Lymph node pick up by separate stations: Option or necessity.

AIM: To evaluate whether lymph node pick up by separate stations could be an indicator of patients submitted to appropriate surgical treatment. METHODS: One thousand two hundred and three consecutive gastric cancer patients submitted to radical resection in 7 general hospitals and for whom no information was available on the extension of lymphatic dissection were included in this retrospective study. RESULTS: Patients were divided into 2 groups: group A, where the stomach specimen was directly formalin-fixed and sent to the pathologist, and group B, where lymph nodes were picked up after surgery and fixed for separate stations. Sixty-two point three percent of group A patients showed < 16 retrieved lymph nodes compared to 19.4% of group B (P < 0.0001). Group B (separate stations) patients had significantly higher survival rates than those in group A [46.1 mo (95%CI: 36.5-56.0) vs 27.7 mo (95%CI: 21.3-31.9); P = 0.0001], independently of T or N stage. In multivariate analysis, group A also showed a higher risk of death than group B (HR = 1.24; 95%CI: 1.05-1.46). CONCLUSION: Separate lymphatic station dissection increases the number of retrieved nodes, leads to better tumor staging, and permits verification of the surgical dissection. The number of dissected stations could potentially be used as an index to evaluate the quality of treatment received.

Gastric stump carcinoma after distal subtotal gastrectomy for early gastric cancer: experience of 541 patients with long-term follow-up.

BACKGROUND: Gastric stump carcinoma (GSC) has been studied after primary gastrectomy for benign disease but few studies have evaluated its correlation with gastric cancer. PATIENTS: We assessed 541 patients submitted to subtotal gastrectomy for early gastric cancer at least 15 years ago. RESULTS: GSC was diagnosed in 16 (2.9%) patients, giving a 4% cumulative risk of GSC 20 years after surgery. Diagnosis was made within 5 years of surgery in 10 patients and after 8 years in 6 cases. GSC occurred in 13/470 (2.8%) patients submitted to Billroth 2 reconstruction, 2/30 (6.7%) patients who underwent Billroth 1, and 1/41 (2.4%) patients after Roux-en-Y reconstruction. Significant risk factors observed for GSC were histologic type and sex. Other synchronous or metachronous extragastric tumors were registered in 56 (11.2%) patients. CONCLUSIONS: The risk of GSC was low, even 20 years after subtotal gastrectomy for early gastric cancer. Lauren intestinal histotype and male sex were frequently associated with GSC. No correlation was observed between GSC and reconstruction technique or multifocality. Clinically speaking, GSC could be considered a subset of gastric cancer.

Is a clear benefit in survival enough to modify patient access to the surgery service? A retrospective analysis in a cohort of gastric cancer patients.

BACKGROUND: Surgery has become an important tool for cancer treatment, requiring many available resources and a good organization of the surgery service. The aim of this study was to provide robust data for policymakers on the impact of hospital volume on survival, taking into account different sources of information. METHODS: We performed a retrospective study in a cohort of patients with gastric cancer submitted to partial or total gastrectomy. Data for the analysis were retrieved from regional administrative databases, the regional death registry, and histological reports. The main outcome measures were operative mortality and long-term survival. The associations between hospital volume and risk of mortality were calculated using a Cox multiple regression analysis. RESULTS: The estimated relationship between operative mortality and volume was not statistically significant. Conversely, high-volume hospitals had an increased likelihood of long-term survival compared to low-volume institutions: hazard ratio 0.79 (95% confidence interval, 0.66-0.94, p = 0.01). The percentage variation between crude and adjusted HRs using only administrative data or administrative and histological data was very small. However, the combined use of administrative and clinical data provided a more accurate model for estimating risk-adjusted mortality. CONCLUSIONS: A positive association between hospital volume and survival was evident for long-term outcome after adjusting for patient and tumor confounding. Moreover, the patient's choice of hospital was not guided by specific care pathways or screening programs, and prognosis was not poorer for patients in high-volume hospitals. These findings suggest that there is leeway for improving access to surgery for gastric cancer patients.

Operating room data management: improving efficiency and safety in a surgical block.

BACKGROUND: European Healthcare Systems are facing a difficult period characterized by increasing costs and spending cuts due to economic problems. There is the urgent need for new tools which sustain Hospitals decision makers work. This project aimed to develop a data recording system of the surgical process of every patient within the operating theatre. The primary goal was to create a practical and easy data processing tool to give hospital managers, anesthesiologists and surgeons the information basis to increase operating theaters efficiency and patient safety. METHODS: The developed data analysis tool is embedded in an Oracle Business Intelligence Environment, which processes data to simple and understandable performance tachometers and tables. The underlying data analysis is based on scientific literature and the projects teams experience with tracked data. The system login is layered and different users have access to different data outputs depending on their professional needs. The system is divided in the tree profile types Manager, Anesthesiologist and Surgeon. Every profile includes subcategories where operators can access more detailed data analyses. The first data output screen shows general information and guides the user towards more detailed data analysis. The data recording system enabled the registration of 14.675 surgical operations performed from 2009 to 2011. RESULTS: Raw utilization increased from 44% in 2009 to 52% in 2011. The number of high complexity surgical procedures (≥120 minutes) has increased in certain units while decreased in others. The number of unscheduled procedures performed has been reduced (from 25% in 2009 to 14% in 2011) while maintaining the same percentage of surgical procedures. The number of overtime events decreased in 2010 (23%) and in 2011 (21%) compared to 2009 (28%) and the delays expressed in minutes are almost the same (mean 78 min). The direct link found between the complexity of surgical procedures, the number of unscheduled procedures and overtime show a positive impact of the project on OR management. Despite a consistency in the complexity of procedures (19% in 2009 and 21% in 2011), surgical groups have been successful in reducing the number of unscheduled procedures (from 25% in 2009 to 14% in 2011) and overtime (from 28% in 2009 to 21% in 2011). CONCLUSIONS: The developed project gives healthcare managers, anesthesiologists and surgeons useful information to increase surgical theaters efficiency and patient safety. In difficult economic times is possible to develop something that is of some value to the patient and healthcare system too.

Early gastric cancer: diagnosis, staging, and clinical impact. Evaluation of 530 patients. New elements for an updated definition and classification.

BACKGROUND: The prevention and early diagnosis of gastric cancer permit clinicians to discover the tumor in the initial phase, during which time it can be completely eradicated, endoscopically or surgically. Since Murakami gave the definition of early gastric cancer (EGC) in 1971, many authors have identified various subtypes of EGC with different morphological characteristics and clinical behaviour. METHODS: We evaluated retrospectively 530 patients: the median follow-up time was 10.4 months (range 0.3-29.2). All tumors were classified according to the macroscopic and microscopic criteria proposed by the Japanese Society of Gastroenterology and Endoscopy and Lauren, respectively. The infiltrative growth pattern was evaluated according to Kodama's classification. Only tumor-related death was considered as an endpoint of interest for the survival analysis. RESULTS: The overall survival rates of our patients were 94 % (95 % CI, 92-96) and 90 % (95 % CI, 87-93) at 5 and 10 years, respectively. Only 44 patients (8.3 %) died of the disease. Kodama's type (p < 0.0001), lymph node status, both for number and pathological stage according to the 7th Edition of TNM (p < 0.0001), and depth of infiltration (p = 0.0006) were significant prognostic factors in univariate analysis. The multivariate analysis identified Kodama's PENA type (HR, 3.91; 95 % CI, 2.08-7.33; p < 0.0001) and lymph node status for more than three positive nodes versus negative nodes (HR, 12.78; 95 % CI, 5.37-30.43; p < 0.0001) as the only independent prognostic factors in our series. CONCLUSION: Lymph node status, especially when more than three lymph nodes are involved, is the most important prognostic factor in EGC. However, it is also important to evaluate the infiltrative growth pattern of the cancers in their early phase according to Kodama's classification, considering PEN A type lesions to be more aggressive than the other EGC types. Then, we propose new elements for an updated definition and classification of EGC, with an important clinical impact on the treatment of patients.

Preoperative multidetector-row computed tomography scan staging for lymphatic gastric cancer spread.

BACKGROUND: Multidetector-row computed tomography (MDCT) is commonly used to stage patients with gastric cancer, even though the technique often shows low specificity for lymph-node involvement. METHODS: In this study, 111 patients with gastric cancer who consecutively underwent MDCT scan followed by radical surgical treatment at our hospital were retrospectively evaluated. RESULTS: In total, 3632 lymph nodes from 643 lymphatic stations were studied and then correlated with radiological features. Lymph-node size was not always associated with infiltration. Of the 261 lymph-node stations that were not radiologically detected, 60 (22.9%) were infiltrated. There were 108 stations with lymph nodes larger than 10 mm seen on MDCT, of which 67 (62%) had lymphatic invasion. The sensitivity was 32.6%, specificity 90.6%, positive predictive value 62.0%, negative predictive value 74.2%, and accuracy 72.1%. When three lymph nodes, at least one of which was larger than 10 mm, were detected in the same station, infiltration was confirmed with 99% specificity in 93.8% of patients. Moreover, all of the 13 patients in whom three lymph nodes larger than 10 mm were detected in different neighboring stations had lymphatic invasion. CONCLUSIONS: Although presence of lymph nodes greater than 10 mm in size is not, in itself, sufficient to confirm lymphatic invasion, nodal involvement can be hypothesized when associated images are detected by MDCT.

Pancreatic resection for metastases from renal cancer: long term outcome after surgery and immunotherapy approach - single center experience.

BACKGROUND/AIMS: Natural history of renal cell carcinoma includes metastases to the pancreas. The literature reports that selected patients may have benefits by pancreatic resection in terms of long term survival. We report patient outcome and considerations on immunotherapy approach. METHODOLOGY: From 2001 to 2010 eight patients underwent pancreatic resection for metastases from renal cancer. We reviewed surgical outcome and following treatment (conventional chemotherapy: 5FU-Vindesine; Immunotherapy: Interleukin 2 - Interferon - Dendritic cells) of these patients. RESULTS: All patients underwent radical pancreatic resection (7 spleno-pancreatectomies; 1 segmental pancreatic resection) and were R0 after surgery. No postoperative mortality was reported. Morbidity was 37% (2 distal leakage; 1 pneumonitis). Two patients did not receive any further treatment; 2 patients received conventional chemotherapy; 2 patients received immunotherapy (interleukin2 + interferon); 2 patients received dendritic cells (DC) interleukin-2 infusion. Three years overall survival rate was 55%. Disease free survival after 3 years was 30%. CONCLUSIONS: Our data confirm that pancreatic resection should be offered to selected patients with no mortality and low morbidity. Long-term survival is achievable, but recurrence rate after surgery is high. Immunotherapy could be effective to control tumour progression especially in selected cases where DC may be used.

GEMOX plus tomotherapy for unresectable locally advanced pancreatic cancer.

BACKGROUND/AIMS: The aim of this prospective phase II study was to evaluate the effect of neoadjuvant GEMOX plus helical tomotherapy on the resectability of locally advanced pancreatic cancer. METHODOLOGY: Between November 2004 and July 2008, 33 enrolled patients received gemcitabine (GEM) 1000 mg/m2 on day 1, and oxaliplatin (OX) 100 mg/m2 on day 2, every two weeks for 3-4 cycles. This was followed by radiotherapy (25 Gy, 5 fractions), 15 days after completion of GEMOX. Patients then received a further 3-4 cycles of GEMOX, underwent restaging and were evaluated for surgery. Potentially resectable patients were submitted to surgery, while unresectable responders received further GEMOX and radiotherapy. RESULTS: Toxicity to GEMOX was similar to that reported elsewhere and radiotherapy was also well tolerated. After treatment, one patient achieved a complete response, 14 had a partial response, 11 showed a stable disease, 6 progressed, and one was not evaluable. Eight patients (24%) underwent surgical laparotomy (7 radical pancreatic resections and one explorative laparotomy). CONCLUSIONS: Our study shows the feasibility and potential efficacy of the GEMOX plus helical tomotherapy regimen in unresectable locally advanced pancreatic cancer.

Subtotal gastrectomy as treatment for distal multifocal early gastric cancer.

INTRODUCTION: Multifocal early gastric cancer (MEGC) is frequently observed and represents a serious risk when minimally invasive treatments are performed. PATIENTS AND METHODS: We present the experience of two Italian centers situated in a relatively high incidence area for gastric cancer. Out of a total of 791 surgical resections for EGC carried out in two Italian centers from 1976 to 2006, we identified 98 patients with multifocal EGC (12.3%). Two hundred and sixteen lesions were observed. Generally sited near the principal tumors, secondary lesions were, however, sometimes detected distally from the upper primary lesion. No secondary lesions were detected in the upper third when the principal lesion was sited at the lower third. RESULTS: Survival of MEGC patients was not significantly lower than that of patients with monofocal EGC. No cases of gastric remnant relapse were observed at a mean follow-up of 9 years (range 1-28) after subtotal gastrectomy. DISCUSSION: When EGCs are detected, the possibility of MEGC must always be investigated by endoscopy and chromoendoscopy. When a MEGC is found in the lower third of the stomach and chromoendoscopy of the upper third has been performed, subtotal gastrectomy can be considered as sufficient treatment.

The ratio between metastatic and examined lymph nodes (N ratio) is an independent prognostic factor in gastric cancer regardless of the type of lymphadenectomy: results from an Italian multicentric study in 1853 patients.

PURPOSE: To investigate whether the ratio between metastatic and examined lymph nodes (N ratio) is a better prognostic factor as compared with traditional staging systems in patients with gastric cancer regardless of the extension of lymph node dissection. PATIENTS & METHODS: We retrospectively reviewed the data of 1853 patients who underwent radical resection for gastric carcinoma at 6 Italian centers. Patients with >15 (group 1, n = 1421) and those with 25%) were determined by the best cut-off approach. RESULTS: After a median follow-up of 45.5 months (range, 4-182 months), the 5-year overall survival of N0, N1, and N2 patients of group 1 versus group 2 was 83.4% versus 74.2% (P = 0.0026), 54.3% versus 44.3% (P = 0.018), and 32.7% versus 14.7% (P = 0.004), respectively, suggesting that a low number of excised lymph nodes can lead to the understaging of patients. N ratio identified subsets of patients with significantly different survival rates within N1 and N2 stages in both groups. At multivariate analysis, the N ratio (but not N stage) was retained as an independent prognostic factor both in group 1 and group 2 (HR for N ratio 1, N ratio 2, and N ratio 3 = 1.67, 2.96, and 6.59, and 1.56, 2.68, and 4.28, respectively). In our series, the implementation of N ratio led to the identification of subgroups of patients prognostically more homogeneous than those classified by the TNM system. CONCLUSION: N ratio is a simple and reproducible prognostic tool that can stratify patients with gastric cancer also in case of limited lymph node dissection. These data may represent the rational for improving the prognostic power of current UICC TNM staging system and ultimately the selection of patients who may most benefit from adjuvant treatments.

Does resection line involvement affect prognosis in early gastric cancer patients? An Italian multicentric study.

BACKGROUND: Resection line involvement has been indicated as an important prognostic factor for gastric cancer. Its late detection renders the choice of treatment difficult for surgeons. MATERIALS AND METHODS: We describe the multicenter experience of a group of 11 patients with early gastric carcinoma (EGC) and positive resection confirmed at histological examination who did not undergo surgical retreatment for reasons of associated disease, surgical considerations on duodenal stump, or patient refusal. RESULTS: The gastric margin was involved in 4 patients, and 7 patients had duodenal resection line involvement. No surgical complications or postoperative deaths were observed. Five and 8-year survival was 100% and 86%, respectively. The only patient who relapsed did not have lymph node involvement and died from liver metastases, without local recurrence. CONCLUSIONS: It is sometimes difficult to accurately define the resection line in gastric cancer surgery, especially in the early stages of disease, but because of the strongly negative prognostic value of an infiltrated margin, frozen sections are recommended if neoplastic invasion is suspected and a new resection is always recommended if possible. Nevertheless, the good prognosis of resected EGC patients with resection line involvement must be considered before submitting patients with associated diseases to radical surgical retreatment.

Prognostic evaluation of stage B colon cancer patients is improved by an adequate lymphadenectomy: results of a secondary analysis of a large scale adjuvant trial.

OBJECTIVE: To determine if the extent of lymphadenectomy (number of recovered lymph nodes) was associated with long-term outcome in patients operated on for stage B and C colon cancer. SUMMARY BACKGROUND DATA: Lymphatic spreading is the main prognostic indicator in colon cancer patients, although the optimal extent of lymphadenectomy and its prognostic impact are still unknown. METHODS: In 3,648 patients (median follow-up 3.6 years) enrolled in two consecutive INTACC multicentric trials on adjuvant therapy for colon cancer, we studied the association of the number of recovered nodes with overall survival and relapse free survival by means of univariate and Cox regression analysis. RESULTS: The worst overall survival was related to ages > 65 (risk ratio [RR] = 1.30), higher grading (RR = 1.96). Better overall survival was related to female gender (RR = 0.80) and to higher number of recovered nodes (8-12 nodes, RR = 0.46, 13-17 nodes, RR = 0.76, nodes > or = 18, RR = 0.79). The same pattern was observed for relapse free survival. Longer overall and relapse free survival were related to a higher number of recovered nodes with P =.034 and P =.003 respectively (stratified analysis for absence or presence of positive nodes). Stage B patients with fewer than 7 nodes in the specimen had both shorter overall survival (P =.0000) and relapse free survival (P =.0016) than the other B patients. Outcome of stage C patients was not related to the number of recovered nodes (P =.28 and 0.12 respectively). The interaction test between stage of disease and number of recovered nodes was statistically significant (P =.017). CONCLUSIONS: Stage B patients with a small number of examined nodes may be understaged. Thus, these patients might be considered for adjuvant therapy because of their poorer life expectancy than other stage B patients. For stage C patients, the number of recovered nodes does not seem to affect long-term outcome.