606 research outputs found

    Methylene blue MMX® tablets for chromoendoscopy. Bioavailability, colon staining and safety in healthy volunteers undergoing a full colonoscopy.

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    Abstract Methylene blue-MMX® tablets are proposed as an aid for detection and visualisation of adenomas and carcinomas in patients undergoing colonoscopy, by improving their detection rate and highlighting the presence of the intestinal dysplastic lesions. Single total doses of 100 and 200 mg were administered to healthy volunteers undergoing a bowel cleansing preparation and a full colonoscopy to investigate the colonic staining. The pharmacokinetics of methylene blue and the safety after exposure to the tablets were also investigated. With 200 mg, the best staining, assessed as the sum of acceptable and good staining, was achieved in the ascending colon and rectosigmoid (75% subjects each), the transverse and the descending colon (approximately 63% each). Absence of staining or overstaining were reported for no colonic region of interest in any subject. Similar results were observed in the 100 mg dose group. Methylene blue blood concentrations reached a peak (Cmax) in a median time (Tmax) of 12 h with 100 mg and 16 h with 200 mg. AUC0-t was 10.7 ± 6.7 μg/mLxh after 100 mg and 25.2 ± 7.4 μg/mLxh after 200 mg. Half-life ranged between 9 and 22 h after the lower dose and between 6 and 26 h after the higher dose. The cumulative urinary excretion was about 28% after 100 mg and about 39% after 200 mg up to 60 h post-dose. The overall frequency of adverse events after single dose of the test product administered along with a bowel cleansing preparation was 39%, but only one was related to the test product: abnormal transaminases. The most frequent adverse event was a transient polyuria (17%). One serious adverse event (gastrointestinal haemorrhage) led the subject to study discontinuation and hospitalisation and another subject withdrew the study due to one adverse event (haematemesis). Either event was not related to methylene blue

    Improvement of functional bloating by an enterovaccine: a preliminary study

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    Background: bloating is a fastidious symptom reported by many patients who also have other gastrointestinal functional dis orders. Bloating is more common in women, and it is often asso ciated with meals and improves or disappears overnight. No spe cific treatments are to date available for this disturbing symptom. Aims: to evaluate the effects of an oral enterovaccine (Colifag ina ® ) on bloating and other abdominal symptoms in patients with prevalent complaints of functional bloating. Patients and methods: one hundred and forty-eight patients with functional bloating according to Rome III criteria were re cruited. Questionnaires and a VAS scale on their symptoms were administered at baseline and after four weeks of therapy with Colifagina ® . Results: after treatment, a significant amelioration of bloating (p < 0.0001), abdominal pain (p < 0.0001) and flatus (p < 0.0001) was observed; nausea and vomiting scores were not sig nificantly different at the end of the treatment. Subjective wellbe ing was also generally improved (p < 0.001) in treated patients. Conclusion: treatment with an enterovaccine may help im prove symptoms in patients with functional bloating

    Malignant gastric outlet obstruction: Which is the best therapeutic option?

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    Malignant gastric outlet obstruction (MGOO) is a clinical condition characterized by the mechanical obstruction of the pylorus or the duodenum due to tumor compression/infiltration, with consequent reduction or impossibility of an adequate oral intake. MGOO is mainly secondary to advanced pancreatic or gastric cancers, and significantly impacts on patients' survival and quality of life. Patients suffering from this condition often present with intractable vomiting and severe malnutrition, which further compromise therapeutic chances. Currently, palliative strategies are based primarily on surgical gastrojejunostomy and endoscopic enteral stenting with self-expanding metal stents. Several studies have shown that surgical approach has the advantage of a more durable relief of symptoms and the need of fewer re-interventions, at the cost of higher procedure-related risks and longer hospital stay. On the other hand, enteral stenting provides rapid clinical improvement, but have the limit of higher stent dysfunction rate due to tumor ingrowth and a subsequent need of frequent re-interventions. Recently, a third way has come from interventional endoscopic ultrasound, through the development of endoscopic ultrasound-guided gastroenterostomy technique with lumen-apposing metal stent. This new technique may ideally encompass the minimal invasiveness of an endoscopic procedure and the long-lasting effect of the surgical gastrojejunostomy, and brought encouraging results so far, even if prospective comparative trial are still lacking. In this Review, we described technical aspects and clinical outcomes of the above-cited therapeutic approaches, and discussed the open questions about the current management of MGOO

    Direct peroral cholangioscopy in the management of difficult biliary stones: a new tool to confirm common bile duct clearance. Results of a preliminary study

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    Background and aims: Endoscopic sphincterotomy (ES) with stone extraction is the standard treatment for choledocholithiasis. After stone retrieval, balloon-occluded cholangiography is generally performed to confirm bile duct clearance but can miss residual stones particularly in patients with residual small-sized stones, a large bile duct or pneumobilia. In addition, difficult common bile duct (CBD) stones requiring advanced endoscopic techniques for retrieval are a potential risk factor for choledocholithiasis recurrence. Methods: We performed a retrospective evaluation of a prospectively maintained procedures database. From July 2016 to December 2017, all patients with difficult CBD stones who underwent endoscopic retrograde cholangiopancreatography (ERCP) with papillary balloon dilation-assisted stone retrieval and subsequent direct per-oral cholangioscopy (DPOC) using standard gastroscopes to confirm CBD clearance were analyzed. Results: Thirty-six patients who underwent ERCP and DPOC were included. Technical success, defined as deep intubation of CBD with hepatic hilum visualization, was achieved in 31 of 36 patients (86%). During DPOC, residual CBD stones were visualized and removed in 7 of 31 patients (22.5%). After a mean of 241 +/- 56 days of follow-up post-DPOC, no serious adverse events were reported, and there was no evidence or suspicion of recurrent choledocholithiasis. Conclusions: Direct per-oral cholangioscopy immediately following difficult CBD stone removal was safe, feasible and accurate. In this setting, DPOC at the time of ERCP appears to be a very useful tool to achieve complete clearance of choledocholithiasis.info:eu-repo/semantics/publishedVersio

    Balanced Propofol Sedation in Patients Undergoing EUS-FNA: A Pilot Study to Assess Feasibility and Safety

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    Introduction and aims. Balanced propofol sedation (BPS) administered by gastroenterologists has gained popularity in endoscopic procedures. Few studies exist about the safety of this approach during endosonography with fine needle aspiration (EUS-FNA). We assessed the safety of BPS in EUS-FNA. Materials and methods. 112 consecutive patients, referred to our unit to perform EUS-FNA, from February 2008 to December 2009, were sedated with BPS. A second gastroenterologist administered the drugs and monitorized the patient. Results. All the 112 patients (62 males, mean age 58.35) completed the examination. The mean dose of midazolam and propofol was, respectively, of 2.1 mg (range 1–4 mg) and 350 mg (range 180–400). All patients received oxygen with a mean flux of 4 liter/minute (range 2–6 liters/minute). The mean recovery time after procedure was 25 minutes (range 18–45 minutes). No major complications related to sedation were registered during all procedures. The oxygen saturation of all patients never reduced to less than 85%. Blood systolic pressure during and after the procedure never reduced to less than 100 mmHg. Conclusions. In our experience BPS administered by non-anaesthesiologists provided safe and successful sedation in patients undergoing EUS-FNA

    Endoscopic Ultrasound Guided Biliary Drainage in Malignant Distal Biliary Obstruction

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    Malignant biliary obstruction (MBO) is a challenging medical problem that often negatively impacts the patient’s quality of life (QoL), postoperative complications, and survival rates. Endoscopic approaches to biliary drainage are generally performed by ERCP or, in selected cases, with a percutaneous transhepatic biliary drainage (PTBD). Recent advances in therapeutic endoscopic ultrasound (EUS) allow drainage where previous methods have failed. EUS has evolved from a purely diagnostic technique to one that allows a therapeutic approach in the event of ERCP failure in distal MBO. Moreover, the introduction of dedicated accessories and prostheses for EUS-guided transmural biliary drainage (EUS-BD) made these procedures more successful with regard to technical success, clinical outcomes and reduction of adverse events (AEs). Finally, lumen-apposing metal stents (LAMS) have improved the therapeutic role of the EUS. Subsequently, the electrocautery enhanced tip of the LAMS (EC-LAMS) allows a direct access of the delivery system to the target lumen, thereby simplifying and reducing the EUS-BD procedure time. EUS-BD using LAMS and EC-LAMS has proven effective and safe with a low rate of AEs. This review aims to evaluate biliary drainage techniques in malignant obstruction, focusing on the role of EUS biliary drainage by LAMS

    Endoscopic ultrasound-guided ablation of solid pancreatic lesions: A systematic review of early outcomes with pooled analysis

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    Contains fulltext : 252157.pdf (Publisher’s version ) (Open Access)BACKGROUND: Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) is emerging as a complementary therapeutic approach for pancreatic solid masses. However, results of published data are difficult to interpret because of a retrospective design and small sample size. AIM: To systematically review data on EUS-RFA for solid lesions and to pool the results of the different experiences in order to provide more consistent evidence in terms of safety and efficacy. METHODS: A comprehensive systematic literature search on the main databases was performed to identify articles in which patients with pancreatic solid lesions underwent EUS-RFA. The primary outcomes were procedure-related adverse events (AEs) and mortality. Secondary outcomes were the technical success rate and the effects on primary tumor growth. Statistical analyses were performed using Stata version 14.0. RESULTS: In total, 14 studies were included, with 120 patients undergoing 153 ablations of 129 solid pancreatic lesions. The STARmed technology was used in seven studies, the Habib system in six studies, and the HybridTherm probe in one study. The pooled technical success rate was 99.0% (I (2): 25.82%). The pooled overall AE rate was 8.0% (I (2): 11.46%). Excluding mild AEs, the pooled rates of serious AEs was 1.0% (I (2): 0%). No mortality related to the procedure was reported. CONCLUSION: The present pooled analysis confirms the safety and feasibility of EUS-RFA

    Gastric peroral endoscopic pyloromyotomy for refractory gastroparesis: a systematic review of early outcomes with pooled analysis

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    Background and Aims: Gastroparesis (GP) is a chronic debilitating condition. Prior pyloric-targeted procedures are either invasive or have questionable efficacy. Gastric peroral pyloromyotomy (G-POEM) has been proposed as a minimally invasive approach. We performed a pooled analysis to evaluate the efficacy and safety of G-POEM for GP. Methods: Electronic databases (Medline, Scopus, EMBASE) were searched up to January 2019. Studies including patients who underwent G-POEM for GP were eligible. Procedural, clinical, and safety outcomes were assessed by pooling data with a random- or fixed-effect model according to the degree of heterogeneity to obtain a proportion with a 95% confidence interval. Results: Ten studies were eligible for inclusion (292 patients), and 2 of the 10 studies were prospective. Seven studies were performed in the United States, 2 in France, and 1 in China. Endoscopic pyloromyotomy was feasible in all patients. Significant symptomatic improvement was achieved after 83.9% of procedures (mean follow-up, 7.8 ± 5.5 months). When comparing the mean values of pre- and postprocedural scintigraphic evolution, there was a significant decrease of the residual percentage at 2 and 4 hours. The overall adverse events rate was 6.8%. Conclusions: G-POEM appears to be a promising approach for GP in terms of safety and efficacy outcomes in the short term
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