Multicenter study on the incidence and treatment of mediastinal leaks after esophagectomy (MuMeLe 2).

BACKGROUND: Management of mediastinal anastomotic leaks (MALs) after Ivor Lewis esophagectomy includes conservative, endoscopic, or surgical management. Endoscopic vacuum therapy (EVAC) is becoming a routine approach for MALs, although the outcomes have not been defined. This study aimed to describe the incidence, treatment, and outcomes of MALs in patients who underwent esophagectomy in 3 Italian high-volume centers that routinely use EVAC for MAL. METHODS: Patients who underwent Ivor Lewis esophagectomy between September 2018 and March 2023 were included. RESULTS: A total of 681 patients underwent Ivor Lewis esophagectomy, of whom 88 had MAL. The MAL rates for open, minimally invasive, and robotic esophagectomies were 11.5%, 13.4%, and 14.8%, respectively. Global and specific 30- and 90-day mortality rates for MAL were 0.9% and 2.1% and 6.8% and 15.9%, respectively. Nonoperative management (NOM) as the primary treatment was chosen for 62 patients. EVAC was the most common NOM (62.9%), and the most common operative management (OM) was anastomotic redo (53.8%). Diversion was the OM for 7 patients, of whom 3 patients died. Primary treatment proved successful in 40 patients. Among them, EVAC alone was successful in 35.9% of patients. Globally, endoscopic treatment, including EVAC, was successful in 79.0% of NOM and 55.7% of MALs. NOM and OM were chosen as secondary treatments for 27 and 10 patients, respectively. Secondary treatment proved successful in 21 patients. CONCLUSION: The incidence of MALs after Ivor Lewis esophagectomy is approximately 13%. Endoscopic techniques have a success rate of almost 80%, with EVAC representing a significant part of this treatment process.

Roux-en-Y with or without jejunal J-pouch reconstruction after total gastrectomy for gastric cancer: systematic review and meta-analysis of long-term functional outcomes.

BACKGROUND: Increased survival of patients undergoing total gastrectomy for gastric cancer has prompted several efforts to improve long-term postgastrectomy syndrome (PGS) outcomes. Whether a J-pouch (JP) reconstruction may be more beneficial than a standard Roux-en-Y (RY) is controversial. METHODS: A systematic review with meta-analysis was conducted, including studies reporting long-term outcomes of patients treated with total gastrectomy and JP vs RY esophagojejunostomy for gastric adenocarcinoma. A literature search was performed on PubMed, Scopus, and Google Scholar. Primary endpoints were symptom control, weight loss, eating capacity (EC), and quality of life (QoL) with at least 6 months of follow-up. Safety endpoints were explored. RESULTS: Overall, 892 patients were included from 15 studies (6 randomized controlled trials [RCTs] and 9 non-RCTs): 452 (50.7%) in the JP group and 440 (49.3%) in the RY group. Compared with RY, JP showed a significantly lower rate of dumping syndrome (13.8% vs 26.9%, odds ratio [OR], 0.29; 95% confidence interval [CI], 0.14-0.58; P < .001; I2 = 22%) and heartburn symptoms (20.4% vs 39.0%; OR, 0.29; 95% CI, 0.14-0.64; P = .002; I2 = 0%). Reflux (OR, 0.61; 95% CI, 0.28-1.32; P = .21; I2 = 42%) and epigastric fullness (OR, 0.60; 95% CI, 0.18-2.05; P = .41; I2 = 69%) were similar in both groups. Weight loss and EC were similar between the groups. QoL outcome seemed to be burdened by bias. There was no difference in morbidity, mortality, and anastomotic leak rate between groups. Operative time was significantly longer for JP than for RY (271.9 vs 251.6 minutes, respectively; mean difference, 21.55; 95% CI, 4.64-38.47; P = .01; I2 = 96%). CONCLUSION: JP reconstruction after total gastrectomy for gastric cancer is as safe as RY and may provide an advantage in postgastrectomy dumping syndrome and heartburn symptoms.

A pragmatic approach improves the clinical management of stage IV gastric cancer: Comparison between the Meta-Gastro results and the GIRCG's retrospective series.

INTRODUCTION: The Italian Research Group for Gastric Cancer developed a prospective database about stage IV gastric cancer, to evaluate how a pragmatic attitude impacts the management of these patients. MATERIALS AND METHODS: We prospectively collected data about metastatic gastric cancer patients thanks to cooperation between radiologists, oncologists and surgeons and we analyzed survival and prognostic factors, comparing the results to those obtained in our retrospective study. RESULTS: Three-hundred and eighty-three patients were enrolled from 2018 to September 2022. We observed a higher percentage of laparoscopic exploration with peritoneal lavage in the prospective cohort. In the registry only 3.6 % of patients was submitted to surgery without associated chemotherapy, while in the retrospective population 44.3 % of patients were operated on without any chemotherapy. At univariate and multivariate analyses, the different metastatic sites did not show any survival differences among each other (OS 20.0 vs 16.10 vs 16.7 months for lymphnodal, peritoneal and hepatic metastases, respectively), while the number of metastatic sites and the type of treatment showed a statistical significance (OS 16,7 vs 13,0 vs 4,5 months for 1, 2 and 3 different metastatic sites respectively, p < 0.001; 24,2 vs 12,0 vs 2,5 months for surgery with/without chemotherapy, chemotherapy alone and best supportive treatment respectively, p < 0.001). CONCLUSIONS: Our data highlight that the different metastatic sites did not show different survivals, but survival is worse in case of multiple localization. In patients where a curative resection can be achieved, acceptable survival rates are possible. A better diagnostic workup and a more accurate staging impact favorably upon survival.

Textbook outcome as indicator of surgical quality in a single Western center: results from 300 consecutive gastrectomies.

Textbook outcome (TO) has been proposed as a tool to evaluate surgical quality. Textbook oncological outcome (TOO) adds chemotherapeutic compliance to TO. This study was conducted to analyze the TO and TOO of patients with gastric adenocarcinoma who underwent surgery at our center. Data from a prospective database of patients operated on for gastric adenocarcinoma between September 2018 and September 2022 were analyzed. Postoperative management followed Enhanced Recovery After Surgery guidelines. The Dutch Upper Gastrointestinal Cancer Audit group defined TO as a multidimensional measure (10 items). TOO also considers guideline-accordant chemotherapeutic compliance. Three hundred patients underwent surgery during the study period (167 men, 133 women). One hundred seventy-six (58.7%) reached TO. Achieving TO was influenced by patients' comorbidities, calculated via the Charlson Comorbidity Score (3 vs. 4; p = 0.002) and surgery type (subtotal gastrectomy; p < 0.001), but not by the American Society of Anesthesiologists (ASA) score (p = 0.057) or surgical approach (laparoscopic vs. open; p = 0.208). The analysis of TOO included 213 patients. Of these, 71 (33%) underwent complete adequate systemic treatment. Compared with the non-TOO group, patients who achieved TOO had a lower median age (64 vs. 73 years; p < 0.001) and lower ASA score (p < 0.001) and more frequently underwent preoperative chemotherapy (p < 0.001). Our results represent the experience of a single team at a high-volume Western institute. Patients' comorbidities and surgery type influenced whether TO was achieved. Conversely, younger age, lower ASA score and preoperative chemotherapy were associated with TOO.

Tumour-specific mesorectal excision for rectal cancer: Systematic review and meta-analysis of oncological and functional outcomes.

BACKGROUND: Tumour-specific mesorectal excision (TSME) practice for rectal cancer only relies on small retrospective studies. This study aimed to perform a systematic review and meta-analysis to assess the oncological and functional outcomes of TSME practice. METHODS: A systematic review protocol was drawn to include all the studies that compared partial versus total mesorectal excision (PME vs TME) practised for rectal adenocarcinoma up to 16 cm from the anal verge. A systematic literature search was conducted on EMBASE-Medline, Pubmed and Cochrane Library. Reports were screened for the study's outcomes: oncological radicality, postoperative anastomotic leak risk and functional outcomes. Included studies were appraised for risk-of-bias and meta-analysed. Evidence was rated with the GRADE approach. RESULTS: Twenty-seven studies were included, consisting of 12325 patients (PME n = 4460, 36.2%; TME n = 7865, 63.8%). PME was performed for tumours higher than 10 cm from the anal verge in 54.5% of patients. There was no difference between PME and TME in circumferential resection margin positivity (OR 1.31, 95%CI 0.43-3.95, p = 0.64; I2 = 38%), and local recurrence risk (HR 1.05, 95%CI 0.52-2.10, p = 0.90; I2 = 40%). The postoperative leak risk (OR 0.42, 95%CI 0.27-0.67, p < 0.001; I2 = 60%) and the major low anterior resection syndrome risk (OR 0.34, 95%CI 0.28-0.40, p < 0.001; I2 = 0%) were lower after PME surgery. No difference was found in urinary incontinence (OR 0.68, 95%CI 0.13-3.67, p = 0.66) and urinary retention after early catheter removal (OR 2.00, 95%CI 0.24-16.51, p = 0.52). CONCLUSIONS: Evidence from this meta-analysis shows that TSME for rectal cancer has good oncological results and leads to the best-fitted functional results possible for the patient's condition.

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.

Three-year survival and distribution of lymph node metastases in gastric cancer following neoadjuvant chemotherapy: results from a European randomized clinical trial.

BACKGROUND: Adequate lymphadenectomy is an important step in gastrectomy for cancer, with a modified D2 lymphadenectomy being recommended for advanced gastric cancers. When assessing a novel technique for the treatment of gastric cancer, lymphadenectomy should be non-inferior. The aim of this study was to assess completeness of lymphadenectomy and distribution patterns between open total gastrectomy (OTG) and minimally invasive total gastrectomy (MITG) in the era of peri-operative chemotherapy. METHODS: This is a retrospective analysis of the STOMACH trial, a randomized clinical trial in thirteen hospitals in Europe. Patients were randomized between OTG and MITG for advanced gastric cancer after neoadjuvant chemotherapy. Three-year survival, number of resected lymph nodes, completeness of lymphadenectomy, and distribution patterns were examined. RESULTS: A total of 96 patients were included in this trial and randomized between OTG (49 patients) and MITG (47 patients). No difference in 3-year survival was observed, this was 57.1% in OTG group versus 46.8% in MITG group (P = 0.186). The mean number of examined lymph nodes per patient was 44.3 ± 16.7 in the OTG group and 40.7 ± 16.3 in the MITG group (P = 0.209). D2 lymphadenectomy of 71.4% in the OTG group and 74.5% in the MITG group was performed according to the surgeons; according to the pathologist compliance to D2 lymphadenectomy was 30% in the OTG group and 36% in the MITG group. Tier 2 lymph node metastases (stations 7-12) were observed in 19.6% in the OTG group versus 43.5% in the MITG group (P = 0.024). CONCLUSION: No difference in 3-year survival was observed between open and minimally invasive gastrectomy. No differences were observed for lymph node yield and type of lymphadenectomy. Adherence to D2 lymphadenectomy reported by the pathologist was markedly low.

Role of microsatellite instability and HER2 positivity in locally advanced esophago-gastric cancer patients treated with peri-operative chemotherapy.

PURPOSE: Neoadjuvant chemotherapy (NAC) significantly improved the prognosis of patients with locally advanced gastric cancer (LAGC). Several biomarkers, including HER2 and MMR/MSI are crucial for treatment decisions in the advanced stage but, currently, no biomarkers can guide the choice of NAC in clinical practice. Our aim was to evaluate the role of MSI and HER2 status on clinical outcomes. METHODS: We retrospectively collected LAGC patients treated with NAC and surgery +/- adjuvant chemotherapy from 2006 to 2018. HER2 and MSI were assessed on endoscopic and surgical samples. Pathologic complete response (pCR) rate, overall survival (OS), and event-free survival (EFS) were estimated and evaluated for association with downstaging and MSI. RESULTS: We included 76 patients, 8% were classified as MSI-H, entirely consistent between endoscopic and surgical samples. Six percent of patients were HER2 positive on endoscopic and 4% on surgical samples. Tumor downstaging was observed in 52.5% of cases, with three pCR (5.1%), none in MSI-H cancers. According to MSI status, event-free survival (EFS) and overall survival (OS) were higher for MSI-H patients to MSS [EFS not reached vs 30.0 months, p = 0.08; OS not reached vs 39.6 months, p = 0.10]. CONCLUSION: Our work confirms the positive prognostic effect of MSI-H in the curative setting of LAGC, not correlated with pathologic tumor downstaging. Prospective ad-hoc trial and tumor molecular profiling are eagerly needed.

Sarcopenia and Patient's Body Composition: New Morphometric Tools to Predict Clinical Outcome After Ivor Lewis Esophagectomy: a Multicenter Study.

BACKGROUND: The impact of preoperative body composition as independent predictor of prognosis for esophageal cancer patients after esophagectomy is still unclear. The aim of the study was to explore such a relationship. METHODS: This is a multicenter retrospective study from a prospectively maintained database. We enrolled consecutive patients who underwent Ivor-Lewis esophagectomy in four Italian high-volume centers from May 2014. Body composition parameters including total abdominal muscle area (TAMA), visceral fat area (VFA), and subcutaneous fat area (SFA) were determined based on CT images. Perioperative variables were systematically collected. RESULTS: After exclusions, 223 patients were enrolled and 24.2% had anastomotic leak (AL). Sixty-eight percent of patients were sarcopenic and were found to be more vulnerable in terms of postoperative 90-day mortality (p = 0.028). VFA/TAMA and VFA/SFA ratios demonstrated a linear correlation with the Clavien-Dindo classification (R = 0.311 and 0.239, respectively); patients with anastomotic leak (AL) had significantly higher VFA/TAMA (3.56 ± 1.86 vs. 2.75 ± 1.83, p = 0.003) and VFA/SFA (1.18 ± 0.68 vs. 0.87 ± 0.54, p = 0.002) ratios. No significant correlation was found between preoperative BMI and subsequent AL development (p = 0.159). Charlson comorbidity index correlated significantly with AL (p = 0.008): these patients had a significantly higher index (≥ 5). CONCLUSION: Analytical morphometric assessment represents a useful non-invasive tool for preoperative risk stratification. The concurrent association of sarcopenia and visceral obesity seems to be the best predictor of AL, far better than simple BMI evaluation, and potentially modifiable if targeted with prehabilitation programs.

A national survey on the current status of minimally invasive gastric practice on behalf of GIRCG.

Italian Research Group for Gastric Cancer (GIRCG), during the 2013 annual Consensus Conference to gastric cancer, stated that laparoscopic or robotic approach should be limited only to early gastric cancer (EGC) and no further guidelines were currently available. However, accumulated evidences, mainly from eastern experiences, have supported the application of minimally invasive surgery also for locally advanced gastric cancer (AGC). The aim of our study is to give a snapshot of current surgical propensity of expert Italian upper gastrointestinal surgeons in performing minimally invasive techniques for the treatment of gastric cancer in order to answer to the question if clinical practice overcome the recommendation. Experts in the field among the Italian Research Group for Gastric Cancer (GIRCG) were invited to join a web 30-item survey through a formal e-mail from January 1st, 2020, to June 31st, 2020. Responses were collected from 46 participants out of 100 upper gastrointestinal surgeons. Percentage of surgeons choosing a minimally invasive approach to treat early and advanced gastric cancer was similar. Additionally analyzing data from the centers involved, we obtained that the percentage of minimally invasive total and partial gastrectomies in advanced cases augmented with the increase of surgical procedures performed per year (p = 0.02 and p = 0.04 respectively). It is reasonable to assume that there is a widening of indications given by the current national guideline into clinical practice. Propensity of expert Italian upper gastrointestinal surgeons was to perform minimally invasive surgery not only for early but also for advanced gastric cancer. Of interest volume activity correlated with the propensity of surgeons to select a minimally invasive approach.

Implementation of the ERAS program in gastric surgery: a nationwide survey in Italy.

Enhanced recovery after surgery (ERAS) programs have been developed by combining several evidence-based techniques for perioperative care, with the intention of reducing the stress response and organ dysfunction, thus allowing improved clinical results. ERAS programs have been widely adopted for colorectal surgery; however, their adoption for upper gastrointestinal surgery has been challenging even though good results have been reported in the literature. Our intent was to investigate the adoption of ERAS programs for resective gastric surgery in Italy. A survey was conducted among 20 departments of surgery belonging to the Italian Group for Research on Gastric Cancer (GC). Analysis of our survey showed that several evidence-based practices and many items of the ERAS guidelines for gastric surgery are not implemented in real practice in Italian centers dedicated to GC. This situation may be related to the hesitation of surgeons to introduce radical changes to the traditional postoperative management after gastrectomy. A multidisciplinary approach to the perioperative care of these patients is not routinely applied in many Italian centers. A strict collaboration of all clinicians involved in the perioperative care of patients undergoing gastrectomy for GC is key for the future implementation of ERAS in gastric surgery in our departments.

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.

Esophagectomy-prevention of complications-tips and tricks for the preoperative, intraoperative and postoperative stage.

Esophagectomy still remains the mainstay of treatment for localized esophageal cancer. Many progresses have been made in the technique of esophagectomy in the last decades but the overall morbidity for this operation remains formidable. Postoperative complication and mortality rate after esophagectomy are significant; anastomotic leak has an incidence of 11,4%. The occurrence of a complication is a significant negative prognostic factor for long term survival and is also linked to longer postoperative stay, a lower quality of life, increased hospital costs. Preventing the occurrence of postoperative morbidity and reducing associated postoperative mortality rate is a major goal for surgeons experienced in resective esophageal surgery. Many details of pre, intra and postoperative care for patients undergoing esophagectomy need to be shared among the professionals taking care of these patients (oncologists, dieticians, physiotherapists, surgeons, nurses, anesthesiologists, gastroenterologists) in order to improve the short and long term clinical results.

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.

End-to-side circular stapled versus side-to-side linear stapled intrathoracic esophagogastric anastomosis following minimally invasive Ivor-Lewis esophagectomy: comparison of short-term outcomes.

PURPOSE: The search for the optimal procedure for creation of a safe gastroesophageal intrathoracic anastomosis with a lower risk of leakage in totally minimally invasive Ivor-Lewis esophagectomy (TMIIL) is ongoing. In the present study, we compared the outcomes of end-to-side (with circular stapler [CS]) and side-to-side (with linear stapler [LS]) techniques for intrathoracic anastomosis during TMIIL performed in 2 European high-volume centers for upper gastrointestinal surgery. A propensity score method was used to compare the CS and LS groups. METHODS: We retrospectively evaluated patients with lower esophageal cancer or Siewert type 1 or 2 esophagogastric junction carcinoma who underwent a planned TMIIL esophagectomy, performed from January 2017 to September 2020. The anastomosis was created by a semi-mechanical technique using a LS in one center and by a mechanical technique using a CS in the other center. General features, operative techniques, pathology data, and short-term outcomes were analyzed. Statistical evaluations were performed on the whole cohort, stratifying the analyses by risk strata factors identified with the propensity scores, and on a subgroup of patients matched by propensity score. The primary endpoint of the study was the rate of anastomotic leakage in the two groups. Secondary endpoints included rates of anastomotic stricture and overall postoperative complications. RESULTS: Considering the whole population, 256 patients were included; of those, 220 received the anastomosis with a circular stapler (CS group), and 36 received the anastomosis with a linear stapler (LS group). No significant differences by group in terms of sex, age, American Society of Anesthesiologists physical status classification, and type of neoplasm were showed. The rate of anastomotic leakage did not differ in the two groups (9.6% CS vs. 5.6% LS, p = 0.438), as well as the rate of anastomotic stricture in the 3-month follow-up (0.9% CS vs. 2.8% LS, p = 0.367). The rate of chyle leakage and of pulmonary, cardiac, and infective complications was not significantly different in the groups. After propensity score matching, 72 patients were included in the analysis. The 2 obtained propensity score matched groups did not differ for any of the clinical and pathologic variables considered for the analysis, resulting in well-balanced cohorts. The results obtained on the whole population were confirmed in the matched groups. CONCLUSIONS: The results of our study suggest that both techniques for esophagogastric anastomosis during TMIIL are feasible, safe, and effective, with comparable rates of postoperative anastomotic leakage and stricture.

Which gastric cancer patients could benefit from staging laparoscopy? A GIRCG multicenter cohort study.

BACKGROUND: This study aimed to investigate which gastric cancer patients could benefit the most from staging laparoscopy. METHODS: A retrospective cohort study was carried out, including 316 (216 cM- and 100 cM+) gastric cancer patients who had undergone staging laparoscopy between 2010 and 2020 in seven GIRCG centers. A model including easily-accessible clinical, biochemical and pathological markers was constructed to predict the risk of carcinomatosis. ROC curve and decision curve analyses were used to verify its accuracy and net benefit. RESULTS: In the cM-population staging laparoscopy could detect 67 cases who had peritoneal carcinomatosis or positive cytology, for a yield of 30.5%. In cM-patients, intestinal type tumors (0.25, 0.12-0.51; p = 0.002), cT4 tumors (2.18, 1.11-4.28; p = 0.023) and cancers of the lower third (0.31, 0.14-0.70; p = 0.004) were associated with the presence of peritoneal carcinomatosis and/or positive cytology. The ROC curve analysis of the model including the three variables showed an AUC of 0.75 (0.68-0.81, p < 0.001). The decision curve analyses showed that the model had a higher net benefit than the treating all strategy between threshold probabilities of 15 and 50%. CONCLUSIONS: Staging laparoscopy is a useful tool to address the patient with gastric cancer to the most adequate treatment. In cM-patients the assessment of the location of the tumor, the Lauren's histotype and the cT status may help in providing additional elements in indicating or not the use of staging laparoscopy.

Generalizability in mixed models: Lessons from corpus linguistics.

Part of the generalizability issues that haunt controlled lab experiment designs in psychology, and more particularly in psycholinguistics, can be alleviated by adopting corpus linguistic methods. These work with natural data. This advantage comes at a cost: in corpus studies, lexemes and language users can show different kinds of skew. We discuss a number of solutions to bolster the control.

Development of the PERI-Gastric (PEritoneal Recurrence Index) and PERI-Gram (Peritoneal Recurrence Index NomoGRAM) for predicting the risk of metachronous peritoneal carcinomatosis after gastrectomy with curative intent for gastric cancer.

BACKGROUND: A model that quantifies the risk of peritoneal recurrence would be a useful tool for improving decision-making in patients undergoing curative-aim gastrectomy for gastric cancer (GC). METHODS: Five Italian centers participated in this study. Two risk scores were created according to the two most widely used pathologic classifications of GC (the Lauren classification and the presence of signet-ring-cell features). The risk scores (the PERI-Gastric 1 and 2) were based on the results of multivariable logistic regressions and presented as nomograms (the PERI-Gram 1 and 2). Discrimination was assessed with the area under the curve (AUC) of receiver operating curves. Calibration graphs were constructed by plotting the actual versus the predicted rate of peritoneal recurrence. Internal validation was performed with a bootstrap resampling method (1000 iterations). RESULTS: The models were developed based on a population of 645 patients (selected from 1580 patients treated from 1998 to 2018). In the PERI-Gastric 1, significant variables were linitis plastica, stump GC, pT3-4, pN2-3 and the Lauren diffuse histotype, while in the PERI-Gastric 2, significant variables were linitis plastica, stump GC, pT3-4, pN2-3 and the presence of signet-ring cells. The AUC was 0,828 (0.778-0.877) for the PERI-Gastric 1 and 0,805 (0.755-0.855) for the PERI-Gastric 2. After bootstrap resampling, the PERI-Gastric 1 had a mean AUC of 0.775 (0.721-0.830) and a 95%CI estimate for the calibration slope of 0.852-1.505 and the PERI-Gastric 2 a mean AUC of 0.749 (0.693-0.805) and a 95%CI estimate for the slope of 0.777-1.351. The models are available at www.perigastric.org . CONCLUSIONS: We developed the PERI-Gastric and the PERI-Gram as instruments to determine the risk of peritoneal recurrence after curative-aim gastrectomy. These models could direct the administration of prophylactic intraperitoneal treatments.

Health related quality of life following open versus minimally invasive total gastrectomy for cancer: Results from a randomized clinical trial.

INTRODUCTION: Minimally invasive techniques show improved short-term and comparable long-term outcomes compared to open techniques in the treatment of gastric cancer and improved survival has been seen with the implementation of multimodality treatment. Therefore, focus of research has shifted towards optimizing treatment regimens and improving quality of life. MATERIALS AND METHODS: A randomized trial was performed in thirteen hospitals in Europe. Patients were randomized between open total gastrectomy (OTG) or minimally invasive total gastrectomy (MITG) after neoadjuvant chemotherapy. This study investigated patient reported outcome measures (PROMs) on health-related quality of life (HRQoL) following OTG or MITG, using the Euro-Qol-5D (EQ-5D) and the European Organization for Research and Treatment of Cancer (EORTC) questionnaires, modules C30 and STO22. Due to multiple testing a p-value < 0.001 was deemed statistically significant. RESULTS: Between January 2015 and June 2018, 96 patients were included in this trial. Forty-nine patients were randomized to OTG and 47 to MITG. A response compliance of 80% was achieved for all PROMs. The EQ5D overall health score one year after surgery was 85 (60-90) in the open group and 68 (50-83.8) in the minimally invasive group (P = 0.049). The median EORTC-QLQ-C30 overall health score one year postoperatively was 83,3 (66,7-83,3) in the open group and 58,3 (35,4-66,7) in the minimally invasive group (P = 0.002). This was not statistically significant. CONCLUSION: No differences were observed between open total gastrectomy and minimally invasive total gastrectomy regarding HRQoL data, collected using the EQ-5D, EORTC QLQ-C30 and EORTC-QLQ-STO22 questionnaires.