Reconstruction Techniques and Associated Morbidity in Minimally Invasive Gastrectomy for Cancer - Insights from the GastroBenchmark and GASTRODATA databases.

OBJECTIVE/BACKGROUND: Various anastomotic and reconstruction techniques are used for minimally invasive total (miTG) and distal gastrectomy (miDG). Their effects on postoperative morbidity have not been extensively studied. METHODS: MiTG and miDG patients were selected from 9356 oncological gastrectomies performed 2017-2021 in 44 centers. Endpoints included anastomotic leakage (AL) rate and postoperative morbidity tested by multivariable analysis. RESULTS: Three major anastomotic techniques (circular stapled (CS); linear stapled (LS); hand sewn (HS)), and three major bowel reconstruction types (Roux (RX); Billroth I (BI); Billroth II (BII)) were identified in miTG (n=878) and miDG (n=3334). Postoperative complications including AL (5.2% vs. 1.1%), overall (28.7% vs. 16.3%) and major morbidity (15.7% vs. 8.2%), as well as 90-day mortality (1.6% vs. 0.5%) were higher after miTG compared with miDG. After miTG, AL rate was higher after CS (4.3%) and HS (7.9%) compared with LS (3.4%). Similarly, major complications (LS: 9.7%, CS: 16.2%, HS: 12.7%) were lowest after LS. Multivariate analysis confirmed anastomotic technique as predictive factor for AL, overall and major complications. In miDG, AL rate (BI: 1.4%, BII 0.8%, RX 1.2%), overall (BI: 14.5%, BII: 15.0%, RX: 18.7%,) and major morbidity (BI: 7.9%, BII: 9.1%, RX: 7.2%), and mortality (BI: 0%, BII: 0.1%, RY: 1.1%%) were not affected by bowel reconstruction. CONCLUSION: In oncologically suitable situations, miDG should be preferred to miTG, as postoperative morbidity is significantly lower. LS should be a preferred anastomotic technique for miTG in Western Centers. Conversely, bowel reconstruction in DG may be chosen according to surgeon's preference.

Textbook Outcome in Colorectal Surgery for Cancer: An Italian Version.

Background/Objectives: The textbook outcome (TO) is a composite tool introduced to uniform surgical units and regulate surgical quality and outcomes. A patient is considered TO only if all predetermined items are met. In colorectal surgery, TO represents a new tool that can achieve important results given the prevalence of colorectal cancers. However, at present, there is a lack of uniformity in the TO's definition. This study utilized the Delphi process to define an Italian version of the TO in colorectal cancer. Methods: The survey consisted of two rounds of online questionnaires submitted to an expert panel in colorectal oncological surgery, renowned academic surgeons, who had attended multiple scientific conferences and who were authors of papers on this specific topic. Five main topics with 26 questions were investigated through an online modified Delphi method. Items with almost 75% agreement achieved consensus. Results: Twenty-eight Italian experts were selected and participated in the two rounds. The Italian version of the textbook outcome in colorectal surgery was defined as the presence of 90-day postoperative survival, negative margins and at least 12 lymph nodes, a minimally invasive approach, ostomy fashioning if preoperatively planned, postoperative complication < Clavien-Dindo 3b, at least 10 ERAS items, no readmission, proper CHT and RT regimens, complete colonoscopy after or before surgery and Tumor Board Evaluation. Conclusions: The textbook outcome in colorectal cancer patients is a quality instrument providing a complete overview of the care of such patients, from diagnosis to treatment. We hereby propose an Italian version of the TO with outcomes chosen by an expert panel.

Clostridium difficile infection after stoma reversal surgery: a systematic review and meta-analysis of the literature.

BACKGROUND: Clostridium difficile infection (CDI) has been described in the early post-operative phase after stoma reversal. This systematic review aimed to describe the incidence of CDI after stoma reversal and to identify pre-operative variables correlated with an increased risk of infection. METHODS: A systematic review of the literature was conducted according to the PRISMA guidelines in March 2024. Manuscripts were included if reported at least one patient with CDI-associated diarrhoea following stoma reversal (colostomy/ileostomy). The primary outcome of interest was the incidence of CDI; the secondary outcome was the comparison of clinical variables (age, sex, time to stoma reversal, neo-adjuvant and adjuvant therapies after index colorectal procedure) in CDI-positive versus CDI-negative patients. A meta-analysis was performed when at least three studies reported on those variables. RESULTS: Out of 43 eligible manuscripts, 1 randomized controlled trial and 10 retrospective studies were selected, including 17,857 patients (2.1% CDI). Overall, the mean age was 64.3 ± 11.6 years in the CDI group and 61.5 ± 12.6 years in the CDI-negative group (p = 0.51), with no significant difference in sex (p = 0.34). Univariable analyses documented that the mean time to stoma reversal was 53.9 ± 19.1 weeks in CDI patients and 39.8 ± 15.0 weeks in CDI-negative patients (p = 0.40) and a correlation between neo-adjuvant and adjuvant treatments with CDI (p < 0.001). A meta-analysis was performed for time to stoma reversal, age, sex, and neo-adjuvant therapies disclosing no significant differences for CDI (stoma delay, MD 11.59; 95%CI  24.32-1.13; age, MD 0.97; 95%CI 2.08-4.03; sex, OR1.11; 95%CI 0.88-1.41; neo-adjuvant, OR0.81; 95%CI 0.49-1.35). Meta-analysis including patients who underwent adjuvant therapy evidenced a higher risk of CDI (OR 2.88; 95%CI 1.01-8.17, p = 0.11). CONCLUSION: CDI occurs in approximately 2.1% of patients after stoma reversal. Although a trend of increased delay in stoma reversal and a correlation with chemotherapy were documented in CDI patients, the use of adjuvant therapy was the only possible risk factor documented on meta-analysis. PROSPERO REGISTRATION NUMBER: CRD42023484704.

Case Report: The molecular fingerprint and the clinical implication of an exceptional response to neoadjuvant therapy in a metastatic cardia adenocarcinoma.

Background: Globally, gastric cancer holds the fifth position in terms of prevalence among malignant tumors and is the fourth leading cause of cancer-related mortality. Particular attention should be paid to cardia adenocarcinoma (CA) due to its increasing incidence and poor prognosis. Diagnosis of CA frequently occurs in advanced stages because of its late symptoms. In such cases, neoadjuvant chemotherapy is the primary treatment option. The response to chemotherapy depends on multiple variables including the tumor's molecular profile, the patient's performance status, and the feasibility of using targeted therapy. Patients exhibiting an exceptional response, defined as a complete response to medical therapy lasting more than 1 year, or a partial response or stable disease lasting more than 2 years, are rarely described. This case report presents one of the longest-lasting exceptional responses to chemotherapy in metastatic cardia adenocarcinoma and discusses its clinical implications. Case presentation: A 49-year-old male patient presented with cardia adenocarcinoma (human epidermal growth factor receptor 2 negative, mismatch repair proficient) and liver metastases. Molecular profiling identified a pathogenic mutation in the TP53 gene (R123W; Arg123Trp) as the sole alteration found. Five months after initiating the neoadjuvant chemotherapy with fluorouracil-leucovorin-oxaliplatin-docetaxel, the patient achieved a complete clinical response. The molecular profile was compared with others previously documented in an international data portal, revealing a similar pattern. At 4 years and 3 months from diagnosis, the exceptional response was still confirmed. The patient underwent a cumulative number of 33 cycles of chemotherapy, leading to chemotherapy-induced liver damage. Conclusions: Exceptional responses to neoadjuvant chemotherapy in cardia adenocarcinomas are rarely reported. The documentation of exceptional responses to cancer therapies should be included in large data repositories to explore the molecular fingerprint of these tumors. In such cases, the clinical implications of long-term chemotherapy should always be taken into account.

Current trends in the management of Gastro-oEsophageal cancers: Updates to the ESSO core curriculum (ESSO-ETC-UGI-WG initiative).

Gastro-oEsophageal Cancers (GECs) are severe diseases whose management is rapidly evolving. The European Society of Surgical Oncology (ESSO) is committed to the generation and spread of knowledge, and promotes the multidisciplinary management of cancer patients through its core curriculum. The present work discusses the approach to GECs, including the management of oligometastatic oesophagogastric cancers (OMEC), the diagnosis and management of peritoneal metastases from gastric cancer (GC), the management of Siewert Type II tumors, the importance of mesogastric excision, the role of robotic surgery, textbook outcomes, organ preserving options, the use of molecular markers and immune check-point inhibitors in the management of patients with GECs, as well as the improvement of current clinical practice guidelines for the management of patients with GECs. The aim of the present review is to provide a concise overview of the state-of-the-art on the management of patients with GECs and, at the same time, to share the latest advancements in the field and to foster the debate between surgical oncologists treating GECs worldwide. We are sure that our work will, at the same time, give an update to the advanced surgical oncologists and help the training surgical oncologists to settle down the foundations for their future practice.

Predicting peritoneal recurrence after radical gastrectomy for gastric cancer: Validation of a prediction model (PERI-Gastric 1 and PERI-Gastric 2) on a Korean database.

BACKGROUND: Peritoneal recurrence is a significant cause of treatment failure after radical gastrectomy for gastric cancer. The prediction of metachronous peritoneal recurrence would have a significantly impact risk stratification and tailored treatment planning. This study aimed to externally validate the previously established PERI-Gastric 1 and 2 models to assess their generalizability in an independent population. METHODS: Retrospective external validation was conducted on a cohort of 8564 patients who underwent elective gastrectomy for stage Ib-IIIc gastric cancer between 1998 and 2018 at the Yonsei Cancer Center. Discrimination was tested using the area under the receiver operating characteristic curves (AUROC). Accuracy was tested by plotting observations against the predicted risk of peritoneal recurrence and analyzing the resulting calibration plots. Clinical usefulness was tested with a decision curve analysis. RESULTS: In the validation cohort, PERI-Gastric 1 and PERI-Gastric 2 exhibited an AUROC of 0.766 (95 % C.I. 0.752-0.778) and 0.767 (95 % C.I. 0.755-0.780), a calibration-in-the-large of 0.935 and 0.700, a calibration belt with a 95 % C.I. over the bisector in the risk range of 24%-33 % and 35%-47 %. The decision curve analysis revealed a positive net benefit in the risk range of 10%-42 % and 15%-45 %, respectively. CONCLUSIONS: This study presents the external validation of the PERI-Gastric 1 and 2 scores in an Eastern population. The models demonstrated fair discrimination and satisfactory calibration for predicting the risk of peritoneal recurrence after radical gastrectomy, even in Eastern patients. PERI-Gastric 1 and 2 scores could also be applied to predict the risk of metachronous peritoneal recurrence in Eastern populations.

European clinical practice guidelines for the definition, diagnosis, and treatment of oligometastatic esophagogastric cancer (OMEC-4).

INTRODUCTION: The OligoMetastatic Esophagogastric Cancer (OMEC) project aims to provide clinical practice guidelines for the definition, diagnosis, and treatment of esophagogastric oligometastatic disease (OMD). METHODS: Guidelines were developed according to AGREE II and GRADE principles. Guidelines were based on a systematic review (OMEC-1), clinical case discussions (OMEC-2), and a Delphi consensus study (OMEC-3) by 49 European expert centers for esophagogastric cancer. OMEC identified patients for whom the term OMD is considered or could be considered. Disease-free interval (DFI) was defined as the time between primary tumor treatment and detection of OMD. RESULTS: Moderate to high quality of evidence was found (i.e. 1 randomized and 4 non-randomized phase II trials) resulting in moderate recommendations. OMD is considered in esophagogastric cancer patients with 1 organ with ≤ 3 metastases or 1 involved extra-regional lymph node station. In addition, OMD continues to be considered in patients with OMD without progression in number of metastases after systemic therapy. 18F-FDG PET/CT imaging is recommended for baseline staging and for restaging after systemic therapy when local treatment is considered. For patients with synchronous OMD or metachronous OMD and a DFI ≤ 2 years, recommended treatment consists of systemic therapy followed by restaging to assess suitability for local treatment. For patients with metachronous OMD and DFI > 2 years, upfront local treatment is additionally recommended. DISCUSSION: These multidisciplinary European clinical practice guidelines for the uniform definition, diagnosis and treatment of esophagogastric OMD can be used to standardize inclusion criteria in future clinical trials and to reduce variation in treatment.

Uniportal video-assisted thoracic surgery Ivor-Lewis oesophagectomy with circular stapling anastomosis.

ABSTRACT: Amongst all minimally invasive oesophagectomies, uniportal video-assisted thoracic surgery (VATS) Ivor-Lewis remains the most challenging procedure due to the skills required for performing the intrathoracic anastomosis. We present an easy and safe circular stapling latero-terminal anastomosis for performing uniportal VATS Ivor-Lewis. The patient had an uneventful post-operative recovery and was disease-free 9 months after surgery.

Global Cancer Surgery: pragmatic solutions to improve cancer surgery outcomes worldwide.

The first Lancet Oncology Commission on Global Cancer Surgery was published in 2015 and serves as a landmark paper in the field of cancer surgery. The Commission highlighted the burden of cancer and the importance of cancer surgery, while documenting the many inadequacies in the ability to deliver safe, timely, and affordable cancer surgical care. This Commission builds on the first Commission by focusing on solutions and actions to improve access to cancer surgery globally, developed by drawing upon the expertise from cancer surgery leaders across the world. We present solution frameworks in nine domains that can improve access to cancer surgery. These nine domains were refined to identify solutions specific to the six WHO regions. On the basis of these solutions, we developed eight actions to propel essential improvements in the global capacity for cancer surgery. Our initiatives are broad in scope, pragmatic, affordable, and contextually applicable, and aimed at cancer surgeons as well as leaders, administrators, elected officials, and health policy advocates. We envision that the solutions and actions contained within the Commission will address inequities and promote safe, timely, and affordable cancer surgery for every patient, regardless of their socioeconomic status or geographic location.

Predictors of Clostridium difficile infection after stoma reversal following TaTME surgery.

BACKGROUND:  The aim of this study was to determine the incidence of Clostridium Difficile infection (CDI) after stoma reversal in patients who underwent transanal Total Mesorectal Excision (TaTME) and to evaluate variables correlated with this post-operative infection. METHODS:  Patients who underwent stoma reversal surgery following TaTME for rectal cancer between 2015 and 2023 at a high-volume Institution, were retrospectively reviewed for the post-operative occurrence of diarrhea and in-hospital CDI (positive toxin in the stools). Patients were divided into the following subgroups according to the post-operative course: Group A-no clinical symptoms; Group B-mild diarrhea (< 10 evacuations/day); Group C-severe watery diarrhea (> 10 evacuations/day) with CDI negative; and Group D-severe watery diarrhea (> 10 evacuations/day) CDI positive. Clinical and laboratory data were analyzed for their correlation with CDI. A machine learning approach was used to determine predictors of diarrhea following stoma reversal. RESULTS:  A total of 126 patients were selected, of whom 79 were assessed as Group A, 16 Group B, 25 Group C and 6 (4.8%) Group D. Univariable analysis documented that delayed stoma reversal correlated with CDI (Group A mean interval 44.6 weeks vs. Group D 68.4 weeks, p 0.01). The machine learning analysis confirmed the delay in stoma closure as a probability factor of presenting diarrhea; also, diarrhea probability was 80.5% in males, 77.8% in patients who underwent neoadjuvant therapy, and 63.9% in patients who underwent adjuvant therapy. CONCLUSIONS:  Stoma reversal surgery can result in moderate rate of in-hospital CDI. Time-to stoma reversal is a crucial variable significantly related with this adverse outcome.

Textbook Oncological Outcome in European GASTRODATA.

OBJECTIVE: To assess the rate of textbook outcome (TO) and textbook oncological outcome (TOO) in the European population based on the GASTRODATA registry. BACKGROUND: TO is a composite parameter assessing surgical quality and strongly correlates with improved overall survival. Following the standard of treatment for locally advanced gastric cancer, TOO was proposed as a quality and optimal multimodal treatment parameter. METHODS: TO was achieved when all the following criteria were met: no intraoperative complications, radical resection according to the surgeon, pR0 resection, retrieval of at least 15 lymph nodes, no severe postoperative complications, no reintervention, no admission to the intensive care unit, no prolonged length of stay, no postoperative mortality and no hospital readmission. TOO was defined as TO with the addition of perioperative chemotherapy compliance. RESULTS: Of the 2558 patients, 1700 were included in the analysis. TO was achieved in 1164 (68.5%) patients. The use of neoadjuvant chemotherapy [odds ratio (OR) = 1.33, 95% CI: 1.04-1.70] and D2 or D2+ lymphadenectomy (OR = 1.55, 95% CI: 1.15-2.10) had a positive impact on TO achievement. Older age (OR = 0.73, 95% CI: 0.54-0.94), pT3/4 (OR = 0.79, 95% CI: 0.63-0.99), ASA 3/4 (OR = 0.68, 95% CI: 0.54-0.86) and total gastrectomy (OR = 0.56, 95% CI: 0.45-0.70), had a negative impact on TO achievement. TOO was achieved in 388 (22.8%) patients. Older age (OR = 0.37, 95% CI: 0.27-0.53), pT3 or pT4 (OR = 0.52, 95% CI: 0.39-0.69), and ASA 3 or 4 (OR = 0.58, 95% CI: 0.43-0.79) had a negative impact on TOO achievement. CONCLUSIONS: Despite successively improved surgical outcomes, stage-appropriate chemotherapy in adherence to the current guidelines for multimodal treatment of gastric cancer remains poor. Further implementation of oncologic quality metrics should include greater emphasis on perioperative chemotherapy and adequate lymphadenectomy.

Profiling complete regression after pre-operative therapy in gastric cancer patients using clinical and pathological data.

INTRODUCTION: The consistent use of pre-operative treatment before surgery for gastric cancer (GC) has resulted in increased rates of complete response. However, factors associated with response have been scantly investigated. METHODS: Patients with GCs treated between 2017 and 2022 undergoing pre-operative treatment followed by resection were included. Clinicopathological data were analyzed for the association with tumor regression grades (TRG); secondary outcomes included the short-term overall (OS), disease-free (DFS) and disease specific survival (DSS). RESULTS: Among 108 patients, 35.1% had an intestinal histotype GC, and 70.4% were treated with FLOT. Complete tumor regression (TRG1) was documented in 6.5% of patients. Univariable analyses documented that a higher pre-operative albumin (p = 0.04) and the expression of HER2 (p = 0.01) were associated to TRG1. In the multinominal regression model, the log-odds of being classified as TRG1 increased with the expression of HER2 by 170.247 times and with higher pre-operative albumin by 34.525 times, while with a higher Charlson Index and a diffuse hystotipe reduced it by 25.467 times and 3759.126 times, respectively. Among 49 patients (mean follow-up: 17.1 months), TRG1-2 was associated to better OS, DFS and DSS curves compared to TRG 3-5 (respectively p < 0.01, p 0.007 and p < 0.01), altogether with the reported negative impact of comorbidities in OS and DSS multivariable analyses (respectively p 0.04 and p 0.006). The random survival forest further confirmed the impact of HER2 and comorbidity on DSS. CONCLUSION: A better clinical profile, HER2 expression and intestinal histotype significantly correlated with GC regression. A complete-major response was an independent factor for survival.

The impact of preoperative nutritional screening, ERAS protocol, and mini-invasive surgery in surgical oncology: A multi-institutional SEM analysis of patients with digestive cancer.

Background: Mini-invasive surgery (MIS), ERAS, and preoperative nutritional screening are currently used to reduce complications and the length of hospital stay (LOS); however, inter-variable correlations have seldom been explored. This research aimed to define inter-variable correlations in a large series of patients with gastrointestinal cancer and their impact on outcomes. Methods: Patients with consecutive cancer who underwent radical gastrointestinal surgery between 2019 and 2020 were analyzed. Age, BMI, comorbidities, ERAS, nutritional screening, and MIS were evaluated to determine their impact on 30-day complications and LOS. Inter-variable correlations were measured, and a latent variable was computed to define the patients' performance status using nutritional screening and comorbidity. Analyses were conducted using structural equation modeling (SEM). Results: Of the 1,968 eligible patients, 1,648 were analyzed. Univariable analyses documented the benefit of nutritional screening for LOS and MIS and ERAS (≥7 items) for LOS and complications; conversely, being male and comorbidities correlated with complications, while increased age and BMI correlated with worse outcomes. SEM analysis revealed that (a) the latent variable is explained by the use of nutritional screening (p0·004); (b) the variables were correlated (age-comorbidity, ERAS-MIS, and ERAS-nutritional screening, p < 0·001); and (c) their impact on the outcomes was based on direct effects (complications: sex, p0·001), indirect effects (LOS: MIS-ERAS-nutritional screening, p < 0·001; complications: MIS-ERAS, p0·001), and regression-based effects (LOS: ERAS, MIS, p < 0·001, nutritional screening, p0·021; complications: ERAS, MIS, p < 0·001, sex, p0·001). Finally, LOS and complications were correlated (p < 0·001). Conclusion: Enhanced recovery after surgery (ERAS), MIS, and nutritional screening are beneficial in surgical oncology; however, the inter-variable correlation is reliable, underlying the importance of the multidisciplinary approach.

Definition, diagnosis and treatment of oligometastatic oesophagogastric cancer: A Delphi consensus study in Europe.

BACKGROUND: Local treatment improves the outcomes for oligometastatic disease (OMD, i.e. an intermediate state between locoregional and widespread disseminated disease). However, consensus about the definition, diagnosis and treatment of oligometastatic oesophagogastric cancer is lacking. The aim of this study was to develop a multidisciplinary European consensus statement on the definition, diagnosis and treatment of oligometastatic oesophagogastric cancer. METHODS: In total, 65 specialists in the multidisciplinary treatment for oesophagogastric cancer from 49 expert centres across 16 European countries were requested to participate in this Delphi study. The consensus finding process consisted of a starting meeting, 2 online Delphi questionnaire rounds and an online consensus meeting. Input for Delphi questionnaires consisted of (1) a systematic review on definitions of oligometastatic oesophagogastric cancer and (2) a discussion of real-life clinical cases by multidisciplinary teams. Experts were asked to score each statement on a 5-point Likert scale. The agreement was scored to be either absent/poor (<50%), fair (50%-75%) or consensus (≥75%). RESULTS: A total of 48 experts participated in the starting meeting, both Delphi rounds, and the consensus meeting (overall response rate: 71%). OMD was considered in patients with metastatic oesophagogastric cancer limited to 1 organ with ≤3 metastases or 1 extra-regional lymph node station (consensus). In addition, OMD was considered in patients without progression at restaging after systemic therapy (consensus). For patients with synchronous or metachronous OMD with a disease-free interval ≤2 years, systemic therapy followed by restaging to consider local treatment was considered as treatment (consensus). For metachronous OMD with a disease-free interval >2 years, either upfront local treatment or systemic treatment followed by restaging was considered as treatment (fair agreement). CONCLUSION: The OMEC project has resulted in a multidisciplinary European consensus statement for the definition, diagnosis and treatment of oligometastatic oesophagogastric adenocarcinoma and squamous cell cancer. This can be used to standardise inclusion criteria for future clinical trials.

The definition of "R1" lymph node dissection status in patients undergoing curative-aim gastrectomy for gastric carcinoma: A proof of concept study.

INTRODUCTION: The aim of this study was to define and investigate the prognostic impact of "R1-Lymph-node dissection" during gastrectomy. METHODS: This was a retrospective study conducted with 499 patients undergoing curative-aim gastrectomy. We defined R1-Lymph dissection as an involvement of lymph node stations anatomically connected with lymph node stations outside the declared level of dissection (D1 to D2+). The primary outcomes were disease-free and disease-specific survival (DFS and DSS). RESULTS: At multivariable analysis, the type of gastrectomy, pT and pN were associated with DFS, and the type of gastrectomy, R1-Margin status, R1-Lymph status, pT, pN and adjuvant therapy were associated with DSS. Moreover, pT and R1-Lymph status were the only factors associated with overall loco-regional recurrence. CONCLUSIONS: In this study, we introduced the concept of R1-Lymph-node dissection, which was significantly associated with DSS and appeared to be a stronger prognostic factor for loco-regional recurrence than the R1 status on the resection margin.

Clinical outcomes of patients with complicated post-operative course after gastrectomy for cancer: a GIRCG study using the GASTRODATA registry.

Gastrectomy for gastric cancer is still performed in Western countries with high morbidity and mortality. Post-operative complications are frequent, and effective diagnosis and treatment of complications is crucial to lower the mortality rates. In 2015, a project was launched by the EGCA with the aim of building an agreement on list and definitions of post-operative complications specific for gastrectomy. In 2018, the platform www.gastrodata.org was launched for collecting cases by utilizing this new complication list. In the present paper, the Italian Research Group for Gastric Cancer endorsed a collection of complicated cases in the period 2015-2019, with the aim of investigating the clinical pictures, diagnostic modalities, and treatment approaches, as well as outcome measures of patients experiencing almost one post-operative complication. Fifteen centers across Italy provided 386 cases with a total of 538 complications (mean 1.4 complication/patient). The most frequent complications were non-surgical infections (gastrointestinal, pulmonary, and urinary) and anastomotic leaks, accounting for 29.2% and 17.3% of complicated patients, with a median Clavien-Dindo score of II and IIIB, respectively. Overall mortality of this series was 12.4%, while mortality of patients with anastomotic leak was 25.4%. The clinical presentation with systemic septic signs, the timing of diagnosis, and the hospital volume were the most relevant factors influencing outcome.

Risk of Lymph Node Metastasis in T1b Gastric Cancer: An International Comprehensive Analysis from the Global Gastric Group (G3) Alliance.

OBJECTIVE: We sought to define criteria associated with low lymph node metastasis risk in patients with submucosal (pT1b) gastric cancer from 3 Western and 3 Eastern countries. SUMMARY BACKGROUND DATA: Accurate prediction of lymph node metastasis risk is essential when determining the need for gastrectomy with lymph node dissection following endoscopic resection. Under present guidelines, endoscopic resection is considered definitive treatment if submucosal invasion is only superficial, but this is not routinely assessed. METHODS: Lymph node metastasis rates were determined for patient groups defined according to tumor pathological characteristics. Clinicopathological predictors of lymph node metastasis were determined by multivariable logistic regression and used to develop a nomogram in a randomly selected subset that was validated in the remainder. Overall survival was compared between Eastern and Western countries. RESULTS: Lymph node metastasis was found in 701 of 3166 (22.1%) Eastern and 153 of 560 (27.3%) Western patients. Independent predictors of lymph node metastasis were female sex, tumor size, distal stomach location, lymphovascular invasion, and moderate or poor differentiation. Patients fulfilling the National Comprehensive Cancer Network guideline criteria, excluding the requirement that invasion not extend beyond the superficial submucosa, had a lymph node metastasis rate of 8.9% (53/594). Excluding moderately differentiated tumors lowered the rate to 3.4% (10/296). The nomogram's area under the curve was 0.690. Regardless of lymph node status, overall survival was better in Eastern patients. CONCLUSIONS: The lymph node metastasis rate was lowest in patients with well differentiated tumors that were ≤3 cm and lacked lymphovascular invasion. These criteria may be useful in decisions regarding endoscopic resection as definitive treatment for pT1b gastric cancer.

Optimal Predictors of Postoperative Complications After Gastrectomy: Results from the Procalcitonin and C-reactive Protein for the Early Diagnosis of Anastomotic Leakage in Esophagogastric Surgery (PEDALES) Study.

BACKGROUND: The aim of this study was to define whether procalcitonin (PCT) is an earlier and more accurate predictor than C-reactive protein (CRP) for anastomotic leakage (AL) and major infective complications (MICs). METHODS: This was a prospective multicentric observational study conducted in three Italian centers, including all patients undergoing gastrectomy from May 2016 to April 2021. The endpoint was the assessment of the discrimination and accuracy achieved by the PCT and CRP values measured from POD1 to POD7 for predicting the occurrence of AL and MICs. Accuracy was assessed by calculating the area under the receiver operating curve (AUROC) values and Youden's statistics. Two charts were created for risk stratification during the postoperative course. RESULTS: The rate of AL was 4.6%, with a median day of occurrence on POD5 (range 3-26). The overall rate of major infective complications was 19.9%, with a median day of occurrence on POD6 (range 2-30). PCT showed a significant association with AL on POD6 and POD7 and a significant association with MICs on POD2, while CRP values showed a significant association with AL on POD4 and a significant association with MICs on POD1. No difference in the prediction of AL was observed between PCT and CRP, while CRP was found to be a superior predictor of major infective complications on POD5 (p = 0.024) and POD7 (p = 0.035). CONCLUSIONS: PCT was not superior to CRP as an early predictor of AL and major infective complications after gastrectomy. CRP should be used as the reference screening postoperative marker.