Long-term survival after curative resection for pancreatic ductal adenocarcinoma--Surgical treatment.

INTRODUCTION: Recent reports have demonstrated improvement in the 5-years serviva with resecate ductal adenocarcinoma. The aim of study is to determinate the factor influencing long-term survival after DCP. MATERIALS AND METHODS: We have critically reviewed a group of 85 patients how were admitted to our department with diagnosis of ductal adenocarcinoma of the head of pancreas between January 1974 and January 1998. RESULTS: Patients were stratified according to stage using TNM classification; in stage I 31 patients with 5 T1aN0M0 disease, 11 patients with T1bN0M0 and 15 patients T2N0M0 disease. By contrast, in stage III 54 patients with 48 patients T2N1M0 and 6 patients with T3N1M0. Tumour size was recorded for 72 patients with a median of 3.8 cm. The R1 dissection was performed in 67 patients. The R2 resection was performed in 18 patients. In our series we verified and analysed the histopathologic features of 5 patients with 15-years survival (5.8%). The features regard age, male or female, tumours size, stage and positive lymph node resection. DISCUSSION: We found a specifically subset of patients where the combination of prognostic factors, in particular, negative surgical margins R0, tumour size ≤ 30 mm and the absence of lymph node metastasis independently reduced the mortality indicating that earlier tumour detection and histologically curative resection are important factors contributing to long term survival and healing of ductal adenocarcinoma of the head of the pancreas.

The first case of acinic cell carcinoma of the breast within a fibroadenoma: case report.

A case of acinic cell carcinoma of the breast is reported in a 26-year-old woman. She presented a lump in her right breast, that seemed to be a fibroadenoma. The open biopsy revealed a well-bordered fibroadenoma, together with a proliferation of cells characterized by serous acinar differentiation and eosinophilic cytoplasmic granules. Tumor cells stained for amylase, lysozyme, α-1-antichymotripsin, epithelial membrane antigen, S-100 protein, pan-cytokeratin, cytokeratin 7 and E-cadherin. Estrogen receptor, progesterone receptor, human epidermal growth factor receptor 2 overexpression, CD10, P63, smooth muscle actin, cytokeratin 5/6 were negative. The sentinel node was negative. 8 months after surgery she is in good clinical conditions without recurrence or metastases.

Acinic cell carcinoma of the breast: review of the literature.

INTRODUCTION: The breast and salivary gland tissue share embryologic and thus pathological similarities. Acinic cell carcinoma (ACC) is a typical tumor in salivary glands, but rarely arises in breast too. We reviewed 38 cases of mammary ACC reported in literature and our case, the first ACC born within a fibroadenoma. MATERIALS AND METHODS: Data were collected by a research for the key words acinic cell carcinoma breast on Pubmed in March 2014, including a case treated in our department. All reviewed cases were compared for clinical approach and histological pattern. RESULTS: To date 23 articles presenting cases of ACC of the breast are reported in literature. We included in our review 38 cases previously described and one new case. The histological pattern was predominantly solid with a microglandular structure. All the tumor cells were cytologically characterized by monotonous round cells with a finely granular, weakly eosinophilic, or clearly vacuolated cytoplasm. The most of the cells were intensely stained with anti-lysozime, anti-amylase, anti-α1-chimotripsin, anti-EMA and anti-S100 protein antisera. Immunohistochemistry was also performed to point out: estrogen receptor (ER), progesterone receptor (PR), androgen receptors (AR), human epidermal growth factor receptor 2 overexpression (HER2/neu), E-cadherin (E-cad), cytokeratin-7 (CK7), gross cystic disease fluid protein 15 (GCDFP15), smooth muscle actin (SMA). CONCLUSION: ACC of the breast is a rare tumor, showing similarities with the salivary gland counterpart, above all in terms of good prognosis, and differences from the ordinary invasive breast carcinoma. Further investigations are needed to elucidate the true histogenesis and the correct treatment.

Positive findings in preoperative testing prior to gastric banding: their real value.

AIM: Relations between laparoscopic adjustable gastric banding (LAGB), gastroesophageal reflux (GER) and hiatal hernia (HH) are controversial. In this context the role of preoperative investigations to assess upper gastrointestinal (GI) function and its impact on the approach to LAGB and outcomes remains unclear. The aim was to define the value of preoperative upper GI testing, and to relate the findings with postoperative outcomes. METHODS: Seventy-eight cases were enrolled among 250 patients undergoing LAGB from January 2010 to December 2011 in our Center for the Multidisciplinary treatment of severe obesity. Patients were submitted preoperatively to endoscopy and radiologic series with oral contrast to assess the state of upper GI mucosa, the presence of HH, GER or cardias incontinence. According to the findings, patients were assigned to group A, if one or both exams showed positive results; or to the control group B if both exams were negative. RESULTS: GI series showed GER in 14.1% of patients, HH in 6.4%, altered motility in 5.1%, gastritis in 3.1%and were negative in 75.6%. Endoscopy showed gastritis in 71.8%of patients, HH in 30.8%, esophagitis in 7.7%, duodenitis in 7.7%, LES incontinence in 8%; while only 21.8% of patients had a negative exam. Differences between group A and B are not statistically significant in terms of pre- and post-operative BMI, EBWL%, long-term complications, time and number of regulations. CONCLUSION: Positive findings in preoperative testing rarely postpone or change the surgical approach and postoperative outcomes. Our results encourage the omission of upper GI series from routine evaluation protocol prior to LAGB.

Gastric emptying after sleeve gastrectomy: statistical evidence of a controlled prospective study with gastric scintigraphy.

AIM: Laparoscopic sleeve gastrectomy (LSG) is a stand-alone bariatric procedure, its feasibility and efficacy being confirmed by long-term data. The effect of the procedure is believed to be based on the gastric restriction and reduction of ghrelin. Nevertheless it remains still controversial the role of LSG on gastric emptying and the impact that this may have on weight loss outcomes. Our aim is to assess gastric emptying after LSG using gastric scintigraphy. METHODS: For this prospective randomized study, 45 patients undergoing LSG at our Centre for the Multidisciplinary Treatment of Severe Obesity from April 2009 to April 2011 were enrolled and observed prospectively (Group A). The inclusion criteria followed the guidelines for bariatric surgery. All patients performed gastric emptying scintigraphy through a standard semisolid meal (250 kcal), marked with 0.5 mCiTc 99. Group A performed the exam before (A1) and after the operation (A2). A control group (Group B) included 20 patients undergoing scintigraphic assessment for other reasons. RESULTS: LSG was performed following a standardized technique. No complications were observed. The scintigraphic study showed a reduced half-life tracer (A1 vs. A2: 80.4±16.5 min vs. 64.3±22 min P=0.06), without a significant difference. Comparing the two groups no differences occurred before operation (B vs. A1). Gastric emptying time resulted significatively reduced in group A2 rather than in group A1 and B. CONCLUSION: Gastric motility plays a role in the pathogenesis of obesity. Our experience suggests that LSG reduces gastric emptying time, but further studies are necessary to reach statystical significativity.

Use of Tachosil® in bariatric surgery: preliminary experience in control of bleeding after sleeve gastrectomy.

AIM: Laparoscopic sleeve gastrectomy (LSG) is one of the most common procedures of bariatric surgery. Nevertheless complications after LSG are common, the most frequent is bleeding. Our purpose was to reduce bleeding after gastric resection, thus reducing the risk of anemia. METHODS: The study took part in our Multidisciplinary Obesity Treatment Centre, between May 2008 and January 2010. Thirty patients were candidates to SG. They were enrolled in this prospective, parallel group, single-blind randomized trial, to proof the effectiveness and safety of the use of hemostatic-sealant drug Tachosil® as a reinforcement of the suture line in sleeve gastrectomy. Patients were enrolled in Group A when TachoSil® was used and Group B if not. We collected data about weight loss every month, RBC, Hb, PLT, ESR, CRP, WBC in the first week daily and at 2, 4 and 6 months on follow-up. RESULTS: Two groups did not significantly differ for mean age, mean of body weight (118.5 vs. 121.9 kg), BMI (48.4 vs. 49.6 kg/m2), operation time (108 vs. 102 min), hospitalization duration (6.5 vs. 7 days). In group B mean drainage fluid collection was 120, 80 and 60 mL on 1st, 2nd and 3rd postoperative day. Tube removal occurred on average on 5th postoperaive day. In group A (no drainage) control echogram ruled out any fluid collection. RBC, Hb and PLT decreased from 2nd postoperative day. Decrease of PLT was non-significantly different. Decrease of RBC and Hb was significantly different (-0.4 x 106/mL vs. -1.7 x 106/mL; -0.5 g/dL vs. -1.2 g/dL). All other values were not different between groups. CONCLUSION: In this prospective experience the hemostatic-sealant drug Tachosil®, that contains a collagen sponge coated by human fibrinogen and thrombin was shown to reduce post-operatory bleeding and probably promote optimal wound healing.

Determinants of health-related quality of life in morbid obese candidates to gastric banding.

OBJECTIVE: To analyse determinants of self reported health-related quality of life (HR-QoL) in morbid obese patients candidates to laparoscopic adjustable gastric banding (LAGB). METHODS: Determinants of HR-QoL were investigated in 383 morbid obese patients (82 M and 301 F) with BMI≥40 kg/m² (BMI≥35 kg/m² if complicated obesity) and age 18-60 years. HR-QoL was determined with the SF-36 questionnaire. Determinants of the two summary measures of SF-36 (physical component and mental component) were analysed by stepwise multiple linear regression analysis with age, BMI, physical comorbidites, mental comorbidites and eating behaviour disorders as independent variables. Physical comorbities (diabetes, hypertension, hypertriglyceridemia, low HDL, sleep apnea and osteoarthritis) were coded as present or absent on the basis of simple diagnostic clinical criteria; mental comorbidities (depression) and eating behaviour disorders (binge eating, sweet eating and nibbling) on the basis of an unstructured clinical interview. RESULTS: Mean age was 38.8±10.2 years and mean BMI was 41.5±5.4 kg/m². Scores in the eight SF-36 subscales were lower in women than in men and lower than in the general Italian population. However, 18.4-43.5% of the participants had HR-QoL levels above the normative values, depending on the scale. In both genders, low scores in the mental component of the SF-36 were associated to the presence of depression and eating behaviour disorders and not to physical comorbidities or BMI levels. Low physical self-perceived well being was associated to high BMI levels in men and to depression, hypertension and hypertriglyceridemia in women. CONCLUSION: HR-QoL was poor in morbid obese candidates to LAGB, particularly in women, and was negatively affected more by mental comorbidites and eating behaviour disorders than by physical comorbidities or BMI levels.

Surgical treatment for IV-degree hemorrhoids: LigaSure™ hemorroidectomy vs. conventional diathermy. A prospective, randomized trial.

AIM: Milligan-Morgan operation is still considered the treatment of choice for IV-degree haemorrhoids: it is frequently associated with significant postoperative pain and prolonged hospital stay. Many instruments were conceived to reduce these complications, such as the LigaSure™ (LS) system, a combination of radiofrequency and pressure that seems mainly effective where a large tissue demolition is required. This randomized study is METHODS: Fifty-two patients with IV-degree hemorrhoids were randomly assigned to two different surgical treatments (conventional diathermy vs. LigaSure™ hemorrhoidectomy). They were evaluated on the basis of the following main outcomes: mean operative time, postoperative pain, day of discharge early and late complications. The time of recovery of work was also assessed. All patients had a minimum follow-up of twelve months (range 12-24). All data were statistically evaluated. RESULTS: Twenty-seven patients were treated by conventional diathermy, 25 by LigaSure™. The mean operative time was significantly shorter in LS, such as postoperative pain, mainly lower on the third and fourth postoperative day: moreover pain disappeared earlier in LS than CD. The time off-work was shorter in LS, while there was no difference in hospital stay and overall complications rate . CONCLUSION: This randomized prospective controlled trial confirms, according to other large trials in literature , the benefits of the LigaSure™ hemorrhoidectomy over conventional diathermy when a large tissue demolition is required, supporting the use of this device as treatment of choice in IV degree hemorrhoids, even if the procedure is more expensive than conventional operation.

[Obesity and Eating Disorders. Indications for the different levels of care. An Italian Expert Consensus Document]. / Documento di Consensus. Obesità e Disturbi dell'Alimentazione Indicazioni per i diversi livelli di trattamento.

This paper is an Italian Expert Consensus Document on multidimensional treatment of obesity and eating disorders. The Document is based on a wide survey of expert opinion. It presents, in particular, considerations regarding how clinicians go about choosing the most appropriate site of treatment for a given patient suffering from obesity and/or eating disorders: outpatient, partial hospitalization, residential rehabilitation centre, inpatient hospitalization. In a majority of instances obesity and eating disorders are long-term diseases and require a multiprofessional team-approach. In determining an initial level of care or a change to a different level of care, it is essential to consider together the overall physical condition, medical complications, disabilities, psychiatric comorbidity, psychology, behaviour, family, social resources, environment, and available services. We first created a review manuscript, a skeleton algorithm and two rating scales, based on the published guidelines and the existing research literature. As the second point we highlighted a number of clinical questions that had to be addressed in the specific context of our National Health Service and available specialized care units. Then we submitted eleven progressive revisions of the Document to the experts up to the final synthesis that was approved by the group. Of course, from point to point, some of the individual experts would differ with the consensus view. The document can be viewed as an expert consultation and the clinical judgement must always be tailored to the particular needs of each clinical situation. We will continue to revise the Document periodically based on new research information and on reassessment of expert opinion to keep it up-to-date. The Document was not financially sponsored.

Dual-time-point [18F]-FDG PET/CT in the diagnostic evaluation of suspicious breast lesions.

PURPOSE: The authors sought to evaluate whether the reacquisition of images 3 h after administration of radiotracer improves the sensitivity of fluorine-18 fluorodeoxyglucose positron emission tomography computed tomography ([(18)F]-FDG PET/CT) in patients with suspicious breast lesions. MATERIALS AND METHODS: Forty-eight patients with 59 breast lesions underwent an [(18)F]-FDG PET/CT study in the prone position with a dual-time-point acquisition performed in the early phase 1 h after FDG administration (PET-1) and in the delayed phase 3 h after FDG administration (PET-2). Both examinations were evaluated qualitatively and semiquantitatively with calculation of the mean percentage variation of the standard uptake values (Delta% SUV(max)) between PET-1 and PET-2. All lesions with an SUV(max) >or=2.5 at PET-1 or a reduction in SUV between PET-1 and PET-2 were considered benign. The definitive histopathological diagnosis was available for all patients included in the study. RESULTS: The dual-time-point acquisition of [(18)F]-FDG PET/CT displayed an accuracy of 85% for lesions with an SUV(max) >or=2.5 and/or positive Delta% SUV(max), with sensitivity and specificity values of 81% and 100% compared with 69%, 63% (both p<0.001) and 100% (p=n.s.), respectively, for the single-time-point acquisition. Malignant lesions showed an increase in FDG uptake between PET-1 and PET-2, with a Delta% SUV(max) of 10+/-7 (p<0.04). In contrast, benign lesions showed a decrease in SUV between PET-1 and PET-2, with a Delta% SUV(max) of -21+/-7 (p<0.001). CONCLUSIONS: The delayed repeat acquisition of PET images improves the accuracy of [(18)F]-FDG PET/CT in patients with suspicious breast lesions with respect to the single-time-point acquisition. In addition, malignant breast lesions displayed an increase in FDG uptake over time, whereas benign lesions showed a reduction. These variations in FDG uptake between PET-1 and PET-2 are a reliable parameter that can be used for differentiating between benign and malignant breast lesions.

Heliosphere Bag in the treatment of severe obesity: preliminary experience.

BACKGROUND: Various intragastric balloons have been used in obese patients for temporary weight loss. Recently, a new balloon, the Heliosphere Bag, was proposed. In a preliminary study, we evaluated the safety and efficacy of this device. METHODS: The Heliosphere Bag was used in 10 patients, selected according to the guidelines for obesity surgery. The manufacturer's instructions were followed in positioning the device. Heliosphere Bag positioning was performed, after diagnostic endoscopy, under unconscious sedation. After placement, the balloon was slowly inflated with 840-960 cc of air, which gives the inflated final volume of 650-700 cc of air, as the air is compressed. On the first and second post-treatment day, intravenous saline (30-35 ml/kg/d) with omeprazole (20 mg/d), ondansetron (8 mg/d) and butylscopolamine bromide (20 mg t.i.d.) were given to all patients. All patients from day 3 after placement began liquid diet and were discharged home on day 4 on a 1000 kcal diet (carbohydrate 146 g, lipid 68 g, protein 1 g/kg ideal weight). After 6 months, the Heliosphere Bag was removed. The patients were followed monthly, and complications and their treatment, post-placement symptoms, BMI and %EWL were recorded. Data were expressed as mean +/- SD. RESULTS: From Sept-Dec 2004, 10 patients (5M/5F) underwent Heliosphere Bag placement, with age 35.2 +/- 15.7 years (17-49), BMI 43.3 +/- 8.1 kg/m(2) (35-51.2), and weight 126.8 +/- 23.7 kg (98.4-148). Heliosphere Bag positioning was quite difficult in all patients due to low pliancy and large size of the bag, causing patient discomfort. System failure at time of Heliosphere Bag positioning was observed in 5/10 patients (50%). At time of removal, the Heliosphere Bag was not found in the stomach in one patient. In 3 other patients, the balloon was found partially deflated. At the time of balloon removal after 6 months, BMI was 37.4 +/- 13.4 (28.9-42.1) and %EWL was 29.1 +/- 20.1 (9.0-57.4). BMI loss was 5.2 +/- 13.1 (1.9-11.2) and mean weight loss was 17.5 +/- 16.2 kg (5-33). CONCLUSIONS: Although weight loss was satisfactory, this device cannot be considered an advance for the temporary treatment of morbid obesity. This balloon still has some instrumental and technical problems that need to be solved: high rate of system failure at positioning, high rate of spontaneous deflation, absence of a marker such as methylene blue, and large size with low pliability that cause significant patient discomfort.

BioEnterics Intragastric Balloon: The Italian Experience with 2,515 Patients.

BACKGROUND: The temporary use of the BioEnterics Intragastric Balloon (BIB) in morbidly obesity is increasing worldwide. The aim of this study is the evaluation of the efficacy of this device in a large population, in terms of weight loss and its influence on co-morbidities. METHODS: Data were retrospectively recruited from the data-base of the Italian Collaborative Study Group for Lap-Band and BIB (GILB). After diagnostic endoscopy, the BIB was positioned and was filled with saline (500-700 ml) and methylene blue (10 ml). Patients were discharged with diet counselling ( approximately 1000 Kcal) and medical therapy. The BIB was removed after 6 months. Positioning and removal were performed under conscious or unconscious sedation. Mortality, complications, BMI, %EWL, BMI loss and co-morbidities were evaluated. RESULTS: From May 2000 to September 2004, 2,515 patients underwent BIB (722M/1,793F; mean age 38.9+/-14.7, range 12-71; mean BMI 44.4+/-7.8 kg/m(2) ; range 28.0-79.1; and mean excess weight 59.5+/-29.8 kg, range 16-210). BIB positioning was uncomplicated in all but two cases (0.08%) with acute gastric dilation treated conservatively. Overall complication rate was 70/2,515 (2.8%). Gastric perforation occurred in 5 patients (0.19%), 4 of whom had undergone previous gastric surgery: 2 died and 2 were successfully treated by laparoscopic repair after balloon removal. 19 gastric obstructions (0.76%) presented in the first week after positioning and were successfully treated by balloon removal. Balloon rupture (n=9; 0.36%) was not prevalent within any particular period of BIB treatment, and was also treated by BIB removal. Esophagitis (n=32; 1.27%) and gastric ulcer (n=5; 0.2%) presented in patients without a history of peptic disease and were treated conservatively by drugs. Preoperative co-morbidities were diagnosed in 1,394/2,471 patients (56.4%); these resolved in 617/1,394 (44.3%), improved (less pharmacological dosage or shift to other therapies) in 625/1,394 (44.8%), and were unchanged in 152/1,394 (10.9%). After 6 months, mean BMI was 35.4+/-11.8 kg/m(2) (range 24-73) and %EWL was 33.9+/-18.7 (range 0-87). BMI loss was 4.9+/-12.7 kg/m(2) (range 0-25). CONCLUSIONS: BIB is an effective procedure with satisfactory weight loss and improvement in co-morbidities after 6 months. Previous gastric surgery is a contraindication to BIB placement.

Peroperative control of surgical infections.

The overall incidence of post-surgical infection actually amount to 3-10%, in different multicentric trial, although the data may underrepresent the true incidence of such infections owing to increase of day-surgery. Antibiotic prophylaxis rapresents the first choice in the management of surgical patients, which standardization and selection can determine a real protection for all the operating time. Standardization of intraoperative procedure, considering utility of a multistep precautionary measure and the weight of these measures on post-operative stay of patients, may be an arm for control really post-operative infectious complications, according with control of sterilization's procedures and diffusion of dedicated device.

Italian Group for Lap-Band System: results of multicenter study on patients with BMI < or =35 kg/m2.

BACKGROUND: The Lap-Band System is the most common bariatric operation world-wide. Current selection criteria do not include patients with BMI < or = 35. We report the Italian multicentre experience with BMI < or = 35 kg/m(2) over the last 5 years. PATIENTS AND METHODS: Data were obtained from 27 centres involved in the Italian Collaborative Study Group for Lap-Band System. Detailed information was collected on a specially created electronic data sheet (MS Access 2000) on patients operated in Italy since January 1996. Items regarding patients with BMI < or = 35 were selected. Data were expressed as mean +/- SD except as otherwise indicated. RESULTS: 225 (6.8%) out of 3,319 Lap-Band patients were recruited from the data-base. 15 patients, previously submitted to another bariatric procedure (BIB =14; VBG= 1) were excluded. 210 patients were eligible for study (34M/176F, mean age 38.19+/-11.8, range 17-66 years, mean BMI 33.9+/-1.1, range 25.1-35 kg/m(2), mean excess weight 29.5+/-7.1, range 8-41). 199 comorbidities were diagnosed preoperatively in 55/210 patients (26.2%). 1 patient (0.4%) (35 F) died 20 months postoperatively from sepsis following perforation of dilated gastric pouch. There were no conversions to laparotomy. Postoperative complications presented in 17/210 patients (8.1%). Follow-up was obtained at 6, 12, 24, 36, 48 and 60 months. At these time periods, mean BMI was 31.1+/-2.15, 29.7+/-2.19, 28.7+/-3.8, 26.7+/-4.3, 27.9+/-3.2, and 28.2+/-0.9 kg/m(2) respectively. Co-morbidities completely resolved 1 year postoperatively in 49/55 patients (89.1%). At 60 months follow-up, only 1 patient (0.4%) has a BMI >30. CONCLUSIONS: Although surgical indications for BMI < or = 35 remain questionable, the Lap-Band in this study demonstrated that all but 1 patient achieved normal weight, and most lost their co-morbidities with a very low mortality rate.

The Italian Group for LAP-BAND: predictive value of initial body mass index for weight loss after 5 years of follow-up.

BACKGROUND: Laparoscopic of the LAP-BAND System placement stage of obesity is a safe operation, but its indication in terms of stage of obesity is controversial. The aim of this study was to evaluate the 5 years stage of obesity results for weight loss in patients with varying preoperative ranges of body mass index (BMI). METHODS: Data were obtained from the Italian Collaborative Study Group for LAP-BAND System (GILB) registry. Detailed information was collected on a specifically created database (MS Access 2000) for patients operated on in Italy from January 1996 to 2003. Patients operated on between January 1996 and December 1997 were allocated to four groups according to preoperative BMI range: 30-39.9 kg/m(2) (group A), 40-49.9 kg/m(2) (group B), 50-59.9 kg/m(2) (group C), and =60 kg/m(2) (group D) percent estimated weight loss respectively. Postoperative complications, mortality, BMI, BMI loss, and (%EWL) were considered in each group. Data are expressed as mean +/- SD, except as otherwise indicated. Statistical analysis was done by means of Fisher's exact test, and p < 0.05 was considered significant. RESULTS: After 5 years from LAP-BAND System surgery, 573 of 3,562 patients were eligible for the study. One hundred fifty-five of 573 (27.0%) were lost to follow-up, 24 of 418 (5.7%) underwent band removal due to complications (gastric pouch dilation, band erosion), eight of 418 (1.9%) were converted to other bariatric procedures, five of 418 (1.2%) died of causes not related to the operation or the band, and 381 of 573 (66.5%) were available for follow-up. Based on 96, 214, 64, and seven patients their preoperative BMI, Were allocated to groups A, B, C, and D, respectively. At time of follow-up mean BMI was 27.5 +/- 5.2 in group A, 31.6 +/- 4.7 in group B, 37.6 +/- 17.3 in group C, and 41.4 +/- 6.9 kg/m(2) in group D. Mean BMI loss was 9.8 +/- 5.4, 12.9 +/- 5.2, 15.8 +/- 8.1, and 23.2 +/- 4.9 kg/m(2), respectively, in groups A, B, C, and D. Mean %EWL at the same time was 54.6 +/- 32.3 in group A, 54.1 +/- 17.2 in group B, 51.6 +/- 35 in group C, and 59.l +/- 17.1 in group D. CONCLUSION: Initial BMI in this series did not correlate with %EWL 5 years after the operation. In fact %EWL was almost the same in each group, independent of preoperative weight. Initial BMI was an accurate indicator of the results obtained 5 years after LAP-BAND in group C (50-59.9 kg/m(2)) and D (=60 kg/m(2)) patients, who remained morbidly obese despite their %EWL.

Lap Band adjustable gastric banding system: the Italian experience with 1863 patients operated on 6 years.

BACKGROUND: The Lap Band system procedure is currently the most common bariatric surgical procedure worldwide. This is an interim report of the experience of the 27 Italian centers participating in the national collaborative study group for Lap Band (GILB). METHODS: An electronic database was specifically created. It was mailed and e-mailed to all of the surgeons now performing the laparoscopic gastric banding operation in Italy. RESULTS: Beginning in January 1996, 1893 patients were recruited for the study. There were 1534 women and 359 men with a mean body mass index (BMI) of (range 30.4-83.6) and a mean age of 37.8 +/- 10.9 years (range; 17-74). The mortality rate has been 0.53% (n = 10), mainly due to cardiovascular complications (myocardial infarction, pulmonary embolism). The laparotomic conversion rate has been 3.1% (59/1893) and was higher in superobese patients (BMI>50) than in to morbidly obese patients (BMI <50) (p <0.05). Postoperative complications occurred in 193 patients (10.2%), including tube port failure (n = 79; 40.9%), gastric pouch dilation (GPD) (n = 93; 48.9%), and gastric erosion (n = 21, 10.8%). Most GPD (65.5%) occurred during the first 50 patients treated at each center. The incidence of GPD decreased as the surgeons acquired more experience. Surgery for complications was often performed by laparoscopic access, rarely via laparotomy. No death was recorded as a consequence of surgery to treat complications. Weight loss has been evaluated at the following intervals: 6, 12, 24, 36, 48, 60, and 72 months, with BMI 37.9, 33.7, 34.8, 34.1, 32.7, 34.8, and 32. CONCLUSIONS: The Lap Band system procedure has a very low mortality rate and a low morbidity rate and it yields satisfactory weight loss. Surgery for complications can be performed safely via laparoscopic access.

Sentinel lymph node identification in breast cancer patients.

PURPOSE: To evaluate the predictive value of sentinel lymph node biopsy versus axillary node dissection on lymph node status in patients with T1-T2 breast cancer. MATERIAL AND METHODS: Twenty-nine patients with T1 and 12 with T2 breast carcinoma and clinically N0 axillary lymph nodes, underwent lymphoscintigraphy following the administration of 99mTc-human albumin nanocolloids. The tracer was injected subdermally, over the tumor mass, in the 34 patients with palpable lesions and peritumorally (n=3) or intratumorally (n=4), under stereotactic or ultrasound guidance, in the 7 patients with non-palpable lesions. Anterior and lateral planar images were acquired 15 min after the injection of the tracer and repeated every 30 min up to 3 hr until identification of sentinel lymph node. At the end of the scintigraphic study, sentinel node skin projection was marked using a dermographic pen. Eighteen hours after lymphoscintigraphy, sentinel lymph node was identified and removed during surgery by hand-held gamma probe, then, the remaining axillary lymph nodes were dissected. All surgical specimens underwent histologic examination. Sentinel lymph nodes free of metastasis at histology, underwent additional examination with immunohistochemistry using monoclonal antibodies against cytokeratin and EMA to search for micrometastases. RESULTS: Sentinel lymph node was identified in the 34 patients injected subdermally and in the 3 patients injected peritumorally, while it remained undetected in the 4 patients injected intratumorally except for one case in which it was isolated by radioguided surgery but not scintigraphically. Sentinel nodes resulted free of metastases both at histology and immunohistochemistry in 32 cases and metastatic in 6. In the 32 patients with non-metastatic sentinel lymph nodes the other axillary nodes were also free of metastases. Among the 6 metastatic sentinel lymph nodes, in 3 cases they were the only metastatic nodes of the axilla while in the other 3 cases metastases were spread to other axillary nodes. CONCLUSIONS: In agreement with previous studies, our results showed that sentinel lymph node radioguided biopsy is a simple and reliable method for predicting axillary lymph nodes status and for avoiding axillary dissection in early breast cancer patients with sentinel node free of metastases.

Results of the Italian multicenter study on 239 super-obese patients treated by adjustable gastric banding.

BACKGROUND: Laparoscopic adjustable gastric banding (LAGB) is the most common bariatric operation. This study is a retrospective analysis of the multicenter Italian experience in patients with BMI > 50 over the last 4 years. METHODS: An electronic data sheet made for LAGB-operated patients since January 1996, was mailed and e-mailed to all surgeons involved in this kind of procedure in Italy. Items regarding patients with BMI > 50 were selected. Analysis used Fisher's exact test and logarithmic regression analysis (P < 0.05 significant). Data were expressed as mean +/- SD. RESULTS: 239 patients (13.3%), out of 1,797 Lap-Band operated patients entered the study (179F / 60M), with mean age 37.6 +/- 11.3 years (19-69) and mean BMI 54.6 +/- 4.8 (50.1-83.6). Laparotomic conversion rate was 5.4% (44/239). Postoperative complications occurred in 24 / 239 patients (9.0%). Follow-up was obtained in 218 / 218, 198 / 198, 121 /147, 75 / 93, 30 / 38 LAGB patients at 6,12, 24, 36, and 48 months respectively. At these time periods, mean BMI was 46.7, 43.9, 42.2, 41.9, and 39.3 kg/m2. At the same intervals, mean %EWL was 24.1, 34.1, 38.8, 38.9, and 52.9%. The number of patients with < 25% EWL at 12, 24, 36, and 48 months follow-up were 34, 10, 4, and 0. Serious co-morbidities (189 in 124 of 239, 57%) had completely resolved 1 year postoperatively in 74 / 124 of the patients (59.6%). CONCLUSION: Although super-obese patients following the LAGB remain obese with BMI > 35, in the short-term most lose their co-morbidities, with a very low morbidity and mortality rate.

Laparoscopic Italian experience with the Lap-Band.

BACKGROUND: An increasing number of surgeons with different levels of experience with laparoscopic surgery and open obesity surgery have started to perform laparoscopic implantation of the Lap-Band. METHODS: An electronic patient data sheet was created and was mailed and e-mailed to all surgeons performing laparoscopic adjustable silicone gastric banding (LASGB) in Italy. Patients were recruited since January 1996. Data on 1,265 Lap-Band System operated patients (258 M/1,007 F; mean BMI 44.1, range 27.0-78.1; mean age 38, range 17-74 years) were collected from 23 surgeons performing this operation. RESULTS: Intra-operative mortality was absent. Post-operative mortality was 0.55% (7 patients) for causes not specifically related to LASGB implantation. The laparotomic conversion rate was 1.7% (22 patients). LASGB related complications occurred in 143 patients (11.3%). Pouch dilatation was diagnosed in 65 (5.2%), and 28 (2.2%) of these underwent re-operation. Band erosion was observed in 24 patients (1.9%). Port or connecting tube-port complications occurred in 54 patients (4.2%), 12 of whom required revision under general anesthesia. Follow-up was obtained at 6, 12, 18, 24, 36 and 48 months, and mean BMI was respectively 38.4, 35.1, 33.1, 30.2, 32.1 and 31.5. The percentage of patients observed at each follow-up was > 60%. There was no intra-operative mortality and no complication-related mortality, with acceptable weight loss. CONCLUSION: The LASGB operation is safe and effective, and deserves wider use for treatment of morbid obesity.

Three years experience with the new intragastric balloon, and a preoperative test for success with restrictive surgery.

BACKGROUND: The BioEnterics Intragastric Balloon (BIB) is a smooth, spherical, saline-filled, silicone elastomer with a black radiopaque filling valve, intended to induce weight loss by limiting food consumption. This can be considered a "restrictive" procedure, and by using this balloon, we can assess the patient's eligibility for a restrictive surgical procedure (the BIB-Test). METHODS: From May 1997 to May 2000, 87 BIB were inserted in 77 moderately to severely obese patients (4 BIB in 1 patient, 2 BIB in 7 patients). 64 patients completed the treatment. Out of these, 18 (16 female, 2 male) underwent laparoscopic gastric banding after BIB removal. RESULTS: After the treatment (3-6 months), weight loss results were as follows: WL 14.3 kg, %EWL 23.5 and loss in BMI 5.3. 12 patients after the preliminary BIB, have been followed > or = 6 months after gastric banding, and have significant further weight loss. CONCLUSIONS: BIB appears to have good results. A supervised nutritional and behavioral regimen is mandatory. The balloon may be indicated to: 1) induce weight loss in patients whose obesity is not severe enough to warrant surgery; 2) reduce the surgical risk in those who are massively obese; 3) select patients for gastric restrictive surgery if they lose weight with the balloon. The data showed that patients who had good results with the BIB (positive BIB-Test) are still losing weight after subsequent gastric banding.