Intragastric balloon for obesity treatment: results of a multicentric evaluation for balloons left in place for more than 6 months.

BACKGROUND: Obesity is a major risk factor for several chronic diseases. The BioEnterics(®) Intragastric Balloon (BIB(®)) is used worldwide as a short-term (6 months) treatment in morbid obese patients. However, removal of BIB(®) past 6 months is a common occurrence in clinical practice often as a result of patient factors. The aim of the present Italian multicentre cohort study was to evaluate the safety and efficacy of the BIB(®) left in situ for more than 6 months. MATERIALS AND METHODS: A total of eight Italian centres participated in the study. Participating centres received a standardised questionnaire designed to capture safety and efficacy data. Weight loss data, as well as date, and reason for removal of the BIB(®) after 6 months were recorded. Adverse events, including mortality and complications, operators' subjective technical notes and findings, and difficulties during removal procedure were also collected. RESULTS: Six hundred and eleven patients were included. In the majority of cases, patient extended BIB(®) treatment due to satisfactory weight loss (44 %). At 6 months, all patients achieved a BMI statistically lower than the initial BMI (p < 0.001). There was a non-significant trend towards greater BMIL % in patients who underwent removal up to 15 months versus the results achieved up to 6 months. No major complications were recorded. CONCLUSION: Extending the duration of BIB(®) use up to 14 months safely maintains weight loss and satiety with greater results than that up to 6 months, without complications.

Tips to facilitate a preoperative diagnosis of adrenal ganglioneuroma. Report of a challenging experience and review of the literature.

AIM: Ganglioneuroma (GN) is the most uncommon and the most benign tumor among neuroblastic neoplasms, and in 29.7% of cases it finds in an adrenal gland. Usually asymptomatic, this tumor is detected incidentally in the majority of cases. It is generally challenging to obtain a precise diagnosis of adrenal ganglioneuroma (AGN) before surgery. Misdiagnosis rate of AGN on CT and MRI is 64.7% and clinicians and surgeons are often lacking in knowledge of this rare disease. For this reason, we pointed out the clinical, biochemical, radiologic and pathologic features of AGN in an our experience, with the aim to find out if there are some features able to facilitate a preoperative diagnosis. The present article also includes a review of the relevant literature in order to compare laparoscopic versus open adrenalectomy. CASE REPORT: Right AGN in a 42-year-old woman, in whom preoperative diagnosis was very difficult and only histopathological studies of the surgical specimen established the exact diagnosis. The patient underwent bilateral subcostal laparotomy for a large mass (sized measuring 14.5 x 11.6 x 6.5 cm.) and a right adrenalectomy was performed. Postoperative recovery was uneventful and the patient, at 12-months follow-up, is disease-free and in good health. DISCUSSION / CONCLUSIONS: Authors stress the importance of interdisciplinary collaboration between surgeons, radiologists and endocrinologists to optimize clinical management and surgical indications. Careful evaluation by endocrine examinations and multiple imaging procedures are necessary to provide a differential diagnosis. Surgeons should consider a diagnosis of AGN in case of: 1) an adrenal incidentaloma; 2) a nonfunctioning tumor with no elevated hormonal secretions, in which compressive symptoms may occur; 3) a homogeneous, encapsulated mass, with well-defined edges, without invasion of nearby structures (no vascular involvement), with presence of calcifications and nonenhanced attenuation of <40 HU on CT; 4) a homogeneous hypointense adrenal mass on T1-weighted MRI, a heterogeneous hyperintense mass on T2-weighted MRI and a poor delayed enhancement on dynamic MRI; a SUV level on PET less than 3.0. Nevertheless, diagnosis of AGN can be extremely challenging and can only be achieved by means of histology. Treatment is complete surgical resection without the need for chemotherapy or radiotherapy. Laparoscopic adrenalectomy is contraindicated in the presence of local infiltration or tumor greater than 12 cm. Even if AGN has an excellent prognosis and recurrences are rare after surgical resections, long-term follow-up is recommended. KEY WORDS: Adrenal gland, Adrenal ganglioneuroma, Laparoscopic adrenalectomy, Open adrenalectomy.

Adjustable intragastric balloon vs non-adjustable intragastric balloon: case-control study on complications, tolerance, and efficacy.

BACKGROUND: The objective of this study is the comparison of a new intragastric balloon recently introduced, the Adjustable Balloon System (ABS), with the BioEnterics intragastric balloon (BIB) in terms of tolerance, safety, and weight loss parameters. METHODS: A case-control study was done: 40 patients were matched with 80 controls. To achieve the same duration therapy (12 months), a single ABS positioning was compared with a BIB followed by another BIB (6 + 6 months). Length of procedure, hospital stay, complications, and weight loss parameters after 6 months (time of first BIB removal) and after 12 months from baseline (time of Spatz and second BIB removal) were considered. Statistical analysis was done by means of Student's t test, χ2 test, or Fisher's test. P < 0.05 was considered significant. RESULTS: Mortality, positioning, and extraction complications were absent. Both the devices were well tolerated with slight duration of post placement symptoms. During this study, the Spatz balloon was adjusted with inflation of 200 cm(3) of saline (total, 800 cm(3)) in 9/40 (22.5 %) patients, for poor weight loss after first 6-months treatment. In the Spatz group, there occurred 7/40 complications linked to the device and in 6/7 patients the balloon was removed. At the end of the study, the weight loss parameters were similar between groups: BMI 31.0 ± 11.8 (Spatz group) vs 31.3 ± 12.3 (BIB group) (p = Ns). CONCLUSIONS: The idea of dynamic balloon therapy needs to be confirmed with wider series. The rate of complication reported is very high, and several studies regarding safety and efficacy are needed.

Effect of consecutive intragastric balloon (BIB®) plus diet versus single BIB® plus diet on eating disorders not otherwise specified (EDNOS) in obese patients.

BACKGROUND: Eating disorders are a group of conditions characterised by abnormal eating habits. Greater than 50 % of patients with eating disorders have an 'eating disorder not otherwise specified' (EDNOS). No specific tools exist to evaluate EDNOS, and patients are identified only with a diagnosis of exclusion from the other eating disorders. The BioEnterics® Intragastric Balloon (BIB®) is used worldwide as a short-term treatment option in obese patients. A new frequency score was used to evaluate the influence of double consecutive BIB® treatment compared with single BIB® treatment followed by diet on four categories of EDNOS (grazing, emotional eating, sweet-eating and after-dinner grazing). METHODS: A prospective study allocated 50 obese patients (age range 25-35, BMI range 40.0-44.9) into two groups: BIB® (6 months) followed by diet therapy (7 months; group A (N = 25)) and BIB® placement for 6 months followed by another BIB® for 6 months, with a 1-month interval between placement (group B (N = 25)). Baseline demographics were similar across both groups. RESULTS: At the time of removal of the first BIB® device, EDNOS scores in both groups were not significantly different, but decreased significantly from baseline. By the end of the study, all EDNOS scores were significantly lower in patients undergoing consecutive BIB®, compared with single BIB® followed by diet therapy. CONCLUSIONS: The placement of an intragastric balloon in obese patients allows for a reduction in the intensity of grazing, emotional eating, sweet-eating and after-dinner grazing. A more significant reduction in the EDNOS score was observed with two consecutive BIBs®.