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.

Open versus minimally invasive total gastrectomy after neoadjuvant chemotherapy: results of a European randomized trial.

BACKGROUND: Surgical resection with adequate lymphadenectomy is regarded the only curative option for gastric cancer. Regarding minimally invasive techniques, mainly Asian studies showed comparable oncological and short-term postoperative outcomes. The incidence of gastric cancer is lower in the Western population and patients often present with more advanced stages of disease. Therefore, the reproducibility of these Asian results in the Western population remains to be investigated. METHODS: A randomized trial was performed in thirteen hospitals in Europe. Patients with an indication for total gastrectomy who received neoadjuvant chemotherapy were eligible for inclusion and randomized between open total gastrectomy (OTG) or minimally invasive total gastrectomy (MITG). Primary outcome was oncological safety, measured as the number of resected lymph nodes and radicality. Secondary outcomes were postoperative complications, recovery and 1-year survival. 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. The mean number of resected lymph nodes was 43.4 ± 17.3 in OTG and 41.7 ± 16.1 in MITG (p = 0.612). Forty-eight patients in the OTG group had a R0 resection and 44 patients in the MITG group (p = 0.617). One-year survival was 90.4% in OTG and 85.5% in MITG (p = 0.701). No significant differences were found regarding postoperative complications and recovery. CONCLUSION: These findings provide evidence that MITG after neoadjuvant therapy is not inferior regarding oncological quality of resection in comparison to OTG in Western patients with resectable gastric cancer. In addition, no differences in postoperative complications and recovery were seen.

Re-laparoscopy in the treatment of anastomotic leak following laparoscopic right colectomy with intracorporeal anastomosis.

BACKGROUND: Anastomotic leak still represents the most feared surgical complication following colorectal resection and is associated with high morbidity and mortality rates. The aim of this study is to assess the feasibility and safety of laparoscopic reoperation for symptomatic anastomotic leak (AL) after laparoscopic right colectomy with mechanical intracorporeal anastomosis (IA). METHODS: From January 2012 to December 2019, 428 consecutive laparoscopic right colectomy with IA were performed. Overall symptomatic AL rate requiring reoperation was 5.8% (26/428). Data on patient demographics as well as operative findings, time elapsed from primary surgery and from the onset of symptoms of anastomotic leak, time and duration of re-laparoscopy, ICU stay, morbidity, mortality rate, length of hospital stay and readmission, were all retrospectively reviewed. RESULTS: Laparoscopic approach was attempted in 23 (88.4%) hemodynamically stable patients. Conversion rate was 21.4%. Reasons for conversion were gross fecal peritonitis (n = 2), colonic ischemia (n = 1), severe bowel distension (n = 2). Eighteen (78.2%) patients underwent successfully laparoscopic (LPS) reoperation. A repair of the anastomotic defect was done in 11 (61.1%) patients, while in 7 patients the intracorporeal mechanical anastomosis was refashioned. A diverting ileostomy was done in 22.2% of cases (n = 4). A second reoperation for leak persistence was necessary in two cases (11.1%). Median (range) length of postoperative hospital stay from re-laparoscopy was 15.5 (9-53) days. Overall morbidity rate was 38.7%. Mortality rate was 5.5% (n = 1) CONCLUSION: laparoscopic re-intervention for the treatment of anastomotic leak following LPS right colectomy with intracorporeal anastomosis in hemodynamically stable and highly selected patients in the experienced hands of dedicated laparoscopic surgeons, is a safe option with acceptable morbidity and mortality rate.

Impact of COVID-19 outbreak on esophageal cancer surgery in Northern Italy: lessons learned from a multicentric snapshot.

Coronavirus Disease-19 (COVID-19) outbreak has significantly burdened healthcare systems worldwide, leading to reorganization of healthcare services and reallocation of resources. The Italian Society for Study of Esophageal Diseases (SISME) conducted a national survey to evaluate changes in esophageal cancer management in a region severely struck by COVID-19 pandemic. A web-based questionnaire (26 items) was sent to 12 SISME units. Short-term outcomes of esophageal resections performed during the lockdown were compared with those achieved in the same period of 2019. Six (50%) centers had significant restrictions in their activity. However, overall number of resections did not decrease compared to 2019, while a higher rate of open esophageal resections was observed (40 vs. 21.7%; P = 0.034). Surgery was delayed in 24 (36.9%) patients in 6 (50%) centers, mostly due to shortage of anesthesiologists, and occupation of intensive care unit beds from intubated COVID-19 patients. Indications for neoadjuvant chemo (radio) therapy were extended in 14% of patients. Separate COVID-19 hospital pathways were active in 11 (91.7%) units. COVID-19 screening protocols included nasopharyngeal swab in 91.7%, chest computed tomography scan in 8.3% and selective use of lung ultrasound in 75% of units. Postoperative interstitial pneumonia occurred in 1 (1.5%) patient. Recovery from COVID-19 pandemic was characterized by screening of patients in all units, and follow-up outpatient visits in only 33% of units. This survey shows that clinical strategies differed considerably among the 12 SISME centers. Evidence-based guidelines are needed to support the surgical esophageal community and to standardize clinical practice in case of further pandemics.

Perfusion speed of indocyanine green in the stomach before tubulization is an objective and useful parameter to evaluate gastric microcirculation during Ivor-Lewis esophagectomy.

BACKGROUND: Anastomotic leakage (AL) during Ivor-Lewis esophagectomy (ILE), owing to gastric conduit (GC) ischemia, is a serious complication. Measurement parameters during intraoperative ICG fluorescence angiography (ICG-FA) are unclear. We aimed to identify objective ICG-FA parameters associated with AL. STUDY DESIGN: Patients > 18 years with an indication for ILE were enrolled. ICG-FA was performed at the abdominal and thoracic stage, and data, such as time of fluorescence appearance, speed of ICG perfusion, quality of GC perfusion (good, poor, ischemic), blood pressure, baseline patient characteristics, GC dimensions, and other intraoperative parameters were collected. On postoperative day 4 to 6, Gastrografin swallow radiography was performed. AL development was classified based on the Clavien-Dindo and SISG severity classifications. Univariate analysis with a 95% confidence level (p < 0.05) was performed. Factors with p < 0.05 were included in the multivariate analysis. RESULTS: 100 patients were enrolled. During ICG-FA, evaluation of subjective perfusion was a very specific test (94.1%) with good negative predictive value (NPV 71.9%, p 0.034), but not powerful enough to detect patients at risk of leak (sensibility 21.8%, PPV 63.6%). The GC perfusion speed (cm/s) after gastric vascular isolation and before tubulization showed a significant association with AL (p < 0.003). Median arterial blood pressure in the thoracic stage (p < 0.001) or use of inotropic (p < 0.033) was associated with AL development. CONCLUSION: GC perfusion speed at ICG-FA is an objective parameter that could predict AL risk. Other results emphasize the importance of the microcirculation in the development of AL.

Intraoperative angiography with indocyanine green to assess anastomosis perfusion in patients undergoing laparoscopic colorectal resection: results of a multicenter randomized controlled trial.

BACKGROUND: Insufficient vascular supply is one of the main causes of anastomotic leak in colorectal surgery. Intraoperative indocyanine-green (ICG) angiography has been shown to provide information on tissue perfusion, identifying a well-perfused location for colonic and rectal transections, and thus possibly reducing the leak rate. Aim of this study was to evaluate the usefulness of intraoperative assessment of anastomotic perfusion using ICG angiography in patients undergoing left-sided colon or rectal resection with colorectal anastomosis. METHODS: This randomized trial involved 252 patients undergoing laparoscopic left-sided colon and rectal resection randomized 1:1 to intraoperative ICG or to subjective visual evaluation of the bowel perfusion without ICG. The primary aim was to assess whether ICG angiography could lead to a reduction in anastomotic leak rate. Secondary outcomes were possible changes in the surgical strategy and postoperative morbidity. RESULTS: After randomization, 12 patients were excluded. Accordingly, 240 patients were included in the analysis; 118 were in the study group, and 122 in the control group. ICG angiography showed insufficient perfusion of the colic stump, which led to extended bowel resection in 13 cases (11%). An anastomotic leak developed in 11 patients (9%) in the control group and in 6 patients (5%) in the study group (p = n.s.). CONCLUSIONS: Intraoperative ICG fluorescent angiography can effectively assess vascularization of the colic stump and anastomosis in patients undergoing colorectal resection. This method led to further proximal bowel resection in 13 cases, however, there was no statistically significant reduction of anastomotic leak rate in the ICG arm. CLINICAL TRIAL: ClinicalTrials.gov NCT02662946.

Early Red Flags Associated with Delayed Discharge in Patients Undergoing Gastrectomy: Analysis of Perioperative Variables and ERAS Protocol Items.

BACKGROUND: Enhanced Recovery After Surgery (ERAS) perioperative pathways are safe and effective for patients undergoing gastrectomy. However, adherence to these protocols varies and is generally underreported. This retrospective study aimed to assess whether perioperative variables or deviation from ERAS items is associated with delayed discharge after gastrectomy. METHODS: All patients undergoing gastrectomy at our institution were managed with a standardised perioperative pathway according to ERAS principles. The target length of stay was set as the ninth post-operative day (POD). All significant variables were derived from a bivariate analysis and were entered into a logistic regression to confirm their statistical value. RESULTS: The study included 180 patients. Multivariate regression analysis revealed that incomplete immunonutrition, failure to extubate the patient at the end of surgery, intraoperative crystalloids >2150 ml and blood transfusion >268 ml, surgery duration >195 min, and failure to mobilise patients within 24 h from surgery were associated with delayed discharge. The logistic regression model was statistically significant (p < 0.001) and correctly classified 73.6% of cases. Sensitivity and specificity were 74.1% and 73.2%, respectively. CONCLUSIONS: These results seem clinically significant and consistent with those of previous studies. The reported perioperative variables showed a strong relationship with the length of hospital stay.

Enhanced Recovery After Surgery (ERAS) Pathway in Esophagectomy: Is a Reasonable Prediction of Hospital Stay Possible?

OBJECTIVE: To assess whether perioperative variables or deviation from enhanced recovery after surgery (ERAS) items could be associated with delayed discharge after esophagectomy, and to convert them into a scoring system to predict it. SUMMARY BACKGROUND DATA: ERAS perioperative pathways have been recently applied to esophageal resections. However, low adherence to ERAS items and high rates of protocol deviations are often reported. METHODS: All patients who underwent esophagectomy between April 2012 and March 2017 were managed with a standardized perioperative pathway according to ERAS principles. The target length of stay was set at eighth postoperative day (POD). All significant variables at bivariate analysis were entered into a logistic regression to produce a predictive score. An initial validation of the score accuracy was carried out on a separate patient sample. RESULTS: Two hundred eighty-six patients were included in the study. Multivariate regression analysis showed that American Society of Anesthesiology score ≥ 3, surgery duration > 255 min, "nonhybrid" esophagectomy, and failure to mobilize patients within 24 h from surgery were associated with delayed discharge. The logistic regression model was statistically significant (P < 0.001) and correctly classified 81.9% of cases. The sensitivity was 96.6%, and the specificity was 17.6%. The prediction score applied to 23 patients correctly identified 100% of those discharged after eighth POD. CONCLUSIONS: The results of this study seem to be clinically meaningful and in line with those from other studies. The initial validation revealed good predictive properties.

Association Between Compliance to an Enhanced Recovery Protocol and Outcome After Elective Surgery for Gastric Cancer. Results from a Western Population-Based Prospective Multicenter Study.

BACKGROUND: The association between compliance to an enhanced recovery protocol (ERAS) and outcome after surgery for gastric cancer has been poorly investigated, particularly in Western patients. The aim of the study was to evaluate whether the rate of adherence to the ERAS program was correlated with outcome and time of discharge. METHODS: A prospective, observational, multicenter study was designed to be performed at Italian referral centers for gastric surgery. The protocol was discussed and approved by the Italian Research Group on Gastric Cancer. Twenty-three ERAS domains were applied. A multivariate logistic regression was used to assess the association between ERAS compliance and overall and major complication rates. The Poisson regression model (measured as mean ratios) was used to assess the association of ERAS compliance rate and length of stay (LOS). RESULTS: Eight centers participated and 290 subjects with a median age of 73 years were enrolled. The overall rates of adherence to pre-, intra-, and postoperative ERAS items were 69.8%, 60.3%, and 82.5%, respectively. At the multivariate model, there was an association between overall rate of morbidity and an overall ERAS compliance rate greater than 70% (OR 0.413; 95% CI 0.235-0.7240; P 0.002). A similar association was found for major complications (OR 0.328; 95% CI 0.151-0.709; P 0.005). The Poisson regression showed that in patients with ERAS compliance rate >70%, LOS was reduced of approximately 20% (mean ratio 0.812; 95% CI 0.694-0.950; P 0.009). CONCLUSIONS: These results suggest a moderate compliance to an ERAS program and a significant association between adherence and outcomes.