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.

Comparative outcomes of Toupet fundoplication and magnetic sphincter augmentation.

Laparoscopic fundoplication is the current surgical gold standard for the treatment of refractory gastroesophageal reflux disease (GERD). Magnetic sphincter augmentation (MSA) is a less invasive, standardized, and reversible option to restore competency of the lower esophageal sphincter. A comparative cohort study was conducted at a tertiary-care referral center on patients with typical GERD symptoms treated with systematic crural repair combined with Toupet fundoplication or MSA. Primary study outcome was decrease of Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) score. Between January 2014 and December 2021, a total of 199 patients (60.3% female, median [Q1-Q3] age: 51.0 [40.0-61.0]) underwent MSA (n = 130) or Toupet fundoplication (n = 69). Operative time and hospital stay were significantly shorter in MSA patients (P < 0.0001). At a median follow-up of 12.0 [12.0-24.0] months, there was a statistically significant decrease of GERD-HRQL score in both patient groups (P = 0.001). The mean delta values did not significantly differ between groups (P = 0.7373). The incidence of severe gas bloating symptoms was similar in the two groups (P = 0.7604), but the rate of persistent postoperative dysphagia was greater in MSA patients (P = 0.0009). Six (8.7%) patients in the Toupet group had recurrent hiatal hernia requiring revisional surgery in one (1.4%). In the MSA group, eight (7.9%) patients necessitated through-the-scope balloon dilation for relief of dysphagia, and six patients had the device removed (4.6%) because of persistent dysphagia (n = 3), device disconnection (n = 1), persistent reflux (n = 1) or need of magnetic resonance (n = 1). Toupet and MSA procedures provide similar clinical outcomes, but MSA is associated with a greater risk of reoperation. Randomized clinical trials comparing fundoplication and MSA are eagerly awaited.

Comparison of pleural drain amylase and serum C-reactive protein for early detection of intrathoracic esophago-gastric anastomotic leaks.

INTRODUCTION: Early detection of anastomotic leaks following esophagectomy has the potential to reduce hospital length of stay and mortality. The aim of this study was to compare the predictive value of pleural drain amylase and serum C-reactive protein for the early diagnosis of leak. METHODS: A retrospective observational cohort study was conducted on 121 patients who underwent Ivor Lewis esophagectomy and intrathoracic gastric conduit reconstruction. Pleural drain amylase levels were measured daily until postoperative day (POD) 5 and compared with CRP values measured on POD 3, 5, and 7. Specificity and sensitivity for both tests, and the respective ROC curves, were calculated. RESULTS: Anastomotic leak occurred in 12 patients. There was a significant statistical association between pleural drain amylase and serum CRP levels and the presence of anastomotic leakage. Pleural drain amylase cutoff of 209 IU/L on POD 2 yielded a sensitivity of 75% and a specificity of 94% (AUC = 0.813), whereas CRP cutoff value of 22.5 mg/dL on POD 3 yielded a sensitivity of 56% and a specificity of 92% (AUC = 0.772). The negative likelihood ratio of pleural drain amylase was 0.27 and 0.12 on POD 2 and 5, respectively. There was no statistically significant difference between ROC curves of amylase and CRP on POD 3 and 5 (p = 0.79 and p = 0.14, respectively). CONCLUSIONS: Pleural drain amylase seems more efficient than serum CRP for early detection of esophago-gastric anastomotic leak. The practice of monitoring drain amylase and CRP may allow safer implementation of enhanced postoperative recovery pathway.

The Effect of Postoperative Complications After Minimally Invasive Esophagectomy on Long-term Survival: An International Multicenter Cohort Study.

BACKGROUND: Esophagectomy is a technically challenging procedure, associated with significant morbidity. The introduction of minimally invasive esophagectomy (MIE) has reduced postoperative morbidity. OBJECTIVE: Although the short-term effect on complications is increasingly being recognized, the impact on long-term survival remains unclear. This study aims to investigate the association between postoperative complications following MIE and long-term survival. METHODS: Data were collected from the EsoBenchmark Collaborative composed by 13 high-volume, expert centers routinely performing MIE. Patients operated between June 1, 2011 and May 31, 2016 were included. Complications were graded using the Clavien-Dindo (CD) classification. To correct for short-term effects of postoperative complications on mortality, patients who died within 90 days postoperative were excluded. Primary endpoint was 5-year overall survival. RESULTS: A total of 915 patients were included with a mean follow-up time of 30.8 months (standard deviation 17.9). Complications occurred in 542 patients (59.2%) of which 50.2% had a CD grade ≥III complication [ie, (re)intervention, organ dysfunction, or death]. The incidence of anastomotic leakage (AL) was 135 of 915 patients (14.8%) of which 84 patients were classified as a CD grade ≥III. Multivariable analysis showed a significantly deteriorated long-term survival in all patients with AL [hazard ratio (HR) 1.68, 95% confidence interval (CI) 1.25-2.24]. This inverse relation was most distinct when AL was scored as a CD grade ≥III (HR 1.83, 95% CI 1.30-2.58). For all other complications, no significant association with long-term survival was found. CONCLUSION: The occurrence and severity of AL, but not overall complications, after MIE negatively affect long-term survival of esophageal cancer patients.

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.

Esophageal Lipoma and Liposarcoma: A Systematic Review.

BACKGROUND: Esophageal lipomatous tumors, also reported as fibrovascular polyp, fibrolipoma, angiolipoma, and liposarcoma, account for less than 1% of all benign mesenchymal submucosal tumors of the esophagus. Clinical presentation and therapy may differ based on location, size, and morphology. A comprehensive and updated systematic review of the literature is lacking. METHODS: A systematic review of the literature was performed according to PRISMA guidelines. Pubmed, Embase, Cochrane, and Medline databases were consulted using MESH keywords. Non-English written articles and abstracts were excluded. Sex, age, symptoms at presentation, diagnosis, tumor location and size, surgical approach and technique of excision, pathology, and morphology were extracted and recorded in an electronic database. RESULTS: Sixty-seven studies for a total of 239 patients with esophageal lipoma or liposarcoma were included in the qualitative analysis. Among 176 patients with benign lipoma, the median age was 55. The main symptoms were dysphagia (64.2%), transoral polyp regurgitation (32.4%), and globus sensation (22.7%). The majority of lipomas (85.7%) were intraluminal polyps, with a stalk originating from the upper esophagus. Overall, 165 patients underwent excision of the mass through open surgery (65.5%), endoscopy (27.9%), or laparoscopy/thoracoscopy (3.6%). Only 5 (3%) of patients required esophagectomy. Of the 11 untreated patients with an intraluminal polyp, 7 died from asphyxia. Overall, liposarcoma was diagnosed in 63 patients, and 12 (19%) underwent esophagectomy. CONCLUSION: Esophageal lipomatous tumors are rare but potentially lethal when are intraluminal and originate from the cervical esophagus. Modern radiological imaging has improved diagnostic accuracy. Minimally invasive transoral and laparoscopic/thoracoscopic techniques represent the therapeutic approach of choice.

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.

Endoscopic stapling versus laser for Zenker diverticulum: a retrospective cohort study.

PURPOSE: Despite the evolution of the endoscopic techniques for the treatment of symptomatic Zenker diverticulum, comparative studies are lacking. Aim of this observational study was to compare safety, efficacy, and outcomes of endoscopic stapling (ES) versus Laser (EL). METHODS: A prospectively collected database of patients who underwent treatment for Zenker diverticulum at a single institution was reviewed. Consecutive patients treated by ES or EL were included in the study. Demographic data, presenting symptoms, diverticulum characteristics, and intra- and postoperative data were analyzed. The Functional Outcome Swallowing Scale (FOSS) and MD Anderson Dysphagia Inventory (MDADI) questionnaires were administered to assess severity of dysphagia and quality of life before and after treatment. RESULTS: Between March 2017 and September 2018, 36 patients underwent ES or EL. In the TL group (n = 19), the diverticulum size was smaller compared to the EL group (n = 17) (p = 0.002). Two perforations occurred in the EL group, one treated conservatively and the other requiring drainage of a mediastinal abscess. At a median follow-up of 16 months, symptoms improved in both groups but the number of patients with a postoperative FOSS score ≥ 2 significantly decreased only after EL (p < 0.001). The scores of all items of the MDADI questionnaire significantly increased in both groups, but the average delta values were greater in the EL patients (p < 0.001). CONCLUSIONS: Both TL and ES are effective treatment options for Zenker diverticulum. Postoperative quality of life was significantly higher in patients undergoing EL compared to ES.

Proinflammatory Interleukin-33 Induces Dichotomic Effects on Cell Proliferation in Normal Gastric Epithelium and Gastric Cancer.

Interleukin (IL)-33 is a member of the interleukin (IL)-1 family of cytokines linked to the development of inflammatory conditions and cancer in the gastrointestinal tract. This study is designed to investigate whether IL-33 has a direct effect on human gastric epithelial cells (GES-1), the human gastric adenocarcinoma cell line (AGS), and the gastric carcinoma cell line (NCI-N87) by assessing its role in the regulation of cell proliferation, migration, cell cycle, and apoptosis. Cell cycle regulation was also determined in ex vivo gastric cancer samples obtained during endoscopy and surgical procedures. Cell lines and tissue samples underwent stimulation with rhIL-33. Proliferation was assessed by XTT and CFSE assays, migration by wound healing assay, and apoptosis by caspase 3/7 activity assay and annexin V assay. Cell cycle was analyzed by means of propidium iodine assay, and gene expression regulation was assessed by RT-PCR profiling. We found that IL-33 has an antiproliferative and proapoptotic effect on cancer cell lines, and it can stimulate proliferation and reduce apoptosis in normal epithelial cell lines. These effects were also confirmed by the analysis of cell cycle gene expression, which showed a reduced expression of pro-proliferative genes in cancer cells, particularly in genes involved in G0/G1 and G2/M checkpoints. These results were confirmed by gene expression analysis on bioptic and surgical specimens. The aforementioned results indicate that IL-33 may be involved in cell proliferation in an environment- and cell-type-dependent manner.

Anastomotic Techniques and Associated Morbidity in Total Minimally Invasive Transthoracic Esophagectomy: Results From the EsoBenchmark Database.

OBJECTIVE: The aim of this study was to describe anastomotic techniques used for total minimally invasive transthoracic esophagectomy (ttMIE) and to analyze the associated morbidity. BACKGROUND: ttMIE faces increasing application in surgical treatment of esophageal cancer. For esophagogastric reconstruction, different anastomotic techniques are currently used, but their effect on postoperative anastomotic leakage and morbidity has not been investigated. PATIENTS AND METHODS: Patients were selected from a basic dataset, collected during a 5-year period from 13 international surgical high-volume centers. Endpoints were anastomotic leakage rate and postoperative morbidity in correlation to anastomotic techniques, measured by the Clavien-Dindo classification and the Comprehensive Complication Index (CCI). RESULTS: Five anastomotic techniques were identified in 966 patients after ttMIE: intrathoracic end-to-side circular-stapled technique in 427 patients (double-stapling n = 90, purse-string n = 337), intrathoracic (n = 109) or cervical (n = 255) side-to-side linear-stapled, and cervical end-to-side hand-sewn (n = 175). Leakage rates were similar in intrathoracic and cervical anastomoses (15.9% vs 17.2%, P = 0.601), but overall complications (56.7%% vs 63.7%, P = 0.029) and median 90-day CCI {21 [interquartile range (IQR) 0-36] vs 29 [IQR 0-40], P = 0.019} favored intrathoracic reconstructions. Leakage rates after intrathoracic end-to-side double-stapling (23.3%) and cervical end-to-side hand-sewn (25.1%) techniques were significantly higher compared with intrathoracic side-to-side linear (15.6%), end-to-side purse-string (13.9%), and cervical side-to-side linear-stapled esophagogastrostomies (11.8%) (P < 0.001). Multivariable analysis confirmed anastomotic technique as independent predictor of leakage after ttMIE. CONCLUSION: Results of this analysis present the current status of the technical evolution of ttMIE with anastomotic leakage as predominant surgical complication. However, technique-related morbidity requires cautious interpretation considering the long learning curve of this complex surgical procedure.

Right hemicolectomy: a network meta-analysis comparing open, laparoscopic-assisted, total laparoscopic, and robotic approach.

BACKGROUND: There are a variety of surgical approaches for the management of right-sided colonic neoplasms. To date, no method has been shown superior in terms of surgical and perioperative outcomes. This meta-analysis compared open (ORH), laparoscopic-assisted (LRH), total laparoscopic (TLRH), and robotic right hemicolectomy (RRH) to assess surgical outcomes and perioperative morbidity and mortality. STUDY DESIGN: We conducted an electronic systematic search using PubMed, EMBASE, and Web of Science that compared RRH, TLRH, LRH, and ORH. Forty-eight studies met the inclusion criteria: 5 randomized controlled trials, 25 retrospective, and 18 prospective studies totalling 5652 patients were included. RESULTS: The overall complication rate was similar between RRH and TLRH (RR 1.0; Crl 0.66-1.5). The anastomotic leak rate was higher in LRH and ORH compared to RRH (RR 1.9; Crl 0.99-3.6 and RR 1.2; Crl 0.55-2.6, respectively), whereas it was lower in TLRH compared to RRH (RR 0.88 Crl 0.41-1.9). The risk of reoperation was significantly higher in ORH compared to TLRH (RR 3.3; Crl 1.3-8.0). Operative time was similar in RRH compared to LRH (RR - 27.0; Crl - 61.0 to 5.9), and to TLRH (RR - 24.0; Crl - 70.0 to 21.0). The hospital stay was significantly longer in LRH compared to RRH (RR 3.7; Crl 0.7-6.7). CONCLUSION: The surgical management of right-sided colonic disease is evolving. This network meta-analysis observed that short-term outcomes following RRH and TLRH were superior to standard LRH and ORH. The adoption of more advanced minimally invasive techniques can be costly and have associated learning phases, but will ultimately improve patient outcomes.

Open Inguinal Hernia Repair: A Network Meta-analysis Comparing Self-Gripping Mesh, Suture Fixation, and Glue Fixation.

The most troublesome complications of inguinal hernia repair are recurrent herniation and chronic pain. A multitude of technological products dedicated to abdominal wall surgery, such as self-gripping mesh (SGM) and glue fixation (GF), were introduced in alternative to suture fixation (SF) in the attempt to lower the postoperative complication rates. We conducted an electronic systematic search using MEDLINE databases that compared postoperative pain and short- and long-term surgical complications after SGM or GF and SF in open inguinal hernia repair. Twenty-eight randomized controlled trials totaling 5495 patients met the inclusion criteria and were included in this network meta-analysis. SGM and GF did not show better outcomes in either short- or long-term complications compared to SF. Patients in the SGM group showed significantly more pain at day 1 compared to those in the GF group (VAS score pain mean difference: - 5.2 Crl - 11.0; - 1.2). The relative risk (RR) of developing a surgical site infection (RR 0.83; Crl 0.50-1.32), hematoma (RR 1.9; Crl 0.35-11.2), and seroma (RR 1.81; Crl 0.54-6.53) was similar in SGM and GF groups. Both the SGM and GF had a significantly shorter operative time mean difference (1.70; Crl - 1.80; 5.3) compared to SF. Chronic pain and hernia recurrence did not statistically differ at 1 year (RR 0.63; Crl 0.36-1.12; RR 1.5; Crl 0.52-4.71, respectively) between SGM and GF. Methods of inguinal hernia repair are evolving, but there remains no superiority in terms of mesh fixation. Ultimately, patient's preference and surgeon's expertise should still lead the choice about the fixation method.

Impact of Laparoscopic Repair of Large Hiatus Hernia on Quality of Life: Observational Cohort Study.

BACKGROUND: Laparoscopic surgery has proven safe and effective in the treatment of large hiatus hernia. Differences may exist between objectively assessed surgical outcomes, symptomatic scores, and patient-reported outcomes. METHODS: An observational, single-arm cohort study was conducted in patients undergoing primary laparoscopic repair with crura mesh augmentation and Toupet fundoplication for large (> 50% of intrathoracic stomach) type III-IV hiatus hernia. Data were extracted from hospital charts and a prospectively updated research database. The main study outcome was quality of life assessed by the Gastroesophageal reflux disease Health-Related Quality of Life (GERD-HRQL) score and the Short-form 36 (SF-36). RESULTS: Between 2013 and 2016, 37 out of 49 operated patients completed the comprehensive quality-of-life evaluation at the 2-year follow-up. The GERD-HRQL score significantly decreased compared to baseline (p < 0.001). All items of the SF-36 significantly improved compared to baseline (p < 0.05). Both Physical and Mental Component Summary scores were significantly higher than preoperative scores, with a medium Cohen's effect size (-0.77 and 0.56, respectively). At the 2-year follow-up, symptoms had disappeared in the majority of patients. The use of proton-pump inhibitors significantly decreased compared to baseline (13.5 vs. 86.4%, p < 0.001). Also, the use of antidepressants and benzodiazepines significantly decreased after surgery (8.1 vs. 32.4%, p < 0.001). The overall alimentary satisfaction score was > 8 in 92% of patients. There were no safety issues related to the use of the absorbable synthetic mesh. The incidence of anatomical hernia recurrence was 5.4%, but no patient with recurrent hernia required surgical revision. CONCLUSIONS: Laparoscopic repair of large hiatus hernia with mesh and partial fundoplication is associated with symptomatic relief, no side-effects, and a significant improvement in disease-specific and generic quality of life at 2-year follow-up.

Esophagectomy for End-Stage Achalasia: Systematic Review and Meta-analysis.

BACKGROUND: Indications for surgery and clinical outcomes of esophagectomy in the management of end-stage achalasia are not clearly defined. The aim of this systematic review and meta-analysis was to provide evidence-based information to help in the decision-making and in the choice of surgical technique. METHODS: An extensive literature search was conducted to identify all reports on esophagectomy for end-stage achalasia patients over the past three decades. MEDLINE, Embase and Cochrane databases were thoroughly consulted matching the terms "achalasia," "end-stage achalasia," "esophagectomy" and "esophageal resection" with "AND" and "OR." Short- and long-term outcome data were extracted. Pooled prevalence of pneumonia, anastomotic leakage and mortality were calculated using Freeman-Tukey double arcsine transformation and DerSimonian-Laird estimator in random effect meta-analysis. Heterogeneity among studies was evaluated using I 2-index and Cochrane Q test. Meta-regression was used to address the effect of potential confounders. RESULTS: Eight papers published between 1989 and 2014 matched the inclusion criteria. In total, 1307 patients were included. Esophagectomy was performed through a transthoracic (78.7%) or a transhiatal (21.3%) approach. The stomach was used as an esophageal substitute in 95% of patients. Pooled prevalence of pneumonia, anastomotic leakage and mortality were 10% (95% CI 4-18%), 7% (95% CI 4-10%) and 2% (95% CI 1-3%), respectively. CONCLUSIONS: Esophagectomy for end-stage achalasia is safe and effective. Based on the results of this study, esophagectomy should be performed without hesitation in patients who are fit for major surgery and present with disabling symptoms, poor quality of life and dolichomegaesophagus recalcitrant to multiple endoscopic dilatations and/or surgical myotomies.

Utility of C-reactive protein as predictive biomarker of anastomotic leak after minimally invasive esophagectomy.

BACKGROUND: Early detection of anastomotic leakage after esophagectomy has the potential to reduce morbidity and mortality. Prompt suspicion of leak may help to exclude patients from fast-track protocols, thereby avoiding early oral feeding and early hospital discharge which could aggravate the prognosis of a clinically occult leak. PATIENTS AND METHODS: Observational retrospective cohort study. Patients with diagnosis of esophageal cancer who underwent elective minimally invasive esophagectomy were included. The following data were collected: age, gender, BMI, comorbidities, ASA score, tumor histology, TNM staging, use of neo-adjuvant therapy, type of operation, operative time, morbidity, and 90-day mortality. A panel of biomarkers including C-reactive protein (CRP), procalcitonin (PCT), white blood cells (WBC), and percentage of neutrophils (PN) were measured at baseline and on postoperative days 3, 5, and 7. RESULTS: Two hundred forty-three patients operated between 2012 and 2017 were included in the study. Anastomotic leakage occurred in 29 patients. There was a statistical association over time between anastomotic leakage and CRP (p < 0.001), PCT (p < 0.001), WBC (p = 0.019), and PN (p = 0.007). The cut-off value of CRP on POD 5 was 8.3 mg/dL, AUC = 0.818, negative LR = 0.176. CONCLUSIONS: Increased serum CRP, PCT, WBC, and PN after minimally invasive esophagectomy are associated with anastomotic leakage. A CRP value lower than 8.3 mg/dL, combined with reassuring clinical and radiological signs, may be useful to exclude leakage on postoperative day 5.

FA01.02: THE EFFECT OF POSTOPERATIVE COMPLICATIONS AFTER MIE ON LONG-TERM SURVIVAL: A RETROSPECTIVE, MULTI-CENTER COHORT STUDY.

BACKGROUND: Esophagectomy has a high incidence of postoperative morbidity. Complications lead to a decreased short-term survival, however the influence of those complications on long-term survival is still unclear. Most of the performed studies are small, single center cohort series with inconclusive or conflicting results. Minimally invasive esophagectomy (MIE) has been shown to be associated with a reduced postoperative morbidity. In this study, the influence of complications on long-term survival for patients with esophageal cancer undergoing a MIE were investigated. METHODS: Data was collected from the EsoBenchmark database, a collaboration of 13 high-volume centers routinely performing MIE. Patients were included in this database from June 1, 2011 until May 31, 2016. Complications were scored according to the Clavien-Dindo (CD) classification for surgical complications. Major complications were defined as a CD grade ≥ 3. The data were corrected for 90-day mortality to correct for the short-term effect of postoperative complications on mortality. Overall survival was analyzed using the Kaplan Meier, log rank- and (uni- and multivariable) Cox-regression analyses. RESULTS: A total of 926 patients were eligible for analysis. Mean follow-up time was 30.8 months (SD 17.9). Complications occurred in 543 patients (59.2%) of which 39.3% had a major complication. Anastomotic leakage (AL) occurred in 135 patients (14.5%) of which 9.2% needed an intervention (CD grade ≥ 3). A significant worse long-term survival was observed in patients with any AL (HR 1.73, 95% CI 1.29-2.32, P < 0.001) and for patients with AL CD grade ≥3 (HR 1.86, 95% CI 1.32-2.63, P < 0.001). Major cardiac complications occurred in 18 patients (1.9%) and were related to a decreased long-term survival (HR 2.72, 95% CI 1.38-5.35, p 0.004). For all other complications, no significant influence on long-term survival was found. CONCLUSION: The occurrence and severity of anastomotic leakage and cardiac complications after MIE negatively affect long-term survival of esophageal cancer patients. DISCLOSURE: All authors have declared no conflicts of interest.

Removal of the Magnetic Sphincter Augmentation Device: Surgical Technique and Results of a Single-center Cohort Study.

OBJECTIVE: The aim of this study was to identify patients' characteristics that may predict failure and removal of the Linx sphincter augmentation device, and to report the results of 1-stage laparoscopic removal and fundoplication. BACKGROUND: The Linx device is a long-term magnetic implant that was developed as a less disruptive and more reproducible surgical option for patients with early-stage gastroesophageal reflux disease (GERD). Removal of the device has been shown to be feasible, but no long-term results of this procedure have been reported yet. METHODS: A review of the prospectively collected research database of antireflux surgery was performed to identify all patients who underwent a Linx implant between 2007 and 2015 in our Institution. Demographics, duration of symptoms and proton pump inhibitor (PPI) therapy, GERD-Health Related Quality of Life scores, esophageal acid exposure, lower esophageal sphincter pressure, number of beads (size) of the implanted device, concurrent crura repair, angle of inclination of the device at postoperative chest film, operative time, postoperative complications, and length of stay were recorded. Data of the explanted patients were compared with those with the device in situ in an attempt to identify factors associated with Linx removal. RESULTS: Over the study period, 164 patients underwent a laparoscopic Linx implant and had a median follow-up of 48 months [interquartile range (IQR) 36]. Eleven (6.7%) of these patients were explanted at a later date. The estimated removal-free probability at 80 months was 0.91 [confidence interval (CI) 0.86-0.96]. Supine esophageal acid exposure before the index operation was associated with Linx removal (odds ratio 1.05, CI 1.01-1.11, P = 0.037). The main presenting symptom requiring device removal was recurrence of heartburn or regurgitation in 5 patients (46%), followed by dysphagia (n = 4, 37%) and chest pain (n = 2, 18%). In 2 patients, full-thickness erosion of the esophageal wall with partial endoluminal penetration of the device occurred. The median implant duration was 20 months, with 82% of the patients being explanted between 12 and 24 months after the implant. Device removal was most commonly combined with partial fundoplication. There were no conversions to laparotomy and the postoperative course was uneventful in all patients. At the latest follow-up, ranging from 12 to 58 months, the GERD-HRQL score was within normal limits in all patients. CONCLUSIONS: Laparoscopic removal of the Linx device can be safely performed as a 1-stage procedure and in conjunction with fundoplication even in patients presenting with device erosion.

Defining Benchmarks for Transthoracic Esophagectomy: A Multicenter Analysis of Total Minimally Invasive Esophagectomy in Low Risk Patients.

OBJECTIVE: To define "best possible" outcomes in total minimally invasive transthoracic esophagectomy (ttMIE). BACKGROUND: TtMIE, performed by experts in patients with low comorbidity, may serve as a benchmark procedure for esophagectomy. PATIENTS AND METHODS: From a cohort of 1057 ttMIE, performed over a 5-year period in 13 high-volume centers for esophageal surgery, we selected a study group of 334 patients (31.6%) that fulfilled criteria of low comorbidity (American Society of Anesthesiologists score ≤2, WHO/ECOG score ≤1, age ≤65 years, body mass index 19-29 kg/m). Endpoints included postoperative morbidity measured by the Clavien-Dindo classification and the comprehensive complication index. Benchmark values were defined as the 75th percentile of the median outcome parameters of the participating centers to represent best achievable results. RESULTS: Benchmark patients were predominantly male (82.9%) with a median age of 58 years (53-62). High intrathoracic (Ivor Lewis) and cervical esophagogastrostomy (McKeown) were performed in 188 (56.3%) and 146 (43.7%) patients, respectively. Median (IQR) ICU and hospital stay was 0 (0-2) and 12 (9-18) days, respectively. 56.0% of patients developed at least 1 complication, and 26.9% experienced major morbidity (≥grade III), mostly related to pulmonary complications (25.7%), anastomotic leakage (15.9%), and cardiac events (13.5%). Benchmark values at 30 days after hospital discharge were ≤55.7% and ≤30.8% for overall and major complications, ≤18.0% for readmission, ≤3.1% for positive resection margins, and ≥23 for lymph node yield. Benchmarks at 30 and 90 days were ≤1.0% and ≤4.6% for mortality, and ≤40.8 and ≤42.8 for the comprehensive complication index, respectively. CONCLUSION: This outcome analysis of patients with low comorbidity undergoing ttMIE may serve as a reference to evaluate surgical performance in major esophageal resection.