ABSTRACT
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.
ABSTRACT
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.
ABSTRACT
BACKGROUND: Fluorescent lymphography (FL) using indocyanine green (ICG) allows for the visualization of all draining lymph nodes (LNs), thereby increasing LN retrieval. However, no studies have assessed the efficacy of FL in high body mass index (BMI) gastric cancer patients, even as LN yield decreases with increasing BMI in gastrectomy. This study aimed to investigate the influence of FL on LN retrieval in high BMI gastric cancer patients. METHODS: Gastric cancer patients who underwent laparoscopic or robotic gastrectomies from 2013 to 2021 were included. Patients were classified into two groups, with FL (FL group) or without FL (non-FL group). The effect of FL on LN retrieval was assessed by BMI. Inverse probability of treatment weighting (IPTW) was used to ensure comparability between groups. RESULTS: Retrieved LN number decreased as BMI increased regardless of FL application (P < 0.001). According to the IPTW analysis, the mean retrieved LN number was significantly higher in the FL group (48.4 ± 18.5) than in the non-FL group (39.8 ± 16.3, P < 0.001), irrespective of BMI. The FL group exhibited a significantly higher proportion of patients with 16 or more LNs (99.5%) than the non-FL group (98.1%, P < 0.001). The FL group also had a significantly higher proportion of patients with 30 or more LNs (86.6%) than the non-FL group (72.2%, P < 0.001). In both the normal and high-BMI patients, the FL group had a significantly larger percentage of patients with a higher nodal classification than the non-FL group. CONCLUSION: FL resulted in more LN retrieval, even in high BMI patients. FL ensures accurate staging by maintaining the appropriate retrieved LN number in high BMI gastric cancer patients.
Subject(s)
Lymphography , Stomach Neoplasms , Humans , Lymphography/methods , Lymph Node Excision/methods , Body Mass Index , Stomach Neoplasms/diagnostic imaging , Stomach Neoplasms/surgery , Stomach Neoplasms/pathology , Lymph Nodes/diagnostic imaging , Lymph Nodes/surgery , Lymph Nodes/pathology , Coloring Agents , Gastrectomy/methods , Retrospective StudiesABSTRACT
BACKGROUND: Previous studies have focused on the non-inferiority of RPG compared with conventional port gastrectomy (CPG); however, we assumed that some candidates might derive more significant benefit from RPG over CPG. METHODS: We retrospectively analyzed the clinicopathological and perioperative parameters of 1442 patients with gastric cancer treated by gastrectomy between 2009 and 2022. The C-reactive protein level on postoperative day 3 (CRPD3) was used as a surrogate parameter for surgical trauma. Patients were grouped according to the extent of gastrectomy [subtotal gastrectomy (STG) or total gastrectomy (TG)] and lymph node dissection (D1+ or D2). The degree of surgical trauma, bowel recovery, and hospital stay between RPG and CPG was compared among those patient groups. RESULTS: Of 1442 patients, 889, 354, 129, and 70 were grouped as STGD1+, STGD2, TGD1+, and TGD2, respectively. Compared with CPG, RPG significantly decreased CRPD3 only among patients in the STGD1+ group (CPG: n = 653, 84.49 mg/L, 95% CI 80.53-88.45 vs. RPG: n = 236, 70.01 mg/L, 95% CI 63.92-76.09, P < 0.001). In addition, the RPG method significantly shortens bowel recovery and hospital stay in the STGD1+ (P < 0.001 and P < 0.001), STGD2 (P < 0.001 and P < 0.001), and TGD1+ (P = 0.026 and P = 0.007), respectively. No difference was observed in the TGD2 group (P = 0.313 and P = 0.740). CONCLUSIONS: The best candidates for RPG are patients who undergo STGD1+, followed by STGD2 and TG D1+, considering the reduction in CRPD3, bowel recovery, and hospital stay.
Subject(s)
Laparoscopy , Stomach Neoplasms , Humans , Stomach Neoplasms/pathology , Retrospective Studies , Laparoscopy/methods , Lymph Node Excision/methods , Gastrectomy/methods , Treatment OutcomeABSTRACT
OBJECTIVE: The aim of this study was to audit the 22 items and assessed each item's predictive value on surgical outcomes. BACKGROUND: The KLASS-02 trial revealed that the oncologic outcomes of laparoscopic distal gastrectomy are not inferior to open distal gastrectomy in patients with advanced gastric cancer. The surgeons participating in this trial were chosen based on the assessment scores from the KLASS-02-QC trial, which used 22 items for standardization of D2 lymphadenectomy and quality control. METHODS: We reviewed proficiency scores (PSs) for 22 items for 20 surgeons who participated in KLASS-02. The surgeons were divided into 2 groups according to PS, and the perioperative outcomes of 924 patients enrolled in KLASS-02 were compared between groups. Each item's predictive value for perioperative outcome was then assessed using multivariable regression models. RESULTS: Of the total 924 patients, 529 were operated on by high-score surgeons (high PS) and 395 were operated on by low-score surgeons (low-PS). High-PS group had less intraoperative blood loss, longer operation times, and fewer complications, major complications, reoperations, and shorter first flatus and hospital stay than low-PS group ( P =0.006, P <0.001, P <0.001, P <0.001, P =0.042, P =0.013, and P <0.001, respectively). Some items used in KLASS-02-QC predicted perioperative outcomes, such as intraoperative blood loss, major complications, reoperation, and hospital stay. CONCLUSIONS: Although this study only analyzed data associated with qualified surgeons, the 22 items effectively assessed the surgeons based on PS. A high score was associated with longer operation times, but better perioperative outcomes.
Subject(s)
Laparoscopy , Stomach Neoplasms , Surgeons , Humans , Blood Loss, Surgical , Gastrectomy/adverse effects , Treatment Outcome , Lymph Node Excision/adverse effects , Quality Control , Reference Standards , Stomach Neoplasms/surgery , Laparoscopy/adverse effects , Retrospective StudiesABSTRACT
BACKGROUND: The benefit of regular follow-up after curative resection for gastric cancer is controversial as there is no evidence that it will improve survival. This study assessed whether regular follow-up leads to improved survival in patients after surgery for gastric cancer. METHODS: A secondary analysis was undertaken of patients who participated in an RCT of laparoscopic versus open distal gastrectomy for advanced gastric cancer between November 2011 and April 2015. Depending on whether patients were compliant with the initial trial follow-up protocol or not, they were analysed as having had either regular or irregular follow-up. Clinicopathological characteristics, recurrence patterns, detection, treatments, and survival were compared between the groups. RESULTS: The regular and irregular follow-up groups comprised 712 and 263 patients respectively. Disease recurrence within 36 months was more common in the regular group than in the irregular group (17.0 versus 11.4 per cent; P = 0.041). Recurrence patterns did not differ between the groups. The 3-year recurrence-free survival rate was worse in the regular than in the irregular group (81.2 versus 86.5 per cent; P = 0.031). However, the 5-year overall survival rate was comparable (84.5 versus 87.5 per cent respectively; P = 0.160). Multivariable analysis revealed that type of follow-up was not an independent factor affecting 5-year overall survival. CONCLUSION: Regular follow-up after radical gastrectomy was not associated with improved overall survival.
Subject(s)
Laparoscopy , Stomach Neoplasms , Humans , Neoplasm Recurrence, Local/surgery , Laparoscopy/methods , Survival Rate , Gastrectomy/methods , Treatment OutcomeABSTRACT
BACKGROUND: The current standard operation for proximal gastric and gastroesophageal junction (P/GEJ) cancers with limited esophageal extension is total gastrectomy (TG). TG is associated with impaired appetite and weight loss due to the loss of gastric functions such as production of ghrelin and with anemia due to intrinsic factor loss and vitamin B12 malabsorption. Theoretically, proximal gastrectomy (PG) can mitigate these problems by preserving gastric function. However, PG with direct esophagogastric reconstruction is associated with severe postoperative reflux, delayed gastric emptying, and poor quality of life (QoL). Minimally invasive PG (MIPG) with antireflux techniques has been increasingly performed by experts but is technically demanding owing to its complexity. Moreover, the actual advantages of MIPG over minimally invasive TG (MITG) with regards to postoperative QoL are unknown. Our overall objective of this study is to determine the short-term QoL benefits of MIPG. Our central hypotheses are that MIPG is safe and that patients have improved appetite after MIPG with effective antireflux techniques, which leads to an overall QoL improvement when compared with MITG. METHODS: Enrollment of a total of 60 patients in this prospective survey-collection study is expected. Procedures (MITG versus MIPG, antireflux techniques for MIPG [double-tract reconstruction versus the double-flap technique]) will be chosen based on surgeon and/or patient preference. Randomization is not considered feasible because patients often have strong preferences regarding MITG and MIPG. The primary outcome is appetite level (reported on a 0-10 scale) at 3 months after surgery. With an expected 30 patients per cohort (MITG versus MIPG), this study will have 80% power to detect a one-point difference in appetite level. Patient-reported outcomes will be longitudinally collected (including questions about appetite and reflux), and specific QoL items, body weight, body mass index and ghrelin, albumin, and hemoglobin levels will be compared. DISCUSSION: Surgeons from the US, Japan, and South Korea formed this collaboration with the agreement that the surgical approach to P/GEJ cancers is an internationally important but controversial topic that requires immediate action. At the completion of the proposed research, our expected outcome is the establishment of the benefit and safety of MIPG. TRIAL REGISTRATION: This trial was registered with Clinical Trials Reporting Program Registration under the registration number NCI-2022-00267 on January 11, 2022, as well as with ClinicalTrials.gov under the registration number NCT05205343 on January 11, 2022.
Subject(s)
Ghrelin , Stomach Neoplasms , Humans , Quality of Life , Prospective Studies , Esophagogastric Junction/surgery , Stomach Neoplasms/surgery , GastrectomyABSTRACT
The surgical paradigm for gastric cancer has been changed from extended surgery to minimally invasive surgery. Laparoscopic surgery is a practical method for minimally invasive surgery for early gastric cancer, and the indication is expanding to advanced gastric cancer. In recent years, robotic gastrectomy has been highlighted as a breakthrough to overcome the drawbacks of laparoscopic gastrectomy. Here, we discuss the recent updates of modern surgical therapy for gastric cancer-robotics and beyond.
Subject(s)
Laparoscopy , Robotics , Stomach Neoplasms , Gastrectomy/methods , Humans , Laparoscopy/methods , Robotics/methods , Stomach Neoplasms/surgery , Treatment OutcomeABSTRACT
BACKGROUND: Minimally invasive surgery is now a standard treatment for gastric cancer. Many retrospective studies have reported that robotic gastrectomy is safe and feasible, with similar short- and long-term outcomes as laparoscopic gastrectomy. However, no studies have reported the details of surgical and survival outcomes for robotic gastrectomy. This study aimed to evaluate the surgical trends and techniques of robotic gastrectomy and analyze the surgical outcomes of 2000 consecutive patients with gastric cancer who underwent robotic gastrectomy over 14 years. METHODS: Between July 2005 and January 2019, 2000 consecutive robotic gastrectomies were performed. We evaluated short- and long-term outcomes as well as surgical trends after robotic gastrectomy. RESULTS: There were 1,560 subtotal gastrectomies (78%), 324 total gastrectomies (16.2%), 83 proximal gastrectomies (4.2%), and 33 completion total gastrectomies (1.7%). The rates of major complications and mortality were 3.1% and 0.3%, respectively. In a subgroup analysis, there were no significant differences in the rate of complications over time (P = 0.696). Five-year overall survival rates were 97.6% for stage I, 91.9% for stage II, and 69.2% for stage III, with a total recurrence rate of 5.3%. Since its adoption in 2005, the proportion of robotic gastrectomies, as well as technically demanding procedures have increased over time. CONCLUSIONS: Our 14 years' experience of 2000 robotic gastrectomies has shown the proportion, as well as the number of robotic gastrectomies, have tended to increase and trends toward to technically demanding procedures. Outcomes of robotic gastrectomy appear safe and feasible with acceptable short- and long-term outcomes.
Subject(s)
Laparoscopy , Robotic Surgical Procedures , Stomach Neoplasms , Gastrectomy/methods , Humans , Laparoscopy/methods , Retrospective Studies , Robotic Surgical Procedures/adverse effects , Stomach Neoplasms/surgery , Treatment OutcomeABSTRACT
Standard-of-care for resectable gastric/gastroesophageal junction cancer includes surgery and neoadjuvant-adjuvant 5-fluorouracil-leucovorin-oxaliplatin-docetaxel (FLOT) chemotherapy. Early-phase clinical studies support further clinical development of the immune checkpoint inhibitor (ICI); durvalumab, an anti-PD-L1 antibody, in patients with gastric/gastroesophageal junction cancer. Accumulating evidence indicates that ICIs combined with FLOT chemotherapy improve clinical outcomes in patients with advanced or metastatic cancer. We describe the rationale for and the design of MATTERHORN, a randomized, double-blind, placebo-controlled, phase III study investigating the efficacy and safety of neoadjuvant-adjuvant durvalumab and FLOT chemotherapy followed by adjuvant durvalumab monotherapy in patients with resectable gastric/gastroesophageal junction cancer. The planned sample size is 900 patients, the primary end point is event-free survival and safety and tolerability will be evaluated. Clinical trial registration: NCT04592913 (ClinicalTrials.gov).
Subject(s)
Adenocarcinoma , Stomach Neoplasms , Adenocarcinoma/pathology , Antibodies, Monoclonal , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Clinical Trials, Phase III as Topic , Esophagogastric Junction/pathology , Fluorouracil/adverse effects , Humans , Neoadjuvant Therapy , Randomized Controlled Trials as Topic , Stomach Neoplasms/pathologyABSTRACT
BACKGROUND: The number of gastric cancer survivors has been increasing, and such survivors experience various changes in their lives post-recovery. Adapting to these changes requires appropriate interventions that can improve their quality of life (QoL). This study was conducted to investigate the factors affecting the QoL of gastric cancer survivors and provide basic data for effective intervention. METHODS: Data were collected between September 8 and September 29, 2017, from the Gastric Cancer Center at a tertiary hospital. Questionnaire surveys were conducted using the EORTC QLQ-C30/STO22, Self-Efficacy-Scale, Multidimensional Scale of Perceived Social Support, and Quality of Life-Cancer Survivors Questionnaire on gastric cancer survivors who were followed up for 3 years after gastrectomy. Data were analyzed using descriptive statistics, t test, ANOVA, Pearson's correlation coefficient, and multiple regression analysis. RESULTS: A total of 136 gastric cancer survivors completed the questionnaire survey. There were significant positive correlations of QoL with self-efficacy, functional status, and social support (r = .35, p < .001; r = .53, p < .001; r = .26, p < .001, respectively). There were significant negative correlations of QoL with general symptoms (r = - .39, p < .001) and gastric cancer-specific symptoms (r = - .51, p < .001). The regression model explained 48.3% of the QoL, and the affecting factors were gastric cancer-specific symptoms (ß = - .397, p < .001), religious belief (ß = .299, p < .001), functional status (ß = .251, p = .003), and self-efficacy (ß = .191, p = .004). CONCLUSION: This study confirmed that gastric cancer-specific symptoms, spiritual well-being, self-efficacy, and functional status affect the QoL of gastric cancer survivors. Hence, these factors should be considered in the interventions to improve the QoL of gastric cancer survivors.
Subject(s)
Cancer Survivors , Stomach Neoplasms , Humans , Quality of Life , Surveys and Questionnaires , SurvivorsABSTRACT
BACKGROUND: Fluorescent lymphography is an excellent technique for complete lymph node dissection during minimally invasive surgery for gastric cancer. This study aimed to evaluate the role of fluorescent lymphography in splenic hilar lymph node dissection during minimally invasive total gastrectomy. METHODS: We retrospectively analyzed 168 gastric cancer patients who underwent minimally invasive total gastrectomy with D2 + No. 10 lymph node dissection from 2013 to 2018. Fluorescent lymphography was used whenever it is possible. However, when near-infrared imaging system and endoscopic indocyanine green injection were not available, we performed surgery without fluorescent lymphography. A total of 74 patients underwent surgery with fluorescent lymphography (FL group) and 94 underwent surgery without it (non-FL group). Perioperative and long-term outcomes including the number of retrieved lymph nodes at each nodal station were compared between groups. RESULTS: The median number of retrieved lymph nodes at the splenic hilum was larger in the FL group {2.5 [Interquartile range (IQR), 1-5]} than in the non-FL group [1 (IQR, 1-3); P = 0.012]. The negative predictive value of fluorescent lymphography for lymph node metastasis at the splenic hilum was 97.1%, although the sensitivity was 66.7%. The overall survival (FL: 96.9% vs. non-FL: 88.9%; P = 0.334) and relapse-free survival (FL: 90.5% vs. non-FL: 65.5%; P = 0.054) were higher in the FL group, although there were no statistical differences. However, among the patients without lymph node metastasis, the relapse-free survival was significantly higher in the FL group (100%) than in the non-FL group (67.1%; P = 0.017). CONCLUSIONS: Fluorescent lymphography is an effective tool for complete lymph node dissection at the splenic hilum. Moreover, it may help select patients who do not need splenic hilar lymph node dissection during a total gastrectomy.
Subject(s)
Stomach Neoplasms , Coloring Agents , Gastrectomy/methods , Humans , Lymph Node Excision/methods , Lymph Nodes/diagnostic imaging , Lymph Nodes/pathology , Lymph Nodes/surgery , Lymphatic Metastasis/pathology , Lymphography/methods , Neoplasm Recurrence, Local/surgery , Retrospective Studies , Stomach Neoplasms/diagnostic imaging , Stomach Neoplasms/pathology , Stomach Neoplasms/surgeryABSTRACT
BACKGROUND: Endoscopic submucosal dissection (ESD) application for patients with tumors beyond the expanded indication for ESD is inconclusive. This study aimed to identify the preoperative clinical features that can be curatively treated with ESD in patients with early gastric cancer (EGC) beyond the indication of ESD. METHODS: From 2006 to 2016, 673 patients who underwent gastrectomy for EGC beyond the expanded indication for ESD based on preoperative assessments were retrospectively reviewed. We identified tumors curatively resected by ESD based on the postoperative pathologic findings. We also analyzed the clinical and pre-treatment features to determine the risk factors associated with curative resection of ESD. RESULTS: 39% of the patients (263/673) who had undergone gastrectomy had tumors of endoscopic curability A or B (eCuraA/B) that could be treated by ESD alone. In multivariate analysis, tumor size ≤ 10 mm (OR 0.240; 95% CI = 0.12-0.46), no ulceration (OR 0.500; 95% CI = 0.29-0.87), differentiated histology (OR 0.599; 95% CI = 0.43-0.84), and location in the distal two-thirds of the stomach (OR 0.499; 95% CI = 0.28-0.88) in pre-treatment assessment were identified as independent predictors of eCuraA/B. Considering the risk factors, 63.6% (7/11)/61.3% (19/31) of patients with a differentiated/undifferentiated tumor size ≤ 10 mm located in distal two-third of the stomach without ulceration were deemed as eCuraA/B. CONCLUSIONS: This study suggests that patients with EGC indicated for surgery can be treated by ESD by adding tumor locations in the indication for ESD. Thus, ESD can be applied for patients with a tumor size ≤ 10 mm located in the lower/middle stomach without ulceration.
Subject(s)
Endoscopic Mucosal Resection , Stomach Neoplasms , Humans , Endoscopic Mucosal Resection/adverse effects , Stomach Neoplasms/surgery , Stomach Neoplasms/pathology , Retrospective Studies , Gastrectomy/adverse effects , Early Detection of Cancer , Gastric Mucosa/surgery , Gastric Mucosa/pathology , Treatment OutcomeABSTRACT
OBJECTIVE: The mechanisms underlying type 2 diabetes resolution after Roux-en-Y gastric bypass (RYGB) are unclear. We suspected that glucose excretion may occur in the small bowel based on observations in humans. The aim of this study was to evaluate the mechanisms underlying serum glucose excretion in the small intestine and its contribution to glucose homeostasis after bariatric surgery. DESIGN: 2-Deoxy-2-[18F]-fluoro-D-glucose (FDG) was measured in RYGB-operated or sham-operated obese diabetic rats. Altered glucose metabolism was targeted and RNA sequencing was performed in areas of high or low FDG uptake in the ileum or common limb. Intestinal glucose metabolism and excretion were confirmed using 14C-glucose and FDG. Increased glucose metabolism was evaluated in IEC-18 cells and mouse intestinal organoids. Obese or ob/ob mice were treated with amphiregulin (AREG) to correlate intestinal glycolysis changes with changes in serum glucose homeostasis. RESULTS: The AREG/EGFR/mTOR/AKT/GLUT1 signal transduction pathway was activated in areas of increased glycolysis and intestinal glucose excretion in RYGB-operated rats. Intraluminal GLUT1 inhibitor administration offset improved glucose homeostasis in RYGB-operated rats. AREG-induced signal transduction pathway was confirmed using IEC-18 cells and mouse organoids, resulting in a greater capacity for glucose uptake via GLUT1 overexpression and sequestration in apical and basolateral membranes. Systemic and local AREG administration increased GLUT1 expression and small intestinal membrane translocation and prevented hyperglycaemic exacerbation. CONCLUSION: Bariatric surgery or AREG administration induces apical and basolateral membrane GLUT1 expression in the small intestinal enterocytes, resulting in increased serum glucose excretion in the gut lumen. Our findings suggest a novel, potentially targetable glucose homeostatic mechanism in the small intestine.
Subject(s)
Blood Glucose/metabolism , Fluorodeoxyglucose F18/metabolism , Intestine, Small/metabolism , Amphiregulin/pharmacology , Animals , Diabetes Mellitus, Experimental , Diabetes Mellitus, Type 2 , Gastric Bypass , Glucose Transporter Type 1/metabolism , Glycolysis , Positron Emission Tomography Computed Tomography , Rats , Rats, Inbred OLETF , Signal Transduction/drug effectsABSTRACT
OBJECTIVE: To evaluate the complication-based learning curve and identify learning-associated complications of robotic gastrectomy. SUMMARY BACKGROUND DATA: With the increased popularity of robotic surgery, a sound understanding of the learning curve in the surgical outcome of robotic surgery has taken on great importance. However, a multicenter prospective study analyzing learning-associated morbidity has never been conducted in robotic gastrectomy. METHODS: Data on 502 robotic gastrectomy cases were prospectively collected from 5 surgeons. Risk-adjusted cumulative sum analysis was applied to visualize the learning curve of robotic gastrectomy on operation time and complications. RESULTS: Twenty-five cases, on average, were needed to overcome complications and operation time-learning curve sufficiently to gain proficiency in 3 surgeons. An additional 23 cases were needed to cross the transitional phase to progress from proficiency to mastery. The moderate complication rate (CD ≥ grade II) was 20% in phase 1 (cases 1-25), 10% in phase 2 (cases 26-65), 26.1% in phase 3 (cases 66-88), and 6.4% in phase 4 (cases 89-125) (P < 0.001). Among diverse complications, CD ≥ grade II intra-abdominal bleeding (P < 0.001) and abdominal pain (P = 0.01) were identified as major learning-associated morbidities of robotic gastrectomy. Previous experience on laparoscopic surgery and mode of training influenced progression in the learning curve. CONCLUSIONS: This is the first study suggesting that technical immaturity substantially affects the surgical outcomes of robotic gastrectomy and that robotic gastrectomy is a complex procedure with a significant learning curve that has implications for physician training and credentialing.
Subject(s)
Education, Medical, Graduate/methods , Gastrectomy/education , Laparoscopy/education , Learning Curve , Robotic Surgical Procedures/education , Surgeons/education , Gastrectomy/methods , Humans , Laparoscopy/methods , Operative Time , Prospective Studies , Robotic Surgical Procedures/methods , Stomach Neoplasms/surgeryABSTRACT
OBJECTIVE: To qualify surgeons to participate in a randomized trial comparing laparoscopic and open distal D2 gastrectomy for advanced gastric cancer. SUMMARY OF BACKGROUND DATA: No studies have sought to qualify surgeons for a randomized trial comparing laparoscopic and open D2 gastrectomy for advanced gastric cancer. METHODS: We conducted a multicenter prospective observational study evaluating unedited videos of laparoscopic and open D2 gastrectomy performed by 27 surgeons. Surgeons performed 3 of each laparoscopic and open distal gastrectomies with D2 lymphadenectomy for gastric cancer. Five peers reviewed each unedited video using a video assessment form. Based on experts' review of videos, a separate review committee decided surgeons as "Qualified" or "Not-qualified." RESULTS: Twelve surgeons (44.4%) were qualified on initial evaluation whereas the other 15 surgeons were not. Another 9 surgeons were finally qualified after re-evaluation. The median score for Qualified was significantly higher than Not-qualified (P < 0.001).Significant differences between Qualified and Not-qualified were noted both in operation type and in all evaluation area of surgical skill, perigastric, and extra-perigastric lymphadenectomy, although the inter-rater variability of the assessment score was low (kappa = 0.285). However, Not-qualified surgeons' scores improved upon re-evaluation of resubmitted videos.When compared laparoscopy with open surgery, median scores were similar between the 2 groups (P = 0.680). However, open gastrectomy scores for surgical skills were significantly higher than for laparoscopic surgery (P = 0.016). CONCLUSIONS: Our surgeon quality control study for gastrectomy represents a milestone in surgical standardization for surgical clinical trials. Our methods could also serve as a system for educating surgeons and assessing surgical proficiency.
Subject(s)
Clinical Competence , Gastrectomy/standards , Laparoscopy/standards , Lymph Node Excision/standards , Quality Control , Stomach Neoplasms/surgery , Adult , Aged , Female , Humans , Male , Middle Aged , Prospective Studies , Randomized Controlled Trials as Topic , Stomach Neoplasms/pathology , Treatment OutcomeABSTRACT
BACKGROUND: Robotic surgery has been widely adopted for complex procedures to overcome technical limitations of open or laparoscopic methods. However, evidence of any subsequent benefit is lacking. This study was undertaken to compare open, laparoscopic, and robotic gastrectomy in technically demanding procedure-D2 dissection in obese patients with gastric cancer. METHODS: Data collected between 2010 and 2018 on D2 gastrectomy in obese patients with gastric cancer were used to conduct retrospective analysis, comparing short- and long-term outcomes of open, laparoscopic, and robotic techniques. RESULTS: In a total of 185 patients, there were 69 open, 62 laparoscopic, and 54 robotic gastrectomy procedures. Median ages for respective surgical groups were 66 (interquartile range [IQR]: 61-64 years), 63 (IQR: 59-63), and 59 years (IQR: 56-60 years) (p = 0.009). Early-stage gastric cancer ranked proportionately higher in the laparoscopic group (p = 0.005), but operative times were similar among groups. Estimated blood loss (p < 0.001) and drainage volumes (p = 0.001) were higher in the open group, relative to others. Although a robotic approach performed best in overall compliance and in mean number of retrieved lymph node, observed rates of early or late complications did not differ by technique. The open group experienced significantly poorer overall (p = 0.039) and relapse-free (p < 0.001) survival compared with the laparoscopic or robotic group. Robotic surgery emerged from multivariable Cox regression as a protective factor for relapse-free survival (HR = 0.314, 95% CI 0.116-0.851). CONCLUSIONS: In obese patients with gastric cancer, robotic gastrectomy with D2 lymphadenectomy proved comparable to open or laparoscopic technique short-term, yielding better long-term outcomes.
Subject(s)
Laparoscopy , Robotic Surgical Procedures , Stomach Neoplasms , Gastrectomy , Humans , Lymph Node Excision , Middle Aged , Neoplasm Recurrence, Local/surgery , Obesity/complications , Retrospective Studies , Stomach Neoplasms/surgery , Treatment OutcomeABSTRACT
BACKGROUND: Although patients with early gastric cancer have good prognosis, recurrence after treatment may occur. Lymphovascular invasion (LVI) in gastric cancer has long been suggested as a poor prognostic indicator. This study sought to evaluate the prognostic effect of LVI in patients with early gastric cancer. METHODS: From 2005 to 2016, 6516 patients with early gastric cancer who underwent radical gastrectomy were analyzed. The patients were categorized according to LVI and lymph node (LN) status. RESULTS: LVI was present in 853 patients (13.1%). Patients with LVI or LN metastasis had more aggressive tumor characteristics than patients without both LVI and LN metastasis. The overall and relapse-free survival in patients with LVI were significantly worse than in patients without LVI. When we compared the survival rate of patients stratified by LVI and LN status, there was a significant overall and relapse-free survival difference between patients without both LVI and LN metastasis compared with those with LVI but without LN metastasis (p < 0.001). The overall and relapse-free survival of patients with LVI but without LN metastasis were similar to those without LVI but with LN metastasis (p = 0.818). Patients with LVI or LN metastasis showed a high frequency of recurrence (p < 0.001). Multivariate analysis showed that LVI and LN status were independent risk factors for relapse-free survival of early gastric cancer patients. CONCLUSIONS: Early gastric cancer with LVI is associated with poor prognosis and frequent recurrence. When predicting the prognosis of patients with early gastric cancer, LVI should be considered.
Subject(s)
Stomach Neoplasms , Humans , Neoplasm Invasiveness/pathology , Neoplasm Recurrence, Local/pathology , Neoplasm Recurrence, Local/surgery , Neoplasm Staging , Prognosis , Retrospective Studies , Stomach Neoplasms/pathology , Stomach Neoplasms/surgeryABSTRACT
BACKGROUND: Indocyanine green fluorescent lymphography helps visualize the lymphatic drainage pattern in gastric cancer; however, it is unknown whether fluorescent lymphography visualizes all metastatic lymph nodes. This study aimed to evaluate the sensitivity of fluorescent lymphography to detect metastatic lymph node stations and lymph nodes and the risk of false-negative findings. METHODS: Patients with clinical T1-4a gastric cancer were included. Indocyanine green was peritumorally injected the day prior to surgery by endoscopy. Gastrectomy with systematic D1+ or D2 lymphadenectomy was performed. Stations and lymph nodes were retrieved at the back-table using near-infrared imaging and classified as "fluorescent" or "non-fluorescent" and later matched with histopathological findings. RESULTS: Among 592 patients who underwent minimally invasive gastrectomy from September 2013 until December 2016, lymph node metastases were present in 150. The sensitivity of fluorescent lymphography in detecting all metastatic lymph node stations was 95.3% (143/150 patients), with a false-negative rate of 4.7% (7/150 patients) and the sensitivity in detecting all metastatic lymph nodes was 81.3% (122/150 patients). The negative predictive value was 99.3% for non-fluorescent stations and 99.2% for non-fluorescent LNs. For detecting all metastatic LN stations, subgroup analysis revealed 100% sensitivity for pT1a, 96.8% for pT1b, 100% for pT2, 91.3% for pT3, and 93.6% for pT4a tumors. CONCLUSIONS: Fluorescent lymphography-guided lymphadenectomy can be a useful method for radical lymphadenectomy by facilitating the complete dissection of all potentially positive LN stations. Fluorescent lymphography-guided lymphadenectomy appears to be a reasonable alternative to conventional systematic lymphadenectomy for gastric cancer.
Subject(s)
Lymph Node Excision/methods , Lymphatic Metastasis/diagnostic imaging , Lymphography/methods , Optical Imaging/methods , Stomach Neoplasms/diagnostic imaging , Aged , Coloring Agents , Databases, Factual , Female , Gastrectomy , Humans , Indocyanine Green , Lymph Nodes/diagnostic imaging , Lymph Nodes/surgery , Male , Middle Aged , Predictive Value of Tests , Prospective Studies , Sensitivity and Specificity , Stomach Neoplasms/pathologyABSTRACT
BACKGROUND: An aberrant left hepatic artery is frequently encountered during upper gastrointestinal surgery, and researchers have yet to propose optimal strategies with which to address this arterial variation. The objective of this study was to determine whether the areas perfused by an aberrant left hepatic artery can be visualized in real-time using near-infrared fluorescence imaging with indocyanine green. METHODS: Patients with gastric adenocarcinoma who underwent minimally invasive radical gastrectomy from May 2018 to August 2019 were enrolled and retrospectively analyzed at a single-center. Patients with an aberrant left hepatic artery and normal preoperative liver function were examined. After the clamping of an aberrant left hepatic artery, indocyanine green was administered via a peripheral intravenous route during surgery. Fluorescence at the liver was visualized under near-infrared fluorescence imaging. RESULTS: In 31 patients with aberrant left hepatic arteries, near-infrared fluorescence imaging was used without adverse events associated with indocyanine green. Six (19%) patients were reported to have an aberrant left hepatic artery upon preoperative CT imaging, while all other instances were detected during surgery. Fluorescence excitation on the liver was, on average, visible after 43 s (range, 25-65). Fluorescence across the entire surface of the liver was noted in 20 (65%) patients in whom the aberrant left hepatic artery could be ligated. Aberrant left hepatic arteries were safely preserved in 10 (32%) patients who showed areas of no or partial fluorescence excitation. Guided by near-infrared fluorescence imaging, ligation of aberrant left hepatic arteries elicited no significant changes in postoperative liver function. CONCLUSION: Near-infrared fluorescence imaging facilitates the identification of aberrant left hepatic arterial territories, guiding decisions on the preservation or ligation of this arterial variation.