The COVID - AGICT study: COVID-19 and advanced gastro-intestinal cancer surgical treatment. A multicentric Italian study on the SARS-CoV-2 pandemic impact on gastro-intestinal cancers surgical treatment during the 2020. Analysis of perioperative and short-term oncological outcomes.

BACKGROUND: This Italian multicentric retrospective study aimed to investigate the possible changes in outcomes of patients undergoing surgery for gastrointestinal cancers during the COVID-19 pandemic. METHOD: Our primary endpoint was to determine whether the pandemic scenario increased the rate of patients with colorectal, gastroesophageal, and pancreatic cancers resected at an advanced stage in 2020 compared to 2019. Considering different cancer staging systems, we divided tumors into early stages and advanced stages, using pathological outcomes. Furthermore, to assess the impact of the COVID-19 pandemic on surgical outcomes, perioperative data of both 2020 and 2019 were also examined. RESULTS: Overall, a total of 8250 patients, 4370 (53%) and 3880 (47%) were surgically treated during 2019 and 2020 respectively, in 62 Italian surgical Units. In 2020, the rate of patients treated with an advanced pathological stage was not different compared to 2019 (P = 0.25). Nevertheless, the analysis of quarters revealed that in the second half of 2020 the rate of advanced cancer resected, tented to be higher compared with the same months of 2019 (P = 0.05). During the pandemic year 'Charlson Comorbidity Index score of cancer patients (5.38 ± 2.08 vs 5.28 ± 2.22, P = 0.036), neoadjuvant treatments (23.9% vs. 19.5%, P < 0.001), rate of urgent diagnosis (24.2% vs 20.3%, P < 0.001), colorectal cancer urgent resection (9.4% vs. 7.37, P < 0.001), and the rate of positive nodes on the total nodes resected per surgery increased significantly (7 vs 9% - 2.02 ± 4.21 vs 2.39 ± 5.23, P < 0.001). CONCLUSIONS: Although the SARS-CoV-2 pandemic did not influence the pathological stage of colorectal, gastroesophageal, and pancreatic cancers at the time of surgery, our study revealed that the pandemic scenario negatively impacted on several perioperative and post-operative outcomes.

Prospective, randomised, multicentre, open-label trial, designed to evaluate the best timing of closure of the temporary ileostomy (early versus late) in patients who underwent rectal cancer resection and with indication for adjuvant chemotherapy: the STOMAD (STOMa closure before or after ADjuvant therapy) randomised controlled trial.

INTRODUCTION: Temporary ileostomy is a valuable aid in reducing the severity of complications related to rectal cancer surgery. However, it is still unclear what is the best timing of its closure in relation to the feasibility of an adjuvant treatment, especially considering patient-reported outcomes and health system costs. The aim of the study is to compare the results of an early versus late closure strategy in patients with indication to adjuvant chemotherapy after resection for rectal cancer. METHODS AND ANALYSIS: This is a prospective multicentre randomised trial, sponsored by Rete Oncologica Piemonte e Valle d'Aosta (Oncology Network of Piedmont and Aosta Valley-Italy). Patients undergone to rectal cancer surgery with temporary ileostomy, aged >18 years, without evidence of anastomotic leak and with indication to adjuvant chemotherapy will be enrolled in 28 Network centres. An early closure strategy (between 30 and 40 days from rectal surgery) will be compared with a late one (after the end of adjuvant therapy). Primary endpoint will be the compliance to adjuvant chemotherapy with and without ileostomy. Complications associated with stoma closure as well as quality of life, costs and oncological outcomes will be assessed as secondary endpoints. ETHICS AND DISSEMINATION: The trial will engage the Network professional teams in a common effort to improve the treatment of rectal cancer by ensuring the best results in relation to the most correct use of resources. It will take into consideration both the patients' point of view (patient-reported outcome) and the health system perspective (costs analysis). The study has been approved by the Ethical Review Board of Città della Salute e della Scienza Hospital in Turin (Italy). The results of the study will be disseminated by the Network website, medical conferences and peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: NCT04372992.

Risk factors for esophago-jejunal anastomosis leakage after total gastrectomy for cancer. A multicenter retrospective study of the Italian research group for gastric cancer.

BACKGROUND: Many Eastern reports attempted to identify predictive variables for esophago-jejunal anastomosis leakage (EJAL) after total gastrectomy for cancer. There are no definitive answers about reliable risk factors for EJAL. This retrospective study shows the largest Western series focused on this topic. METHODS: This is a multicenter retrospective study analyzing patients' datasets collected by 18 Italian referral Centres of the Italian Research Group for Gastric Cancer (GIRCG) from 2000 to 2018. The inclusion criteria were pathological diagnosis of gastric and esophageal (Siewert III) carcinoma requiring total gastrectomy. The primary end point of risk analysis was the occurrence of EJAL; secondary end points were post-operative (30-day) morbidity and mortality, length of stay (LoS), and survival. RESULTS: Data of 1750 patients submitted to total gastrectomy were collected. EJAL developed in 116 (6.6%) patients and represented the 26.3% of all the 441 observed post-operative surgical complications. EJAL diagnosis was followed by a reoperation in 39 (33.6%) patients and by an endoscopic/radiological procedure in 30 cases (25.9%). In 47 patients (40.5%) EJAL was managed with conservative approach. Post-operative LoS and mortality were significantly higher after EJAL occurrence (27 days versus 12 days and 8.6% versus 1.6%, respectively). At risk analysis, comorbidities (particularly, if respiratory), minimally invasive surgery, extended lymphadenectomy, and anastomotic technique resulted significant predictive factors for EJAL. EJAL did not significantly affect survival. CONCLUSIONS: These results were consistent with Asian experiences: the frequency of EJAL and its higher rate observed in patients with comorbidities or after minimally invasive approach were confirmed.

Neoadjuvant chemotherapy for gastric cancer. Is it a must or a fake?

AIM: To investigate the neoadjuvant chemotherapy (NAC) effect on the survival of patients with proper stomach cancer submitted to D2 gastrectomy. METHODS: We proceeded to a review of the literature with PubMed, Embase, ASCO and ESMO meeting abstracts as well as computerized use of the Cochrane Library for randomized controlled trials (RCTs) comparing NAC followed by surgery (NAC + S) with surgery alone (SA) for gastric cancer (GC). The primary outcome was the overall survival rate. Secondary outcomes were the site of the primary tumor, extension of node dissection according to Japanese Gastric Cancer Association (JGCA) performed in both arms, disease-specific (DSS) and disease-free survival (DFS) rates, clinical and pathological response rates and resectability rates after perioperative treatment. RESULTS: We identified a total of 16 randomized controlled trials comparing NAC + S (n = 1089) with SA (n = 973) published in the period from January 1993 - March 2017. Only 6 of these studies were well-designed, structured trials in which the type of lymph node (LN) dissection performed or at least suggested in the trial protocol was reported. Two out of three of the RCTs with D2 lymphadenectomy performed in almost all cases failed to show survival benefit in the NAC arm. In the third RCT, the survival rate was not even reported, and the primary end points were the clinical outcomes of surgery with and without NAC. In the remaining three RCTs, D2 lymph node dissection was performed in less than 50% of cases or only recommended in the "Study Treatment" protocol without any description in the results of the procedure really perfomed. In one of the two studies, the benefit of NAC was evident only for esophagogastric junction (EGJ) cancers. In the second study, there was no overall survival benefit of NAC. In the last trial, which documented a survival benefit for the NAC arm, the chemotherapy effect was mostly evident for EGJ cancer, and more than one-fourth of patients did not have a proper stomach cancer. Additionally, several patients did not receive resectional surgery. Furthermore, the survival rates of international reference centers that provide adequate surgery for homogeneous stomach cancer patients' populations are even higher than the survival rates reported after NAC followed by incomplete surgery. CONCLUSION: NAC for GC has been rapidly introduced in international western guidelines without an evidence-based medicine-related demonstration of its efficacy for a homogeneous population of patients with only stomach tumors submitted to adequate surgery following JGCA guidelines with extended (D2) LN dissection. Additional larger sample-size multicentre RCTs comparing the newer NAC regimens including molecular therapies followed by adequate extended surgery with surgery alone are needed.

Gastric Cancer After Restrictive Bariatric Surgery: A Clinical Pitfall.

Although vertical banded gastroplasty is rarely performed at present, most bariatric surgery departments continue to follow up patients who underwent this procedure in the past few decades. In view of this, it is advisable for bariatric and general surgeons to know how to diagnose the very rare event of the development of a gastric cancer after this restrictive procedure. In this report, 2 cases of gastric cancer occurring years after vertical banded gastroplasty are presented, and clinical presentation and diagnostic difficulties are discussed.

Esophagogastric cancer after bariatric surgery: systematic review of the literature.

BACKGROUND: Because the number of patients with a previous bariatric procedure continues to rise, it is advisable for bariatric surgeons to know how to manage the rare event of the development of an esophagogastric cancer. The aim of the study was to perform a systematic review of all reported cases of esophagogastric cancers after bariatric surgery. METHODS: Systematic review of English and French written literature in MEDLINE and EMBASE database. RESULTS: Globally, 28 articles describing 33 patients were retrieved. Neoplasms were diagnosed at a mean of 8.5 years after bariatric surgery (range 2 months-29 years). There were 11 esophageal and 22 gastric cancers; although adenocarcinoma represented most cases (90.6%), a tubulovillous adenoma with high-grade atypia, an intramural gastrointestinal stromal tumor, and a diffuse large B-cell lymphoma of the gastric fundus were also reported. Node involvement was reported in 14 cases, and distal metastases in 5. The most frequently reported symptoms were dysphagia and food intolerance, vomiting, epigastric pain, and weight loss. Surgery was performed in 28 patients, although 4 underwent only chemotherapy and/or radiotherapy and 1 received palliative care. Reported mortality rate was 48.1%. CONCLUSIONS: To date, it is not possible to quantify the incidence of esophagogastric cancer after bariatric surgery because of the paucity of reported data. Nevertheless, because the main concern is the delay in diagnosis, it is of critical importance to carefully evaluate any new or modified upper digestive tract symptom occurring during bariatric surgery follow-up.