Short-term Outcomes of a Multicenter Randomized Controlled Trial Comparing Laparoscopic Distal Gastrectomy With D2 Lymphadenectomy to Open Distal Gastrectomy for Locally Advanced Gastric Cancer (KLASS-02-RCT)

Lee, Hyuk Joon; Hyung, Woo Jin; Yang, Han Kwang; Han, Sang Uk; Park, Young Kyu; An, Ji Yeong; Kim, Wook; Kim, Wook; Kim, Hyung‐Ho; Ryu, Seung Wan; Hur, Hoon; Kong, Seong Ho; Cho, Gyu Seok; Kim, Jin-Jo; Park, Do Joong; Ryu, Keun Won; Kim, Young Woo; Kim, Jong Won; Lee, Joo Ho; Kim, Min Chan

doi:10.1097/sla.0000000000003217

Cited by 333 publications

(261 citation statements)

References 20 publications

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“…[23][24][25] However, some studies have raised the concern that early discharge could miss complications and lead to a higher readmission rate. 26,27 Complication rates (13.4%) within 30 days after surgery were comparable to previous conventional studies (13.0%-16.6%) 5,6 and our conventional CP group (9.5%, P = 0.338). The readmission rate (6.3%) in this study was also comparable to previous studies that applied conventional management (3.8%-7.5%), [28][29][30] although it was higher than that of our conventional CP group (0.7%).…”

Section: Discussionsupporting

confidence: 86%

“…One case showed leakage from the duodenal stump after Billroth II reconstruction, and the other showed anastomosis leakage after Billroth I reconstruction. Thus, the incidence of anastomosis leakage was 0.8% (1 of 127), similar to previous studies that applied conventional perioperative management (0.7%‐1.8%) . Early oral feeding may not have a deleterious effect on the anastomotic site or affect complication rates.…”

Section: Discussionsupporting

confidence: 82%

“…Thus, the incidence of anastomosis leakage was 0.8% (1 of 127), similar to previous studies that applied conventional perioperative management (0.7%-1.8%). 5,6 Early oral feeding may not have a deleterious effect on the anastomotic site or affect complication rates. Therefore, an ERAS CP that includes early oral feeding on POD 1 might be safely implemented in patients after gastric cancer surgery.…”

Section: Discussionmentioning

confidence: 99%

“…Discharge on POD 4 was recommended when the patient met the following criteria: (1) tolerance to the last three soft blended meals, (2) passage of first flatus, (3) ability to walk independently, (4) normal body temperature in the previous 24 hours, (5) no gastrointestinal symptom in the previous 24 hours, (6) no wound problems, and (7) pain score (numeric pain intensity scale) < 4. If the patient did not meet all discharge criteria, they were re-evaluated every day to determine discharge.…”

Section: Eras Cp Discharge Criteriamentioning

confidence: 99%

“…We have previously described the suitable indications for ERAS CP in gastric cancer patients in a study performed at Ajou University Hospital in 2011. 3 Based on those indications, we specified the inclusion criteria for this study as follows: (1) age between 20 and 65 years, (2) histologically proven adenocarcinoma of the stomach, (3) clinical stage I or IIA gastric cancer confirmed by esophagogastroduodenoscopy and abdominal computed tomography (CT), (4) middle to lower third of the tumor expected to be treated by subtotal gastrectomy and R0 resection, (5) possibility for minimally invasive gastrectomy (laparoscopy or robot), (6) Eastern Cooperative Oncology Group performance status of 0 or 1, (7) American Society of Anesthesiology score of class I or II, (8) no possibility for combined resection confirmed by abdominal CT, except gallbladder, (9) and written informed consent obtained before any study-specific assessment. Patients were excluded from this study for the following reasons: (1) clinically apparent distant metastasis, (2) past history of chemotherapy or radiotherapy for gastric cancer, (3) past history of gastric resection for any reason, (4) past history of other malignancy within 5 years, or (5) vulnerable patients who could not communicate.…”

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confidence: 99%

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Clinical pathway for enhanced recovery after surgery for gastric cancer: A prospective single‐center phase II clinical trial for safety and efficacy

Roh

Son

Lee

et al. 2020

Journal of Surgical Oncology

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Background We aimed to evaluate the safety and efficacy of a clinical pathway (CP) for enhanced recovery after surgery (ERAS) in gastric cancer patients, including early oral feeding and discharge on postoperative day 4. Methods We performed a prospective, single‐center, phase II clinical trial. Based on proposed indications for an ERAS CP in our retrospective study, we enrolled 133 patients younger than 65 years who were undergoing minimally invasive subtotal gastrectomy. The primary endpoint was the ERAS CP completion rate. Secondary endpoints included complication, mortality, hospital stay, and readmission. Results Among 133 patients, six patients were dropped out from this study. The ERAS CP completion rate (77.2%, 98 of 127) was comparable to the historical control group that completed a conventional CP (85.4%, P = .085). The postoperative complication incidence (13.4%, 15 of 127) was also similar to that of the conventional CP group (9.5%, P = .174). We identified reduced hospital stays (4.7 ± 1.3 vs 7.2±2.3 days; P < .001) and lower hospital costs ($7771 vs 8539; P < .001) in the ERAS CP group compared with the conventional CP group. Conclusions An ERAS CP can be safely and effectively adopted for patients with gastric cancer without increasing the complication rate and could shorten hospital stays. Trial Registration http://ClinicalTrials.gov (NCT01642953).

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Section: Discussionsupporting

confidence: 86%

Section: Discussionsupporting

confidence: 82%

Section: Discussionmentioning

confidence: 99%

Section: Eras Cp Discharge Criteriamentioning

confidence: 99%

mentioning

confidence: 99%

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Clinical pathway for enhanced recovery after surgery for gastric cancer: A prospective single‐center phase II clinical trial for safety and efficacy

Roh

Son

Lee

et al. 2020

Journal of Surgical Oncology

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Effect of Laparoscopic vs Open Distal Gastrectomy on 3-Year Disease-Free Survival in Patients With Locally Advanced Gastric Cancer

Huang

Sun

et al. 2019

JAMA

514

367

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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 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. 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 ϱ, 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.

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Comparison of Survival and Patterns of Recurrence in Gastric Neuroendocrine Carcinoma, Mixed Adenoneuroendocrine Carcinoma, and Adenocarcinoma

Zhao

Zhou

et al. 2021

JAMA Netw Open

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IMPORTANCE Gastric neuroendocrine carcinoma and mixed adenoneuroendocrine carcinoma are rare pathological types of gastric cancer, and there is a lack of multicenter studies comparing the prognosis and recurrence patterns of gastric neuroendocrine carcinoma, gastric mixed adenoneuroendocrine carcinoma, and gastric adenocarcinoma.OBJECTIVE To compare the differences in long-term survival and patterns of recurrence among gastric neuroendocrine carcinoma, gastric mixed adenoneuroendocrine carcinoma, and gastric adenocarcinoma. DESIGN, SETTING, AND PARTICIPANTSThis cohort study included patients with resectable gastric neuroendocrine carcinoma and gastric mixed adenoneuroendocrine carcinoma at 23 hospitals in China from January 2006 to December 2016. In addition, patients with gastric adenocarcinoma were selected as controls. Propensity score-matched analysis was used to match pathological stage among the different pathological types, and disease-free survival (DFS), postrecurrence survival (PRS), and patterns of recurrence were examined. Data analysis was conducted from July 15, 2020, to October 21, 2020.EXPOSURES Curative resection for gastric neuroendocrine carcinoma, gastric mixed adenoneuroendocrine carcinoma, and gastric adenocarcinoma. MAIN OUTCOMES AND MEASURESThe main outcomes were DFS and patterns of recurrence. RESULTS A total of 3689 patients were analyzed (median [interquartile range] age, 62 [55][56][57][58][59][60][61][62][63][64][65][66][67][68][69] years; 2748 [74.5%] men), including 503 patients (13.6%) with gastric neuroendocrine carcinoma, 401 patients (10.9%) with gastric mixed adenoneuroendocrine carcinoma, and 2785 patients (75.5%) with gastric adenocarcinoma. After propensity score matching, 5-year DFS was 47.6% (95% CI, 42.7%-52.5%) for patients with gastric neuroendocrine carcinoma, compared with 57.6% (95% CI, 55.1%-60.1%) with gastric adenocarcinoma (P < .001) and 51.1% (95% CI, 46.0%-56.2%) for patients with gastric mixed adenoneuroendocrine carcinoma, compared with 57.8% (95% CI, 55.1%-60.5%) patients with gastric adenocarcinoma (P = .02). Multivariable analyses found that, compared with gastric adenocarcinoma, gastric neuroendocrine carcinoma (hazard ratio [HR], 1.64; 95% CI, 1.40-1.93) and gastric mixed adenoneuroendocrine carcinoma (HR, 1.25; 95% CI, 1.05-1.49) were independent risk factors associated with worse DFS. Compared with matched patients with gastric adenocarcinoma, patients with gastric neuroendocrine carcinoma were more likely to have distant recurrence (268 patients [17.2%] vs 101 patients [23.7%]; P = .002), as were patients with gastric mixed adenoneuroendocrine carcinoma (232 patients [17.3%] vs 76 patients [22.8%]; P = .02). In (continued) Key Points Question Are there any differences in prognoses or recurrence patterns associated with gastric neuroendocrine carcinoma, mixed adenoneuroendocrine carcinoma, or adenocarcinoma? Findings This cohort study included 3689 patients with resectable gastric adenocarcinoma, gastric neuroendocrine carcinoma, or gastric mixed adeno...

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Short-term Outcomes of a Multicenter Randomized Controlled Trial Comparing Laparoscopic Distal Gastrectomy With D2 Lymphadenectomy to Open Distal Gastrectomy for Locally Advanced Gastric Cancer (KLASS-02-RCT)

Cited by 333 publications

References 20 publications

Clinical pathway for enhanced recovery after surgery for gastric cancer: A prospective single‐center phase II clinical trial for safety and efficacy

Clinical pathway for enhanced recovery after surgery for gastric cancer: A prospective single‐center phase II clinical trial for safety and efficacy

Effect of Laparoscopic vs Open Distal Gastrectomy on 3-Year Disease-Free Survival in Patients With Locally Advanced Gastric Cancer

Comparison of Survival and Patterns of Recurrence in Gastric Neuroendocrine Carcinoma, Mixed Adenoneuroendocrine Carcinoma, and Adenocarcinoma

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