BioEnterics Intragastric Balloon (BIB): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients.

BACKGROUND: The BioEnterics Intragastric Balloon (BIB) System in association with restricted diet has been used for the short-term treatment of morbid obesity. Aim of this study was to evaluate the real, short term, efficacy of the BIB for weight reduction in morbidly obese patients by using a prospective, double-blind, randomised, sham-controlled, crossover study. METHODS: Patients were recruited from January 2003 to December 2003. After selection, they were randomly allocated into two groups: BIB followed by sham procedure after 3 months (Group A), and sham procedure followed by BIB after 3 months (Group B). All endoscopic procedures were performed under unconscious intravenous sedation. The BioEnterics Intragastric Balloon (Inamed Health; Santa Barbara, CA, USA) was filled by using saline (500 ml) and methylene blue (10 ml). Patients were discharged with omeprazole therapy and diet (1000 kcal). Patients were followed up weekly by a physician blinded to randomisation. In both groups mortality, complications, BMI, BMI reduction and %EWL were considered. Data were expressed as mean +/- s.d., except as otherwise indicated. Statistical analysis was performed by means of Student's t-test, Fisher's exact test or chi (2) with Yates correction; P < 0.05 was considered significant. RESULTS: A total of 32 patients were selected and entered the study (8M/24F; mean age: 36.2 +/- 5.6 years, range 25-50 years; mean BMI 43.7+/-1.5 kg/m(2), range 40-45 kg/m(2); mean %EW: 43.1 +/- 13.1, range: 35-65). All patients completed the study. Mortality was absent. Complications related to endoscopy, balloon placement and removal were absent. Mean time of BIB positioning was 15 +/- 2 min, range 10-20 min. After the first 3 months of the study, in Group A patients the mean BMI significantly (P < 0.001) lowered from 43.5 +/- 1.1 to 38.0 +/- 2.6 kg/m(2), while in Group B patients the decrease was not significant (from 43.6 +/- 1.8 to 43.1 +/- 2.8 kg/m(2)). The mean %EWL was significantly higher in Group A than in Group B (34.0 +/- 4.8 vs 2.1 +/- 1%; P < 0.001). After crossover, at the end of the following 3 months, the BMI lowered from 38.0 +/- 2.6 to 37.1 +/- 3.4 kg/m(2) and from 43.1 +/- 2.8 to 38.8 +/- 3.1 kg/m(2) in Groups A and B, respectively. CONCLUSIONS: The results of this study show that treatment of obese patients with BioEnterics Intragastric Balloon is a safe and effective procedure. In association with appropriate diet it is significantly effective in weight reduction when compared to sham procedure plus diet. The BIB procedure can play a role in weight reduction in morbidly obese patients or in the preoperative treatment of bariatric patients.

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.

Antral nodularity identifies children infected with Helicobacter pylori with higher grades of gastric inflammation.

BACKGROUND: The endoscopic pattern of antral nodularity is a peculiar finding in children with Helicobacter pylori infection. The aim of this study was to determine whether this finding is related to more severe gastritis. METHODS: One hundred seventy-four consecutive children (median age 8.7 years) referred for gastroscopy were studied. Biopsy specimens from the antrum and body of the stomach were taken to assess H pylori status, gastritis score, and lymphoid follicles. Clinical diagnosis, major symptoms and endoscopic findings were recorded. RESULTS: Eighty-four (48%) children (median age 10.5 years) had evidence of H pylori infection. The endoscopic pattern of antral nodularity was found only in children infected with H pylori (34/84, 40.5% vs. 0/90, 0%, p < 0.0001% 100% specificity, 40.5% sensitivity). Among all children infected with H pylori, the gastritis score was higher (p < 0.0001) in those with antral nodularity (n = 34) than in those without (n = 50). Completely normal gastric mucosal histology was never found in children infected with H pylori with antral nodularity. The presence and number of lymphoid follicles was strongly related to the finding of antral nodularity (p < 0.01). CONCLUSIONS: The endoscopic pattern of antral nodularity identifies children with H pylori infection, severe gastritis, and increased lymphoid follicles.

Testing for serum IgG antibodies to Helicobacter pylori cytotoxin-associated protein detects children with higher grades of gastric inflammation.

BACKGROUND: Little information is available about the relationships between Helicobacter pylori cytotoxin-associated protein (CagA) and clinicopathologic features in children. The purpose of this study was to test whether determining serum IgG antibodies to CagA is a useful tool for detecting more severe disease. METHODS: One hundred twenty-seven consecutive children (age range, 0.75-17.8 years; median, 9.4 years) referred for gastroscopy were included in the study. Antral and corpus biopsies were taken for gastric histology and H. pylori detection. Major symptoms and endoscopic findings were recorded. A serum sample was drawn from each child and assayed for IgG antibodies CagA by a commercial enzyme-linked immunosorbent assay. RESULTS: Sixty-three (50%) children had no evidence of H. pylori infection, 28 (22%) were H. pylori positive/CagA positive, and 36 (28%) were H. pylori positive/CagA negative. There were no differences in clinical diagnosis and occurrence of any predominant symptom according to H. pylori and CagA status. Findings of antral nodularity were more frequent (p = 0.003) in H. pylori-positive/CagA-positive children than in H. pylori-positive/CagA-negative children. The gastritis score was significantly higher in H. pylori-positive/CagA-positive children than in H. pylori-positive/CagA-negative children (5.7 +/- 1.9 vs. 3.8 +/- 1.6, respectively; p = 0.0003), either in the antral (p = 0.0002) or in the corpus (p = 0.001) mucosa. Inflammation (p = 0.0001) and activity (p = 0.0001) scores were both higher in H. pylori-positive/CagA-positive children than in H. pylori-positive/CagA-negative children, but the H. pylori density score was not significantly different (p = NS). In no case was normal gastric mucosa found in H. pylori-positive/ CagA-positive children. Lymphocytic gastritis (p = 0.0008) and lymphoid follicles (p = 0.000003) were a more frequent finding in H. pylori-positive children than in H. pylori negative children, irrespective of CagA status. CONCLUSION: Testing for serum IgG to CagA detects higher grades of gastric inflammation among children with H. pylori infection. It may be useful in targeting H. pylori-positive/ CagA-positive children for antimicrobial therapy while reducing the need for endoscopy and gastric biopsy.

Changes in the mucosal expression of interleukin 15 in Helicobacter pylori-associated gastritis.

Transcripts for interleukin (IL) 15 were detected in the gastric mucosal samples of 5/5 (100%) patients with no evidence of Helicobacter pylori infection and in 4/14 (28%) H. pylori-infected patients (P< 0.05). Both IL-15 mRNA and IL-15 protein were detected in 1/6 (17%) patients who successfully underwent H. pylori eradication therapy, before treatment and in 5/6 (83%) cases after eradication. Even though a parallel significant (P < 0.03) improvement of gastritis score occurred after eradication, the severity of gastritis did not differ according to the mucosal IL-15 expression among H. pylori-infected patients, irrespective of the CagA serology. This study demonstrates, for the first time, that transcripts for IL-15 are expressed in the human gastric mucosa. Changes occurring during H. pylori colonisation and after eradication raise the hypothesis that H. pylori may down-regulate IL-15 expression in the gastric mucosa.

Helicobacter pylori infection in children with celiac disease: prevalence and clinicopathologic features.

BACKGROUND: Celiac disease is frequently associated with chronic gastritis. Helicobacter pylori is the main etiologic agent of chronic gastritis. The aim of this study was to assess the prevalence of H. pylori, the related symptoms, and the endoscopic and histologic gastric features in children with celiac disease. METHODS: Eight-one (24 boys, 57 girls; age range: 1.4-17.7 years, median 6.8) children with celiac disease were studied. All children had a blood sample taken. In a subgroup of 30 children who underwent endoscopy, three gastric biopsy specimens were taken for histology (hematoxylin and eosin, Giemsa, immunohistochemistry) and urease quick test. Symptom complaints were recorded. Age- and sex-matched (one case, one control) children without celiac disease were used for comparison. Serum H. pylori IgG were measured by means of a locally validated commercial enzyme-linked immunoassay. RESULTS: Overall, 15 of 81 (18.5%) children with celiac disease and 14 of 81 (17.3%) control children were positive for H. pylori. The percentage of H. pylori positivity was similar in children with untreated and treated celiac disease. Recurrent abdominal pain was the only symptom that helped to distinguish between H. pylori-positive and H. pylori-negative children. However, symptoms disappeared in patients with celiac disease after gluten withdrawal, irrespective of H. pylori status. All endoscopic (erythema, nodularity) and histologic (superficial-, interstitial-, lymphocytic-gastritis, activity, lymphoid follicles) findings did not differ between celiac and nonceliac H. pylori-positive children. CONCLUSIONS: Prevalence and clinical expressivity of H. pylori infection is not increased in children with celiac disease. The clinicopathologic pattern of the infection is not specifically influenced in this condition.

Clinical and prognostic evaluation of bone marrow infiltration (biopsy versus aspirate) in early chronic lymphocytic leukemia. A single center study.

BACKGROUND AND OBJECTIVE: Recently published studies dealing with chronic lymphocytic leukemia (CLL) patients in early clinical stage reported that bone marrow (BM) biopsies and aspirates can be considered complementary methods of evaluating the extent of BM involvement. Consequently, we designed the present study to investigate the clinical and prognostic implications of BM biopsies and aspirates in a series of stage A CLL patients followed-up in a single center. PATIENTS AND METHODS: BM biopsy sections and aspirate smears obtained at the time of diagnosis from 102 CLL stage A patients were retrospectively evaluated. Results were correlated with clinical and hematological features as well as with survival and disease-progression risk. RESULTS: Diffuse (D) BM histology was detected in 10 patients (9.8%) while 21 (20.5%) displayed lymphocyte infiltration (LI) > 80%. Twenty-six patients (25.4%) died with a 5- and 10-year survival probability of 85% and 50%, respectively. The survival of patients with D-BM histology was significantly shorter than that of patients with non-diffuse (non-D) histology (p < 0.05). Interestingly, when considering only CLL-related deaths (i.e. leukemia progression, infections) were considered, there was an increase in the statistical significance of BM histology (p = 0.01). There was no difference in life expectancy in cases with LI either using different cut-off levels (i.e. 70% and 80%) or excluding non-CLL related deaths. According to our experience, disease progression could only be predicted by BM histology (p = 0.008), while LI was not useful for forecasting progression to more advanced stages (p = NS). INTERPRETATION AND CONCLUSIONS: In patients with early CLL, BM histology provides more reliable information regarding the clinical outcome of the disease than LI.

[Cytopathology in the diagnosis of benign breast lesions]. / La citopatologia nella diagnostica delle lesioni mammarie benigne.

In this review dealing with cytologic features of non-malignant diseases of the breast, authors try to correlate cytopathologic findings with clinical condition. Five different clinical presentations are recognized: cystic nodule, solid nodule, not palpable lesions, spontaneous secretion, mastitis. An overview of literature data is provided by authors who emphasize either reliability or specificity of cytopathological methodologies. Furthermore, they conclude that along with clinico-radiologic diagnostic procedures, cytology represents a mainstay for prognostic assessment and presurgical evaluation of breast lesions.