Minimally invasive vs. open segmental resection of the splenic flexure for cancer: a nationwide study of the Italian Society of Surgical Oncology-Colorectal Cancer Network (SICO-CNN)

Background Evidence on the efficacy of minimally invasive (MI) segmental resection of splenic flexure cancer (SFC) is not available, mostly due to the rarity of this tumor. This study aimed to determine the survival outcomes of MI and open treatment, and to investigate whether MI is noninferior to open procedure regarding short-term outcomes. Methods This nationwide retrospective cohort study included all consecutive SFC segmental resections performed in 30 referral centers between 2006 and 2016. The primary endpoint assessing efficacy was the overall survival (OS). The secondary endpoints included cancer-specific mortality (CSM), recurrence rate (RR), short-term clinical outcomes (a composite of Clavien-Dindo > 2 complications and 30-day mortality), and pathological outcomes (a composite of lymph nodes removed >= 12, and proximal and distal free resection margins length >= 5 cm). For these composites, a 6% noninferiority margin was chosen based on clinical relevance estimate. Results A total of 606 patients underwent either an open (208, 34.3%) or a MI (398, 65.7%) SFC segmental resection. At univariable analysis, OS and CSM were improved in the MI group (log-rank test p = 0.004 and Gray's tests p = 0.004, respectively), while recurrences were comparable (Gray's tests p = 0.434). Cox multivariable analysis did not support that OS and CSM were better in the MI group (p = 0.109 and p = 0.163, respectively). Successful pathological outcome, observed in 53.2% of open and 58.3% of MI resections, supported noninferiority (difference 5.1%; 1-sided 95%CI - 4.7% to infinity). Successful short-term clinical outcome was documented in 93.3% of Open and 93.0% of MI procedures, and supported noninferiority as well (difference - 0.3%; 1-sided 95%CI - 5.0% to infinity). Conclusions Among patients with SFC, the minimally invasive approach met the criterion for noninferiority for postoperative complications and pathological outcomes, and was found to provide results of OS, CSM, and RR comparable to those of open resection

Infected pancreatic necrosis: outcomes and clinical predictors of mortality. A post hoc analysis of the MANCTRA-1 international study

: The identification of high-risk patients in the early stages of infected pancreatic necrosis (IPN) is critical, because it could help the clinicians to adopt more effective management strategies. We conducted a post hoc analysis of the MANCTRA-1 international study to assess the association between clinical risk factors and mortality among adult patients with IPN. Univariable and multivariable logistic regression models were used to identify prognostic factors of mortality. We identified 247 consecutive patients with IPN hospitalised between January 2019 and December 2020. History of uncontrolled arterial hypertension (p = 0.032; 95% CI 1.135-15.882; aOR 4.245), qSOFA (p = 0.005; 95% CI 1.359-5.879; aOR 2.828), renal failure (p = 0.022; 95% CI 1.138-5.442; aOR 2.489), and haemodynamic failure (p = 0.018; 95% CI 1.184-5.978; aOR 2.661), were identified as independent predictors of mortality in IPN patients. Cholangitis (p = 0.003; 95% CI 1.598-9.930; aOR 3.983), abdominal compartment syndrome (p = 0.032; 95% CI 1.090-6.967; aOR 2.735), and gastrointestinal/intra-abdominal bleeding (p = 0.009; 95% CI 1.286-5.712; aOR 2.710) were independently associated with the risk of mortality. Upfront open surgical necrosectomy was strongly associated with the risk of mortality (p < 0.001; 95% CI 1.912-7.442; aOR 3.772), whereas endoscopic drainage of pancreatic necrosis (p = 0.018; 95% CI 0.138-0.834; aOR 0.339) and enteral nutrition (p = 0.003; 95% CI 0.143-0.716; aOR 0.320) were found as protective factors. Organ failure, acute cholangitis, and upfront open surgical necrosectomy were the most significant predictors of mortality. Our study confirmed that, even in a subgroup of particularly ill patients such as those with IPN, upfront open surgery should be avoided as much as possible. Study protocol registered in ClinicalTrials.Gov (I.D. Number NCT04747990)

Risk factors for anastomotic leakage after anterior resection for rectal cancer (RALAR study): A nationwide retrospective study of the Italian Society of Surgical Oncology Colorectal Cancer Network Collaborative Group

Aim: Anastomotic leakage after restorative surgery for rectal cancer shows high morbidity and related mortality. Identification of risk factors could change operative planning, with indications for stoma construction. This retrospective multicentre study aims to assess the anastomotic leak rate, identify the independent risk factors and develop a clinical prediction model to calculate the probability of leakage. Methods: The study used data from 24 Italian referral centres of the Colorectal Cancer Network of the Italian Society of Surgical Oncology. Patients were classified into two groups, AL (anastomotic leak) or NoAL (no anastomotic leak). The effect of patient-, disease-, treatment- and postoperative outcome-related factors on anastomotic leak after univariable and multivariable analysis was measured. Results: A total of 5398 patients were included, 552 in group AL and 4846 in group NoAL. The overall incidence of leaks was 10.2%, with a mean time interval of 6.8 days. The 30-day leak-related mortality was 2.6%. Sex, body mass index, tumour location, type of approach, number of cartridges employed, weight loss, clinical T stage and combined multiorgan resection were identified as independent risk factors. The stoma did not reduce the leak rate but significantly decreased leak severity and reoperation rate. A nomogram with a risk score (RALAR score) was developed to predict anastomotic leak risk at the end of resection. Conclusions: While a defunctioning stoma did not affect the leak risk, it significantly reduced its severity. Surgeons should recognize independent risk factors for leaks at the end of rectal resection and could calculate a risk score to select high-risk patients eligible for protective stoma construction

Surveillance for hepatocellular carcinoma with a 3-months interval in “extremely high-risk” patients does not further improve survival

Background An enhanced surveillance schedule has been proposed for cirrhotics with viral etiology, who are considered at extremely high-risk of hepatocellular carcinoma (HCC). Aims We compared the 3- and 6-months surveillance interval, evaluating cancer stage at diagnosis and patient survival. Methods Data of 777 HBV and HCV cirrhotic patients with HCC diagnosed under a 3-months (n = 109, 3MS group) or a 6-months (n = 668, 6MS group) surveillance were retrieved from the Italian Liver Cancer database. Survival in the 3MS group was considered as observed and adjusted for lead-time bias, and survival analysis was repeated after a propensity score matching. Results The 3-months surveillance interval neither reduced the share of patients diagnosed outside the Milano criteria, nor increased their probability to receive curative treatments. The median survival of 6MS patients (55.0 months [45.9–64.0]) was not significantly different from the observed (47.0 months [35.0–58.9]; p = 0.43) and adjusted (44.9 months [33.4–56.4]; p = 0.30) survival of 3MS patients. A propensity score analysis confirmed the absence of a survival advantage for 3MS patients. Conclusions A tightening of surveillance schedule does not increase the diagnosis of early-stage tumors, the feasibility of curative treatments and the survival. Therefore, we should maintain the 6-months interval in the surveillance of viral cirrhotics

Monofocal hepatocellular carcinoma: how much does size matter?

none88mixedPelizzaro, Filippo; Penzo, Barbara; Peserico, Giulia; Imondi, Angela; Sartori, Anna; Vitale, Alessandro; Cillo, Umberto; Giannini, Edoardo G.; Forgione, Antonella; Rapaccini, Gian Ludovico; Di Marco, Maria; Caturelli, Eugenio; Zoli, Marco; Sacco, Rodolfo; Cabibbo, Giuseppe; Marra, Fabio; Mega, Andrea; Morisco, Filomena; Gasbarrini, Antonio; Svegliati‐Baroni, Gianluca; Foschi, Francesco Giuseppe; Olivani, Andrea; Masotto, Alberto; Nardone, Gerardo; Raimondo, Giovanni; Azzaroli, Francesco; Vidili, Gianpaolo; Oliveri, Filippo; Trevisani, Franco; Farinati, Fabio; Biselli, Maurizio; Caraceni, Paolo; Garuti, Francesca; Gramenzi, Annagiulia; Neri, Andrea; Santi, Valentina; Granito, Alessandro; Muratori, Luca; Piscaglia, Fabio; Sansone, Vito; Tovoli, Francesco; Dajti, Elton; Marasco, Giovanni; Ravaioli, Federico; Cappelli, Alberta; Golfieri, Rita; Mosconi, Cristina; Renzulli, Matteo; Marina Cela, Ester; Facciorusso, Antonio; Cacciato, Valentina; Casagrande, Edoardo; Moscatelli, Alessandro; Pellegatta, Gaia; de Matthaeis, Nicoletta; Allegrini, Gloria; Lauria, Valentina; Ghittoni, Giorgia; Pelecca, Giorgio; Chegai, Fabrizio; Coratella, Fabio; Ortenzi, Mariano; Missale, Gabriele; Inno, Alessandro; Marchetti, Fabiana; Busacca, Anita; Cabibbo, Giuseppe; Cammà, Calogero; Di Martino, Vincenzo; Emanuele Maria Rizzo, Giacomo; Stella Franzè, Maria; Saitta, Carlo; Sauchella, Assunta; Bevilacqua, Vittoria; Borghi, Alberto; Casadei Gardini, Andrea; Conti, Fabio; Chiara Dall’Aglio, Anna; Ercolani, Giorgio; Mirici, Federica; Campani, Claudia; Di Bonaventura, Chiara; Gitto, Stefano; Coccoli, Pietro; Malerba, Antonio; Guarino, Maria; Brunetto, Maurizia; Romagnoli, VeronicaPelizzaro, Filippo; Penzo, Barbara; Peserico, Giulia; Imondi, Angela; Sartori, Anna; Vitale, Alessandro; Cillo, Umberto; Giannini, Edoardo G.; Forgione, Antonella; Rapaccini, Gian Ludovico; Di Marco, Maria; Caturelli, Eugenio; Zoli, Marco; Sacco, Rodolfo; Cabibbo, Giuseppe; Marra, Fabio; Mega, Andrea; Morisco, Filomena; Gasbarrini, Antonio; Svegliati‐baroni, Gianluca; Foschi, Francesco Giuseppe; Olivani, Andrea; Masotto, Alberto; Nardone, Gerardo; Raimondo, Giovanni; Azzaroli, Francesco; Vidili, Gianpaolo; Oliveri, Filippo; Trevisani, Franco; Farinati, Fabio; Biselli, Maurizio; Caraceni, Paolo; Garuti, Francesca; Gramenzi, Annagiulia; Neri, Andrea; Santi, Valentina; Granito, Alessandro; Muratori, Luca; Piscaglia, Fabio; Sansone, Vito; Tovoli, Francesco; Dajti, Elton; Marasco, Giovanni; Ravaioli, Federico; Cappelli, Alberta; Golfieri, Rita; Mosconi, Cristina; Renzulli, Matteo; Marina Cela, Ester; Facciorusso, Antonio; Cacciato, Valentina; Casagrande, Edoardo; Moscatelli, Alessandro; Pellegatta, Gaia; de Matthaeis, Nicoletta; Allegrini, Gloria; Lauria, Valentina; Ghittoni, Giorgia; Pelecca, Giorgio; Chegai, Fabrizio; Coratella, Fabio; Ortenzi, Mariano; Missale, Gabriele; Inno, Alessandro; Marchetti, Fabiana; Busacca, Anita; Cabibbo, Giuseppe; Cammà, Calogero; Di Martino, Vincenzo; Emanuele Maria Rizzo, Giacomo; Stella Franzè, Maria; Saitta, Carlo; Sauchella, Assunta; Bevilacqua, Vittoria; Borghi, Alberto; Casadei Gardini, Andrea; Conti, Fabio; Chiara Dall’Aglio, Anna; Ercolani, Giorgio; Mirici, Federica; Campani, Claudia; Di Bonaventura, Chiara; Gitto, Stefano; Coccoli, Pietro; Malerba, Antonio; Guarino, Maria; Brunetto, Maurizia; Romagnoli, Veronic

Recalibrating survival prediction among patients receiving trans\u2010arterial chemoembolization for hepatocellular carcinoma

Background & Aims The Pre-TACE-Predict model was devised to assess prognosis of patients treated with trans-arterial chemoembolization (TACE) for hepatocellular carcinoma (HCC). However, before entering clinical practice, a model should demonstrate that it performs a useful role. Methods We performed an independent external validation of the Pre-TACE model in a cohort that differs in setting and time period from the one that generated the original model. Data from 826 patients treated with TACE for naïve HCC (2008-2018) were used to assess calibration and discrimination of the Pre-TACE-Predict model. Results The four risk-categories identified by the Pre-TACE-Predict model had gradient monotonicity, with median survivals of 52.0, 36.2, 29.9, and 14.1 months respectively. However, predicted survivals systematically underestimated observed survivals (R2: 0.667). A recalibration was adopted maintaining fixed the prognostic index and modifying the baseline survival function. This resulted in an almost perfect calibration (R2: 0.995) in all the four risk categories. Cox regressions showed that aetiology and macrovascular invasion, included in the Pre-TACE-Predict model, had no prognostic impact in the present study population, and that coefficients for tumour size and multiplicity were overestimated. The c-index was similar to that of the m-HAP-III, but higher than those of HAP, m-HAP-II and the six-and-twelve models. Conclusions The recalibration of Pre-TACE-Predict model improved the estimation of survival probabilities of HCC patients treated with TACE. The highest discriminatory ability of the Pre-TACE-model in comparison to other available models, together with risk stratification and recalibration, makes it the best prognostic tool currently available for these patients