Endoscopic Device Research Articles

Clinical follow-up on weight loss, glycemic control, and safety aspects of 24 months of duodenal-jejunal bypass liner implantation

BackgroundThe duodenal-jejunal bypass liner (DJBL) is an endoscopic device designed to induce weight loss and improve glycemic control. The liner is licensed for a maximum implant duration of 12 months. It might be hypothesized that extension of the dwelling time results in added value. The goals of our study were to determine weight change, change in glycemic control, and safety in patients with an intended 24 months of DJBL dwelling time.MethodsPatients were initially selected for a 12-month implantation period. When no physical complaints or adverse events (AEs) occurred, motivated patients who responded well were selected for extension of dwelling time to 24 months. Patients underwent a control endoscopy 12 months after implantation and visited the out-patient clinic every 3 months up to explantation. Patients agreed to remove the DJBL when complaints or AEs occurred that could not be treated conservatively.ResultsImplantation was extended in 44 patients, and 24 (55%) patients completed the full 24 months. Twenty patients required early removal due to AEs. During dwelling time, body weight decreased significantly (15.9 kg; TBWL 14.6%). HbA1c decreased non-significantly (4.9 mmol/mol). The number of insulin users and daily dose of insulin both decreased significantly. At 24 months after removal, glycemic control had worsened, while body weight was still significantly lower compared to baseline. In total, 68% of the patients experienced at least one AE. Two patients developed a hepatic abscess.ConclusionsDJBL treatment results in significant weight loss and improves glycemic control during implantation. The largest beneficial effects occur during the first 9–12 months after implantation. Extension of dwelling time to 24 months results only in stabilization of body weight and glycemic control. After explantation, weight improvements are maintained, but glycemic control worsens. As the cumulative risk of AEs increases with time, a maximal dwelling time of 12 months is advisable.

Endoscopic stabilization device evaluation using IDEAL framework: A quality improvement study.

To determine whether clinical evaluation reporting using the IDEAL (Idea, Development, Exploration, Assessment and Long-term study) framework improves a novel double-balloon endoscopic stabilization technology. Observational registry 6 month study with no follow-up. Using the Prospective Development Study (PDS) format recommended by the IDEAL collaboration, we report on continued refinement and optimization of an endoscopic stabilization platform during a clinical study conducted by two clinicians from the first case onwards. Key outcomes (ability to reach cecum, inflation of balloons in the sigmoid and ascending colon, and complications) were prospectively reported for each patient sequentially. All changes to technique were highlighted, showing when they occurred and an explanation for the change. 30 colonoscopies were undertaken using the device from April to September 2017. Two patients were excluded from the analysis for protocol deviations. Cecum was reached in 89% of the per protocol population of patients in an average time of 13.5 ± 11 min. Therapeutic zone creation was successful in 89% of patients on the right side of the intestine and 100% in those that reached the sigmoid. There were five deliberate changes in technique that occurred during the study that enabled improved device technical performance. There were no serious complications and one polyp was removed successfully using the device. Clinicians reported endoscope stability and increased visibility of the intestinal mucosa increased when using the device. The IDEAL framework provided a structured reporting of the changes made to technique. Those changes facilitated a device that is safe, has achieved stability with improved performance.

Percutaneous cystolitholapaxy: A safe and effective alternative to open stone surgery for the management of complex bladder stones in patients with no urethral access

Objectives: Bladder stone management in patients with reconstructed bladders drained by Mitrofanoff catheterizable channels, with no urethral access, generates multiple challenges. Trans-Mitrofanoff access limits the size of endoscopic stone fragmenting devices, risking prolonged procedures, incomplete stone clearance and damage to the continent conduit. Access through previous surgical access sites risks bowel injury. This case series reports outcomes in patients undergoing percutaneous cystolitholapaxy (PCCL), using ultrasound-guided access and direct track closure, thereby limiting radiation exposure and avoiding suprapubic catheters (SPCs). Patients and methods: Seven PCCL procedures were performed in five patients with closed urethras. Average age 32 years, primary diagnoses: spina bifida, vertebrae, anus, trachea, esophagus, renal (VATER) syndrome, bladder exstrophy and traumatic brain injury. Four used Mitrofanoff stomas and one an SPC. Average largest stone was 18.57 mm (range 10–30 mm). Five procedures were for multiple stones (range 2–30 stones). Results: Each PCCL achieved complete stone clearance. Average operative time: 146 min (range 72–250 min). No intraoperative blood loss or bladder perforation. Postoperative median length of stay was 2 days. Conclusion: PCCL is a safe, minimally invasive alternative to open surgery for large and multiple bladder stones in individuals with complex lower urinary tract anatomy, specifically reconstructed bladders drained by Mitrofanoff catheterizable channels with no urethral access. Level of evidence: Level 4

Solutions for submucosal injection: What to choose and how to do it.

During the past decades, endoscopic resection techniques have gradually improved and gained more importance for the management of premalignant lesions and early cancers. These endoscopic resection techniques can be divided in 3 major groups: snare polipectomy, endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD). The use of submucosal injection is essential for the majority of EMR techniques and is an integral part of ESD, whereas during polipectomy it is not crucial in most cases except to prevent bleeding in large polyps and/or those with large stalks as an alternative to mechanical methods. Injection provides a lifting up effect of the lesion separating it from the muscular layer, thereby reducing thermal injury and the risk of perforation and bleeding while also facilitating en-bloc resection by improving technical feasibility. With this work, we aim to review the most common endoscopic resection techniques and the importance of submucosal injection in each one of them. For that, we present some of the most commonly used submucosal injection solutions, taking into account their advantages and disadvantages. We also discuss, based on current recommendations and our own experience, how and when to preform submucosal injection, depending on lesions features and endoscopic resection technique that´s being used, to assure complete resection and to prevent associated adverse events. Finally, we also present and discuss some new proposed submucosal injection solutions, endoscopic resection techniques and devices that may have a major impact on the future of therapeutic endoscopy.

Michigan Medicine: The University of Michigan Head and Neck Anesthesiology and Advanced Airway Management Fellowship

Michigan Medicine: The University of Michigan Head and Neck Anesthesiology and Advanced Airway Management Fellowship

Evolution of Endoscopic Bariatric Devices: From Development to Practice.

To familiarize medical providers with the Food and Drug Administration approval process for antiobesity devices and to provide a brief overview of current and promising endoscopy-based bariatric devices. Literature review of published scholarly articles. There has been a rapid development of novel endoscopic bariatric therapies in recent years, resulting in the approval of multiple devices. Several promising endoscopic strategies are currently under investigation and review. The Food and Drug Administration has laid down an objective-tiered model to review antiobesity device applications. Endoscopic bariatric devices provide a new and promising paradigm in obesity management both as first-line therapy and as adjunctive treatment to medical and surgical strategies. Physicians who plan to offer endoscopic bariatric therapy in their practice need appropriate understanding of the regulatory processes involved in the development and approval of such devices.

Endoscopic resection techniques for colorectal neoplasia: Current developments.

Endoscopic polypectomy and endoscopic mucosal resection (EMR) are the established treatment standards for colorectal polyps. Current research aims at the reduction of both complication and recurrence rates as well as on shortening procedure times. Cold snare resection is the emerging standard for the treatment of smaller (< 5mm) polyps and is possibly also suitable for the removal of non-cancerous polyps up to 9 mm. The method avoids thermal damage, has reduced procedure times and probably also a lower risk for delayed bleeding. On the other end of the treatment spectrum, endoscopic submucosal dissection (ESD) offers en bloc resection of larger flat or sessile lesions. The technique has obvious advantages in the treatment of high-grade dysplasia and early cancer. Due to its minimal recurrence rate, it may also be an alternative to fractionated EMR of larger flat or sessile lesions. However, ESD is technically demanding and burdened by longer procedure times and higher costs. It should therefore be restricted to lesions suspicious for high-grade dysplasia or early invasive cancer. The latest addition to endoscopic resection techniques is endoscopic full-thickness resection with specifically developed devices for flexible endoscopy. This method is very useful for the treatment of smaller difficult-to-resect lesions, e.g., recurrence with scar formation after previous endoscopic resections.

Simplified synchronous disconnection of pulmonary arteries and veins for right upper lobectomy.

Video-assisted thoracoscopic lobectomy with lymphadenectomy is considered one of the most effective treatments for early non-small cell lung cancer. We developed a novel approach for lobectomy in patients with right upper lung cancer through simplified synchronous disconnection of pulmonary arteries and veins. This study aimed to evaluate the feasibility, efficacy, safety, and cost-effectiveness of this minimally invasive technique in managing right upper lobectomy. From March 2016 to September 2017, 62 patients with right upper lung cancer underwent lobectomy via simplified synchronous disconnection of pulmonary arteriovenous by video-assisted thoracoscopic surgery. All patients were followed up for 6-12 months after the procedure through clinic visits or telephone/e-mail interviews. Of the 62 patients (mean age, 57.2 ± 8.7years), 28 were men (45.2%) and 34 (54.8%) were women. All procedures were successfully performed by thoracoscopy, with a mean operating time of 66.2 ± 9.0min. The mean blood loss was 40.3 ± 19.5mL. Only 1 (1.61%) patient required blood transfusion. The mean number of endoscopic linear stapling devices used was 2.6 ± 0.7. The mean number of lymph nodes harvested was 16.0 ± 1.6. Postoperative pneumonia was encountered in 4 (6.45%) patients. There was no postoperative mortality. The mean length of hospital stay was 5.3 ± 1.3days. Six-month follow-up revealed an excellent clinical result and degree of satisfaction. Simplified synchronous disconnection of pulmonary arteries and veins is a feasible, economical, safe, and effective therapeutic procedure for right upper lung carcinoma. This novel procedure shows promise as a viable surgical approach for right upper lobectomy.

Enzymatic detergent reuse in gastroscope processing: a potential source of microorganism transmission.

Objective:to evaluate the potential contamination of enzymatic detergent from its reuse and to identify the microbiological profile in the solution used to clean gastrointestinal endoscopic devices.Method:cross-sectional study based on microbiological analysis of 76 aliquots of 19 different enzymatic detergent solutions used to clean endoscopic devices. The aliquots were homogenized, subjected to Millipore® 0.45 µm membrane filtration and the presumptive identification of microorganisms was performed by biochemical-physiological methods according to previously established specific bacterial groups that are of clinical and epidemiological relevance.Results:the mean values, as well as the standard deviation and the median, of the enzymatic detergent microbial load increased as the solution was reused. There was a significant difference between the means of after first use and after fifth reuse. A total of 97 microorganisms were identified, with predominance of the coagulase-negative Staphylococcus, Pseudomonas spp., Klebsiella spp., Enterobacter spp. genus, and Escherichia coli species.Conclusion:the reuse of the enzymatic detergent solution is a risk to the safe processing of endoscopic devices, evidenced by its contamination with pathogenic potential microorganisms, since the enzymatic detergent has no bactericidal property and can contribute as an important source for outbreaks in patients under such procedures.

Minimally Invasive Repair of Pediatric Morgagni Hernias Using Transfascial Sutures with Extracorporeal Knot Tying.

Morgagni hernias are rare, with a reported incidence of 2% to 5% of congenital diaphragmatic hernias. To review a laparoscopic technique to repair Morgagni hernias in pediatric patients. Retrospective chart review of pediatric patients who underwent minimally invasive repair of a Morgagni hernia from November 2009 to September 2017 within a defined population. During an 8-year period, 15 patients with Morgagni hernias were identified. Four patients with Morgagni hernias were excluded because they had open repairs. Eleven Morgagni hernias were repaired through a completely minimally invasive approach. Three repairs were completed using a soft-tissue patch (Gore-Tex patch, W L Gore & Associates Inc, Flagstaff, AZ). All minimally invasive repairs were completed with transfascial sutures using an endoscopic suturing device (Endo Close, Covidien/Medtronic, Fridley, MN) and 2-0 nonabsorbable synthetic sutures with extracorporeal knot tying. Median follow-up was 40 months (range = 2.6 months to 7.3 years). No patients had postoperative pectus excavatum defects. There were no recurrences. Morgagni hernias are amenable to minimally invasive repair with this simple technique. With large defects, synthetic patches should be used. Recurrences are rare, and morbidity is low.

Study on flexibility of endoscopic ultrasonic device using opposite phase vibration

Study on flexibility of endoscopic ultrasonic device using opposite phase vibration

EUS-specific stents: Available designs and probable lacunae.

Interventional EUS has seen exponential growth in its indications and applications in the last decade.[1,2,3] Dedicated endoscopic devices for EUS-guided interventions are still limited. Up until recently, the tools used have been borrowed from other procedures such as ERCP. In interventional EUS, the linear-array echoendoscope allows a needle to be advanced under EUS-guidance from the upper gastrointestinal lumen to the biliary, pancreatic, or another adjacent intestinal lumen. Real-time puncture can be performed and provide the possibility of EUS-guided transluminal drainage (EUS-TLD). Plastic stents and conventional self-expandable metallic stents (SEMSs) were initially used but present several limitations due to their design.[1,4,5] They lack lumen-to-lumen anchorage and present migratory risks in the absence of stricture to hold them in place. Plastic stents are associated with potential pneumoperitoneum and bile peritonitis, whereas fully-covered SEMS (FCSEMS), despite preventing bile leak, will not maintain secure apposition between two nonadherent organs. Furthermore, their length often exceeds the anatomical requirement of a shorter transluminal anastomosis and predisposes them to obstruction as well as difficult positioning. With the rise in new EUS-guided interventional techniques, new tools, in particular, new stent designs have evolved to facilitate the various applications. A few EUS-specific stents have now become available for EUS-TLD.[4,5] We hereby review the stent designs and discuss lacunae to be addressed to improve the efficacy, safety, and ease of procedures.

Современные лучевые технологии оценки почечной перфузии у больных мочекаменной болезнью

Urinary stone disease is the current issue for healthcare system worldwide. High prevalence of urinary stone disease (at least 5% of the population of developed countries) determines clinical significance of the studying of its etiology and pathogenesis, improving of diagnostic methods and novel treatment technologies. The development of endoscopic devices, creation of new eswl machines and improvement of endourology interventions under X-ray guidance allowed to solve the problem of surgical treatment. Therefore, one of the actual issue is the choice of X-ray method for predicting and evaluating of treatment efficiency in patients with urinary stone disease. The changes of renal blood flow depend on urodynamic disturbances, stone location and size, the duration of disease, complications, patients age. Therefore, for comprehensive studying of renal function the hemodynamics evaluation is needed. In this review the advantages, drawbacks and perspective on developing of different radiologic methods for renal hemodynamic assessment are given.

Comparison of a novel, endoscopic chest tube insertion technique versus the standard, open technique performed by novice users in a human cadaver model: a randomized, crossover, assessor-blinded study

BackgroundThe technique of tube thoracostomy has been standardized for years without significant updates. Alternative procedural methods may be beneficial in certain prehospital and inpatient environments with limited resources. We sought to compare the efficacy of chest tube insertion using a novel, endoscopic device (The Reactor™) to standard, open tube thoracostomy.MethodsNovice users were randomly assigned to pre-specified sequences of six chest tube insertions performed on a human cadaver model in a crossover design, alternating between the Reactor™ and standard technique. All subjects received standardized training in both procedures prior to randomization. Insertion site, which was randomly assigned within each cadaver’s hemithorax, was marked by the investigators; study techniques began with skin incision and ended with tube insertion. Adequacy of tube placement (intrapleural, unkinked, not in fissure) and incision length were recorded by investigators blinded to procedural technique. Insertion time and user-rated difficulty were documented in an unblinded fashion. After completing the study, participants rated various aspects of use of the Reactor™ compared to the standard technique in a survey evaluation.ResultsSixteen subjects were enrolled (7 medical students, 9 paramedics) and performed 92 chest tube insertions (n = 46 Reactor™, n = 46 standard). The Reactor™ was associated with less frequent appropriate tube positioning (41.3% vs. 73.9%, P = 0.0029), a faster median insertion time (47.3 s, interquartile range 38–63.1 vs. 76.9 s, interquartile range 55.3–106.9, P < 0.0001) and shorter median incision length (28 mm, interquartile range 23–30 vs. 32 mm, interquartile range 26–40, P = 0.0034) compared to the standard technique. Using a 10-point Likert scale (1-easiest, 10-hardest) participants rated the ease of use of the Reactor™ no different from the standard method (3.8 ± 1.9 vs. 4.7 ± 1.9, P = 0.024). The Reactor™ received generally favorable scores for all parameters on the post-participation survey.ConclusionsIn this randomized, assessor-blinded, crossover human cadaver study, chest tube insertion using the Reactor™ device resulted in faster insertion time and shorter incision length, but less frequent appropriate tube placement compared with the standard technique. Additional studies are needed to evaluate the efficacy, safety and potential advantages of this novel device.

Reprocessing of flexible endoscopes and endoscopic accessories used in gastrointestinal endoscopy: Position Statement of the European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology Nurses and Associates (ESGENA) – Update 2018

This Position Statement from the European Society of Gastrointestinal Endoscopy (ESGE) and the European Society of Gastroenterology Nurses and Associates (ESGENA) sets standards for the reprocessing of flexible endoscopes and endoscopic devices used in gastroenterology. An expert working group of gastroenterologists, endoscopy nurses, chemists, microbiologists, and industry representatives provides updated recommendations on all aspects of reprocessing in order to maintain hygiene and infection control.

Multi-Spectral Fluorescence Imaging of Colon Dysplasia InVivo Using a Multi-Spectral Endoscopy System

BACKGROUND AND STUDY AIM: To develop a molecular imaging endoscopic system that eliminates tissue autofluorescence and distinguishes multiple fluorescent markers specifically on the cancerous lesions. METHODS: Newly developed multi-spectral fluorescence endoscope device has the potential to eliminate signal interference due to autofluorescence and multiplex fluorophores in fluorescent probes. The multiplexing capability of the multi-spectral endoscope device was demonstrated in the phantom studies and multi-spectral imaging with endoscopy and macroscopy was performed to analyze fluorescence signals after administration of fluorescent probe that targets cancer in the colon. Because of the limitations in the clinical application using rigid-type small animal endoscope, we developed a flexible channel insert-type fluorescence endoscope, which was validated on the colonoscopy of dummy and porcine model. RESULTS: We measured multiple fluorescent signals simultaneously, and the fluorescence spectra were unmixed to separate the fluorescent signals of each probe, in which multiple fluorescent probes clearly revealed spectral deconvolution at the specific targeting area in the mouse colon. The positive area of fluorescence signal for each probe over the whole polyp was segmented with analyzing software, and showed distinctive patterns and significantly distinguishable values: 0.46 ± 0.04, 0.39 ± 0.08 and 0.73 ± 0.12 for HMRG, CET-553 and TRA-675 probes, respectively. The spectral unmixing was finally demonstrated in the dummy and porcine model, corroborating the targeted multi-spectral fluorescence imaging of colon dysplasia. CONCLUSION: The multi-spectral endoscopy system may allow endoscopists to clearly identify cancerous lesion that has different patterns of various target expression using multiple fluorescent probes.

Technical Feasibility of a Guidetube for Various Endoscopic Procedures in Human Gastrointestinal Simulators.

Background/AimsMany gastrointestinal (GI) endoscopic procedures are difficult and cumbersome owing to the limitation of currently available endoscopic devices. This study aimed to develop an endoscopic guidetube for multipurpose endoscopic procedures and assess its use in a realistic GI endoscopic simulator. MethodsThe guidetube used is a soft overtube composed of neoprene and is designed to assist various endoscopic procedures on demand. In total, 15 types of procedures were performed in GI simulators. Four procedures were performed in the stomach model and 11 in the colon model. The procedures include repeated endoscopic insertion and foreign body removal in various positions. The mean insertion and procedure time were assessed in each session. All procedures were performed by 5 expert endoscopists. ResultsEndoscopic procedures with the new guidetube were faster and more effective than the conventional endoscopic techniques. The mean insertion time of the endoscope with the guidetube was significantly shorter than that without the guidetube. The guidetube was safely inserted without scratch using low pushing force. Objects of various sizes larger than the endoscopic channel were easily removed by the guidetube-assisted endoscopic procedures. ConclusionsThis preliminary study shows that guidetube-assisted endoscopic procedures are faster, easier, safer and cheaper than conventional endoscopic procedures.

Endoscopic Full-Thickness Defects and Closure Techniques.

Gastrointestinal transmural defects are defined as total rupture of the gastrointestinal wall and can be divided into three main categories: perforations, leaks, and fistulas. Due to an increase in the number of therapeutic endoscopic procedures including full-thickness resections and the increase incidence of complications related to bariatric surgeries, there has been an increase in the number of transmural defects seen in clinical practice and the number of non-invasive endoscopic treatment procedures used to treat these defects. The variety of endoscopic approaches and devices, including closure techniques using clips, endoloop, and endoscopic sutures; covering techniques such as the cardiac septal occluder device, luminal stents, and tissue sealants; and drainage techniques including endoscopic vacuum therapy, pigtail, and septotomy with balloon dilation are transforming endoscopy as the first-line approach for therapy of these conditions. In this review, we describe the various transmural defects and the endoscopic techniques and devices used in their closure.

Competences in bronchoscopy for Intensive Care Unit, anesthesiology, thoracic surgery and lung transplantation.

Over the last decades, the use of flexible bronchoscopy has greatly increased in intensive care, anesthesia and thoracic surgery for diagnostic purpose, management of critical patients and to facilitate airway management for tracheal intubation, one lung ventilation and lung transplant management. The huge availability of endoscopic instruments and devices for airway management has amplified indications and possibilities for bronchoscopic procedures performed by intensive care physicians, anesthesiologist, endoscopists, and surgeons too. These practices need adequate technical skills that can be acquired only through defined learning pathways. This manuscript summarizes the indications and the competencies needed to perform bronchoscopic procedures in intensive care, anesthesia and thoracic surgery settings.

Therapeutic effect of endoscopic anterior fundoplication by MUSE™ in thirteen patients with gastroesophageal reflux disease

Objective To evaluate the efficacy and safety of endoscopic anterior fundoplication by the MUSE™ endoscopic stapling device in gastroesophageal reflux disease (GERD). Methods From March to November 2017, in the Department of Gastroenterology of Chinese PLA General Hospital in Beijing, The First People′s Hospital Affiliated to Shanghai Jiao Tong University and Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, thirteen GERD patients who underwent the endoscopic anterior fundoplication by the MUSE™ system were enrolled. The GERD health related quality of life questionnaire (GERD-HRQL) score, satisfaction of symptomatic control, questionnaire for gastroesophageal reflux disease (GERD-Q) score, the degree of esophagitis, condition of gastroesophageal flap valve, medicine administration and side effects were compared before and after the operation. Paired t test and Wilcoxon rank sum test were performed for statistical analysis. Results The total GERD-HRQL score decreased from 23 points (14 to 36 points) before operation when proton pump inhibitor (PPI) was stopped for seven days to 3 points (0 to 21 points) at three months after operation and 1 point (0 to 18 points) at six months after operation; and the differences were statistically significant (Z=-3.111 and -3.183, both P 0.05). The number of patients without esophagitis increased from three before treatment to eight after treatment. Additionally, the number of patients whose gastroesophageal flap valve was less than grade Ⅱ increased from three before operation to 11 at six months after operation. The patients were followed up for six months, among 13 patients, 10 patients were completely deprived of PPI, one patient was reduced over 50%, and two patients were treated with less than 50% reduction. All 13 patients had mild tolerable abdominal pain and sore throat within 48 hours after operation. No other adverse reactions were observed. Conclusion The endoscopic anterior fundoplication by the MUSE™ is a safe and effective treatment for GERD. Key words: Gastroesophageal reflux; Fundoplication; Proton pump inhibitors; Medigus ultrasonic surgical endostapler