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The removal of large bile duct stones (>12 mm) after endoscopic sphincterotomy (EST) remains a challenging issue in therapeutic endoscopy. The aim of this prospective, randomized, controlled trial was to compare the effectiveness and complications of EST followed by large balloon dilation (LBD) with that of EST followed by mechanical lithotripsy (ML) for the management of large bile duct stones. A total of 90 patients with large bile duct stones (12-20 mm) were randomized to EST followed by LBD (n=45) or EST followed by ML (n=45). Success rate was determined with a final cholangiogram, whereas type and rate of post-procedure complications were assessed prospectively. Complete bile duct stone removal was accomplished in 97.7% of patients subjected to EST-LBD as compared with 91.1% of those subjected to EST-ML (P=0.36). Post-procedure complications were observed in two (4.4%) patients subjected to EST-LBD and in nine (20%) patients subjected to EST-ML (P=0.049). Rates of pancreatitis were similar between the two groups (one case in each), as was post-endoscopic retrograde cholangio pancreatography (ERCP) hemorrhage (one case in each group). None of the patients subjected to EST-LBD developed cholangitis, while this was seen in six patients subjected to EST-ML (0.0 vs. 13.3%, P=0.026). One patient subjected to EST-ML developed perforation, which was successfully managed conservatively. None of our patients with complications died. EST followed by LBD is equally effective as EST followed by ML for the removal of large bile duct stones, although it is associated with fewer complications.

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.

The mechanism by which pancreas divisum may lead to recurrent episodes of acute pancreatitis in a subset of individuals is unknown. Abnormalities of the cystic fibrosis gene product (CFTR) have been implicated in the genesis of idiopathic chronic pancreatitis. The aim of this study was to determine if CFTR function is abnormal in patients with pancreas divisum and recurrent acute pancreatitis (PD/RAP). A total of 69 healthy control subjects, 12 patients with PD/RAP, 16 obligate heterozygotes with a single CFTR mutation, and 95 patients with cystic fibrosis were enrolled. CFTR function was analyzed by nasal transepithelial potential difference testing in vivo. The outcomes of the PD/RAP patients following endoscopic and surgical treatments were concomitantly analyzed. Direct measurement of CFTR function in nasal epithelium in response to isoproterenol demonstrated that the values for PD/RAP were intermediate between those observed for healthy controls and cystic fibrosis patients. The median value was 13 mV for PD/RAP subjects, which was statistically different from healthy controls (22 mV, p= 0.001) and cystic fibrosis pancreatic sufficient (-1 mV, p < 0.0001) and pancreatic insufficient (-3 mV, p < 0.0001) patients. These results suggest a link between CFTR dysfunction and recurrent acute pancreatitis in patients with pancreas divisum and may explain why a subset of patients with pancreas divisum develops recurrent acute pancreatitis.

The optimal preoperative evaluation of periampullary neoplasms remains controversial. The aim of this study was to analyze the accuracy of helical computed tomography (CT) and CT angiography with three-dimensional reconstruction in predicting resectability. Between March 1996 and May 1999, a total of 100 patients with periampullary neoplasms were prospectively staged by helical CT and CT angiography with three-dimensional reconstruction. Vascular involvement was graded from 0 to 4, with grade 0 representing no vascular involvement and grade 4 total encasement of either the superior mesenteric vein or artery. Patients with grade 4 lesions were considered unresectable. Sixty-eight patients underwent surgical exploration with intent to perform a pancreaticoduodenectomy. Forty-four lesions were grade 0, five were grade 1, eight were grade 2, and 11 were grade 3. Resectability for grades 0 to 3 was 96%, 100%, 50%, and 9%, respectively, for an overall resectability rate of 76%. Resectability in patients with vascular encroachment (grade 2) is usually determined by the extent of local disease rather than the presence of extrapancreatic disease. Resection is rarely possible in patients with evidence of vascular encasement (grade 3). Additional imaging modalities such as diagnostic laparoscopy are superfluous in patients with no evidence of local vascular involvement on CT angiography (grades 0 and 1) because of the high resectability rate and infrequency of unsuspected distant metastatic deposits.

Aim of present study was to develop a solid nanoemulsion preconcentrate of paclitaxel (PAC) using oil [propylene glycol monocaprylate/glycerol monooleate, 4 : 1 w/w], surfactant [polyoxyethylene 20 sorbitan monooleate/polyoxyl 15 hydroxystearate, 1 : 1 w/w], and cosurfactant [diethylene glycol monoethyl ether/polyethylene glycol 300, 1 : 1 w/w] to form stable nanocarrier. The prepared formulation was characterized for droplet size, polydispersity index, and zeta potential. Transmission electron microscopy (TEM), differential scanning calorimetry (DSC), X-ray diffraction (XRD), and Fourier transform infrared spectroscopy (FTIR) were used to assess surface morphology and drug encapsulation and its integrity. Cumulative drug release of prepared formulation through dialysis bag and permeability coefficient through everted gut sac were found to be remarkably higher than the pure drug suspension and commercial intravenous product (Intaxel), respectively. Solid nanoemulsion preconcentrate of PAC exhibited strong inhibitory effect on proliferation of MCF-7 cells in MTT assay. In vivo systemic exposure of prepared formulation through oral administration was comparable to that of Intaxel in γ scintigraphy imaging. Our findings suggest that the prepared solid nanoemulsion preconcentrate can be used as an effective oral solid dosage form to improve dissolution and bioavailability of PAC.

Background General endotracheal (GET) anesthesia is often used during single-balloon enteroscopy (SBE). However, there is currently limited data regarding monitored anesthesia care (MAC) without endotracheal intubation for this procedure. Aims The aim of the study was to determine the safety and efficacy of MAC sedation during SBE and to identify risk factors for adverse events. Methods All patients who underwent SBE and SBE-assisted endoscopic retrograde cholangiopancreatography between June 2011 and July 2013 at a tertiary-care referral center were studied in a retrospective analysis of a prospectively collected database. Patients received MAC anesthesia or GET. The main outcome measurements were sedation-related adverse events, diagnostic yield, and therapeutic yield. Results Of the 178 cases in the study, 166 cases (93 %) were performed with MAC and 12 (7 %) with GET. Intra-procedure sedation-related adverse events occurred in 17 % of cases. The most frequent event was transient hypotension requiring pharmacologic intervention in 11.8 % of procedures. In MAC cases, the diagnostic yield was 58.4 % and the therapeutic yield was 30.1 %. Anesthesia duration was strongly associated with the occurrence of a sedation-related adverse event ( P  = 0.005). Conclusions MAC is a safe and efficacious sedation approach for most patients undergoing SBE. Sedation-related complications in SBE are uncommon, but are more frequent in longer procedures.

Background: The currently available radiopharmaceuticals are not specific for tumor imaging. Purpose: The present study was conducted to radiolabel doxorubicin with Technetium-99m ([99m]Tc) as a scintigraphic marker of high DNA turnover/intercalation in malignant cells. Methods: Labeling was done by direct method and the developed radiotracer was subjected to quality control tests. The blood kinetics, scintigraphy of tumor-bearing mice, and biodistribution were studied after intravenous injection of about 7.4 MBq of [99m]Tc-doxorubicin. The isotime (5 minutes) anterior images were acquired at different time intervals of 1.5, 3, and 4 hours. Results: The labeling efficiency of [99m]Tc-doxorubicin was estimated to be more than 95%. The protein-binding efficiency was greater than 88% and in vitro stability was up to 24 hours. The biodistribution data support the clearance of the radioligand by dual (renal and hepatic) pathways. A semiquantitative data analysis of the anterior images indicated that a focal concentration of the radiotracer was seen in the tumor at 1.5 hours, which persisted in 3-hour and 4-hour images, respectively. Conclusions: This scintigraphic approach, therefore, could be a powerful tool for cancer detection at early stage. The technique, however, needs further validation through animal experimentation and clinical studies.