Clinical utility of novel ultrathin single-balloon enteroscopy: a feasibility study.

BACKGROUND: The advent of balloon-assisted enteroscopy (BAE) has facilitated the examination of the entire digestive tract. However, using a rigid sliding tube during the procedure reduces patient acceptance. This study evaluated the clinical application of a newly developed ultrathin single-balloon enteroscope for BAE. METHODS: 28 outpatients underwent enteroscopy with a novel ultrathin single-balloon enteroscope. None of the subjects required therapeutic procedures, such as balloon dilation or hemostasis. The insertability, efficacy, and safety of the ultrathin single-balloon endoscope were evaluated retrospectively. RESULTS: 7 patients underwent transoral enteroscopy and 21 patients underwent transanal enteroscopy under conscious sedation. No adverse events related to the procedure were reported in any patients. Targeted observation and/or targeted biopsy were achieved in all procedures. All transoral procedures allowed evaluation of the jejunum beyond the ligament of Treitz. All transanal procedures allowed intubation of the terminal ileum, despite several patients having severe stenosis of the colon and ileum. CONCLUSION: A novel ultrathin single-balloon enteroscope showed adequate insertability and safety for outpatient surveillance enteroscopy under conscious sedation.

Procedures in endoscope reprocessing and monitoring: an Italian survey.

BACKGROUND: The high diffusion of endoscopes worldwide and the need for effective reprocessing methods requested the development of guidelines and implementation of surveillance procedures at local level. STUDY DESIGN: In order to collect data on everyday's practice and adherence to available guidelines, endoscopy units from different public institutions were surveyed using a dedicated questionnaire. METHODS: Between July and November 2015 a survey was carried in 12 main hospitals from 10 different Italian regions, involving 22 endoscopy units. The state of the art of national and international guidelines was investigated to compare the protocols adopted at local level. RESULTS: In all the surveyed hospitals, the reprocessing activity is based on pre-established protocols in adherence with principal guidelines. Enzymatic detergents, which are recommended by the international guidelines, are used in 55.6% of units and peracetic acid is currently the most widely used chemical disinfectant. Discrepancies were observed in the application of periodic quality controls. CONCLUSION: Updated guidelines are generally applied in reprocessing practice. Quality controls may represent a critical issue to improve effectiveness and surveillance. The whole of acquired data can promote a positive trend towards the application of best practices.

[Hygiene in endoscopy in clinic and practice 2013 in comparison with 2003--structure and process quality]. / Struktur- und Prozessqualität bei der Aufbereitung flexibler Endoskope in Klinik und Praxis in Frankfurt am Main--2013 im Vergleich zu 2003.

BACKGROUND: Endoscopy is an important part of modern medical diagnostics and therapy. The invasive procedures are however associated with a risk to transmit infections. Against this background the KRINKO has published the "Hygienic requirements for the reprocessing of flexible endoscopes and endoscopic accessories" in 2002 and has updated these recommendations in 2012. In 2003 and 2013 all gastroenterological facilities in Frankfurt am Main using flexible endoscopes were monitored for compliance with the recommendations. METHODS: The inspections were performed after prior notice by a staff member of the health authority using a checklist which had been developed on the basis of the current KRINKO recommendations. RESULTS: In both years all institutions performing endoscopic procedures were visited: 2003 15 hospitals and 23 practices; 2013 14 clinics and 10 practices. In 2013 (data for 2003 in brackets) 100 % (93 %) of the hospitals and 60 % (22 %) of practices reprocessed their endoscopes by automated methods. The appropriate reprocessing and filling of water bottles for rinsing the scope channels with sterile water and the sterilisation of accessories were satisfactorily performed in 2003 and 2013 by all hospitals. However in 2013 only 90 % (2003: 74 %) of the practices correctly reprocessed water bottles and 80 % (52 %) used sterile water for filling the bottle. In 2013 100 % (2003: 57 %) of the practices correctly sterilised accessory instruments, while 2 practices used disposable, i. e., single-use materials. In 2013 all institutions performed microbiological tests according to KRINKO recommendations, while in 2003 all hospitals but only 43 % of the practices could present such tests. DISCUSSION: While the gastroenterological departments of Frankfurt hospitals already complied with the KRINKO recommendations in 2003, the inspection of several practices in 2003 had revealed considerable shortcomings in the implementation of these recommendations. Subsequently the practices have improved their hygiene management.

'Short' double-balloon enteroscope endoscopic retrograde cholangiopancreatography in patients with a surgically altered upper gastrointestinal tract.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) remains a challenge for endoscopists in patients with surgically altered anatomy of the upper gastrointestinal tract. Double-balloon enteroscopes (DBEs) have revolutionized the ability to access the small bowel. The indication for its therapeutic use is expanding to include ERCP for patients who have undergone small bowel reconstruction. Most of the published experiences in DBE-assisted ERCP have used conventional double-balloon enteroscopes that are 200 cm in length, which do not permit use of the standard ERCP accessories. The authors report their experience with DBE-assisted ERCP using a 'short' DBE in patients with surgically altered anatomy. METHODS: A retrospective review of patients with previous small bowel reconstruction who underwent ERCP with a 'short' DBE at the Centre for Therapeutic Endoscopy and Endoscopic Oncology (Toronto, Ontario) between February 2007 and November 2008 was performed. RESULTS: A total of 20 patients (10 men) with a mean age of 57.9 years (range 26 to 85 years) underwent 29 sessions of ERCP with a DBE. Six patients underwent Billroth II gastroenterostomy, seven patients Roux-en-Y hepaticojejunostomy, five patients Roux-en-Y gastrojejunostomy, one patient Roux-en-Y esophagojejunostomy and one patient a Whipple's operation with choledochojejunostomy. Some patients (n=12 [60%]) underwent previous attempts at ERCP in which the papilla of Vater or bilioenteric anastomosis could not be reached with either a duodenoscope or pediatric colonoscope. All procedures were performed with a commercially available DBE (working length 152 cm, distal end diameter 9.4 mm, channel diameter 2.8 mm). The procedures were performed under conscious sedation with intravenous midazolam, fentanyl and diazepam, except in one patient in whom general anesthesia was administered. Either the papilla of Vater or bilioenteric anastomosis was reached in 25 of 29 cases (86.2%) in a mean duration of 20.8 min (range 5 min to 82 min). Bile duct cannulation was successful in 24 of 25 cases in which the papilla or bilioenteric anastomosis was reached. Therapeutic interventions were successful in 15 patients (24 procedures) including sphincterotomy (n=7), stone extraction (n=9), biliary dilation (n=8), stent placement (n=9) and stent removal (n=8). The mean total duration of the procedures was 70.7 min (range 30 min to 117 min). There were no procedure-related complications. CONCLUSION: DBEs enable successful diagnostic and therapeutic ERCP in patients with a surgically altered anatomy of the upper gastrointestinal tract. It is a safe, feasible and less invasive therapeutic option in this group of patients. Standard 'long' DBEs have limitations of long working length and the need for modified ERCP accessories. 'Short' DBEs are equally as effective in reaching the target limb as standard 'long' DBEs, and overcomes some limitations of long DBEs to result in high success rates for endoscopic therapy.

Natural orifice translumenal endoscopic surgery.

PURPOSE OF REVIEW: Since its introduction in 2000, natural orifice translumenal endoscopic surgery (NOTES) has gained a great deal of attention from gastroenterologists and surgeons all over the world. In this article, we will review the progress in the field of NOTES and present the latest publications that provide some answers and solutions to the barriers suggested by the Natural Orifice Surgery Consortium for Assessment and Research white paper. RECENT FINDINGS: Because of the first human NOTES procedure by Rao and Reddy, more pioneering procedures, including transgastric and transvaginal cholecystectomies, appendectomies, and hernia repairs, have been performed. Although NOTES researchers continue to experiment with new innovative equipment and procedures in the lab, more structured work, including randomized controlled trials, has been published. SUMMARY: In the last several years, there has been growing interest in NOTES, which has translated into exciting animal research work and publication of randomized controlled trials. Additionally, preliminary NOTES human procedures have been successfully performed. When suitable instruments become available, the subsequent step should be comparing NOTES with current laparoscopic approaches. Superiority or even equality of NOTES to laparoscopic surgery would be the best argument for advancing and integrating implementation into clinical practice.

Enteral nutrition access devices.

The ASGE Technology Committee provides reviews of existing, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Evidence-based methodology is used, performing a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported complications of a given technology. Both are supplemented by accessing the "related articles" feature of PubMed and by scrutinizing pertinent references cited by the identified studies. Controlled clinical trials are emphasized, but, in many cases, data from randomized, controlled trials are lacking. In such situations, large case series, preliminary clinical studies, and expert opinions are used. Technical data are gathered from traditional and Web-based publications, proprietary publications, and informal communications with pertinent vendors. Technology Status Evaluation Reports are drafted by 1 or 2 members of the ASGE Technology Committee, reviewed and edited by the committee as a whole, and approved by the ASGE Governing Board. When financial guidance is indicated, the most recent coding data and list prices at the time of publication are provided. For this review, the MEDLINE database was searched through August 2009 for articles related to endoscopy in patients requiring enteral feeding access by using the keywords "endoscopy," "percutaneous," "gastrostomy," "jejunostomy," "nasogastric," "nasoenteric," "nasojejunal," "transnasal," "feeding tube," "enteric," and "button." Technology Status Evaluation Reports are scientific reviews provided solely for educational and informational purposes. Technology Status Evaluation Reports are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment.

Automated endoscope reprocessors.

The ASGE Technology Committee provides reviews of existing, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Evidence-based methodology is used, with a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported complications of a given technology. Both are supplemented by accessing the "related articles" feature of PubMed and by scrutinizing pertinent references cited by the identified studies. Controlled clinical trials are emphasized, but in many cases data from randomized, controlled trials are lacking. In such cases, large case series, preliminary clinical studies, and expert opinions are used. Technical data are gathered from traditional and Web-based publications, proprietary publications, and informal communications with pertinent vendors. Technology Status Evaluation Reports are drafted by 1 or 2 members of the ASGE Technology Committee, reviewed and edited by the committee as a whole, and approved by the Governing Board of the ASGE. When financial guidance is indicated, the most recent coding data and list prices at the time of publication are provided. For this review, the MEDLINE database was searched through February 2010 for articles related to automated endoscope reprocessors, using the words endoscope reprocessing, endoscope cleaning, automated endoscope reprocessors, and high-level disinfection. Technology Status Evaluation Reports are scientific reviews provided solely for educational and informational purposes. Technology Status Evaluation Reports are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment.

The role of the U.S. Food and Drug Administration in device evaluation and monitoring.

The American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee provides reviews of existing, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Evidence-based methodology is used by performing a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported complications of a given technology. Both are supplemented by accessing the "related articles" feature of PubMed and by scrutinizing pertinent references cited by the identified studies. Technology Status Evaluation Reports are drafted by 1 or 2 members of the ASGE Technology Committee, reviewed and edited by the committee as a whole, and approved by the Governing Board of the ASGE. When financial guidance is indicated, the most recent coding data and list prices at the time of publication are provided. For this review, the MEDLINE database was searched through October 2009 for articles and references related to devices and the U.S. Food and Drug Administration by using the keywords "FDA" and "devices." In addition, the Web was searched using the same keywords. The U.S. Food and Drug Administration website was also thoroughly reviewed. Practitioners should continue to monitor the medical literature for subsequent data about these issues. Technology Status Evaluation Reports are scientific reviews provided solely for educational and informational purposes. Technology Status Evaluation Reports are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment.

Robotic versus manual control in magnetic steering of an endoscopic capsule.

BACKGROUND AND STUDY AIMS: Capsular endoscopy holds promise for the improved inspection of the gastrointestinal tract. However, this technique is limited by a lack of controlled capsule locomotion. Magnetic steering has been proposed by the main worldwide suppliers of commercial capsular endoscopes and by several research groups. The present study evaluates and discusses how robotics may improve diagnostic outcomes compared with manual magnetic steering of an endoscopic capsule. MATERIALS AND METHODS: An endoscopic capsule prototype incorporating permanent magnets was deployed in an ex vivo colon segment. An operator controlled the external driving magnet manually or with robotic assistance. The capsule was maneuvered through the colon, visualizing and contacting targets installed on the colon wall. Procedure completion time and number of targets reached were collected for each trial to quantitatively compare manual versus robotic magnetic steering ( T-test analysis with P = 0.01). Then, through a set of in vivo animal trials, the efficacy of both approaches was qualitatively assessed. RESULTS: In ex vivo conditions, robotic-assisted control was superior to manual control in terms of targets reached (87 % +/- 13 % vs 37 % +/- 14 %). Manual steering demonstrated faster trial completion time (201 +/- 24 seconds vs 423 +/- 48 seconds). Under in vivo conditions, the robotic approach confirmed higher precision of movement and better reliability compared with manual control. CONCLUSIONS: Robotic control for magnetic steering of a capsular endoscope was demonstrated to be more precise and reliable than manual operation. Validation of the proposed robotic system paves the way for automation of capsular endoscopy and advanced endoscopic techniques.

Computer-aided recording of automatic endoscope washing and disinfection processes as an integral part of medical documentation for quality assurance purposes.

BACKGROUND: The reprocessing of medical endoscopes is carried out using automatic cleaning and disinfection machines. The documentation and archiving of records of properly conducted reprocessing procedures is the last and increasingly important part of the reprocessing cycle for flexible endoscopes. METHODS: This report describes a new computer program designed to monitor and document the automatic reprocessing of flexible endoscopes and accessories in fully automatic washer-disinfectors; it does not contain nor compensate the manual cleaning step. The program implements national standards for the monitoring of hygiene in flexible endoscopes and the guidelines for the reprocessing of medical products. No FDA approval has been obtained up to now. The advantages of this newly developed computer program are firstly that it simplifies the documentation procedures of medical endoscopes and that it could be used universally with any washer-disinfector and that it is independent of the various interfaces and software products provided by the individual suppliers of washer-disinfectors. RESULTS: The computer program presented here has been tested on a total of four washer-disinfectors in more than 6000 medical examinations within 9 months. CONCLUSIONS: We present for the first time an electronic documentation system for automated washer-disinfectors for medical devices e.g. flexible endoscopes which can be used on any washer-disinfectors that documents the procedures involved in the automatic cleaning process and can be easily connected to most hospital documentation systems.

[Improvement of endoscopic treatment of the acute cholecystitis].

Treatment results of 763 patients with acute cholecystitis were analyzed. Destructive forms of the disease was diagnosed by the ultrasound examination in all cases. Choledocholithiasis was diagnosed in 35 (4.6%), choledocholithiasis with papilla Vatery stricture was in 9 (1.2%) patients and isolated papilla Vatery stricture was registered in 5 (0.7%) patients. All patients were attempted to treat laparoscopically with the use of original "Device for antegrade papillotomy" and "Method of antegrade bipolar papillosphincterotomy". Authors state, that a final decision about the possibility of endoscopic treatment of the acute cholecystitis can be made after detection of anatomical structures of the Calo triangle. By complicated forms of the disease a one-stage laparoscopic treatment should be preferred. Endoscopic papillosphincterotomy should be performed only by the enblocked concrement of the papilla Vatery.

The Centers for Disease Control and Prevention Guidance on Flexible Gastrointestinal Endoscopes: Lessons Learned from Outbreaks, Infection Control.

Flexible endoscopes require cleaning, high-level disinfection, and sterilization between each patient use to reduce risk of transmitting pathogens. Public health investigations have identified concerns, including endoscope damage, mishandling, and reprocessing deficiencies, placing patients at risk for transmission of bacterial, viral, and other pathogens. Findings from outbreak investigations and other studies have led to innovations in endoscope design, use, and reprocessing, yet infection risks related to contaminated or damaged endoscopes remain. Strict adherence to infection control guidelines and manufacturer instructions for use, utilization of supplemental guidance, and training and oversight of reprocessing personnel, reduce risk of pathogen transmission by flexible endoscopes.

Double-balloon endoscopy: past, present, and future.

Double-balloon endoscopy (DBE) was developed as a new technique for visualization of and intervention in the entire small intestine. In DBE, the intestinal walls are held apart by a balloon attached to the distal end of a soft overtube. DBE has been reported worldwide to be very useful for not only diagnosis but also endoscopic therapy. Biopsy samples of small intestinal tumors can be obtained using DBE, and the appropriate treatment can be selected before a surgical procedure. For inflammatory diseases, DBE can reveal the localization of ulcers in the lumen (on the mesenteric or antimesenteric side), which is important for differential diagnosis. Some endoscopic therapies such as hemostatic procedures, polypectomy, and dilation therapy for benign strictures can be performed in the same manner as in the large intestine. DBE may also be suitable for colonoscopy for difficult insertion cases and therapeutic procedures such as endoscopic submucosal dissection. Furthermore, a double-balloon endoscope can be selectively inserted into the afferent loop to perform endoscopic retrograde cholangiopancreatography in patients with Roux-en-Y anastomosis, allowing various kinds of endoscopic treatments for biliary diseases to be successfully performed. Endoscopic therapy in the small intestine, whose wall is very thin, should be performed with special care to avoid complications such as bleeding and perforation. In the future, improvement is expected in terms of maneuverability, therapeutic capability, and imaging technology such as the addition of a magnifying function and flexible spectral imaging color enhancement. We anticipate that DBE will contribute to the establishment of medical science of the small intestine and to research elucidating the mechanisms of small intestinal diseases.

Small bowel enteroscopy.

For the examination of the small bowel in patients with suspected small bowel bleeding, endoscopic tools to perform deep enteroscopy have become essential. Double balloon enteroscopy has gained worldwide acceptance as an endoscopic technique that can be used safely and effectively to provide complete examination of the small bowel, offer therapeutic intervention, and favorably affect clinical outcomes. Single balloon enteroscopy seems to have utility similar to that of the double balloon system. Preliminary experience with a novel overtube device using either the single or double balloon enteroscope has suggested that this may be a very viable approach to deep enteroscopy. Collectively, these are remarkable innovations that allow access to portions of the small bowel that were previously only available by intraoperative enteroscopy or laparotomy. On the basis of the available data, each of these procedures seems to have unique merits, is generally safe and well tolerated, and is highly likely to be clinically beneficial.

A novel device for endoscopic submucosal dissection, the Fork knife.

AIM: To introduce and evaluate the efficacy and technical aspects of endoscopic submucosal dissection (ESD) using a novel device, the Fork knife. METHODS: From March 2004 to April 2008, ESD was performed on 265 gastric lesions using a Fork knife (Endo FS) (group A) and on 72 gastric lesions using a Flexknife (group B) at a single tertiary referral center. We retrospectively compared the endoscopic characteristics of the tumors, pathological findings, and sizes of the resected specimens. We also compared the en bloc resection rate, complete resection rate, complications, and procedure time between the two groups. RESULTS: The mean size of the resected specimens was 4.27 +/- 1.26 cm in group A and 4.29 +/- 1.48 cm in group B. The en bloc resection rate was 95.8% (254/265 lesions) in group A and 93.1% (67/72) in group B. Complete ESD without tumor cell invasion of the resected margin was obtained in 81.1% (215/265) of group A and in 73.6% (53/72) of group B. The perforation rate was 0.8% (2/265) in group A and 1.4% (1/72) in group B. The mean procedure time was 59.63 +/- 56.12 min in group A and 76.65 +/- 70.75 min in group B (P < 0.05). CONCLUSION: The Fork knife (Endo FS) is useful for clinical practice and has the advantage of reducing the procedure time.

Advanced endoscopic technologies.

The use of endoscopy for diagnosing and treating ailments of the alimentary tract has evolved steadily over the past few decades, with tremendous growth and innovation in the past few years. Initially, endoscopy relied on rigid telescopes, direct visualization, and dangerously exothermic sources of illumination. The introduction of fiber optics, charge-coupled-device cameras, and increasingly efficient light sources has enabled researchers to investigate areas of the human gastrointestinal tract through flexible endoscopy not previously thought to be reachable without formal surgical exploration. The more recent advances in scope platforms, devices, and techniques have allowed researchers to push the envelope of endoscopic diagnostics and therapeutics to greater heights. Specific new platforms include ColonoSight and mother-daughter endoscopes such as the ShapeLock TransPort and the SpyGlass direct visualization system. Specific devices include the EndoCinch suturing system, the full-thickness Plicator procedure, Esophyx, the Stretta system, and the HALO(360) system. Specific new techniques include small-caliber endoscopy, endoscopic mucosal and submucosal resection, and natural orifice translumenal endoscopic surgery (NOTES). This article describes the most relevant recent advances in endoscopic innovation with regard to platform design, devices, and techniques anticipated to serve as the foundation for further research and design for developing generations of endoscopic technologies to come.

Transnasal esogastroduodenoscopy (EGD): comparison with conventional EGD and new applications.

Technical improvements have allowed to significantly reduce the diameter of endoscopes used to examine the upper gastrointestinal tract. Hence, transnasal introduction of endoscopes used to perform a standard esogastroduodenoscopy (EGD) has become possible. Transnasal EGD (T-EGD) is better tolerated by patients than conventional EGD (C-EGD), and it presents the advantage of requiring no sedation in most patients (and, consequently, to reduce associated costs). However, the reduction in endoscope diameter has been obtained at the expense of a somewhat inferior image quality and a smaller biopsy channel diameter. Specific diagnostic and therapeutic applications taking advantage of the transnasal approach have also recently emerged (e.g., cholangioscopy placement of feeding tubes or of nasobiliary drains). The technique, feasibility, patient tolerance to unsedated procedure, diagnostic accuracy, costs, and novel therapeutic applications of T-EGD are reviewed.