Preoperative assessment of simple and complex anorectal fistulas: Tridimensional endoanal ultrasound? Magnetic resonance? Both?

PURPOSE: The purpose of the study is to evaluate the diagnostic value of tridimensional endoanal ultrasound (3D-EAUS) and magnetic resonance (MR) in the preoperative assessment of both simple and complex anorectal fistulas. METHODS: All the patients referred for the treatment of anal fistulas were enrolled in this study and underwent, as preoperative assessment, anamnestic evaluation, clinical examination, and unenhanced and H2O2-enhanced 3D-EAUS and MR. The results of imaging evaluation were compared with surgical findings, considered as reference standard. RESULTS: During the study period, 124 patients operated on for anal fistulas underwent complete preoperative imaging assessment. Perfect agreement between 3D-EAUS and surgery in the anal fistulas' severity grading was found (K = 1). The fistulas were classified as simple in 68/126 (53.9%) and complex in 58/126 (46.03%) cases, according to fistulas' Parks' classification and the most recent American Guidelines. In both simple and complex anal fistulas, 3D-EAUS did not show a significantly higher accuracy in the evaluation of internal openings, if compared with MR (P = 0.47; McNemar's Chi-square test). In the complex anal fistulas, MR showed a significantly higher accuracy in the evaluation of secondary extensions if compared with 3D-EAUS (P = 0.041; McNemar's Chi-square test), whereas in the simple anal fistulas, no significant difference was found. CONCLUSION: In the preoperative work-up of patients with anorectal fistulas, 3D-EAUS may represent the first-line diagnostic tool. In cases of fistulas classified as complex by 3D-EAUS, MR may be indicated as adjunctive diagnostic imaging examination, to more carefully describe the fistulas' complete anatomy.

Serum CD26 levels in patients with gastric cancer: a novel potential diagnostic marker.

BACKGROUND: CD26 is an ectoenzyme with dipeptidyl peptidase 4 (DPP4) activity expressed on a variety of cell types. Considering that serum CD26 levels have been previously associated with different cancers, we examined the potential diagnostic value of serum CD26 levels in gastric cancer. METHODS: Soluble serum CD26 levels were measured in pre and postoperative serum samples of 30 patients with gastric cancer and in 24 healthy donors by a specific ELISA kit. RESULTS: We found significantly lower serum CD26 levels in patients with gastric cancer (557.7 ± 118.3 pg/mL) compared with healthy donors (703.4 ± 170.3 pg/mL). Moreover patients with HER2 positive tumors had significantly lower CD26 serum levels (511.8 ± 84.8 pg/mL) compared with HER2 negative tumors (619.1 ± 109.9 pg/mL, p = 0.006). A binary logistic model having gastric cancer as the dependent variable while age, gender, CEA, CA19.9 and CD26 levels as covariates, showed that CD26 serum levels were independently associated with gastric cancer presence. Indeed after 3 months from surgery serum CD26 levels significantly increased (700.1 ± 119.9 pg/mL vs 557.7 ± 118.3 pg/ml) in all patients (t = -4.454, p < 0.0001). CONCLUSIONS: This is a preliminary study showing that the measurement of serum CD26 levels could represent an early detection marker for gastric cancer.

Role of tridimensional endoanal ultrasound (3D-EAUS) in the preoperative assessment of perianal sepsis.

PURPOSE: The aim of this study was to evaluate the accuracy of tridimensional endoanal ultrasound (3D-EAUS) in the diagnosis of perianal sepsis comparing the results with the surgical findings, considered as reference standard. METHODS: From January 2009 to January 2013, all the patients referred for the assessment and treatment of perianal sepsis with suspected anorectal origin were enrolled in the study. All patients gave informed written consent. Prior to surgery, all the patients underwent anamnestic evaluation, clinical examination, and unenhanced and H2O2-enhanced 3D-EAUS. Surgery was performed by a colorectal surgeon blinded to the 3D-EAUS results. RESULTS: A total of 212 patients with suspected perianal suppurations were assessed during the study period. In 12 patients, the H2O2-enhanced 3D-EAUS was not performed, and so, they were excluded from the study. Very good agreement between 3D-EAUS and examination under anesthesia (EUA) in the classification of primary fistula tracts (kappa = 0.93) and in the identification of fistula internal opening (kappa = 0.97) was found. There was a good concordance (kappa = 0.71) between 3D-EAUS and surgery in the detection of fistula secondary extensions. The overall sensitivity and specificity of 3D-EAUS in the diagnosis of perianal sepsis were 98.3 and 91.3% respectively. CONCLUSION: 3D-EAUS is a safe and reliable technique in the assessment of perianal sepsis. It may assist the surgeon in delineating the fistula tract anatomy and in determining the origin of sepsis, supporting the preoperative planning of definitive and appropriate surgical therapy.

Comparison of the 6th and 7th editions of the AJCC/UICC TNM staging system for gastric cancer focusing on the "N" parameter-related survival: the monoinstitutional NodUs Italian study.

BACKGROUND: A large number of Asian population studies examined the difference between the 6th and the 7th tumor, node, metastasis (TNM) while it is still poorly validated among Caucasian populations. This is a retrospective study aimed at investigating the efficacy of the 7th edition American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) staging system for gastric cancer focusing on the "N" parameter-related survival for prognostic assessment in gastric cancer patients of a single Western high-volume institution. METHODS: From January 2002 to December 2009, the data of 274 patients with gastric cancer who underwent gastric surgery at the 8th General and Gastrointestinal Surgical Centre of the Second University of Naples were analyzed retrospectively. We collected data for patient demographics, tumor characteristics, surgical characteristics, and TNM stage. Particularly, the nodal status, with the number of dissected nodes and metastatic nodes, was reviewed from the pathology records. The same patient dataset was used to stage patients according to both the 6th and 7th edition criteria. RESULTS: Age at surgery, tumor location, histological grade, Lauren's classification subtypes, and 6th and 7th AJCC/UICC N categories were found to have statistically significant associations with overall survival on univariate analysis. In the 6th edition staging system, the Kaplan-Meier plot did not show significant overlapped survival curves: significant differences were found between N0 and N1, P<.001; N1 and N2, P=.04; and N2 and N3, P<.001. On the contrary, in the 7th edition, among all five substages, there were similar survival curves between N categories 2 and 3a (P=.98) with a statistically significant discriminatory ability only between N1 versus N3b and N2 versus N3b (P=.02 and .04, respectively). CONCLUSIONS: Based on analysis, we found that several clinicopathological variables, especially histological grade and Lauren's classification, were significant prognostic factors in our database. The 6th and 7th AJCC/UICC N classifications represent significantly independent prognostic factors, and the 6th AJCC/UICC N classification seems to be superior to the 7th AJCC/UICC N classification in terms of uniformity, differentiation, and monotonicity of gradients.

Peripherally inserted central catheter tip position: a novel empirical-ultrasonographical index in a modern surgical oncology department.

BACKGROUND: The correct positioning of ultrasound-guided, peripherally inserted central catheters (UGPICCs) is essential to avoid multiple complications. We describe for the first time a retrospective study to evaluate a novel and easy transabdominal ultrasound-guided approach, so-called "Marano index," to place the UGPICCs tip correctly, making oncological surgeons able to obtain a high successful initial placement rate without postinsertion chest radiography. METHODS: We examined the placement of UGPICCs applying, in 53 patients, the "Marano index." The tip catheter location was controlled by postprocedural chest radiography. Sensitivity, positive predictive value, and accuracy of index application also were calculated and compared with radiographic findings. RESULTS: The ultrasonographic-guided insertion was successful in all patients (100%). The identification of catheter inside the inferior vena cava was registered in 50 patients (94.3%), and in all cases it was clear the precise catheter placement, after Marano index application, with the real tip position and the concordance between postprocedural radiography in 100% of cases. The overall accuracy of this novel empirical-ultrasonographical index was 94%, with positive predictive value of 94% and sensitivity of 100%. CONCLUSIONS: This technique, once validated in a larger cohort, would allow the insertion of UGPICC without radiologic confirmation in selected patients with an adequate ultrasound body habitus. This would avoid unneeded radiation exposure from chest X-rays and would potentially save cost and time. This strategy provides only minimal deviation from the current practice and it is hence technically easy to learn and perform accurately with basic training by digestive oncological surgeons.

Earliest videofluoromanometric pharyngeal signs of dysphagia in ALS patients.

The aim of this study was to find whether there are manometric pharyngeal changes that may have diagnostic and prognostic relevance in the amyotrophic lateral sclerosis (ALS) patient who does not show changes in contrast-medium oropharyngeal transit in a videofluoroscopic swallowing study. Ten ALS patients, with an ALS Severity Scale Score of at least 7, no need to change dietary habit, no aspiration and/or penetration, and no other changes in contrast-medium oropharyngeal transit, were collected from our institution's database of videofluoromanometric swallowing studies. They were included in the study together with a group of 11 healthy volunteers. For each subject, 12 manometric items-7 for the pharyngeal phase and 5 for UES functionality-were evaluated. Statistically significant differences between the ALS patients and the healthy volunteers were found for pharyngeal contraction time of the upper region (median = 1,120, range = 880-1,420 vs. median = 970, range = 800-1,140), pharyngeal contraction time of the intermediate region (median = 1140, range = 960-1,360 vs. median = 770, range = 280-1,180), pharyngeal contraction time of the lower region (median = 1,320, range = 920-1,760 vs. median = 800, range = 620-1,780), and residual pressure after the relaxation of the UES (median = 2.2, range = -20.2 to 27.8 vs. median = -5.7, range = -2.9 to 8.4). A videofluoromanometric swallowing study may show an increase in the pharyngeal contraction time and in residual pressure after relaxation of the UES in ALS patients without videofluoroscopic changes in contrast-medium oropharyngeal transit.

The laparoscopic hiatoplasty with antireflux surgery is a safe and effective procedure to repair giant hiatal hernia.

BACKGROUND: Although minimally invasive repair of giant hiatal hernias is a very surgical challenge which requires advanced laparoscopic learning curve, several reports showed that is a safe and effective procedure, with lower morbidity than open approach. In the present study we show the outcomes of 13 patients who underwent a laparoscopic repair of giant hiatal hernia. METHODS: A total of 13 patients underwent laparoscopic posterior hiatoplasty and Nissen fundoplication. Follow-up evaluation was done clinically at intervals of 3, 6 and 12 months after surgery using the Gastro-oesophageal Reflux Health-Related Quality of Life scale, a barium swallow study, an upper gastrointestinal endoscopy, an oesophageal manometry, a combined ambulatory 24-h multichannel impedance pH and bilirubin monitoring. Anatomic recurrence was defined as any evidence of gastric herniation above the diaphragmatic edge. RESULTS: There were no intraoperative complications and no conversions to open technique. Symptomatic GORD-HQL outcomes demonstrated a statistical significant decrease of mean value equal to 3.2 compare to 37.4 of preoperative assessment (p < 0.0001). Combined 24-h multichannel impedance pH and bilirubin monitoring after 12 months did not show any evidence of pathological acid or non acid reflux. CONCLUSION: All patients were satisfied of procedure and no hernia recurrence was recorded in the study group, treated respecting several crucial surgical principles, e.g., complete sac excision, appropriate crural closure, also with direct hiatal defect where possible, and routine use of antireflux procedure.

Clinical and immunological impact of early postoperative enteral immunonutrition after total gastrectomy in gastric cancer patients: a prospective randomized study.

BACKGROUND: Enteral immunodiet has been gaining increasing attention, but experimental data of its clinical effects in patients with gastric cancer are inconsistent, contradictory, and poorly investigated. The aim of this study was to assess the impact of early postoperative enteral immunonutrition on clinical and immunological outcomes in a homogeneous group of gastric cancer patients submitted to total gastrectomy. METHODS: A total of 109 patients with gastric cancer were randomized to receive early postoperative enteral immunonutrition (formula supplemented with arginine, omega-3 fatty acids and ribonucleic acid [RNA]), or an isocaloric-isonitrogenous control. The postoperative outcome was evaluated based on clinical variables, including postoperative infectious complications, anastomotic leak rate, and length of hospitalization. In addition, state of cellular immunity was evaluated and compared between the 2 groups. RESULTS: The incidence of postoperative infectious complications in the immunodiet group (7.4%) was significantly (p < .05) lower than that of the control group (20%), as well as the anastomotic leak rate (3.7% in immunodiet group vs 7.3% in standard nutrition group, p < .05). Mortality rate did not show any significant differences; patients of the immunodiet group were found to have a significantly reduced length of hospitalization (12.7 ± 2.3 days) when compared with standard diet group (15.9 ± 3.4 days, p = .029). The data on cellular immunity showed that the postoperative CD4(+) T-cell counts decreased in both groups, but the reduction in the IED group was significantly higher (p = .032) compared with the SND group. CONCLUSIONS: Early postoperative enteral immunonutrition significantly improves clinical and immunological outcomes in patients undergoing gastrectomy for gastric cancer.

Sutureless jejuno-jejunal anastomosis in gastric cancer patients: a comparison with handsewn procedure in a single institute.

BACKGROUND: The biofragmentable anastomotic ring has been used to this day for various types of anastomosis in the gastrointestinal tract, but it has not yet achieved widespread acceptance among surgeons. The purpose of this retrospective study is to compare surgical outcomes of sutureless with suture method of Roux-and-Y jejunojejunostomy in patients with gastric cancer. METHODS: Two groups of patients were obtained based on anastomosis technique (sutureless group versus hand sewn group): perioperative outcomes were recorded for every patient. RESULTS: The mean time spent to complete a sutureless anastomosis was 11 ± 4 min, whereas the time spent to perform hand sewn anastomosis was 23 ± 7 min. Estimated intraoperative blood loss was 178 ± 32 ml in the sutureless group and 182 ± 23 ml in the suture-method group with no significant differences. No complications were registered related to enteroanastomosis. Intraoperative mortality was none for both groups. CONCLUSIONS: The Biofragmentable Anastomotic Ring offers a safe and time-saving method for the jejuno-jejunal anastomosis in gastric cancer surgery, and for this purpose the ring has been approved as a standard method in our clinic. Nevertheless currently there are few studies on upper gastrointestinal sutureless anastomoses and this could be the reason for the low uptake of this device.

Laparoscopic Nissen-Rossetti fundoplication is a safe and effective treatment for both Acid and bile gastroesophageal reflux in patients poorly responsive to proton pump inhibitor.

PURPOSE: The aim of this study was to evaluate the effectiveness of laparoscopic Nissen-Rossetti fundoplication in patients with gastroesophageal reflux disease (GERD) poorly responsive to standard dose proton pump inhibitor (PPI) therapy. METHODS: A total of 35 patients (19 women, 16 men, mean age 44.6 ± 14.01 years) were enrolled. All the patients underwent symptom questionnaires, upper gastrointestinal endoscopy, esophageal manometry, and combined 24-hour esophageal pH and bilirubin monitoring. Following this, the patients with persistent pathological esophageal acid and/or bilirubin exposure underwent laparoscopic antireflux surgery, followed by clinical and instrumental 12-month follow-up. RESULTS: One year after surgery, there was a significant improvement of symptom score, compared with standard PPI dose period (3.54 ± 1.67 vs 20.8 ± 10.9, P < .0001; paired t test) and mean percentage total time acid and bile exposure showed a significant decrease (4.9 ± 2.9 vs 2.03 ± 0.74 and 8.3 ± 3.03 vs 0.84 ± 0.56, P < .0001; paired t test). CONCLUSIONS: In patients with GERD poorly responsive to standard PPI dose, laparoscopic Nissen-Rossetti fundoplication appears to be a safe and effective treatment of symptoms, esophageal damage, as well as both acid and bile reflux.

Weekly chemotherapy with cisplatin and paclitaxel and concurrent radiation therapy as preoperative treatment in locally advanced esophageal cancer: a phase II study.

We evaluated the association of a weekly cisplatin (35 mg/mq) and paclitaxel (45 mg/mq) regimen with radiotherapy (46 Gy) as primary treatment in locally advanced esophageal cancer (LAEC). The main end point was the activity in terms of pathologic complete response (pathCR) rate. Thirty-three LAEC patients received chemoradiation therapy during weeks 1-6 followed by esophagectomy. A pathCR was observed in 10/33 patients; 20/33 and 3/33 patients showed PR and SD, respectively. The EUS maximal transverse cross sectional area reduction >50% significantly correlated with pathCR. Three-year survival rate was 35%. These results support the activity and mild toxicity of this regimen.

Perspectives in adjuvant therapy of gastric cancer.

Although the incidence of gastric cancer has been declining in Western countries, it is still a major health problem and a leading cause of cancer mortality. Surgery is the mainstay of treatment for gastric adenocarcinoma. However, even among patients undergoing gastrectomy with curative intent, 5-year survival rates are disappointing due to locoregional relapse and distant metastases. This emphasizes the importance of multidisciplinary management of patients with gastric cancer. In contrast to the preoperative approach, several phase III trials have been carried out in the adjuvant setting, but postoperative chemotherapy has not proven to be superior to surgery alone. Therefore, at present the routine use of adjuvant therapy should be regarded as an investigational approach. Improved clinical trial designs with standardized surgical techniques and the incorporation of newer active drugs are needed.

Oncologic Effectiveness and Safety of Bursectomy in Patients with Advanced Gastric Cancer: A Systematic Review and Updated Meta-Analysis.

Purpose/Aim: In the past few decades some researchers have questioned whether bursectomy for gastric cancer is essential from an oncological point of view and no consistent recommendations have been proposed. The aim of this systematic review with meta-analysis is to investigate the oncologic effectiveness and safety of bursectomy for the treatment of advanced gastric cancer patients. MATERIALS AND METHODS: We planned and performed this systematic review and meta-analysis in accordance with Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) statement and Cochrane Handbook for Systematic Reviews of Intervention. RESULTS: Overall, four studies with a total of 1,340 patients met inclusion criteria. The pooled hazard ratio for overall survival between the bursectomy versus nonbursectomy groups was [HR = 0.85, 95% CI 0.66-1.11, p =.252]. Interestingly, the pooled HR between the two groups in serosa-positive cases subgroup, showed a significant improvement of overall survival rate in favor of bursectomy [HR = 0.72, 95% CI 0.73-0.99, p <.05]. CONCLUSIONS: Bursectomy represents a surgical procedure that might be able to improve overall survival in serosa positive gastric cancer patients. However, a definitive conclusion could not be made because of the studies' methodological limitations. This meta-analysis points to the urgent need of high quality, large-scaled, clinical trials with short- as well as long-term evaluation comparing bursectomy with non bursectomy procedures, in a controlled randomized manner, helping future researches and establishing a modern and tailored approach to gastric cancer.

Characteristics and outcomes of laparoscopic surgery in patients with large hiatal hernia. A single center study.

INTRODUCTION: Giant hiatal hernia is characterized by the presence of more than 1/3 of the stomach in the chest, through the diaphragmatic hiatus, with or without other intra-abdominal organs. It is a rare pathology, representing the 5-10% of all hiatal hernias. The advent of laparoscopic surgery led to new surgical techniques, which include the simple reduction with the excision of the hernial sac and the execution of a posterior hiatoplasty, with or without mesh, and the execution of a Collis-Nissen gatroplasty in case of short esophagus. PRESENTATION OF CASES: We followed 24 cases of giant hiatal hernia with more than 1/3 stomach located in the chest, analyzing the results reached by the miniinvasive procedure, and the long-term pathophysiologic results of the disease. DISCUSSION: Laparoscopic hiatal hernia repair results in less postoperative pain compared with the open approach. The smaller incisions of minimally-invasive surgery are less likely to be complicated by incisional hernias and wound infection. Postoperative respiratory complications are reduced. CONCLUSION: Results from multiple studies are similar, with shorter hospital stay and less morbidity resulting from the minimally invasive approach.

Applicability of the Proposed Japanese Model for the Classification of Gastric Cancer Location: The "PROTRADIST" Retrospective Study.

BACKGROUND: The extension of lymphadenectomy for surgical treatment of gastric cancer remains discordant among European and Japanese surgeons. Kinami et al. (Kinami S, Fujimura T, Ojima E, et al. PTD classification: proposal for a new classification of gastric cancer location based on physiological lymphatic flow. Int. J. Clin. Oncol. 2008;13:320-329) proposed a new experimental classification, the "Proximal zone, Transitional zone, Distal zone" (PTD) classification, based on the physiological lymphatic flow of gastric cancer site. The aim of the present retrospective study is to assess the applicability of PTD Japanese model in gastric cancer patients of our Western surgical department. METHODS: Two groups of patients with histologically documented adenocarcinoma of the stomach were retrospectively obtained: In the first group were categorized 89 patients with T1a-T1b tumor invasion; and in the second group were 157 patients with T2-T3 category. The data collected were then categorized according to the PTD classification. RESULTS: In the T1a-T1b group there were no lymph node metastases within the r-GA or r-GEA compartments for tumors located in the P portion, and similarly there were no lymphatic metastases within the l-GEA or p-GA compartments for tumors located in the D portion. On the contrary, in the T2-T3 group the lymph node metastases presented a diffused spreading with no statistical significance between the two classification models. CONCLUSIONS: Our results show that the PTD classification based on physiological lymphatic flow of the gastric cancer site is a more physiological and clinical version than the Upper, Medium And Lower classification. It represents a valuable and applicable model of cancer location that could be a guide to a tailored surgical approach in Italian patients with neoplasm confined to submucosa. Nevertheless, in order to confirm our findings, larger and prospective studies are needed.

An unusual case of left hepatectomy for Focal Nodular Hyperplasia (FNH) linked to the use of Anabolic Androgenic Steroids (AASs).

INTRODUCTION: Focal Nodular Hyperplasia (FNH) is the second most common benign tumor of the liver. Clinically FNH is asymptomatic and discovered incidentally . The pathogenesis is unclear; FNH is usually asymptomatic. When the tumor is large, it may be painful. Surgery is recommended only in the case of complications such as compression of adjacent organs, lesion progression with tumor size >5cm and presence of symptoms. PRESENTATION OF CASE: A 30 years old man, was evaluated during a routine visit, for diffuse abdominal pain and weight loss; Abdominal ultrasound showed no evidence of biliary obstruction but the US shows a hypoechoic, well defined focal lesion in the left liver. For a more accurate diagnosis a Magnetic Resonance detected a focal area about 14×9 cm in diameter, hypointense. Liver biopsy was not done.We could not diagnose it definitively as FNH from the results of imaging studies; so for the size of symptomatic lesion, the undefined diagnosis of FNH ,and due to the great increase in the size of the mass located in the left lobe, during such a short period , the surgery was been recommended. DISCUSSION: FNH is the second most common hepatic lesion, but clinically relevant cases of FNH are rare with a reported prevalence in US studies of 0,03%. In our case the young patient was taking dietary supplements including anabolic androgenic steroids (AASs), carnitine and l-arginine. CONCLUSION: The particularity of our case is the increasing of the lesion in two years in which the patient made use of anabolic steroids. under use of . This could be the explanation for increasing of nodule.

Predictive biomarkers along gastric cancer pathogenetic pathways.

INTRODUCTION: Gastric cancer is the second leading cause of cancer all over the world. Unfortunately, several gastric cancers are diagnosed in an advanced stage and chemotherapy and/or target therapies remain the only options to treat patients. Areas covered: Herein we evaluate the new molecular proposal of gastric cancer classification, offering the possibility to recognize different pathogenetic mechanisms and molecular biomarkers potentially useful for target therapies. Expert commentary: The possibility of introducing new specific tests for identification of molecular biomarkers critical for targeted therapies response represents the new frontier in the selection of gastric cancer patients to improve their survival. Besides HER2, already used in clinical settings as a target biomarker for biological therapy in gastric cancer patients with tissue cancer cells overexpressing HER2, other promising target biomarkers which are deregulated in gastric cancer, such as MET and FGFR, could be identified in tissue and then used for therapeutic purposes. In addition immunotherapy represents the most promising possibility of advanced gastric cancer treatment. In particular, as in other solid tumors, PD-1/PDL1 pathway has emerged in several clinical trials as an interesting therapeutic target.

Efficacy of a triplet and doublet-based chemotherapy as first-line therapy in patients with HER2-negative metastatic gastric cancer: a retrospective analysis from the clinical practice.

The best choice of chemotherapy regimen for patients with metastatic gastric cancer is still debated. Although several studies support a superior efficacy of a triplet chemotherapy regimen over a doublet-based regimen, the magnitude of this benefit appears small and accompanied by an increased toxicity. Based on this background, we evaluated the outcome of patients with HER2-negative metastatic gastric cancer (mGC) who received in the clinical practice a triplet or doublet regimen as first-line therapy. A total of 165 patients (pts) with HER2-negative mGC treated outside of clinical trials at our department with FOLFOX-4 or ECX from 2012 and 2015 were included in our retrospective analysis: FOLFOX-4: 86 pts; ECX: 79 pts. Median progression-free survival (PFS) was 5.1 months for FOLFOX-4 and 5.6 months for ECX regimen, respectively. Median overall survival (OS) was 10.3 months for FOLFOX-4 and 10.9 months for ECX regimens. TOXICITY: grade 3-4 vomiting (12.6%), neutropenia (31.6%), mucositis (11.3%) and fatigue (22.7%) occurred more frequently in ECX regimen, while grade 3-4 peripheral neuropathy was more common with FOLFOX-4 (19.7%). Both evaluated regimens are active and safe in the palliation of HER2-negative mGC in the first-line setting: Three-drug chemotherapy regimen appear more active but offer only a slight improvement in OS with an increased G3-G4 toxicity. Our data suggest that a doublet therapy should be preferred in the clinical practice, preferentially reserving a three-drug combination to pts with bulky disease and/or to pts with initially unresectable locally advanced disease.

Efficacy of Human Fibrinogen-Thrombin Patch (TachoSil) Clinical Application in Upper Gastrointestinal Cancer Surgery.

BACKGROUND: Previous studies investigated the efficacy and applicability of tissue adhesives in gastrointestinal surgery while no evidence is available to date about a novel compound, TachoSil (Takeda, Zurich, Switzerland). The primary aim of this observational study was to assess the effect of new fibrin sealant on the incidence of postoperative complications in a homogeneous group of patients submitted to upper gastrointestinal surgery for cancer. METHODS: Two cohorts of 28 and 34 patients undergoing upper gastrointestinal for surgery were compared. In the first cohort, the anastomotic site was treated with TachoSil fibrinogen-thrombin-collagen patches and in the second no collagen sponge or any other hemostatic sealant was used. Postoperative complications and outcomes as well as postoperative biochemical parameters were analyzed. RESULTS: Postoperative complications occurred in 12 patients (35.3%) and 2 patients (7.1%) in control and collagen sponge group respectively (χ2 = 3.539, p < 0.05), with no anastomotic leakage in the collagen sponge group. A binary logistic regression analysis showed that the nonuse of collagen sponge [odds ratio (OR) = 0.025, 95% confidence interval (CI) = 0.001-0.457, p = 0.01] was independently associated with postoperative complication occurrence. CONCLUSIONS: The addition of fibrinogen-thrombin-collagen sponge patch may reduce postoperative complication rate after upper gastrointestinal surgery for cancer. Further study to delineate the role of TachoSil in gastrointestinal surgery are also needed to demonstrate improved effectiveness and applicability.

Surgery or Peroral Esophageal Myotomy for Achalasia: A Systematic Review and Meta-Analysis.

To date very few studies with small sample size have compared peroral esophageal myotomy (POEM) with the current surgical standard of care, laparoscopic Heller myotomy (LHM), in terms of efficacy and safety, and no recommendations have been proposed.To investigate the efficacy and safety of POEM compared with LHM, for the treatment of achalasia.The databases of Pubmed, Medline, Cochrane, and Ovid were systematically searched between January 1, 2005 and January 31, 2015, with the medical subject headings (MeSH) and keywords "achalasia," "POEM," "per oral endoscopic myotomy," and "peroral endoscopic myotomy," "laparoscopic Heller myotomy" (LHM), "Heller myotomy."All types of study designs including adult patients with diagnosis of achalasia were selected. Studies that did not report the comparison between endoscopic and surgical treatment, experimental studies in animal models, single case reports, technical reports, reviews, abstracts, and editorials were excluded.The total number of included patients was 486 (196 in POEM group and 290 in LHM group).There were no differences between POEM and LHM in reduction in Eckardt score (MD = -0.659, 95% CI: -1.70 to 0.38, P = 0.217), operative time (MD = -0.354, 95% CI: -1.12 to 0.41, P = 0.36), postoperative pain scores (MD = -1.86, 95% CI: -5.17 to 1.44, P = 0.268), analgesic requirements (MD = -0.74, 95% CI: -2.65 to 1.16, P = 0.445), and complications (OR = 1.11, 95% CI: 0.5-2.44, P = 0.796). Length of hospital stay was significantly lower for POEM (MD = -0.629, 95% CI: -1.256 to -0.002, P = 0.049). There was a trend toward significant reduction in symptomatic gastroesophageal reflux rate in favors of LHM compared to POEM group (OR = 1.81, 95% CI: 1.11-2.95, P = 0.017).All included studied were not randomized. Furthermore all selected studies did not report the results of follow-up longer than 1 year and most of them included patients who were both treatment naive and underwent previous endoscopic or surgical interventions for achalasia.POEM represents a safe and efficacy procedure comparable to the safety profile of LHM for achalasia at a short-term follow-up. Long-term clinical trials are urgently needed.