Prospective randomized comparison of gastrotomy closure associating tunnel access and over-the-scope clip (OTSC) with two other methods in an experimental ex vivo setting

Background: Safe transgastric natural orifice transluminal endoscopic surgery (NOTES) procedures require a reliable closure of the gastrotomy. Recently a novel peritoneal access method via a submucosal tunnel has been described with encouraging preliminary results. Aim: The aim is to compare a submucosal tunnel access plus over-the-scope clip (OTSC) system for closure with two other closure modalities. Patients and methods: This is a prospective ex vivo study conducted on 42 porcine stomach models equally randomized into three groups in an academic medical center. The procedures performed in each group included: (1) Tunnel (6 cm) + endoclips; (2) Knife + balloon dilation access + OTSC; and (3) Tunnel + OTSC. A pressurized air-leak test was performed to evaluate the strength of the closure. Stomach volumes, procedure times, number of clips, and incision sizes were also registered. Results: The mean air-leak pressure was statistically higher in Group 3 than in Groups 1 and 2–95.2 ± 19.3 mmHg versus 72.5 ± 35.2 and 79.0 ± 24.5 mmHg (P < 0.05). The gastrotomy creation times for Groups 1, 2, and 3 were 28.0 ± 10.1, 4.3 ± 1.4, and 20.1 ± 10.6 minutes, respectively, with significantly lower time in Group 2 (P < 0.001). The closure times were 16.1 ± 6.1, 6.5 ± 1.2, and 5.3 ± 3.0 minutes, respectively, and significantly longer in the endoclip group (P < 0.001). There were no differences in the volumes and the incision sizes among the three groups. Conclusion: The combination of a submucosal tunnel access and OTSC offers a stronger closure than the other methods studied

A meta-analysis on efficacy and safety: single-balloon vs. double-balloon enteroscopy

Background and aim: Double-balloon enteroscopy (DBE) and single-balloon enteroscopy (SBE) are new techniques capable of providing deep enteroscopy. Results of individual studies comparing these techniques have not been able to identify a superior strategy. Our aim was to systematically pool all available studies to compare the efficacy and safety of DBE with SBE for evaluation of the small bowel. Methods: Databases were searched, including PubMed, Embase, and the Cochrane Central Register of Controlled Trials. The main outcome measures were complete small-bowel visualization, diagnostic yield, therapeutic yield, and complication rate. Statistical analysis was performed using Review Manager (RevMan version 5.2). Meta-analysis was performed using fixed-effect or random-effect methods, depending on the absence or presence of significant heterogeneity. We used the χ2 and I2 test to assess heterogeneity between trials. Results were expressed as risk ratios (RR) or mean differences with 95% confidence intervals (CI). Results: Four prospective, randomized, controlled trials with a total of 375 patients were identified. DBE was superior to SBE for visualization of the entire small bowel [pooled RR = 0.37 (95% CI: 0.19–0.73; P = 0.004)]. DBE and SBE were similar in ability to provide diagnosis [pooled RR = 0.95 (95% CI: 0.77–1.17; P = 0.62)]. There was no significant difference between DBE and SBE in therapeutic yield [pooled RR = 0.78 (95% CI: 0.59–1.04; P = 0.09)] and complication rate [pooled RR = 1.08 (95% CI: 0.28–4.22); P = 0.91]. Conclusions: DBE was superior to SBE with regard to complete small bowel visualization. DBE was similar to SBE with regard to diagnostic yield, ability to provide treatment and complication rate, but these results should be interpreted with caution as they is based on very few studies and the overall quality of the evidence was rated as low to moderate, due to the small sample size

Light scattering spectroscopy identifies the malignant potential of pancreatic cysts during endoscopy

Pancreatic cancers are usually detected at an advanced stage and have poor prognosis. About one fifth of these arise from pancreatic cystic lesions. Yet not all lesions are precancerous, and imaging tools lack adequate accuracy for distinguishing precancerous from benign cysts. Therefore, decisions on surgical resection usually rely on endoscopic ultrasound-guided fine needle aspiration (EUS-FNA). Unfortunately, cyst fluid often contains few cells, and fluid chemical analysis lacks accuracy, resulting in dire consequences, including unnecessary pancreatic surgery for benign cysts and the development of cancer. Here, we report an optical spectroscopic technique, based on a spatial gating fibre-optic probe, that predicts the malignant potential of pancreatic cystic lesions during routine diagnostic EUS-FNA procedures. In a double-blind prospective study in 25 patients, with 14 cysts measured in vivo and 13 postoperatively, the technique achieved an overall accuracy of 95%, with a 95%confidence interval of 78–99%, in cysts with definitive diagnosis

Outcomes of intragastric balloon placements in a private practice setting

Intragastric balloons are used as a treatment for obesity. Much of the data collected on balloons has been in the context of clinical trials in academic medical centers or as a bridge to bariatric surgery in obesity centers. The aim of this study was to investigate the efficacy and safety of balloon treatment in private practice. This was a retrospective analysis of 6-month weight loss data and balloon-related complications of patients referred to three private centers for obesity treatment. A total of 815 patients (131 males) were referred for balloon treatment (mean age 36.5 years, mean body weight 111.7 kg, mean body mass index [BMI] 38.1 kg/m(2)). The 6-month weight loss data were available for 672 patients. Mean weight loss was 20.9 kg (7.2 BMI units). A total of 372 patients visited the center only once following balloon placement (i. e. for balloon removal), but these patients still achieved a mean weight loss of 19.4 kg (6.6 BMI units). Successful weight loss (i. e. ≥ 10 %) was achieved in 85.0 %. Severe complications consisted of dehydration requiring hospital admission (n = 2; 0.2 %), and intestinal obstruction caused by balloon deflation, which required surgery (n = 2; 0.2 %). A total of 35 deflated balloons (4.3 %) were passed rectally without any adverse events. Severe esophagitis following balloon placement was diagnosed in 12 patients (1.5 %). A total of 53 patients (6.5 %) requested balloon removal during the first month. Nine balloons (1.1 %) were removed for medical reasons. In the private practice setting, intragastric balloons on their own, without an intensive lifestyle program and supportive consultations, resulted in safe and substantial weight losses, and may fill the therapeutic gap between pharmacotherapy and surger