Clinical Efficacy of Laparoscopic Sentinel Node Navigation Surgery for Stomach Preservation in Patients With Early Gastric Cancer: 5-year Results of the SENORITA Trial.

OBJECTIVE: This study aimed to compare laparoscopic standard gastrectomy (LSG) and laparoscopic sentinel node navigation surgery (LSNNS) for EGC in terms of 5-year long-term oncologic outcomes. SUMMARY BACKGROUND DATA: The oncological safety of LSNNS for early gastric cancer (EGC) has not been confirmed. Three-year disease-free survival (DFS), which is the primary endpoint of the phase III multicenter randomized controlled clinical trial (SEntinel Node ORIented Tailored Approach [SENORITA] trial), did not show the non-inferiority of LSNNS relative to LSG. METHODS: The SENORITA trial, a multicenter randomized clinical trial, was designed to show that LSNNS is non-inferior to LSG in terms of 3-year DFS. In the present study, we collected 5-year follow-up data from 527 patients recruited in the SENORITA trial as the full analysis set (FAS). Disease-free survival (DFS), overall survival (OS), disease-specific survival (DSS), and recurrence patterns were evaluated using the FAS of both LSG (n=269) and LSNNS (n=258). RESULTS: The 5-year DFS was not significantly different between the LSG and LSNNS groups (P=0.0561). During the 5-year follow-up, gastric cancer-related events, such as metachronous cancer, were more frequent in the LSNNS group than in the LSG group. However, ten recurrent cancers in the remnant stomach of both groups were curatively resected by additional gastrectomy and one by additional endoscopic resection. Two of the 198 patients who underwent local resection for stomach preservation based on the LSNNS results developed distant metastasis. However, there was no statistically significant difference in the 5-year OS and DSS (P=0.7403 and P=0.9586, respectively) between the two groups. CONCLUSION: The 5-year DFS, DSS and OS did not differ significantly between the two groups. Considering the benefits of LSNNS on postoperative quality of life, LSNNS could be recommended as an alternative treatment option for EGC.

Feasibility of Regional Lymphadenectomy for Stomach-Preserving Surgery in Early Gastric Cancer Omitting Sentinel Node Navigation: A Post Hoc Analysis of the SENORITA Trial.

BACKGROUND: Sentinel node navigation (SNN) has been known as the effective treatment for stomach-preserving surgery in early gastric cancer; however, SNN presents several technical difficulties in real practice. OBJECTIVE: This study aimed to evaluate the feasibility of regional lymphadenectomy omitting SNN, using the post hoc analysis of a randomized controlled trial. METHODS: Using data from the SENORITA trial that compared laparoscopic standard gastrectomy with lymphadenectomy and laparoscopic SNN, 237 patients who underwent SNN were included in this study. Tumor location was divided into longitudinal and circumferential directions. According to the location of the tumor, the presence or absence of lymph node (LN) metastases between sentinel and non-sentinel basins were analyzed. Proposed regional LN stations were defined as the closest area to the primary tumor. Sensitivities, specificities, positive predictive values, and negative predictive values (NPV) of SNN and regional lymphadenectomy were compared. RESULTS: Metastasis to non-sentinel basins with tumor-free in sentinel basins was observed in one patient (0.4%). The rate of LN metastasis to non-regional LN stations without regional LN metastasis was 2.5% (6/237). The sensitivity and NPV of SNN were found to be significantly higher than those of regional lymphadenectomy (96.8% vs. 80.6% [p = 0.016] and 99.5% vs. 97.2% [p = 0.021], respectively). CONCLUSIONS: This study showed that regional lymphadenectomy for stomach-preserving surgery, omitting SNN, was insufficient; therefore, SNN is required in stomach-preserving surgery.

A predictive model using MRI and clinicopathologic features for breast cancer recurrence in young women treated with upfront surgery.

OBJECTIVES: To identify preoperative breast MR imaging and clinicopathological variables related to recurrence and develop a risk prediction model for recurrence in young women with breast cancer treated with upfront surgery. METHODS: This retrospective study analyzed 438 consecutive women with breast cancer aged 35 years or younger between January 2007 and December 2016. Breast MR images before surgery were independently reviewed by breast radiologists blinded to patient outcomes. The clinicopathological data including patient demographics, clinical features, and tumor characteristics were reviewed. Univariate and multivariate logistic regression analyses were used to identify the independent factors associated with recurrence. The risk prediction model for recurrence was developed, and the discrimination and calibration abilities were assessed. RESULTS: Of 438 patients, 95 (21.7%) developed recurrence after a median follow-up of 65 months. Tumor size at MR imaging (HR = 1.158, p = 0.006), multifocal or multicentric disease (HR = 1.676, p = 0.017), and peritumoral edema on T2WI (HR = 2.166, p = 0.001) were identified as independent predictors of recurrence, while adjuvant endocrine therapy (HR = 0.624, p = 0.035) was inversely associated with recurrence. The prediction model showed good discrimination ability in predicting 5-year recurrence (C index, 0.707 in the development cohort; 0.686 in the validation cohort) and overall recurrence (C index, 0.699 in the development cohort; 0.678 in the validation cohort). The calibration plot demonstrated an excellent correlation (concordance correlation coefficient, 0.903). CONCLUSION: A prediction model based on breast MR imaging and clinicopathological features showed good discrimination to predict recurrence in young women with breast cancer treated with upfront surgery, which could contribute to individualized risk stratification. CLINICAL RELEVANCE STATEMENT: Our prediction model, incorporating preoperative breast MR imaging and clinicopathological features, predicts recurrence in young women with breast cancer undergoing upfront surgery, facilitating personalized risk stratification and informing tailored management strategies. KEY POINTS: Younger women with breast cancer have worse outcomes than those diagnosed at more typical ages. The described prediction model showed good discrimination performance in predicting 5-year and overall recurrence. Incorporating better risk stratification tools in this population may help improve outcomes.

Prognostic Performance of Preoperative Staging: Assessed by Using Multidetector Computed Tomography-Between the New Clinical Classification and the Pathological Classification in the Eighth American Joint Committee on Cancer Classification for Gastric Carcinoma.

BACKGROUND: Since the eighth American Joint Committee on Cancer (AJCC) classification recently introduced the clinical classification for preoperative staging of gastric cancer, the new clinical classification has not been extensively validated yet. Therefore, in this study, we compared the prognostic performance of the new clinical classification and the pathologic classification for preoperative staging of gastric cancer. METHODS: We reviewed 3027 patients with gastric cancer who were surgically treated between 2009 and 2013. Patient survival was analyzed according to the preoperative stage by the clinical classification and the pathologic classification in the eighth AJCC classification. The prognostic performance was examined using the Akaike information criterion (AIC) value and Harrell c-index. RESULTS: Patient survival was significantly different across the different stages when both classifications were used. However, individual pairwise comparisons showed that survival differences between each stage were more distinctive and homogeneous in the pathologic classification. In the multivariate model adjusted for the final pathologic stage, preoperative staging by the pathologic classification was an independent prognostic factor, whereas the clinical classification was not. The pathologic classification showed a lower AIC value compared with the clinical classification (5100.64 vs. 5114.14). The Harrell c-index was higher in the pathologic classification than in the clinical classification (0.741 vs. 0.739). CONCLUSIONS: The new clinical classification in the eighth AJCC classification discriminates patient survival well. However, it does not appear to have a better prognostic performance compared with the pathologic classification for preoperative staging of gastric cancer.

Reduced anastomotic complications with intracorporeal esophagojejunostomy using endoscopic linear staplers (overlap method) in laparoscopic total gastrectomy for gastric carcinoma.

BACKGROUND: With advances in surgical technique and instrumentation, intracorporeal anastomosis is increasingly being performed for laparoscopic total gastrectomy (LTG). However, the benefits of intracorporeal anastomosis in reducing postoperative complications have not been demonstrated, although its technical feasibility has been proven in many studies. In this study, we investigated the impact of intracorporeal anastomosis in reducing postoperative complications after LTG. METHODS: We analyzed 410 consecutive gastric cancer patients who underwent LTG between 2008 and 2018. Of these, 118 underwent intracorporeal anastomosis using linear staplers (overlap method), while 292 underwent extracorporeal anastomosis using a circular stapler. Short-term surgical outcomes including postoperative complications were compared between the two groups. RESULTS: The two groups showed no significant differences in age, sex, comorbidity, and abdominal surgery history. D2 lymph node dissection was more frequently performed in the intracorporeal group because of the presence of more advanced cancer stages. The overall morbidity in the intracorporeal and extracorporeal group was 23.7% and 27.7%, respectively (p = 0.405). However, the intracorporeal group showed a significantly lower incidence of late complications (0.8% vs. 7.5%, p = 0.008). Concerning complications, the incidence of anastomotic bleeding (0% vs. 5.5%, p = 0.008) and anastomotic stenosis (0% vs. 4.5%, p = 0.024) was significantly lower in the intracorporeal group. In univariate and multivariate analyses, American Society of Anesthesiologists score and operative bleeding were independent predictive factors for postoperative complications in patients who underwent intracorporeal anastomosis. CONCLUSIONS: Intracorporeal anastomosis using linear staplers reduced anastomotic bleeding and stenosis compared to extracorporeal anastomosis after LTG. Future research will be required to determine the ideal method for intracorporeal anastomosis in LTG.

Compliance with an Enhanced Recovery After a Surgery Program for Patients Undergoing Gastrectomy for Gastric Carcinoma: A Phase 2 Study.

BACKGROUND: Enhanced recovery after surgery (ERAS) programs have gained widespread acceptance in different fields of major surgery. However, most elements of perioperative care in ERAS are based on practices that originated from colorectal surgery. This study investigated compliance with the main elements of ERAS for patients undergoing gastrectomy for gastric carcinoma. METHODS: This phase 2 study enrolled 168 patients undergoing elective gastrectomy for gastric carcinoma. An ERAS program consisting of 18 main elements was implemented, and compliance with each element was evaluated (ClinicalTrials.gov, NCT01653496). RESULTS: Distal gastrectomy was performed for 142 patients (84.5%) and total gastrectomy for 26 patients (10.1%). Laparoscopic surgery was performed for 141 patients (86%). The postoperative morbidity rate was 9.5%, and the mortality rate was 0%. The rates of compliance with the 18 main elements of ERAS ranged from 88.1 to 100%. The lowest compliance rate was observed in the restriction of intravenous fluid element (88.1%). Overall, all ERAS elements were successfully applied for 122 patients (72.6%). In the multivariate analysis, the significant factors that adversely affected compliance with ERAS were surgery during the early study period [odds ratio (OR) 0.39; p = 0.038], open surgery (OR 0.15; p <0.001), and postoperative morbidity (OR 0.16; p = 0.003). CONCLUSIONS: Most elements of ERAS can be successfully applied for patients undergoing gastrectomy for gastric carcinoma. Multimodal collaboration between providers is essential to achieve proper application of ERAS.

Prevalence of Malnutrition in Hospitalized Patients: a Multicenter Cross-sectional Study.

BACKGROUND: Malnutrition is associated with many adverse clinical outcomes. The present study aimed to identify the prevalence of malnutrition in hospitalized patients in Korea, evaluate the association between malnutrition and clinical outcomes, and ascertain the risk factors of malnutrition. METHODS: A multicenter cross-sectional study was performed with 300 patients recruited from among the patients admitted in 25 hospitals on January 6, 2014. Nutritional status was assessed by using the Subjective Global Assessment (SGA). Demographic characteristics and underlying diseases were compared according to nutritional status. Logistic regression analysis was performed to identify the risk factors of malnutrition. Clinical outcomes such as rate of admission in intensive care units, length of hospital stay, and survival rate were evaluated. RESULTS: The prevalence of malnutrition in the hospitalized patients was 22.0%. Old age (≥ 70 years), admission for medical treatment or diagnostic work-up, and underlying pulmonary or oncological disease were associated with malnutrition. Old age and admission for medical treatment or diagnostic work-up were identified to be risk factors of malnutrition in the multivariate analysis. Patients with malnutrition had longer hospital stay (SGA A = 7.63 ± 6.03 days, B = 9.02 ± 9.96 days, and C = 12.18 ± 7.24 days, P = 0.018) and lower 90-day survival rate (SGA A = 97.9%, B = 90.7%, and C = 58.3%, P < 0.001). CONCLUSION: Malnutrition was common in hospitalized patients, and resulted in longer hospitalization and associated lower survival rate. The rate of malnutrition tended to be higher when the patient was older than 70 years old or hospitalized for medical treatment or diagnostic work-up compared to elective surgery.

Compliance with Guidelines of Enhanced Recovery After Surgery in Elderly Patients Undergoing Gastrectomy.

BACKGROUND: Enhanced recovery after surgery (ERAS) aims at expediting postoperative recovery by implementing specific strategies in perioperative management. However, the tolerance to such fast-tracking protocols is under debate, especially in elderly patients. We aimed to investigate rate of compliance with the main ERAS guidelines in elderly gastrectomy patients. METHODS: Using data for 168 gastric cancer patients who underwent ERAS after gastrectomy as part of Clinical Trial NCT01653496, we calculated the rates of compliance with nine main ERAS guidelines and compared the compliance rates of elderly (≥70 years) and non-elderly (<70 years) patients. Surgical outcomes and fulfillment of criteria for postoperative discharge were also compared. RESULTS: The study included 55 elderly and 113 non-elderly patients. There were no significant differences between these groups of patients with respect to operative techniques and tumor stage. Except for restricted intravenous fluid administration, the patients in both groups showed very high compliance rates (>90%) for every ERAS guideline. Notably, the overall compliance rates did not differ significantly between the groups. Postoperatively, the mean time to fulfillment of discharge criteria was slightly longer for elderly patients (4.7 vs. 4.2 days, p = 0.005), but there were no significant differences between the groups with respect to the incidence of postoperative complications, length of hospitalization, and readmission rate. CONCLUSION: Compliance of the medically and physically fit elderly patients with the main ERAS guidelines is comparable to that of non-elderly patients, and such protocols can be safely applied to elderly patients without significant modification.

Effect of Intravenous Ferric Carboxymaltose on Hemoglobin Response Among Patients With Acute Isovolemic Anemia Following Gastrectomy: The FAIRY Randomized Clinical Trial.

IMPORTANCE: Acute isovolemic anemia occurs when blood loss is replaced with fluid. It is often observed after surgery and negatively influences short-term and long-term outcomes. OBJECTIVE: To evaluate the efficacy and safety of ferric carboxymaltose to treat acute isovolemic anemia following gastrectomy. DESIGN, SETTING, AND PARTICIPANTS: The FAIRY trial was a patient-blinded, randomized, phase 3, placebo-controlled, 12-week study conducted between February 4, 2013, and December 15, 2015, in 7 centers across the Republic of Korea. Patients with a serum hemoglobin level of 7 g/dL to less than 10 g/dL at 5 to 7 days following radical gastrectomy were included. INTERVENTIONS: Patients were randomized to receive a 1-time or 2-time injection of 500 mg or 1000 mg of ferric carboxymaltose according to body weight (ferric carboxymaltose group, 228 patients) or normal saline (placebo group, 226 patients). MAIN OUTCOMES AND MEASURES: The primary end point was the number of hemoglobin responders, defined as a hemoglobin increase of 2 g/dL or more from baseline, a hemoglobin level of 11 g/dL or more, or both at week 12. Secondary end points included changes in hemoglobin, ferritin, and transferrin saturation levels over time, percentage of patients requiring alternative anemia management (oral iron, transfusion, or both), and quality of life at weeks 3 and 12. RESULTS: Among 454 patients who were randomized (mean age, 61.1 years; women, 54.8%; mean baseline hemoglobin level, 9.1 g/dL), 96.3% completed the trial. At week 12, the number of hemoglobin responders was significantly greater for ferric carboxymaltose vs placebo (92.2% [200 patients] for the ferric carboxymaltose group vs 54.0% [115 patients] for the placebo group; absolute difference, 38.2% [95% CI, 33.6%-42.8%]; P = .001). Compared with the placebo group, patients in the ferric carboxymaltose group experienced significantly greater improvements in serum ferritin level (week 12: 233.3 ng/mL for the ferric carboxymaltose group vs 53.4 ng/mL for the placebo group; absolute difference, 179.9 ng/mL [95% CI, 150.2-209.5]; P = .001) and transferrin saturation level (week 12: 35.0% for the ferric carboxymaltose group vs 19.3% for the placebo group; absolute difference, 15.7% [95% CI, 13.1%-18.3%]; P = .001); but there were no significant differences in quality of life. Patients in the ferric carboxymaltose group required less alternative anemia management than patients in the placebo group (1.4% for the ferric carboxymaltose group vs 6.9% for the placebo group; absolute difference, 5.5% [95% CI, 3.3%-7.6%]; P = .006). The total rate of adverse events was higher in the ferric carboxymaltose group (15 patients [6.8%], including injection site reactions [5 patients] and urticaria [5 patients]) than the placebo group (1 patient [0.4%]), but no severe adverse events were reported in either group. CONCLUSION AND RELEVANCE: Among adults with isovolemic anemia following radical gastrectomy, the use of ferric carboxymaltose compared with placebo was more likely to result in improved hemoglobin response at 12 weeks. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01725789.

Assessment of laparoscopic stomach preserving surgery with sentinel basin dissection versus standard gastrectomy with lymphadenectomy in early gastric cancer-A multicenter randomized phase III clinical trial (SENORITA trial) protocol.

BACKGROUND: Along with the marked increase in early gastric cancer (EGC) in the Eastern countries, there has been an effort to adopt the sentinel node concept in EGC to preserve gastric function and reduce the occurrence of postoperative complications. Based on promising results from a previous quality control study, this prospective multicenter randomized controlled phase III clinical trial aims to elucidate the oncologic safety of laparoscopic stomach-preserving surgery with sentinel basin dissection (SBD) compared to a standard laparoscopic gastrectomy. METHODS/DESIGN: This trial is an investigator-initiated, open-label, multicenter randomized controlled phase III trial with a non-inferiority design. Patients diagnosed with a single lesion of clinical stage T1N0M0 gastric adenocarcinoma, with a diameter of 3 cm or less are eligible for the present study. A total of 580 patients (290 per group) will be randomized to either laparoscopic stomach-preserving surgery with SBD or standard surgery. The primary end-point is 3-year disease-free survival (DFS) and the secondary endpoints include postoperative morbidity and mortality, quality of life, 5-year DFS, and overall survival. Qualified investigators who completed the prior quality control study are exclusively allowed to participate in this phase III clinical trial. DISCUSSION: The proposed trial is expected to verify whether laparoscopic stomach-preserving surgery with SBD achieves similar oncologic outcomes and improved quality of life compared to a standard gastrectomy in EGC patients. TRIAL REGISTRATION: This study was registered at the NIH ClinicalTrial.gov database ( NCT01804998 ) on March 4th, 2013.

HOXB5 induces invasion and migration through direct transcriptional up-regulation of ß-catenin in human gastric carcinoma.

HOX (homeobox) genes encode a family of transcriptional regulators, which have an important role in morphogenesis and differentiation during embryonic development. Their deregulated expression is involved in the carcinogenesis of many human solid tumours. In the present study, we show that HOXB5 mRNA was significantly overexpressed in gastric cancer tissues compared with adjacent normal tissues. HOXB5-up-regulated cancer cells showed increased invasion and migration activity, but no change in proliferation activity, whereas HOXB5-down-regulated cells showed decreased invasion and migration activity. Up-regulation of HOXB5 resulted in up-regulation of ß-catenin, whereas inhibition of HOXB5 expression by siRNA led to the down-regulation of ß-catenin. Moreover, a significant correlation between HOXB5 and CTNNB1 (ß-catenin) mRNA expression was detected in gastric cancer tissues. Furthermore, we found that HOXB5 binds directly to the CTNNB1 promoter region and activates the transcriptional expression of ß-catenin, as well as its downstream target genes, encoding cyclin D1 and c-Myc, leading to an increase in the invasion and migration activity of human gastric cancer cells. Thus HOXB5 may be an important regulator of the Wnt/ß-catenin signalling pathway, thereby contributing to gastric cancer progression and metastasis.

Safety and feasibility during the initial learning process of intracorporeal Billroth I (delta-shaped) anastomosis for laparoscopic distal gastrectomy.

BACKGROUND: Intracorporeal Billroth I (ICBI) (delta-shaped) anastomosis is being increasingly used for laparoscopic distal gastrectomy. However, few studies have focused on the safety and feasibility of adopting this new technique. The present study aimed to review the surgical outcomes after the initial experience of performing ICBI anastomosis and to evaluate whether this technique can be safely adopted without increasing operative risk during the early learning process. METHODS: Forty-two consecutive patients who underwent ICBI anastomosis with laparoscopic distal gastrectomy by a single surgeon were enrolled, and their operative outcomes and hospital course were compared with those of 179 patients who underwent conventional extracorporeal Billroth I (ECBI) anastomosis by the same operator. The learning curve was assessed by evaluating the moving average of anastomosis time. RESULTS: The operating time in the ICBI group was significantly longer than that in the ECBI group (142 vs. 116 min, p < 0.001). However, there were no significant differences in the postoperative hospital course such as gas passage, diet initiation, postoperative fever, and hospital stay between the two groups. Postoperative morbidity did not significantly differ between the ICBI and ECBI groups (7.1 vs. 12.3 %, p = 0.428). No anastomosis-related complications occurred in the ICBI group. The mean anastomosis time for ICBI anastomosis was 24 ± 5 min, and the anastomosis average time curve showed that it reached a plateau approximately after the 14th case. CONCLUSIONS: ICBI anastomosis has a steep learning curve without increasing operative risk in the early learning process, when performed by experienced laparoscopic surgeons. The technical feasibility and clinical advantages of intracorporeal anastomosis need to be proven in future clinical trials.

Thymosin ß4 induces invasion and migration of human colorectal cancer cells through the ILK/AKT/ß-catenin signaling pathway.

Thymosin ß4 (Tß4) is a 43-amino-acid peptide involved in many biological processes. However, the precise molecular signaling mechanism(s) of Tß4 in cell invasion and migration remain unclear. In this study, we show that Tß4 was significantly overexpressed in colorectal cancer tissues compared to adjacent normal tissues and high levels of Tß4 were correlated with stage of colorectal cancer, and that Tß4 expression was associated with morphogenesis and EMT. Tß4-upregulated cancer cells showed increased adhesion, invasion and migration activity, whereas Tß4-downregulated cells showed decreased activities. We also demonstrated that Tß4 interacts with ILK, which promoted the phosphorylation and activation of AKT, the phosphorylation and inactivation of GSK3ß, the expression and nuclear localization of ß-catenin, and integrin receptor activation. These results suggest that Tß4 is an important regulator of the ILK/AKT/ß-catenin/Integrin signaling cascade to induce cell invasion and migration in colorectal cancer cells, and is a potential target for cancer treatment.

The safety and feasibility of early postoperative oral nutrition on the first postoperative day after gastrectomy for gastric carcinoma.

BACKGROUND: Unlike the wide acceptance of early enteral nutrition after colorectal surgery, little information is available regarding the feasibility of immediate oral nutrition after gastric cancer surgery. This study evaluated the feasibility and safety of oral nutrition on the first postoperative day after gastrectomy. METHODS: From September 2010 to March 2011, 74 consecutive gastric cancer patients received an oral diet on the first postoperative day after gastrectomy. Surgical outcomes, including hospital stay, morbidity, and mortality, were compared with a conventional diet group (n = 96, before September 2010), in which an oral diet was started on the third or fourth postoperative day. RESULTS: No significant differences were found in the clinicopathological characteristics or operation types between the two groups. Average diet start times in the early diet (ED) and conventional diet (CD) groups were 1.8 and. 3.2, respectively (p < 0.001). The mean hospital stay was significantly shorter in the ED group (7.4 vs. 8.9 days, p = 0.004). There was no significant difference in postoperative morbidity (p = 0.947) between the two groups. Gastrointestinal-related complications, such as anastomosis leakage or postoperative ileus, were also similar in the two groups. Overall compliance to early oral nutrition in the ED group was 78.5 %, and an old age (≥70 years) was found to affect the compliance to early postoperative oral nutrition. CONCLUSIONS: Postoperative oral nutrition is safe and feasible on the first postoperative day after gastrectomy. However, elderly patients require careful monitoring when applying early oral nutrition after gastrectomy.

Quality of Life and Nutritional Outcomes of Stomach-Preserving Surgery for Early Gastric Cancer: A Secondary Analysis of the SENORITA Randomized Clinical Trial.

Importance: The Sentinel Node Oriented Tailored Approach (SENORITA) randomized clinical trial evaluated quality of life (QoL) and nutritional outcomes between the laparoscopic sentinel node navigation surgery (LSNNS) and laparoscopic standard gastrectomy (LSG). However, there has been no report on the QoL and nutritional outcomes of patients who underwent stomach-preserving surgery among the LSNNS group. Objective: To compare long-term QoL and nutritional outcomes between patients who underwent stomach-preserving surgery and those who underwent standard gastrectomy and to identify factors associated with poor QoL outcomes in patients who underwent stomach-preserving surgery. Design, Setting, and Participants: This study is a secondary analysis of the SENORITA trial, a randomized clinical trial comparing LSNNS with LSG. Patients from 7 tertiary or general hospitals across the Republic of Korea were enrolled from March 2013 to December 2016, with follow-up through 5 years. Data were analyzed between August and September 2022. Among trial participants, patients who underwent actual laparoscopic standard gastrectomy in the LSG group and those who underwent stomach-preserving surgery in the LSNNS group were included. Patients who did not complete the baseline or any follow-up questionnaire were excluded. Intervention: Stomach-preserving surgery vs standard gastrectomy. Main Outcomes and Measures: Overall European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC QLQ-C30) and stomach module (STO22) scores, body mass index, hemoglobin, protein, and albumin levels. Results: A total of 194 and 257 patients who underwent stomach-preserving surgery and standard gastrectomy, respectively, were included in this study (mean [SD] age, 55.6 [10.6] years; 249 [55.2%] male). The stomach-preserving group had better QoL scores at 3 months postoperatively in terms of physical function (87.2 vs 83.9), dyspnea (5.9 vs 11.2), appetite loss (13.1 vs 19.4), dysphagia (8.0 vs 12.7), eating restriction (10.9 vs 18.2), anxiety (29.0 vs 35.2), taste change (7.4 vs 13.0), and body image (19.5 vs 27.2). At 1 year postoperatively, the stomach-preserving group had significantly higher body mass index (23.9 vs 22.1, calculated as weight in kilograms divided by height in meters squared) and hemoglobin (14.3 vs 13.3 g/dL), albumin (4.3 vs 4.25 g/dL), and protein (7.3 vs 7.1 g/dL) levels compared to the standard group. Multivariable analyses showed that tumor location (greater curvature, lower third) was favorably associated with global health status (ß, 10.5; 95% CI, 3.2 to 17.8), reflux (ß, -8.4; 95% CI, -14.7 to -2.1), and eating restriction (ß, -5.7; 95% CI, -10.3 to -1.0) at 3 months postoperatively in the stomach-preserving group. Segmental resection was associated with risk of diarrhea (ß, 40.6; 95% CI, 3.1 to 78.1) and eating restriction (ß, 15.1; 95% CI, 1.1 to 29.1) at 3 years postoperatively. Conclusions and Relevance: Stomach-preserving surgery after sentinel node evaluation was associated with better long-term QoL and nutritional outcomes than standard gastrectomy. These findings may help facilitate decision-making regarding treatment for patients with early-stage gastric cancer. Trial Registration: ClinicalTrials.gov Identifier: NCT01804998.

Morbidity and Mortality After Laparoscopy-Assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy to Treat Gastric Cancer: An Interim Report: A Phase III Multicenter, Prospective, Randomized Trial (The KLASS-07 Trial).

PURPOSE: We conducted a randomized prospective trial (KLASS-07 trial) to compare laparoscopy-assisted distal gastrectomy (LADG) and totally laparoscopic distal gastrectomy (TLDG) for gastric cancer. In this interim report, we describe short-term results in terms of morbidity and mortality. METHODS AND METHODS: The sample size was 442 participants. At the time of the interim analysis, 314 patients were enrolled and randomized. After excluding patients who did not undergo planned surgeries, we performed a modified per-protocol analysis of 151 and 145 patients in the LADG and TLDG groups, respectively. RESULTS: The baseline characteristics, including comorbidity status, did not differ between the LADG and TLDG groups. Blood loss was somewhat higher in the LADG group, but statistical significance was not attained (76.76±72.63 vs. 62.91±65.68 mL; P=0.087). Neither the required transfusion level nor the operation or reconstruction time differed between the 2 groups. The mini-laparotomy incision in the LADG group was significantly longer than the extended umbilical incision required for specimen removal in the TLDG group (4.79±0.82 vs. 3.89±0.83 cm; P<0.001). There were no between-group differences in the time to solid food intake, hospital stay, pain score, or complications within 30 days postoperatively. No mortality was observed in either group. CONCLUSIONS: Short-term morbidity and mortality rates did not differ between the LADG and TLDG groups. The KLASS-07 trial is currently underway. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03393182.

Reappraisal of optimal reconstruction after distal gastrectomy - a study based on the KLASS-07 database.

BACKGROUNDS: This study aimed to compare the incidence of bile reflux, quality of life (QoL), and nutritional status among Billroth II (BII), Billroth II with Braun anastomosis (BII-B), and Roux-en-Y (RY) reconstruction after laparoscopic distal gastrectomy (LDG). MATERIALS AND METHODS: We reviewed the prospective data of 397 patients from a multicentre database who underwent LDG for gastric cancer between 2018 and 2020 at 20 tertiary teaching hospitals in Korea. Postoperative endoscopic findings, QoL surveys using the European Organization for Research and Treatment of Cancer questionnaire (C30 and STO22), and nutritional and surgical outcomes were compared among groups. RESULTS: In endoscopic findings, bile reflux was the lowest in the RY group ( n =67), followed by the BII-B ( n =183) and BII groups ( n =147) at 1 year (3.0 vs. 67.8 vs. 84.4%, all P <0.05). The anti-reflux capability of BII-B was statistically better than that of BII, but not as perfect as that of RY. From the perspective of QoL, BII-B was not inferior to RY, but better than BII reconstruction in causing fewer STO22 reflux symptoms at 6 and 12 months. However, only RY caused fewer C30 nausea symptoms than BII at 6 and 12 months, but not BII-B. Nutritional status and morbidities were similar among the three groups, and the operative time did not differ between the BII-B and RY groups. CONCLUSIONS: BII-B cannot substitute for RY in preventing bile reflux, shortening the operative time, or reducing morbidities. Regarding short-term QoL, BII-B was sufficient to reduce STO22 reflux symptoms but failed to reduce C30 nausea symptoms postoperatively.

Totally laparoscopic versus laparoscopy-assisted distal gastrectomy: the KLASS-07: a randomized controlled trial.

BACKGROUNDS: Strong evidence is lacking as no confirmatory randomized controlled trials (RCTs) have compared the efficacy of totally laparoscopic distal gastrectomy (TLDG) with laparoscopy-assisted distal gastrectomy (LADG). The authors performed an RCT to confirm if TLDG is different from LADG. METHODS: The KLASS-07 trial is a multi-centre, open-label, parallel-group, phase III, RCT of 442 patients with clinical stage I gastric cancer. Patients were enroled from 21 cancer care centres in South Korea between January 2018 and September 2020 and randomized to undergo TLDG or LADG using blocked randomization with a 1:1 allocation ratio, stratified by the participating investigators. Patients were treated through R0 resections by TLDG or LADG as the full analysis set of the KLASS-07 trial. The primary endpoint was morbidity within postoperative day 30, and the secondary endpoint was quality of life (QoL) for 1 year. This trial is registered at ClinicalTrials.gov (NCT03393182). RESULTS: Four hundred forty-two patients were randomized (222 to TLDG, 220 to LADG), and 422 patients were included in the pure analysis (213 and 209, respectively). The overall complication rate did not differ between the two groups (TLDG vs. LADG: 12.2% vs. 17.2%). However, TLDG provided less postoperative ileus and pulmonary complications than LADG (0.9% vs. 5.7%, P= 0.006; and 0.5% vs. 4.3%, P= 0.035, respectively). The QoL was better after TLDG than after LADG regarding emotional functioning at 6 months, pain at 3 months, anxiety at 3 and 6 months, and body image at 3 and 6 months (all P< 0.05). However, these QoL differences were resolved at 1 year. CONCLUSIONS: The KLASS-07 trial confirmed that TLDG is not different from LADG in terms of postoperative complications but has the advantages to reduce ileus and pulmonary complications. TLDG can be a good option to offer better QoL in terms of pain, body image, emotion, and anxiety at 3-6 months.

JOURNAL/ijos/04.03/01279778-202408000-00031/figure1/v/2024-08-13T152924Z/r/image-jpeg.

A propensity score-matched case-control comparative study of laparoscopic and open extended (D2) lymph node dissection for distal gastric carcinoma.

BACKGROUND: Technical proficiency at laparoscopic D2 lymph node dissection (LND) is essential for extending the use of laparoscopic surgery beyond the treatment of early gastric cancer (EGC). The aim of this study was to evaluate the technical and oncological feasibility of laparoscopic distal gastrectomy (LDG) with D2 LND for distal gastric cancer. METHODS: Of 922 patients who underwent open or LDG with D2 LND for gastric carcinoma, 133 treated by LDG and 133 treated by open distal gastrectomy (ODG) were selected using the propensity score matching method. The short-term surgical outcomes and long-term survivals of these matched groups were compared. RESULTS: The two study groups were well matched with respect to age, sex, body mass index, comorbidity, ASA score, abdominal operation history, and tumor stage. The LDG group had a significantly longer mean operating time (227 vs. 161 min, p < 0.001) but showed significantly less intraoperative blood loss (149 vs. 189 ml, p = 0.007). Total numbers of collected lymph nodes were similar in the two groups. Postoperatively, no significant intergroup differences were found for hospital stay, morbidity, or mortality. Furthermore, overall survivals were similar in the two groups (p = 0.621). Multivariate analysis showed that male gender, age ≥70 years, and intraoperative blood loss of ≥200 ml were independent risk factors of postoperative morbidity. CONCLUSIONS: Laparoscopic D2 LND for distal gastric cancer is technically safe and feasible compared with ODG. A prospective randomized trial is warranted to evaluate long-term oncological outcomes in advanced gastric carcinoma.