36 research outputs found

    Global prospective case series of ERCPs using a single-use duodenoscope

    Get PDF
    Background The first commercialized single-use duodenoscope was cleared by the US Food and Drug Administration in December 2019. Data regarding endoscopic retrograde cholangiopancreatography (ERCP) using a single-use duodenoscope are needed on a broader range of cases conducted by endoscopists with varying levels of experience in a wide range of geographic areas. Methods 61 endoscopists at 22 academic centers in 11 countries performed ERCP procedures in adult patients aged ? 18. Outcomes included ERCP completion for the intended indication, rate of crossover to a reusable endoscope, device performance ratings, and serious adverse events (SAEs). Results Among 551 patients, 236 (42.8 %) were aged &gt;65, 281 (51.0 %) were men, and 256 (46.5 %) had their procedure as an inpatient. ERCPs included 196 (35.6 %) with American Society for Gastrointestinal Endoscopy complexity of grades 3 4. A total of 529 ERCPs (96.0 %) were completed: 503 (91.3 %) using only the single-use duodenoscope, and 26 (4.7 %) with crossover to a reusable endoscope. There were 22 ERCPs (4.0 %) that were not completed, of which 11 (2.0 %) included a crossover and 11 (2.0 %) were aborted cases (no crossover). Median ERCP completion time was 24.0 minutes. Median overall satisfaction with the single-use duodenoscope was 8.0 (scale of 1 to 10 [best]). SAEs were reported in 43 patients (7.8 %), including 17 (3.1 %) who developed post-ERCP pancreatitis. Conclusions In academic medical centers over a wide geographic distribution, endoscopists with varying levels of experience using the first marketed single-use duodenoscope had good ERCP procedural success and reported high performance ratings for this device.</p

    Percutaneous transhepatic or endoscopic ultrasound-guided biliary drainage in malignant distal bile duct obstruction using a self-expanding metal stent: Study protocol for a prospective European multicenter trial (PUMa trial)

    Full text link
    Background Endoscopic ultrasound-guided biliary drainage (EUS-BD) was associated with better clinical success and a lower rate of adverse events (AEs) than fluoroscopy-guided percutaneous transhepatic biliary drainage (PTBD) in recent single center studies with mainly retrospective design and small case numbers (< 50). The aim of this prospective European multicenter study is to compare both drainage procedures using ultrasound-guidance and primary metal stent implantation in patients with malignant distal bile duct obstruction (PUMa Trial). Methods The study is designed as a non-randomized, controlled, parallel group, non-inferiority trial. Each of the 16 study centers performs the procedure with the best local expertise (PTBD or EUS-BD). In PTBD, bile duct access is performed by ultrasound guidance. EUS-BD is performed as an endoscopic ultrasound (EUS)-guided hepaticogastrostomy (EUS-HGS), EUS-guided choledochoduodenostomy (EUS-CDS) or EUS-guided antegrade stenting (EUS-AGS). Insertion of a metal stent is intended in both procedures in the first session. Primary end point is technical success. Secondary end points are clinical success, duration pf procedure, AEs graded by severity, length of hospital stay, re-intervention rate and survival within 6 months. The target case number is 212 patients (12 calculated dropouts included). Discussion This study might help to clarify whether PTBD is non-inferior to EUS-BD concerning technical success, and whether one of both interventions is superior in terms of efficacy and safety in one or more secondary endpoints. Randomization is not provided as both procedures are rarely used after failed endoscopic biliary drainage and study centers usually prefer one of both procedures that they can perform best

    A deep learning system for detection of early Barrett's neoplasia:a model development and validation study

    Get PDF
    BACKGROUND: Computer-aided detection (CADe) systems could assist endoscopists in detecting early neoplasia in Barrett's oesophagus, which could be difficult to detect in endoscopic images. The aim of this study was to develop, test, and benchmark a CADe system for early neoplasia in Barrett's oesophagus.METHODS: The CADe system was first pretrained with ImageNet followed by domain-specific pretraining with GastroNet. We trained the CADe system on a dataset of 14 046 images (2506 patients) of confirmed Barrett's oesophagus neoplasia and non-dysplastic Barrett's oesophagus from 15 centres. Neoplasia was delineated by 14 Barrett's oesophagus experts for all datasets. We tested the performance of the CADe system on two independent test sets. The all-comers test set comprised 327 (73 patients) non-dysplastic Barrett's oesophagus images, 82 (46 patients) neoplastic images, 180 (66 of the same patients) non-dysplastic Barrett's oesophagus videos, and 71 (45 of the same patients) neoplastic videos. The benchmarking test set comprised 100 (50 patients) neoplastic images, 300 (125 patients) non-dysplastic images, 47 (47 of the same patients) neoplastic videos, and 141 (82 of the same patients) non-dysplastic videos, and was enriched with subtle neoplasia cases. The benchmarking test set was evaluated by 112 endoscopists from six countries (first without CADe and, after 6 weeks, with CADe) and by 28 external international Barrett's oesophagus experts. The primary outcome was the sensitivity of Barrett's neoplasia detection by general endoscopists without CADe assistance versus with CADe assistance on the benchmarking test set. We compared sensitivity using a mixed-effects logistic regression model with conditional odds ratios (ORs; likelihood profile 95% CIs).FINDINGS: Sensitivity for neoplasia detection among endoscopists increased from 74% to 88% with CADe assistance (OR 2·04; 95% CI 1·73-2·42; p&lt;0·0001 for images and from 67% to 79% [2·35; 1·90-2·94; p&lt;0·0001] for video) without compromising specificity (from 89% to 90% [1·07; 0·96-1·19; p=0·20] for images and from 96% to 94% [0·94; 0·79-1·11; ] for video; p=0·46). In the all-comers test set, CADe detected neoplastic lesions in 95% (88-98) of images and 97% (90-99) of videos. In the benchmarking test set, the CADe system was superior to endoscopists in detecting neoplasia (90% vs 74% [OR 3·75; 95% CI 1·93-8·05; p=0·0002] for images and 91% vs 67% [11·68; 3·85-47·53; p&lt;0·0001] for video) and non-inferior to Barrett's oesophagus experts (90% vs 87% [OR 1·74; 95% CI 0·83-3·65] for images and 91% vs 86% [2·94; 0·99-11·40] for video).INTERPRETATION: CADe outperformed endoscopists in detecting Barrett's oesophagus neoplasia and, when used as an assistive tool, it improved their detection rate. CADe detected virtually all neoplasia in a test set of consecutive cases.FUNDING: Olympus.</p

    Clinical Management of Bile Duct Diseases: Role of Endoscopic Ultrasound in a Personalized Approach

    No full text
    Contains fulltext : 229384.pdf (publisher's version ) (Open Access)Biliary diseases are common, but clinical symptoms are often unspecific and direct access and visualization of the biliopancreatic system for diagnostic purpose is difficult. In the last decades endoscopic ultrasound (EUS) has become a primary method in the gastrointestinal tract. It significantly changed the role of endoscopy in diagnostic imaging in the gastrointestinal tract and adjacent organs. EUS has become an effective diagnostic tool in biliary stone disease as well as in the diagnosis of indeterminate biliary strictures. Furthermore, an EUS-directed transmural approach emerged as a safe and effective alternative to ERCP in patients requiring biliary drainage, in particular as a backup method if standard ERCP-approach fails. Development of new techniques, specific accessories and stents during the last decade led to an enormous step forward in terms of efficacy and safety of an EUS-directed approach. In the current article technical and clinical aspects of EUS-guided diagnostic and therapeutic approaches in different clinical indications will be discussed together with a review of the available data

    Endoscopic treatment of pancreatic duct stones under direct vision: Revolution or resignation? Systematic review

    No full text
    Item does not contain fulltextBACKGROUND AND AIM: The main treatment aim in chronic pancreatitis (CP) is symptom control and especially pain relief. Management of stone-predominant CP is challenging and requires a multidisciplinary approach. Extracorporeal shock wave lithotripsy (ESWL) has emerged as the cornerstone of non-surgical treatment as a result of disappointing results of available endoscopic treatment options during the last decades. With new developments in the field of direct peroral pancreatoscopy (POP) and intracorporeal lithotripsy, direct intraluminal treatment of main pancreatic duct (MPD) stones returns to the spotlight. METHODS: Herein, we reviewed the current data on direct pancreatoscopic treatment of MPD stones with a focus on efficiency and safety of available technologies, endoscopes and lithotripsy devices. A systematic Medline search for relevant studies was done. RESULTS: Ten relevant publications meeting the inclusion criteria were identified (two prospective series, six retrospective trials, two case reports, n = 87 patients). Successful ductal clearance for POP-guided treatment was reported as between 43% and 100% compared to ESWL with 59% to 80%. Adverse event rate for POP-guided therapy was reported as 0-13.5%. One study showed a noticeable higher adverse event rate of 43%. In this trial, POP was carried out after ESWL. There is no reported mortality following POP treatment. CONCLUSION: Available results are promising in terms of ductal clearance and pain relief compared to standard endoscopic techniques and ESWL as the current gold standard for lithotripsy. Interpretation of this data is limited by the small number of cases for POP and the lack of prospective randomized controlled trials

    Endobiliary polypectomy of biliary tumor using a prototype dedicated cholangioscope with double-bending technology

    No full text
    Contains fulltext : 200082.pdf (Publisher’s version ) (Open Access

    Hemoclips during motorized spiral enteroscopy—A unique case

    No full text
    corecore