Background The over-the-scope clip (OTSC) provides more durable and full-thickness closure as compared with standard clips. Only case reports and small case series have reported on outcomes of OTSC ...closure of GI defects. Objective To describe a large, multicenter experience with OTSCs for the management of GI defects. Secondary goals were to determine success rate by type of defect and type of therapy and to determine predictors of treatment outcomes. Design Multicenter, retrospective study. Setting Multiple, international, academic centers. Patients Consecutive patients who underwent attempted OTSC placement for GI defects, either as a primary or as a rescue therapy. Interventions OTSC placement to attempt closure of GI defects. Main Outcome Measurements Long-term success of the procedure. Results A total of 188 patients (108 fistulae, 48 perforations, 32 leaks) were included. Long-term success was achieved in 60.2% of patients during a median follow-up of 146 days. Rate of successful closure of perforations (90%) and leaks (73.3%) was significantly higher than that of fistulae (42.9%) ( P < .05). Long-term success was significantly higher when OTSCs were applied as primary therapy (primary 69.1% vs rescue 46.9%; P = .004). On multivariate analysis, patients who had OTSC placement for perforations and leaks had significantly higher long-term success compared with those who had fistulae (OR 51.4 and 8.36, respectively). Limitations Retrospective design and multiple operators with variable expertise with the OTSC device. Conclusion OTSC is safe and effective therapy for closure of GI defects. Clinical success is best achieved in patients undergoing closure of perforations or leaks when OTSC is used for primary or rescue therapy. Type of defect is the best predictor of successful long-term closure.
Summary Background Everolimus-eluting stent (EES) reduces the risk of restenosis in elective percutaneous coronary intervention. However, the use of drug-eluting stent in patients with ST-segment ...elevation myocardial infarction (STEMI) is still controversial. Data regarding the performance of second-generation EES in this setting are scarce. We report the 1-year result of the EXAMINATION (clinical Evaluation of the Xience-V stent in Acute Myocardial INfArcTION) trial, comparing EES with bare-metal stents (BMS) in patients with STEMI. Methods This multicentre, prospective, randomised, all-comer controlled trial was done in 12 medical centres in three countries. Between Dec 31, 2008, and May 15, 2010, we recruited patients with STEMI up to 48 h after the onset of symptoms requiring emergent percutaneous coronary intervention. Patients were randomly assigned (ratio 1:1) to receive EES or BMS. Randomisation was in blocks of four or six patients, stratified by centre and centralised by telephone. Patients were masked to treatment. The primary endpoint was the patient-oriented combined endpoint of all-cause death, any recurrent myocardial infarction, and any revascularisation at 1 year and was analysed by intention to treat. The secondary endpoints of the study included the device-oriented combined endpoint of cardiac death, target vessel myocardial infarction or target lesion revascularisation, and rates of all cause or cardiac death, recurrent myocardial infarction, target lesion or target vessel revascularisation, stent thrombosis, device and procedure success, and major and minor bleeding. This trial is registered with ClinicalTrials.gov , number NCT00828087. Findings Of the 1504 patients randomised, 1498 patients were randomly assigned to receive EES (n=751) or BMS (n=747). The primary endpoint was similar in both groups (89 11·9% of 751 patients in the EES group vs 106 14·2% of 747 patients in the BMS group; difference −2·34 95% CI −5·75 to 1·07; p=0·19). Device-oriented endpoint (44 5·9% in the EES group vs 63 8·4% in the BMS group; difference −2·57 95% CI −5·18 to 0·03; p=0·05) did not differ between groups, although rates of target lesion and vessel revascularisation were significantly lower in the EES group (16 2·1% vs 37 5·0%, p=0·003, and 28 3·7% vs 51 6·8%, p=0·0077, respectively). Rates of all cause (26 3·5% for EES vs 26 3·5% for BMS, p=1·00) or cardiac death (24 3·2% for EES vs 21 2·8% for BMS, p=0·76) or myocardial infarction (10 1·3% vs 15 2·0%, p=0·32) did not differ between groups. Stent thrombosis rates were significantly lower in the EES group (4 0·5% patients with definite stent thrombosis in the EES group vs 14 1·9% in the BMS group and seven 0·9% patients with definite or probable stent thrombosis in the EES group vs 19 2·5% in the BMS group, both p=0·019). Although device success rate was similar between groups, procedure success rate was significantly higher in the EES group (731 97·5% vs 705 94·6%; p=0·0050). Finally, Bleeding rates at 1 year were comparable between groups (29 3·9% patients in the EES group vs 39 5·2% in the BMS group; p=0·19). Interpretation The use of EES compared with BMS in the setting of STEMI did not lower the patient-oriented endpoint. However, at the stent level both rates of target lesion revascularisation and stent thrombosis were reduced in recipients of EES. Funding Spanish Heart Foundation.
Background The true efficacy of EUS-guided ethanol lavage (EEL) of pancreatic cystic neoplasms is unclear. This study aimed to assess long-term outcomes and adverse events of EEL by using a ...standardized protocol. Methods Single-center, prospective, pilot study in which participants with suspected mucinous cyst neoplasms or branch duct intraductal papillary mucinous neoplasms ≥1 cm in maximum diameter underwent EEL with 80% ethanol. Follow-up cross-sectional imaging was obtained to assess for changes in cyst volume. Results Twenty-three patients underwent EEL (57% male, mean age 70 years). Mean duration of follow-up was 40 months (range 9-82 months). Mean calculated final concentration of ethanol achieved in treated cysts was 50% (range 0%-79%). Complete resolution of pancreatic cystic neoplasms occurred in 2 participants (9%). When stratified into those participants who achieved ≥80% versus <80% reduction in cyst volume, no statistically significant differences were seen with regard to patient demographics, cyst characteristics, or final concentration of ethanol achieved in the treated cyst. Greater decreases in cyst volume were seen in presumed nonmucinous cysts compared with presumed mucinous cysts ( P = .006). Two early adverse events occurred. Five participants died during the study follow-up period (4 from nonpancreatic causes), including 1 participant who was diagnosed with pancreatic adenocarcinoma thought to have arisen from the treated branch duct intraductal papillary mucinous neoplasm 41 months after undergoing EEL. Conclusions As performed in this study, EEL therapy does not appear to be a promising method for prevention of malignancy in pancreatic cysts. Endoscopic methods that effectively and completely ablate pancreatic cystic neoplasms are needed. (Clinical trial registration number: NCT02158039 .)
Background Probe-based confocal laser endomicroscopy (pCLE) is an emerging tool for in vivo imaging of the GI tract that requires the endoscopist to interpret microscopic images. The learning curve ...for interpretation of pCLE images is unknown. Objective To examine the learning curve of correctly identifying benign and neoplastic colorectal lesions by using pCLE and to evaluate the learning curve of obtaining high-quality images. Design Prospective, double-blind review of pCLE images of 76 colorectal lesions by using corresponding polypectomies as the reference standard. A training set of 20 images with known histology was first reviewed to standardize image interpretation, followed by blinded review of 76 unknown images. Setting Eleven endoscopists from 3 different endoscopy centers evaluated the images obtained by 1 endoscopist using the high-definition confocal probe. Patients Patients undergoing screening and surveillance colonoscopies. Intervention Intravenous fluorescein pCLE imaging of colorectal lesions followed by polypectomies. Main Outcome Measurements Accuracy of image interpretation with constructing learning curve for pCLE image interpretation and acquisition. Results Of the 76 colorectal lesions, 51 (67%) were neoplastic and 25 (33%) were benign, based on histopathology. Accuracy for the overall group was 63% for lesions 1 to 20, 64% for lesions 21 to 40, 79% for lesions 41 to 60, and 86% for lesions 61 to 76. The ability to obtain high-quality images was stable over the 76 cases. Limitations Small sample size and use of offline video sequences. Conclusions Accurate interpretation of pCLE images for predicting neoplastic lesions can be learned rapidly by a wide range of GI specialists. Furthermore, the ability to acquire high-quality pCLE images is also quickly learned.
Background and Aims The presence and significance of epithelial denudation among treatment-naïve pancreatic cystic lesions (PCLs) remain undetermined. The aims of this study were to determine the ...prevalence, extent, and predictors of epithelial denudation in treatment-naïve PCLs. Methods Single-center retrospective study including patients who underwent EUS preceded by cross-sectional imaging and who subsequently underwent surgical resection of treatment-naïve PCLs. Surgically resected PCLs were reviewed by a pathologist in a fashion that allowed evaluation from evenly distributed regions of the cyst. Results A total of 140 patients were identified (60% female, mean age 63 years). Eighty-five cysts (60.7%) were classified as intraductal papillary mucinous neoplasms (IPMNs), 33 (23.5%) as main duct IPMNs (m-IPMNs), 11 (7.9%) as serous cystadenomas (SCAs), and 11 (7.9%) were composed of other cyst subtypes. A greater extent of epithelial denudation was seen in mucinous cystic neoplasm (MCN) compared with IPMN and SCA (mean percentage of denuded epithelium 45.1%, 10.8%, and 22.4%, respectively P < .0001). An association existed between the extent of denuded epithelium and degree of cyst epithelial dysplasia for IPMN and MCN combined (mean percentage of denuded epithelium for low-, moderate-, and high-grade dysplasia being 23.3%, 4.5%, and 1.2%, respectively; P = .02). PCLs resected from the neck and/or body and/or tail of the pancreas were associated with a greater extent of mean percentage of denuded epithelium than PCLs resected from the head and/or uncinate of the pancreas (23.9% vs 13.4%; P = .035). Conclusions The presence and extent of cyst epithelial denudation of treatment-naïve PCLs vary with cyst histology and other factors. The observation of denudation after intracystic ablative therapy may not provide an adequate metric of successful intervention. Further studies are needed to validate these findings.
Currently, testing for immunoglobulin E (IgE) sensitization is the cornerstone of diagnostic evaluation in suspected allergic conditions. This review provides a thorough and updated critical ...appraisal of the most frequently used diagnostic tests, both in vivo and in vitro. It discusses skin tests, challenges, and serological and cellular in vitro tests, and provides an overview of indications, advantages and disadvantages of each in conditions such as respiratory, food, venom, drug, and occupational allergy. Skin prick testing remains the first line approach in most instances; the added value of serum specific IgE to whole allergen extracts or components, as well as the role of basophil activation tests, is evaluated. Unproven, non-validated, diagnostic tests are also discussed. Throughout the review, the reader must bear in mind the relevance of differentiating between sensitization and allergy; the latter entails not only allergic sensitization, but also clinically relevant symptoms triggered by the culprit allergen.
In “hot” pursuit of an evasive gallbladder Mejía Pérez, Lady Katherine, MD; Brahmbhatt, Bhaumik, MBBS; Gómez, Victoria, MD
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