ODG in terms of adverse events and short-term clinical outcomes. LADG may be an alternative procedure in clinical IA/IB gastric cancer if the noninferiority of LADG in terms of RFS is confirmed.
273 citations
Cites methods or result from "Decreased Morbidity of Laparoscopic..."
...In South Korea, an RCT named KLASS-01 [6] was started prior to this study (JCOG0912) to compare LADG with ODG in a noninferiority design....
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...Second, in JCOG0912, the proportion of postoperative complications was similarly low in the LADG and ODG arms, whereas postoperative morbidity was higher in the ODG arm than in the LADG arm in KLASS-01....
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...%) than in KLASS-01 (88.7 %)....
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...In addition, the higher proportion who underwent a procedural switch in KLASS-01 could have a significant influence, especially in noninferiority trials....
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...The morbidity and mortality in KLASS-01 have already been reported....
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TL;DR: Laroscopic distal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer shows benefits in terms of lower complication rate, faster recovery, and less pain compared with open surgery.
Abstract: Objective:The aim of the study was to evaluate the short-term outcomes of KLASS-02-RCT, a multicenter randomized controlled trial comparing laparoscopic distal gastrectomy (LDG) with D2 lymphadenectomy with open distal gastrectomy (ODG).Summary Background Data:Although several benefits of laparoscop
270 citations
Cites background or methods or result from "Decreased Morbidity of Laparoscopic..."
...According to a multicenter randomized controlled trial (RCT) of laparoscopic distal gastrectomy (LDG) versus open distal gastrectomy (ODG) in 1416 patients with clinical stage I gastric cancer (KLASS-01), postoperative morbidity rate of the laparoscopic group was significantly lower than that of the open group.(4) In addition, there was no significant difference of 5-year survival rate between both groups....
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...In brief, with strict qualification and standardization of surgical procedure, KLASS-02-RCT showed acceptable short-term outcomes in respect to those found in KLASS-01....
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...In brief, with strict qualification and standardization of surgical procedure, KLASS-02-RCT showed acceptable short-term outcomes in respect to those found in KLASS-01.(4) In this KLASS-02-RCT, we used 2 types of analysis groups, which were ‘‘actual treatment (AT)’’ group and ‘‘modified per protocol (mPP)’’ group....
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...Copyright © 2019 Wolters Kluw More than 80 cases were asked to be performed in the surgeon’s 984 | www.annalsofsurgery.com institute each year, similar to KLASS-01....
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...Mean number of patients enrolled in each hospital per year in KLASS-02-RCT was 29.2, which was much higher than 13.4 in KLASS-01....
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References
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TL;DR: In this article, an international panel of pancreatic surgeons, working in well-known, high-volume centers, reviewed the literature on the topic and worked together to develop a simple, objective, reliable, and easy-to-apply definition of postoperative pancreatic fistula, graded primarily on clinical impact.
3,622 citations
01 Jan 2005
TL;DR: The present definition and clinical grading of POPF should allow realistic comparisons of surgical experiences in the future when new techniques, new operations, or new pharmacologic agents that may impact surgical treatment of pancreatic disorders are addressed.
Abstract: Background. Postoperative pancreatic fistula (POPF) is still regarded as a major complication. The incidence of POPF varies greatly in different reports, depending on the definition applied at each surgical center. Our aim was to agree upon an objective and internationally accepted definition to allow comparison of different surgical experiences. Methods. An international panel of pancreatic surgeons, working in well-known, high-volume centers, reviewed the literature on the topic and worked together to develop a simple, objective, reliable, and easyto-apply definition of POPF, graded primarily on clinical impact. Results. A POPF represents a failure of healing/sealing of a pancreatic-enteric anastomosis or a parenchymal leak not directly related to an anastomosis. An all-inclusive definition is a drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of POPF (grades A, B, C) are defined according to the clinical impact on the patient’s hospital course. Conclusions. The present definition and clinical grading of POPF should allow realistic comparisons of surgical experiences in the future when new techniques, new operations, or new pharmacologic agents that may impact surgical treatment of pancreatic disorders are addressed. (Surgery 2005;138:8-13.)
3,617 citations
"Decreased Morbidity of Laparoscopic..." refers background in this paper
...All rights reserved. diagnosed when the drain amylase level is over 3 times the serum amylase level on POD#3.23 When our trial was designed, there were no consensus guidelines for pancreatic fistula....
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...We defined pancreatic fistula as a drain amylase level greater than 1000 IU/L after POD#3.9 Intestinal obstruction and ileus are defined as no Copyright © 2015 Wolters Kluw 2015 Wolters Kluwer Health, Inc....
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...diagnosed when the drain amylase level is over 3 times the serum amylase level on POD#3.(23) When our trial was designed, there were no consensus guidelines for pancreatic fistula....
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TL;DR: In selected patients with rectal cancer treated by skilled surgeons, laparoscopic surgery resulted in similar safety, resection margins, and completeness of resection to that of open surgery, and recovery was improved after laparoscope surgery.
Abstract: Summary Background Laparoscopic surgery as an alternative to open surgery in patients with rectal cancer has not yet been shown to be oncologically safe. The aim in the COlorectal cancer Laparoscopic or Open Resection (COLOR II) trial was to compare laparoscopic and open surgery in patients with rectal cancer. Methods A non-inferiority phase 3 trial was undertaken at 30 centres and hospitals in eight countries. Patients (aged ≥18 years) with rectal cancer within 15 cm from the anal verge without evidence of distant metastases were randomly assigned to either laparoscopic or open surgery in a 2:1 ratio, stratified by centre, location of tumour, and preoperative radiotherapy. The study was not masked. Secondary (short-term) outcomes—including operative findings, complications, mortality, and results at pathological examination—are reported here. Analysis was by modified intention to treat, excluding those patients with post-randomisation exclusion criteria and for whom data were not available. This study is registered with ClinicalTrials.gov, number NCT00297791. Findings The study was undertaken between Jan 20, 2004, and May 4, 2010. 1103 patients were randomly assigned to the laparoscopic (n=739) and open surgery groups (n=364), and 1044 were eligible for analyses (699 and 345, respectively). Patients in the laparoscopic surgery group lost less blood than did those in the open surgery group (median 200 mL [IQR 100–400] vs 400 mL [200–700], p vs 188 min [150–240]; p vs 3·0 days [2·0–4·0]; p vs 9·0 days [7·0–14·0]; p=0·036). Macroscopically, completeness of the resection was not different between groups (589 [88%] of 666 vs 303 [92%] of 331; p=0·250). Positive circumferential resection margin ( vs 3·0 cm [1·8–5·0], respectively; p=0·676). In the laparoscopic and open surgery groups, morbidity (278 [40%] of 697 vs 128 [37%] of 345, respectively; p=0·424) and mortality (eight [1%] of 699 vs six [2%] of 345, respectively; p=0·409) within 28 days after surgery were similar. Interpretation In selected patients with rectal cancer treated by skilled surgeons, laparoscopic surgery resulted in similar safety, resection margins, and completeness of resection to that of open surgery, and recovery was improved after laparoscopic surgery. Results for the primary endpoint—locoregional recurrence—are expected by the end of 2013. Funding Ethicon Endo-Surgery Europe, Swedish Cancer Foundation, West Gothia Region, Sahlgrenska University Hospital.
1,298 citations
"Decreased Morbidity of Laparoscopic..." refers result in this paper
...Other RCTs regarding colorectal cancer surgery comparing conventional open and laparoscopic colorectal surgery also showed no differences in postoperative bleeding.(19,20) In the present study, 4 patients in each group underwent reoperations for bleeding; there was no significant difference in the patients requiring reoperations....
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Journal Article•
TL;DR: A technique of laparoscopy-assisted Billroth I gastrectomy under an abdominal wall-elevating method is described, which shows good results under conditions of a pneumoperitoneum.
Abstract: Laparoscopic distal partial gastrectomy is still technically difficult under conditions of a pneumoperitoneum because of the lack of appropriate techniques and laparoscopic instruments. We describe here a technique of laparoscopy-assisted Billroth I gastrectomy under an abdominal wall-elevating method.
1,146 citations
"Decreased Morbidity of Laparoscopic..." refers background in this paper
...Keywords: complication, laparoscopy, morbidity, mortality, stomach neoplasm (Ann Surg 2016;263:28–35) S ince laparoscopy-assisted distal gastrectomy (LADG) was firstreported in 1994, it has been rapidly adopted in Korea and Japan.1 Many articles have reported the safety and short/long-term oncologic results of this procedure, and the Japanese Laparoscopic Surgery Study Group reported 99.8% and 98.7% disease-free survival in stage IA and IB gastric cancers in their multicenter retrospective study.2 Before proving the oncologic safety of new surgical procedures, the operative safety of laparoscopic surgery should be guaranteed....
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...S ince laparoscopy-assisted distal gastrectomy (LADG) was first reported in 1994, it has been rapidly adopted in Korea and Japan.(1) Many articles have reported the safety and short/long-term oncologic results of this procedure, and the Japanese Laparoscopic Surgery Study Group reported 99....
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TL;DR: Laparoscopic radical subtotal gastrectomy for distal gastric cancer is a feasible and safe oncologic procedure with short- and long-term results similar to those obtained with an open approach.
Abstract: The recommended treatment of distal gastric cancer consists of a radical resection of the distal 4/5 of the stomach with a free margin of 5 to 6 cm.1–3 The extent of the associated lymph node dissection is still debated. Japanese authors suggest an extended dissection with the routine involvement of D1 and D2 lymph nodes, while an even wider (D3 and D4) dissection is advocated in cases of suspected invasion of more distant lymph nodes.4–8 Western authors often prefer a limited dissection (D1) because of the higher operative mortality and morbidity rates associated with extended lymphadenectomy (D2),9–13 even when distal pancreatectomy is avoided, as well as the lack of a significantly improved long-term survival data.14–18
In the past decade, laparoscopic techniques have gained wide clinical acceptance in surgical practice. This approach offers important advantages when compared with open surgery: reduced intraoperative blood loss, reduced postoperative pain and accelerated recovery, earlier return to normal bowel function with earlier resumption of oral intake, early discharge from hospital, and lower financial costs.19–22
The same advantages have been reported after laparoscopic subtotal or total gastrectomy for benign tumors as well as early gastric cancers.23–31 However, laparoscopically assisted subtotal gastrectomy for distal gastric cancer can only be justified and widely accepted as a safer alternative to open surgery if equal long-term results are obtained. This would suggest an equivalent radical oncologic resection.
The purpose of our study was to compare early and 5-year results of subtotal gastrectomy performed for distal gastric cancer using both a laparoscopic and an open approach, therefore defining the role of laparoscopic surgery in the treatment of this disease.
824 citations