Laparoscopic right hemicolectomy: a SICE (Società Italiana di Chirurgia Endoscopica e Nuove tecnologie) network prospective study on the approach to right colon lymphadenectomy in Italy: is there a standard?-CoDIG 2 (ColonDx Italian Group).

BACKGROUND: Colon cancer is a disease with a worldwide spread. Surgery is the best option for the treatment of advanced colon cancer, but some aspects are still debated, such as the extent of lymphadenectomy. In Japanese guidelines, the gold standard was D3 dissection to remove the central lymph nodes (203, 213, and 223), but in 2009, Hoenberger et al. introduced the concept of complete mesocolic excision, in which surgical dissection follows the embryological planes to remove the mesentery entirely to prevent leakage of cancer cells and collect more lymph nodes. Our study describes how lymphadenectomy is currently performed in major Italian centers with an unclear indication on the type of lymphadenectomy that should be performed during right hemicolectomy (RH). METHODS: CoDIG 2 is an observational multicenter national study that involves 76 Italian general surgery wards highly specialized in colorectal surgery. Each center was asked not to modify their usual surgical and clinical practices. The aim of the study was to assess the preference of Italian surgeons on the type of lymphadenectomy to perform during RH and the rise of any new trends or modifications in habits compared to the findings of the CoDIG 1 study conducted 4 years ago. RESULTS: A total of 788 patients were enrolled. The most commonly used surgical technique was laparoscopic (82.1%) with intracorporeal (73.4%), side-to-side (98.7%), or isoperistaltic (96.0%) anastomosis. The lymph nodes at the origin of the vessels were harvested in an inferior number of cases (203, 213, and 223: 42.4%, 31.1%, and 20.3%, respectively). A comparison between CoDIG 1 and CoDIG 2 showed a stable trend in surgical techniques and complications, with an increase in the robotic approach (7.7% vs. 12.3%). CONCLUSIONS: This analysis shows how lymphadenectomy is performed in Italy to achieve oncological outcomes in RH, although the technique to achieve a higher lymph node count has not yet been standardized. Trial registration (ClinicalTrials.gov) ID: NCT05943951.

European Association for Endoscopic Surgery (EAES) consensus on Indocyanine Green (ICG) fluorescence-guided surgery.

BACKGROUND: In recent years, the use of Indocyanine Green (ICG) fluorescence-guided surgery during open and laparoscopic procedures has exponentially expanded across various clinical settings. The European Association of Endoscopic Surgery (EAES) initiated a consensus development conference on this topic with the aim of creating evidence-based statements and recommendations for the surgical community. METHODS: An expert panel of surgeons has been selected and invited to participate to this project. Systematic reviews of the PubMed, Embase and Cochrane libraries were performed to identify evidence on potential benefits of ICG fluorescence-guided surgery on clinical practice and patient outcomes. Statements and recommendations were prepared and unanimously agreed by the panel; they were then submitted to all EAES members through a two-rounds online survey and results presented at the EAES annual congress, Barcelona, November 2021. RESULTS: A total of 18,273 abstracts were screened with 117 articles included. 22 statements and 16 recommendations were generated and approved. In some areas, such as the use of ICG fluorescence-guided surgery during laparoscopic cholecystectomy, the perfusion assessment in colorectal surgery and the search for the sentinel lymph nodes in gynaecological malignancies, the large number of evidences in literature has allowed us to strongly recommend the use of ICG for a better anatomical definition and a reduction in post-operative complications. CONCLUSIONS: Overall, from the systematic literature review performed by the experts panel and the survey extended to all EAES members, ICG fluorescence-guided surgery could be considered a safe and effective technology. Future robust clinical research is required to specifically validate multiple organ-specific applications and the potential benefits of this technique on clinical outcomes.

Could fluorescence-guided surgery be an efficient and sustainable option? A SICE (Italian Society of Endoscopic Surgery) health technology assessment summary.

BACKGROUND: Indocyanine green fluorescence vision is an upcoming technology in surgery. It can be used in three ways: angiographic and biliary tree visualization and lymphatic spreading studies. The present paper shows the most outstanding results from an health technology assessment study design, conducted on fluorescence-guided compared with standard vision surgery. METHODS: A health technology assessment approach was implemented to investigate the economic, social, ethical, and organizational implications related to the adoption of the innovative fluorescence-guided view, with a focus on minimally invasive approach. With the support of a multidisciplinary team, qualitative and quantitative data were collected, by means of literature evidence, validated questionnaires and self-reported interviews, considering the dimensions resulting from the EUnetHTA Core Model. RESULTS: From a systematic search of literature, we retrieved the following studies: 6 on hepatic, 1 on pancreatic, 4 on biliary, 2 on bariatric, 4 on endocrine, 2 on thoracic, 11 on colorectal, 7 on urology, 11 on gynecology, 2 on gastric surgery. Fluorescence guide has shown advantages on the length of hospitalization particularly in colorectal surgery, with a reduction of the rate of leakages and re-do anastomoses, in spite of a slight increase in operating time, and is confirmed to be a safe, efficacious, and sustainable vision technology. Clinical applications are still presenting a low evidence in the literature. CONCLUSION: The present paper, under the patronage of Italian Society of Endoscopic Surgery, based on an HTA approach, sustains the use of fluorescence-guided vision in minimally invasive surgery, in the fields of general, gynecologic, urologic, and thoracic surgery, as an efficient and economically sustainable technology.

Stemness and osteogenic and adipogenic potential are differently impaired in subcutaneous and visceral adipose derived stem cells (ASCs) isolated from obese donors.

Today adipose tissue is not just considered as the primary energy storage organ, but it is also recognized as an important endocrine tissue and an abundant source of mesenchymal stem cells (adipose-derived stem cells, ASCs). During the last decade, several studies have provided preclinical data on the safety and efficacy of ASCs, supporting their use in cell-based therapy for regenerative medicine purposes. Little is known about the effect of obesity on ASCs properties. Since ASCs differentiation and proliferation are determined by their niche, the differences in body fat distribution and the obesity-related co-morbidities may have several consequences. In this study we compared ASCs of subcutaneous adipose tissue from obese (obS-ASCs) and non-obese (nS-ASCs) donors in order to compare their immunophenotype and osteogenic and adipogenic potential. Moreover, in order to evaluate the possible difference between subcutaneous and visceral fat, obS-ASCs were also compared to ASCs derived from visceral adipose tissue of the same obese donors (obV-ASCs). Our results show that subcutaneous and visceral ASCs derived from obese donors have an impaired cell proliferation, clonogenic ability and immunophenotype. Nevertheless, obS-ASCs are able to differentiate toward osteogenic and adipogenic lineages, although to a small extent with respect to non-obese donors, whereas obV-ASCs lose most of their stem cell characteristics, including multi-differentiation potential. Taken together our findings confirm that not all ASCs present the same behavior, most likely due to their biological microenvironment in vivo. The specific stimuli which can play a key role in ASCs impairment, including the effects of the obesity-related inflammation, should be further investigated to have a complete picture of the phenomenon.

Laparoscopic incisional hernia repair by lightweight polypropylene mesh with resorbable coating. Technical notes, preliminary results.

Laparoscopic repair of ventral hernias has gained popularity, since many studies have reported encouraging results. The choice of the mesh and fixation methods are crucial issues in preventing complications and recurrence. 30 laparoscopic ventral hernia repair performed consecutively in 28 patients (11 males, 17 females) for different kinds of incisional hernias from February 2011 to June 2012 were prospectively evaluated. All patients received total laparoscopic incisional hernia repair by the use of the new lightweight polypropylene mesh with resorbable coating (PhysiomeshTM, Ethicon Endo-Surgery, Johnson Johnson, Inc.). No major postoperative complications were reported. Two recurrences were diagnosed after 5 months from the first repair. Both patients received laparoscopic repair by the same kind of mesh. Lightweight polypropylene mesh with resorbable coating, with its properties of easy positioning and bio-compatibility, represents an innovation in laparoscopic incisional hernia repair, and should be considered for clinical intra-operative as well as long term evaluations.

Feasibility of capsule endoscopy in elderly patients with obscure gastrointestinal bleeding. An up-to-date report.

BACKGROUND: Anemia is the most common hematologic abnormality in older populations. Furthermore, iron deficiency anemia is common and merits investigation and treatment, as it usually results from chronic occult bleeding from the gastrointestinal tract. In view of a wide use of capsule endoscopy as a diagnostic procedure for occult gastrointestinal bleeding and of the growth of aging population, we performed a literature review about the feasibility of capsule endoscopy in the elderly. METHODS: We conducted a literature search in the PubMed database in July 2012, and all English-language publications on capsule endoscopy in elderly patients since 2005 were retrieved. The potential original articles mainly focused on obscure gastrointestinal bleeding were all identified and full texts were obtained and reviewed for further hand data retrieving. RESULTS: We retrieved only six papers based on different primary end-points. Four were retrospective non randomized studies and two were prospective non randomized studies. In the end 65, 70, 80 and 85 years were used as an age cut-off. All studies evaluate the diagnostic yield of capsule endoscopy in iron deficiency anemia. Only three studies assess the feasibility of capsule examination of the elderly. CONCLUSIONS: Iron deficiency anemia in the elderly with or without obscure gastrointestinal bleeding is the major indication for capsule endoscopy after a negative esophago-gastro-duodenoscopy and colonoscopy. It is safe and effective to identify a small bowel pathology without a great discomfort for the elderly. Inability to swallow the capsule, battery failure before capsule reaches the cecum, and capsule retention are some of the important problems associated with capsule endoscopy in elderly as well as in younger patients.

Bariatric emergencies: what the general surgeon should know.

BACKGROUND: bariatric surgery presented a dramatic increase due to the obesity epidemics and the laparoscopic approach. General surgeons might face acute or chronic complications of bariatric surgery, considering the increasing figures of obesity procedures performed every year in USA, as well as in Europe. AIM: to present the possible surgical emergencies after bariatric surgery. METHODS: laparoscopic adjustable gastric banding is the most widely performed bariatric procedure in Europe. Acute anterior/posterior slippage of the gastric wall is the most frequent complication, and needs emergency treatment: band's deflation, laparoscopy for repositioning/removal. Intragastric band migration is diagnosed at the radiological or endoscopic controls and usually does not represent a surgical emergency. Anastomotic marginal ulcer may appear after gastric bypass GBP or biliopancreatic diversion BPD (with/without duodenal switch DS), and can be complicated by bleeding or rarely by perforation. Small bowel obstruction due to internal hernia after GBP or BPD represents major emergency that can be caused as well by trocar site hernia, intussusceptions, adhesions, strictures, kinking or blood clots. Correct diagnosis and immediate treatment are mandatory. Rapid weight loss after bariatric surgery can cause gallbladder diseases and choledocholitiasis that can be difficult to treat after gastric bypass procedures. CONCLUSIONS: General surgeon has to know the most diffuse bariatric procedures and their complications and to treat them as other gastrointestinal surgical procedures. Minimally-invasive approach should be considered in most of the cases, but the approach depends on the general surgeon's experience.

Weight Regain and Diabetes Evolution After Sleeve Gastrectomy: a Cohort Study with over 5 Years of Follow-Up.

BACKGROUND: A number of meta-analyses have demonstrated the effectiveness of bariatric surgery in improving morbid obesity and its associated co-morbidities. The aim of the study was to evaluate at long term a cohort of obese patients with type 2 diabetes (T2DM) submitted to laparoscopic sleeve gastrectomy (LSG) analyzing the incidence of weight regain (WR) and the impact of the WR on T2DM evolution. METHODS: Seventy-eight morbid obese patients (54 females) with T2DM, aged 49.6 ± 8.7 years, weight 121.1 ± 24.4 kg, BMI 44.1 ± 7.2 kg/m2, underwent primary LSG. The trend over time of T2DM after LSG was analyzed in the different groups, subdivided on the basis of the absence or presence of WR and of its different degrees: no regain (NR), mild regain (MR), and severe regain (SR) groups. RESULTS: In the NR group, 54% show complete remission, 46% persistence, and no case of diabetes relapse; in the MR group, 59% show complete remission, 36% persistence, and 5% relapse; in the SR group, 61% show complete remission, 22% persistence, and 17% relapse. A statistically significant difference concerns the preoperative values of fasting glucose, glycosylated hemoglobin, and duration of diabetes, major in the group with diabetes relapse (respectively, p = 0.002, p = 0.001, and p < 0.0001). CONCLUSIONS: The results of this study showed no significant difference regarding the trend of diabetes remission comparing the "no regain," "mild regain," and "severe regain" groups and confirmed the importance of the duration of the illness and an early intervention towards surgical therapy.

Alexithymia and obesity: controversial findings from a multimethod assessment.

OBJECTIVE: The aim of the study is to assess alexithymia levels in obese patients using a multimethod measurement (TAS-20 and TSIA) to evaluate both possible differences between the two instruments and their relationship with body weight. PATIENTS AND METHODS: 54 obese patients, seeking surgical treatment, were enrolled. They completed a socio-demographic questionnaire, 20-items Toronto Alexithymia Scale and the Toronto Structured Interview for Alexithymia. RESULTS: Data analysis showed a significant positive association between TAS-20 and TSIA total scores (r=.28, p<.05), but only the TSIA score was positively related to body weight (r=.39; p<.001). Multivariable linear regression models showed the predictive effects of TSIA total score (beta=.41; p<.001) and difficulty in identifying feelings (DIF) (beta=.56; p<.001) respectively on weight. CONCLUSIONS: The findings showed a different association between body weight and alexithymia according to the instrument employed to evaluate alexithymia, supporting the importance of a multimethod assessment in some clinical conditions.

Two-stage laparoscopic biliopancreatic diversion with duodenal switch as treatment of high-risk super-obese patients: analysis of complications.

INTRODUCTION: The aim of this study is to retrospectively analyze the incidence of complications after two-stage laparoscopic biliopancreatic diversion with duodenal switch (Lap BPD-DS) in high-risk super-obese patients and explore the possible predictive factors of specific complications after laparoscopic sleeve gastrectomy (SG). METHODS: High-risk patients--body mass index (BMI) > 50 kg/m(2) with at least two major comorbidities: type 2 diabetes, obstructive sleep apnea syndrome (OSAS), hypertension--undergoing two-stage laparoscopic BPD-DS were retrospectively analysed. The SG pouch volume was 100-150 ml; in the second stage, the common channel and the alimentary loop were 100 cm and 150 cm, respectively. RESULTS: Eighty-seven patients (50 female, 57.5%) underwent SG (two open). The mean age was 41.8 +/- 10.22 years with BMI of 55.2 +/- 6.69 kg/m(2). Four patients had Prader-Willy syndrome. Fourteen (16.46%) patients (6 female, 42.8%) had postoperative complications such as bleeding, fistula, pulmonary embolism, transitory acute renal failure, and abdominal abscess. One patient died at postoperative day 5 of pulmonary embolism. One patient was reoperated for hemoperitoneum by laparoscopy. The risk of complications after SG was lower in patients where reinforcement of the suture line was used (0.492), while it was higher in men (1.780). Neither difference was statistically significant [p = not significant (NS)]. After 9-24 months, 27 patients (BMI 43 +/- 8 kg/m(2)) underwent a second stage of BPD-DS (two open). Major postoperative complications were registered in eight patients (29.6%): three bleeding, four duodeno-ileal stenosis and one rhabdomyolysis. Two cases of internal hernia required laparoscopic reoperation. The reoperation rate was 1/85 (1.2%) after SG and 2/27 (7.4%) after second stage. CONCLUSIONS: Complications after SG greatly decrease after the learning curve period and can be successfully managed without need of reoperation. Suture-line reinforcement, at least selectively in the middle-upper portion of the staple line and in super-super-obese patients, is recommended to decrease the incidence of specific complications.

Laparoscopic splenectomy: the clinical practice guidelines of the European Association for Endoscopic Surgery (EAES).

BACKGROUND: Although laparoscopic splenectomy (LS) has become the standard approach for most splenectomy cases, some areas still remain controversial. To date, the indications that preclude laparoscopic splenectomy are not clearly defined. In view of this, the European Association for Endoscopic Surgery (EAES) has developed clinical practice guidelines for LS. METHODS: An international expert panel was invited to appraise the current literature and to develop evidence-based recommendations. A consensus development conference using a nominal group process convened in May 2007. Its recommendations were presented at the annual EAES congress in Athens, Greece, on 5 July 2007 for discussion and further input. After a further Delphi process between the experts, the final recommendations were agreed upon. RESULTS: Laparoscopic splenectomy is indicated for most benign and malignant hematologic diseases independently of the patient's age and body weight. Preoperative investigation is recommended for obtaining information on spleen size and volume as well as the presence of accessory splenic tissue. Preoperative vaccination against meningococcal, pneumococcal, and Haemophilus influenzae type B infections is recommended in elective cases. Perioperative anticoagulant prophylaxis with subcutaneous heparin should be administered to all patients and prolonged anticoagulant prophylaxis to high-risk patients. The choice of approach (supine [anterior], semilateral or lateral) is left to the surgeon's preference and concomitant conditions. In cases of massive splenomegaly, the hand-assisted technique should be considered to avoid conversion to open surgery and to reduce complication rates. The expert panel still considered portal hypertension and major medical comorbidities as contraindications to LS. CONCLUSION: Despite a lack of level 1 evidence, LS is a safe and advantageous procedure in experienced hands that has displaced open surgery for almost all indications. To support the clinical evidence, further randomized controlled trials on different issues are mandatory.

Re-sleeve Gastrectomy 4 Years Later: Is It Still an Effective Revisional Option?

Laparoscopic sleeve gastrectomy (LSG) is the most performed surgical procedure worldwide. Long-term outcomes report that up to 30% of patients require revisional surgery and re-sleeve gastrectomy (rLSG) is one of the revisional procedures available. The aim was to update the outcomes of a cohort of rLSG at 52 months. This study reports the 52-month follow-up of a cohort of 19 patients previously published after 24-month follow-up. Sixteen patients completed the follow-up. Nine patients complained of GERD symptoms after 36 months. Five patients were converted to laparoscopic RYGB. Two patients were converted to a laparoscopic BPD-DS for weight regain 4 patients are asymptomatic with stable weight. On the basis of our disappointing results, it can be said that rLSG is not currently offered as revisional procedure in both centers.

Clinical evaluation of fibrin glue in the prevention of anastomotic leak and internal hernia after laparoscopic gastric bypass: preliminary results of a prospective, randomized multicenter trial.

BACKGROUND: Gastro-jejunal anastomotic leak and internal hernia can be life-threatening complications of laparoscopic Roux-en-Y gastric bypass (LRYGBP), ranging from 0.1-4.3% and from 0.8-4.5% respectively. The safety and efficacy of a fibrin glue (Tissucol) was assessed when placed around the anastomoses and over the mesenteric openings for prevention of anastomotic leaks and internal hernias after LRYGBP. METHODS: A prospective, randomized, multicenter, clinical trial commenced in January 2004. Patients with BMI 40-59 kg/m2, aged 21-60 years, undergoing LRYGBP, were randomized into: 1) study group (fibrin glue applied on the gastro-jejunal and jejuno-jejunal anastomoses and the mesenteric openings); 2) control group (no fibrin glue, but suture of the mesenteric openings). 322 patients, 161 for each arm, will be enrolled for an estimated period of 24 months. Sex, age, operative time, time to postoperative oral diet and hospital stay, early and late complications rates are evaluated. An interim evaluation was conducted after 15 months. RESULTS: To April 2005, 204 patients were randomized: 111 in the control group (mean age 39.0+/-11.6 years, BMI 46.4 +/- 8.2) and 93 in the fibrin glue group (mean age 42.9+/-11.7 years, BMI 46.9+/-6.4). There was no mortality or conversion in both groups; no differences in operative time and postoperative hospital stay were recorded. Time to postoperative oral diet was shorter for the fibrin glue group (P = 0.0044). Neither leaks nor internal hernias have occurred in the fibrin glue group. The incidence of leaks (2 cases, 1.8%) and the overall reoperation rate were higher in the control group (P=0.0165). CONCLUSION: The preliminary results suggest that Tissucol application has no adverse effects, is not time-consuming, and may be effective in preventing leaks and internal hernias in morbidly obese patients undergoing LRYGBP.

Laparoscopic splenectomy for non-traumatic diseases.

At present, laparoscopic splenectomy (LS) is mostly indicated in hematologic benign diseases, and in case of normal size spleen it is considered the gold standard. The technique is under a continuous evolution and several studies have demonstrated feasibility and safety of laparoscopic approach also in case of massive splenomegaly, malignant diseases and even in the treatment of selected cases traumatic lesions. LS is an advanced surgical procedure that requires a management of a full trained team involved in the preoperative preparation, surgical strategy and postoperative care. A fully comprehension of the impact of the surgical strategy is needed to plan the treatment of diseases that often are managed in a multidisciplinary setting. Indications and contraindications to surgery does not differ significantly from open traditional splenectomy, but the nature of the disease and the volume of the spleen can greatly influence the operation. A preoperative study with definition of these parameters along with a standard preparation to surgery is required. Over the years the technique has been developed and adapted to respond to emergent necessities related to those parameters. Anterior, semilateral, later and hand assisted approaches offer advantages and drawbacks that should be weighed in each case. They depend on surgeons preferences but most of the time are related to the preoperative studies, even when new surgical tools (i.e. harmonic scalpel and radiofrequency). No randomized, prospective trials have been conducted, however several studies with strong evidence have shown that less surgical trauma, intraoperative blood loss, early hospital discharge, rapid return to normal activities and better cosmesis can be obtained with a laparoscopic approach.

Is type 2 diabetes really resolved after laparoscopic sleeve gastrectomy? Glucose variability studied by continuous glucose monitoring.

The study was carried out on type 2 diabetic obese patients who underwent laparoscopic sleeve gastrectomy (LSG). Patients underwent regular glycemic controls throughout 3 years and all patients were defined cured from diabetes according to conventional criteria defined as normalization of fasting glucose levels and glycated hemoglobin in absence of antidiabetic therapy. After 3 years of follow-up, Continuous Glucose Monitoring (CGM) was performed in each patient to better clarify the remission of diabetes. In this study, we found that the diabetes resolution after LSG occurred in 40% of patients; in the other 60%, even if they showed a normal fasting glycemia and A1c, patients spent a lot of time in hyperglycemia. During the oral glucose tolerance test (OGTT), we found that 2 h postload glucose determinations revealed overt diabetes only in a small group of patients and might be insufficient to exclude the diagnosis of diabetes in the other patients who spent a lot of time in hyperglycemia, even if they showed a normal glycemia (<140 mg/dL) at 120 minutes OGTT. These interesting data could help clinicians to better individualize patients in which diabetes is not resolved and who could need more attention in order to prevent chronic complications of diabetes.

A phase I trial of 5-day chronomodulated infusion of 5-fluorouracil and 1-folinic acid in patients with metastatic colorectal cancer.

The aim of this phase I study was to establish the maximum tolerated dose (MTD) of 5-fluorouracil (5-FU), administered as a 5-day chronomodulated infusion in combination with 1-folinic acid (FA) to ambulatory metastatic colorectal cancer patients. Consecutive cohorts of 6 patients were given 5-FU and FA infusions from 10.00 p.m. to 10.00 a.m. with peak delivery at 4.00 a.m. by means of a multichannel programmable pump. The FA dose was always the same (150 mg/m2/d). For the first cohort, the 5-FU dose level was 600 mg/m2/d at the first course, escalated by 100 mg/m2 for each subsequent cohort. Intrapatient dose was also escalated by 100 mg/m2 if toxicity was less than grade 2. The courses were repeated every 3 weeks. Thirty-four patients (17 previously treated) received a total of 154 courses. Dose-limiting toxicity consisted of stomatitis and diarrhoea. No significant haematological, cutaneous or cardiac toxicity was encountered. The MTD of 5-FU was reached at the fourth level (first course at 900 mg/m2/d equal to 4500 mg/m2/course) with 5-FU increased to 1100 mg/m2/d (5500 mg/m2/course) in 4 patients. The received 5-FU dose intensity (DI) over the first 3 courses at this level was 1318 mg/m2/week. Thirty-three patients were assessed for response. An objective response was achieved in 1 out of the 13 previously-treated and in 8 out of the 20 previously-untreated patients. The chronomodulated infusion of 5-FU at a dose of 900 mg/m2/d, together with FA at 150 mg/m2/d for 5 days, was safely delivered to out-patients with metastatic colorectal cancer. The low toxic profile and activity of this regimen in previously untreated patients deserves further exploration for the treatment of 5-FU-sensitive tumours.

Sequential evaluation of gastric intraluminal prostaglandin E2 release, acid secretion and DNA-flow cytometry in N-methyl-N-nitro-N-nitrosoguanidine gastric carcinogenesis in the rat.

The study was initiated to evaluate the sequential changes of gastric intraluminal prostaglandin E2 (PGE2), gastric acid secretion and of the DNA-flowcytometric patterns during gastric carcinogenesis induced by 45-week N-methyl-N-nitro-N-nitrosoguanidine (NG) administration in the rat. Twenty male chronic gastric fistula Sprague-Dawley rats received NG solution (120 mg/l) for 45 weeks and 20 were used as controls. Samples of gastric juice (1 h) were obtained from all animals under basal conditions and every 5 weeks until the end of the experiment. Aliquots of gastric juice were titrated with 0.1 N NaOH. Other aliquots were extracted with ethylacetate and processed for specific PGE2 RIA. On the day following gastric juice collection a gastric lavage and gastric biopsies (n = 4) were obtained through the fistula and processed for flowcytometry. All surviving animals were killed after 45 weeks and histology was obtained. The incidence of cancer in NG treated chronic gastric fistula rats was 66%. Flowcytometry segregated at an early stage (30-35 weeks) those animals which were to develop gastric carcinoma from those which were not. Administration of NG decreased gastric secretion volume, acid and intraluminal PGE2 concentration both in animals developing and not developing cancer. During the last 10 weeks a sharp rise in gastric intraluminal PGE2 concentration was observed in tumor-bearing animals only probably due to production by tumor cells. Prostaglandin deficiency may contribute to the NG-induced mucosal damage and may be involved in gastric carcinogenesis.

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.

Role of prostaglandins in the early phases of experimental gastric carcinogenesis in the rat.

The study was initiated to evaluate the effect of N-methyl-N-nitro-N-nitrosoguanidine (NG) on gastric intraluminal prostaglandin release during a 30-day treatment period and to investigate the effect of a stable prostaglandin E1 analogue (misoprostol) on NG-induced gastric mucosal damage during the same time period. Samples of gastric juice (1 h) were obtained from 40 male Sprague-Dawley rats with chronic gastric fistulas, in basal conditions and after 5, 15 and 30 days of continuous oral administration of NG (120 mg/l) or tap water. Aliquots of gastric juice were titrated with 0.1 M NaOH. Other aliquots were extracted with ethyl acetate and subjected to specific radioimmunoassay for prostaglandin E2. The severity of gastric mucosal lesions was evaluated in 60 rats after 5 days and 30 days of continuous oral administration of NG (120 mg/l) or NG plus misoprostol (200 micrograms/kg-1/day-1) or tap water, and a histological study was carried out. Administration of NG induced a significant decrease of gastric intraluminal prostaglandin E2 concentration at 15 and 30 days. Oral administration of misoprostol, at non-antisecretory doses, protected the rats against NG-induced gastric mucosal damage. Prostaglandins may be involved in the early phases of experimental gastric carcinogenesis.

Time-related interference of misoprostol with experimental gastric cancer formation induced by N-methyl-N'-nitro-N-nitrosoguanidine in the rat.

The purpose of this study was to investigate the effect of long-term misoprostol administration, at non-antisecretory doses, on N-methyl-N'-nitro-N-nitrosoguanidine(MNNG)-induced gastric carcinogenesis. The incidence of gastric carcinomas and precancerous lesions was evaluated in 50 male 250-g Sprague-Dawley rats after 52 weeks of continuous oral administration of MNNG (120 mg/l; n = 20), MNNG plus misoprostol (2 mg kg-1 day-1; n = 20) or tap water (n = 10) (experiment 1), and in 30 rats treated with MNNG for 30 weeks followed by tap water (n = 15) or by misoprostol (n = 15) for 22 weeks; a third group (n = 10) received tap water only for 52 weeks (experiment 2). After sacrifice, gastric mucosal lesions were macroscopically evaluated and their histology obtained. MNNG consumption was comparable in all groups (6.5 +/- 1.1 mg rat-1 day-1). Misoprostol consumption was 180 +/- 0.25 mg kg-1 day-1 rat-1. In experiment 1 the incidence of gastric carcinomas was 60% in the MNNG group and 25% in the group treated with MNNG plus misoprostol (P less than 0.05). Cytotoxic and hyperplastic gastric mucosal lesions were also significantly reduced by misoprostol. In experiment 2 the incidence of carcinomas was 31% and 38.6% respectively. Misoprostol significantly decreased the incidence of gastric cancer formation when given from the beginning of the experiment. By contrast, when administered after 30 weeks of MNNG treatment it did not interfere with experimental gastric cancer formation. Exogenous prostaglandins are able to prevent the early MNNG-induced gastric mucosal lesions, thus interfering with gastric carcinogenesis.