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.

Conversion rate to open surgery during transanal total mesorectal excision (TaTME) for rectal cancer: a single-center experience.

Minimally invasive techniques for rectal cancer have demonstrated considerable advantages in terms of faster recovery and less post-operative complications. However, due to the complex anatomy and a limited surgical field, conversion to open surgery is still sometimes required, with a negative impact on the short-and long-term outcomes. The purpose of this study was to analyse the conversion rate to open abdominal surgery during laparoscopic transanal total mesorectal excision (TaTME) procedures performed at a high-volume Italian referral center. All consecutive TaTME performed for mid-to-low rectal cancer between 2015 and 2023 were reviewed, independently if treated with a primary anastomosis (with/without a diverting ostomy) or an end stoma. All procedures were performed using a standardized approach by the same surgical team. Patients with benign diagnosis that underwent different-from rectal resection procedures and cases pre-operatively scheduled for open surgery were excluded. The primary outcome of interest was the rate of conversion, defined as an un-planned intraoperative switch to open surgery using a midline laparotomy. Secondary aims included the comparison of patients who had a longer vs shorter operative time. Out of 220 patients, 210 were selected. In 187 cases, a primary anastomosis was performed, while 23 patients received a terminal colostomy (1 in the converted group; 22 in the full MIS- TaTME group, 10.6%). A surgical approach modification occurred in two cases, with a conversion rate of 0.95%. Median operative time was 281 min. Reasons for conversions included intra-operative difficulties impairing the mini-invasive procedure without intra-operative complications in one case, and difficulties in the laparoscopic control of an intraoperative bleeding due to a splenic lesion in another patient. Male sex and a higher BMI were found to be statistically significantly associated to longer operative time (respectively: p = 0.001 and p = 0.0025). In a high-volume center, a standardized TaTME is associated to a low conversion rate to open abdominal 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.

'4-Check' protocol for intraoperative anastomotic assessment during transanal total mesorectal excision: retrospective cohort study.

BACKGROUND: Anastomotic leakage is a major complication following rectal cancer surgery. The primary aim of this study was to investigate the efficacy of a protocol based on a quadruple intraoperative anastomotic assessment (4-Check) during transanal total mesorectal excision (TaTME). METHODS: Patients who underwent TaTME for rectal cancer with primary anastomosis were reviewed and divided into two groups: before (pre-4-Check: April 2015 - April 2019) and after the implementation of the 4-Check protocol (May 2019 - May 2022). This protocol consisted of a multimodal anastomotic integrity assessment, including indocyanine green-evaluation of colonic stump and intraluminal anastomosis perfusion, a reverse air leak test and anastomotic doughnuts assessment. The primary outcome was incidence of clinical and/or radiological anastomotic leakage. The secondary outcome included intraoperative anastomosis defects and repairs and 30-day complication rate. Propensity score matching and multivariable analyses were performed. RESULTS: Of 186 patients, 160 were selected: 86 patients in the pre-4-Check and 74 in the 4-Check group. After propensity score matching, there was no difference in postoperative anastomotic leakage (pre-4-Check versus 4-Check: 11.1 per cent versus 7.4 per cent; P = 0.50). However, in the 4-Check group, the intraoperative detection of defects and repairs was significantly increased (P = 0.03), and the number of complications was reduced (pre-4-Check versus 4-Check: 33.3 per cent versus 9.3 per cent, P = 0.004). Multivariable analyses confirmed that the use of the 4-Check protocol, the detection of anastomotic defects and increased albumin levels were associated with a reduced number of complications. CONCLUSION: The 4-Check protocol allowed the intraoperative detection and repair of anastomotic defects. Anastomotic leakage rates were not reduced; however, 30-day complication rates were lower after implementation of this protocol.

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.

Current practice in assessment and management of malnutrition in surgical oncology practice - An ESSO-EYSAC snapshot analysis.

INTRODUCTION: Malnutrition is common in patients suffering from malignant diseases and has a major impact on patient outcomes. Prevention and early detection are crucial for effective treatment. This study aimed to investigate current international practice in the assessment and management of malnutrition in surgical oncology departments. MATERIAL AND METHODS: The survey was designed by European Society of Surgical Oncology (ESSO) and ESSO Young Surgeons and Alumni Club (EYSAC) Research Academy as an online questionnaire with 41 questions addressing three main areas: participant demographics, malnutrition assessment, and perioperative nutritional standards. The survey was distributed from October to November 2021 via emails, social media and the ESSO website to surgical networks focussing on surgical oncologists. Results were collected and analysed by an independent team. RESULTS: A total of 156 participants from 39 different countries answered the survey, reflecting a response rate of 1.4%. Surgeons reported treating a mean of 22.4 patients per month. 38% of all patients treated in surgical oncology departments were routinely screened for malnutrition. 52% of patients were perceived as being at risk for malnutrition. The most used screening tool was the "Malnutrition Universal Screening Tool" (MUST). 68% of participants agreed that the surgeon is responsible for assessing preoperative nutritional status. 49% of patients were routinely seen by dieticians. In cases of severe malnutrition, 56% considered postponing the operation. CONCLUSIONS: The reported rate of malnutrition screening by surgical oncologists is lower than expected (38%). This indicates a need for improved awareness of malnutrition in surgical oncology, and nutritional screening.

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.

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.

Pathologic stage of ypT0N+ rectal cancers following neo-adjuvant treatment: clinical interpretation of an orphan status.

Approximately 20% of locally advanced rectal cancers treated with neoadjuvant therapy achieve a pathologic complete response, but approximately 10% of them present residual nodal metastases (ypT0N+). We aimed this research to compare the survival rates of ypT0/ypTisN+ and stage 3a rectal cancer patients. A large multicenter study recently investigated ypT0/ypTis rectal cancers treated between 2005 and 2015 in Italy and Spain. ypT0/ypTisN+ were selected and compared with stage 3a rectal cancers treated at the same institutions with upfront surgery (ySICO group). Additionally, the SEER database was searched for patients with stage 3a rectal cancers treated with surgery in the same years. Overall survival (OS), disease-free survival (DFS), and disease-specific survival (DSS) were analyzed using Kaplan-Meier curves and random survival forest analysis (RSF). The ySICO study population consisted of 19 ypT0/2ypTisN+ (mean follow-up 41.8 months) and 72 Stage 3a patients (mean follow-up 56.9 months). These subgroups were comparable, but stage 3a patients were treated more frequently with adjuvant therapy (90.5% vs 61.9%, p 0.0001). No significant differences were reported between the ySICO subgroups for the OS, DFS, and DSS curves. When the 1213 SEER patients were added to Stage 3a, the RFS model failed to differentiate OS between groups that presented identical survival. Root analysis showed that adjuvant therapy was the only variable differentiating OS and DSS in the ySICO population. These findings suggest that ypT0/ypTisN+ and stage 3a rectal cancers could be ranked together based on their similar outcomes and pathologic assessment, and they stress the importance of adjuvant therapy in patients presenting with residual nodal metastases.

The Use of Indocyanine Green (ICG) and Near-Infrared (NIR) Fluorescence-Guided Imaging in Gastric Cancer Surgery: A Narrative Review.

Near-infrared fluorescence imaging with indocyanine green is an emerging technology gaining clinical relevance in the field of oncosurgery. In recent decades, it has also been applied in gastric cancer surgery, spreading among surgeons thanks to the diffusion of minimally invasive approaches and the related development of new optic tools. Its most relevant uses in gastric cancer surgery are sentinel node navigation surgery, lymph node mapping during lymphadenectomy, assessment of vascular anatomy, and assessment of anastomotic perfusion. There is still debate regarding the most effective application, but with relatively no collateral effects and without compromising the operative time, indocyanine green fluorescence imaging carved out a role for itself in gastric resections. This review aims to summarize the current indications and evidence for the use of this tool, including the relevant practical details such as dosages and times of administration.

Enhanced recovery after surgery (ERAS) program in octogenarian patients: a propensity score matching analysis on the "Lazio Network" database.

PURPOSE: The aim of this study was to evaluate the safety and compliance with the enhanced recovery after surgery (ERAS) protocol in octogenarian patients undergoing colorectal surgery in 12 Italian high-volume centers. METHODS: A retrospective analysis was conducted in a consecutive series of patients who underwent elective colorectal surgery between 2016 and 2018. Patients were grouped by age (≥ 80 years vs < 80 years), propensity score matching (PSM) analysis was performed, and the groups were compared regarding clinical outcomes and the mean number of ERAS items applied. RESULTS: Out of 1646 patients identified, 310 were octogenarians. PSM identified 2 cohorts of 125 patients for the comparison of postoperative outcomes and ERAS compliance. The 2 groups were homogeneous regarding the clinical variables and mean number of ERAS items applied (11.3 vs 11.9, p-ns); however, the application of intraoperative items was greater in nonelderly patients (p 0.004). The functional recovery was similar between the two groups, as were the rates of postoperative severe complications and 30-day mortality rate. Elderly patients had more overall complications. Furthermore, the mean hospital stay was higher in the elderly group (p 0.027). Multivariable analyses documented that postoperative stay was inversely correlated with the number of ERAS items applied (p < 0.0001), whereas age ≥ 80 years significantly correlated with the overall complication rate (p 0.0419). CONCLUSION: The ERAS protocol is safe in octogenarian patients, with similar levels of compliance and surgical outcomes. However, octogenarian patients have a higher rate of overall complications and a longer hospital stay than do younger patients.

Nutritional support in surgical oncology: A survey by SICO in collaboration with the Intersociety Italian Working Group for Nutritional Support in Cancer Patients.

PURPOSE: Nutritional support is a keystone component in perioperative care in patients undergoing oncological surgery with a direct impact on surgical outcomes. This study aimed to evaluate how nutritional support in the surgical setting is managed and applied in Italian hospitals. METHODS: A national survey was designed by the Italian Society of Surgical Oncology (SICO) and disseminated in early 2021. The results were analyzed for the entire population and for comparing the following different subgroups: northern vs. southern regions; high-volume vs. low-volume centers; and junior vs. senior surgeons. RESULTS: Out of the 141 responses collected from all Italian regions, 43.2% of the participants worked in a surgical unit where nutritional status evaluations and interventions were not routinely practiced, although the key features (nutritional counseling, oral supplementation, enteral and parenteral nutrition) were available in 77.3% of the hospitals. Among the participating centers, the ERAS protocol was systematically applied in only 29.5% of cases, and in 25.5% of cases, most of the items were followed, although not systematically. Among the surgeons who practiced in compliance with the ERAS pathways, almost half of the participants declared that the protocol was applied only for low-risk patients. No significant differences were documented when comparing Italian regions, high-volume vs. low-volume institutions or junior vs. senior participants. CONCLUSION: Nutritional support in oncological surgery is frequently neglected in Italian hospitals, regardless of the geographic distribution and volumes of the institutions. A cultural change and an improvement in the availability of nutritional services are needed for widespread implementation.

Quality Over Volume: Modeling Centralization of Gastric Cancer Resections in Italy.

Background: The correlation between hospital volume and postoperative outcomes has led to the centralization of complex procedures in several countries. However, the results reported in relation to gastric cancer (GC) are contradictory. This study aimed to analyze GC surgical volumes and 30-day postoperative mortality in Italy and to provide a simulation for modeling centralization of GC resections based on district case volumes. Methods: A national registry was used to identify all GC resections, record mortality rates, and track the national in-border GC resection health travel. Hospitals were grouped according to caseload. Centralization of all GC procedures performed within the same district was modeled. The outcome measures were a minimal volume of 25 GC resections/year and the 30-day postoperative mortality. Results: In 2018, 5,873 GC resections were performed in 498 Italian hospitals (mean resections per hospital per year: 11.8); the postoperative mortality rate (5.51%) was tracked from 2016-2018. GC resection health travel ranged from 2% to 50.5%, with a significant (P<0.001) difference between northern and central/southern Italy. The mean mortality rate was 7.7% in hospitals performing one to 3 GC resections per year, compared with 4.7% in those with >17 GC resections/year (P≤0.01). Most Italian districts achieved 25 procedures/year after centralization; however, 66.3% of GC cases in southern Italy vs. 42.2% in central and 52.7% in the northern regions (P<0.001) required reallocation. Conclusion: Postoperative mortality after GC resection correlated with hospital volume. Despite health travel, most Italian districts can reach a high-volume threshold, but discrepancies in mortality rates are alarming.Trial RegistrationResearch Registry Identifier: researchregistry6869.

Feasibility of discharge within 72†hours of major colorectal surgery: lessons learned after 5 years of institutional experience with the ERAS protocol.

BACKGROUND: Early postoperative discharge after colorectal surgery within the enhanced recovery after surgery (ERAS) guidelines has been demonstrated to be safe, although its applicability has not been universal. The primary aim of this study was to identify the predictors of early discharge and readiness for discharge in a study population. METHODS: Early discharge was defined as discharge occurring in 72 h or less after surgery. The characteristics and clinical outcomes of the patients in the early and non-early discharge groups were compared, and variables associated with early discharge were identified. Additionally, independent variables associated with the readiness for discharge within 48 h were evaluated. RESULTS: Of 965 patients who underwent colorectal surgery between January 2015 and July 2020, 788 were included in this study. No differences in readmission, reoperation, or 30-day mortality were observed between the early and non-early discharge groups. Both early discharge and readiness for discharge had a positive association with adherence to 80 per cent or more of the ERAS items and a negative association with the female sex, duration of surgery, drain positioning, and postoperative complications. CONCLUSION: Early discharge after colorectal surgery is safe and feasible, and is not associated with a high risk of readmission or reoperation. Discharge at 48 h can be reliably predicted in a subset of patients. Future studies should collect prospective data on early discharge related to safety, as well as patients' expectations, possible organizational issues, and effective costs reduction in Italian clinical practice.

Standards in surgical training in advanced pelvic malignancy across Europe and beyond - A Snapshot analysis.

INTRODUCTION: Multimodal treatment of patients with advanced pelvic malignancies (APM) is challenging and surgical expertise is usually concentrated in highly specialised centres. Given significant regional variation in APM surgery, surgical training represents a cornerstone in standardising and future-proofing of this complex therapy. The aim of this study was to describe the availability and current satisfaction levels with surgical training for APM. MATERIAL AND METHODS: An online questionnaire was developed and distributed through the Redcap© platform with 32 questions addressing participant and institution demographics, and training in APM surgeries. The survey was electronically disseminated in 2021 to surgical networks across Europe including all specialities treating APM via the European Society of Surgical Oncology (ESSO). All statistical analysis were performed using R. RESULTS: The survey received 280 responses from surgeons across 49 countries, representing general surgery (36%), surgical oncology (30%), gynaeoncology (15%), colorectal surgery (14%) and urology (5%). Fifty-three percent of participants report performing >25 APM procedures/year. Respondents were departmental chiefs (12%), consultants (34%), specialist surgeons (40%) and fellows (15%). 34% were happy/very happy with their training with 70% satisfaction about their exposure to surgical procedures. Respondents reported a lack of standardised training (72%), monitoring tools (41%) and mentorship (56%). 57% rated attended courses as useful for training, while 80% rated visiting expert centres as useful. CONCLUSION: This study has identified a learning need for improved structured training in APM, with low current satisfaction levels with exposure to APM training. Organisations such as ESSO provide an important platform for visiting expert centres, courses, and structured training.

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.

Systematic review of transanal total mesorectal excision literature according to the ideal framework: The evolution never ends.

BACKGROUND: Designing studies to assess critically novel procedures can be challenging; thus, the process to achieve robust evidence is frequently problematic. The aim of this systematic review was to evaluate if literature on transanal total mesorectal excision is evolving according to the Idea, Development, Exploration, Assessment, and Long-term results framework. METHODS: Literature on transanal total mesorectal excision was searched according to the preferred reporting items for systematic reviews and meta-analyses statement, and these variables were recorded: bibliometric data, design, corresponding author's nationality, number of patients enrolled, and Idea, Development, Exploration, Assessment, and Long-term results stages (stage 0, stage 1, stage 2, stage 3, and stage 4). RESULTS: Out of 447 articles retrieved, 247 were selected (76.5% single center and 23.5% multicenter collaborations), including 35 reviews, 15 meta-analyses, 24 other publications, and 173 articles classified according to Idea, Development, Exploration, Assessment, and Long-term results stages (19 stage 0, 27 stage 1, 111 stage 2, 7 stage 3, and 9 stage 4). Overall, impact factor produced was 634.10. Reviewing corresponding authors' nationalities, 32 countries were identified, with the United States, China, and the United Kingdom the most reported; nearly all were from the Northern Hemisphere. Publication of stage 3 and 4 articles started in 2014, whereas stage 0 and 1 articles were stably published over time. The number of patients increased in correspondence with the Idea, Development, Exploration, Assessment, and Long-term results stages (case series with >51 patients, respectively, 100.0% stage 3, 77.8% stage 4, and 33.3% stage 2, P = .005). CONCLUSION: The number of stage 3 and 4 articles is still low; however, the technical innovation of transanal total mesorectal excision is a non-stop process with preclinical studies stably published over time.