Motorised spiral enteroscopy: first prospective clinical feasibility study.

OBJECTIVE: Currently available methods for small bowel endoscopy are often time consuming; motorised PowerSpiral Enteroscopy (PSE) is a further development of spiral enteroscopy to facilitate the approach to the small bowel. The aim of this bicentric prospective trial was to study feasibility and yield of peroral PSE. DESIGN: Consecutive patients with suspected small bowel disease and indication for antegrade enteroscopy were included in two tertiary referral centres. Primary objective was diagnostic yield of antegrade PSE. Secondary objectives included technical success (defined as successful endoscope insertion at least to ligament of Treitz), depth of maximum insertion (DMI), median insertion time to DMI, rate of therapeutic procedures and adverse events. RESULTS: During a 30-month period, 140 procedures were performed on 132 patients (58 female, 74 male; median age: 68 (20-100) years) under general anaesthesia. Overall diagnostic yield of PSE was 74.2%; with 68.2% of procedures including some form of endotherapy. Technical success rate of PSE was 97%; median DMI was 450 cm (0-600) with a median insertion time to DMI of 25 min (3-122). Antegrade panenteroscopy to the cecum was achieved in 14 cases (10.6%). Overall adverse event (AE) rate was 14.4%; two major serious AEs occurred (1.5%), one delayed perforation, one bleeding from Mallory-Weiss lesion. CONCLUSION: This pilot clinical trial demonstrates that PSE is effective for diagnostic and therapeutic antegrade enteroscopy and may compare favourably with traditional methods of deep enteroscopy in ease of use and procedural duration. More comparative data are required to assess clinical application and safety of PSE. TRIAL REGISTRATION NUMBER: NCT02965209.

Nosocomial outbreak linked to a flexible gastrointestinal endoscope contaminated with an amikacin-resistant ST17 clone of Pseudomonas aeruginosa.

Endoscope contamination is infrequent but can be the source of nosocomial infections and outbreaks. In August 2016, an unexpected increase in the incidence of amikacin-resistant P. aeruginosa isolates (AK-Pae) was observed at a tertiary care center in the south of Spain. An epidemiological and microbiological investigation (August-October 2016) was performed to explain this finding. Isolates from clinical and environmental samples (2 endoscopes used for retrograde cholangiopancreatography; ERCP) were identified by MALDI-TOF. Antimicrobial susceptibility testing was performed using the MicroScan system. Whole-Genome-Sequencing (Miseq, Illumina) was performed to determine the resistome and virulome. Clonal relatedness among isolates was assessed by SpeI-PFGE and MLST. A Caenorhabditis elegans killing assay was performed for virulence testing. Biofilm formation was performed using a colorimetric assay. Four of the 5 patients infected and/or colonized with AK-Pae in August 2016 had undergone ERCP ≤5 days before sample collection. Two endoscopes were contaminated with AK-Pae. Isolates from one endoscope showed an identical PFGE pattern to 9 isolates (cluster I) and differed (1-2 bands) to 5 isolates (cluster II). Isolates from these clusters belonged to the ST17 clone. This S17 clone was characterized by its low virulence in the C. elegans killing assay, and its biofilm-forming ability, slightly superior to that of high-risk clones of P. aeruginosa ST175 and ST235. This outbreak was caused by an endoscope used for ERCP contaminated with an invasive, moderately virulent, biofilm-forming AK-Pae ST17 clone, suggesting the possible emergence of a new high-risk lineage of this clone.

Evaluation of complications after endoscopic retrograde cholangiopancreatography using a short type double balloon endoscope in patients with altered gastrointestinal anatomy: a single-center retrospective study of 1,576 procedures.

BACKGROUND AND AIM: Endoscopic retrograde cholangiopancreatography (ERCP) using balloon-assisted endoscope such as double-balloon endoscope is even effective for patients with surgically altered anatomy. Yet comprehensive studies on complications of ERCP using balloon-assisted endoscope have not been made. We analyzed the characteristics and the causes of complications of ERCP using double-balloon endoscope (DB-ERCP) procedures and aimed to suggest effective managements. METHODS: A total of 1576 procedures of DB-ERCP in 714 patients with surgically altered gastrointestinal anatomy in our hospital were evaluated retrospectively using a statistic analysis. RESULTS: The overall complication occurrence rate was 5.8%. By type of complications are perforation 3.2%, mucosal laceration 0.5%, hemorrhage 1.0%, pancreatitis 0.6%, respiratory disorder 0.4%, and others 0.2%. By type of surgical reconstruction methods were Roux-en-Y reconstruction with choledocho-jejunal anastomosis 4.2%, Roux-en-Y reconstruction without choledocho-jejunal anastomosis 6.7%, pancreaticoduodenectomy 4.5%, pylorus preserving pancreaticoduodenectomy 4.2%, Billroth II gastrectomy (B-II) 11.6%, and other reconstruction method (others) 7.4%. The contributing factors calculated by a multivariate analysis were B-II (odds ratio: 1.864, 95% confidence interval: 1.001-3.471, P = 0.050) and the presence of naïve papilla (odds ratio: 3.268, 95% confidence interval: 1.426-7.490, P = 0.005). CONCLUSIONS: DB-ERCP is a safe method with a total complication rate of 5.8% that could be considered within an acceptable range. The most common complication was the injury of the digestive tract such as perforation. Affecting risk factors for complications were B-II and the presence of naïve papilla. DB-ERCP procedures should be performed carefully of these factors.

Single-session esophagogastroduodenoscopy and endoscopic ultrasound using a forward-viewing radial scan ultrasonic endoscope.

BACKGROUND: Endoscopic ultrasound is useful for obtaining high-resolution images of pancreaticobiliary diseases, but is not readily available for physical checkups. In this study, we evaluated the safety and efficacy of single-session esophagogastroduodenoscopy and endoscopic ultrasound in the detection of upper-gastrointestinal and pancreaticobiliary diseases using a forward-viewing radial scan ultrasonic endoscope. METHODS: A total of 148 patients who were scheduled for upper-gastrointestinal screening using an endoscope were prospectively included. All patients were examined by EUS in combination with EGD using a forward-viewing radial scan ultrasonic endoscope. The primary endpoint was the safety of the procedures. The secondary endpoints were the prevalence of diseases, the basal imaging capability of EUS, the procedure time, total dose of propofol, and the correlation between background factors and the prevalence of pancreatic disease. The imaging capability at each region was scored as 0 (invisible) to 2 (sufficient visualization to evaluate the organs). RESULTS: Intraoperative hypotension occurred as an adverse event of intravenous anesthesia in one patient. There were 82 pancreaticobiliary findings and 165 upper-gastrointestinal findings (malignancy not included). Follicular lymphoma of the intra-abdominal lymph nodes was detected in one patient. The mean imaging scores of each section were 1.95 (pancreatic head and papilla), 2.0 (pancreatic body), 1.99 (pancreatic tail), and 1.89 (common bile duct and gallbladder). Age, history of diabetes mellitus, and smoking history were significantly associated with the prevalence of pancreatic diseases. CONCLUSION: The simultaneous performance of EGD and EUS using a new ultrasonic endoscope is tolerable and safe for upper-gastrointestinal and pancreaticobiliary screening.

Multisocieties position paper: Microbiological surveillance on flexible endoscopes.

Transmission with endoscopes, particularly duodenoscope, of potential lethal infections prompted different scientific societies to deliver recommendations aimed reducing this risk. Some International societies extended recommendations on microbial surveillance to all the endoscopes and devices used in the reprocessing procedure. Considering the relevance of the topic, 8 Italian scientific societies of physicians, nurses and technical operators prepared a concerted document taking into account Institutional advisories and facilities in Italy. The rules for a correct microbial surveillance on endoscopes were detailed in term of what, how and when to perform the procedure, also suggesting behaviors in case of contamination.

Cutting-Edge Technologies for Gastrointestinal Therapeutic Endoscopy.

With advancements in the development of flexible endoscopes and endoscopic devices and the increased demand for minimally invasive treatments, the indications of therapeutic endoscopy have been expanded. Methods of endoscopic treatment used for tissue removal, hemostasis, and dilatation are as follows. Endoscopic submucosal dissection (ESD) is considered the gold standard curative method for removal of gastrointestinal node-negative neoplasms, regardless of their size or the presence of ulcer formation. Laparoscopic endoscopic cooperative surgery (LECS), which incorporates ESD, was introduced for removal of lesions in deeper layers. Another technique is endoscopic full-thickness resection, which is challenging without the assistance of laparoscopy. In terms of hemostasis, management of iatrogenic bleeding after endoscopic treatment is an important issue. Shielding methods and suturing techniques have been introduced for large mucosal defects after ESD, and their efficacy has been investigated clinically. Peroral endoscopic myotomy (POEM) is a new alternative surgical approach for minimally invasive treatment of esophageal achalasia. Furthermore, endoscopic fundoplication after POEM was devised to prevent post-POEM gastroesophageal reflux disease. Many endoscopic treatments, including ESD, LECS, and POEM, have been introduced in Japan. With the aging of the population, more attention will be directed toward therapeutic endoscopy for elderly patients, because it is less invasive. Development of endoscopic treatments with expanded indications is expected.

Krefeld CONTRA study: conventional peroral Esophago-Gastro-Duodenoscopy (EGD) vs. transnasal EGD--a prospective and randomised study with independent evaluation of conscious sedation, endoscope diameter, and access path.

BACKGROUND: The guidelines of the German Gastroenterology Society (Deutsche Gesellschaft für Verdauungs- und Stoffwechselkrankheiten, DGVS) demand the presence of an additional qualified person solely responsible for patient monitoring during sedated endoscopy. Transnasal esophagogastroduodenoscopy (EGD) allows easy access to the upper gastrointestinal tract and may avoid the complications induced by conscious sedation and reduce medical costs. PATIENT AND METHOD: 120 patients referred to diagnostic EGD were assigned to six groups: group 1, unsedated peroral EGD with normal-caliber endoscope; group 2, unsedated peroral EGD with small-caliber endoscope; group 3, sedated peroral EGD with normal-caliber endoscope; group 4, sedated peroral EGD with small-caliber endoscope; group 5, unsedated transnasal EGD with small-caliber endoscope; group 6, sedated transnasal EGD with small-caliber endoscope. Outcome parameters included objective (duration, oxygen saturation) and subjective measures (standardised visual analogue scales) of the endoscopy staff (handling, insertion, retroflexion, tolerability, overall assessment) and patients (pain, unpleasantness, sore throat, choking, gagging, meteorism, anxiety, acceptability). RESULTS: The patients were comparable according to age, sex, anxiety, and respiratory function before EGD. Sedoanalgesia was without effect on EGD handling and duration, patient tolerability and overall assessment by endoscopists and assistants. Negative effects of sedoanalgesia (decreased oxygen saturation, patient acceptability) were much lower and without significance for transnasal compared to peroral EGD. Patient tolerability and acceptability of the endoscopic staff (handling, insertion, retroflexion) were significantly better for the small-caliber endoscope. Duration of unsedated transnasal EGD was slightly but significantly longer, pain, unpleasantness, and anxiety slightly but significantly higher compared to sedated peroral EGD. However, these differences could no loner be detected seven days after endoscopy. Cost analysis revealed major advantage for transnasal EGD. CONCLUSION: Unsedated transnasal EGD may replace diagnostic peroral EGD, reduces costs with acceptable patient discomfort and has advantagous acceptability of the endoscopic staff.

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.

Endoscope presence during endoluminal functional lumen imaging probe (FLIP) influences FLIP metrics in the evaluation of esophageal dysmotility.

BACKGROUND: The functional lumen imaging probe (FLIP) system is an FDA-approved tool for dynamic evaluation of the esophagogastric junction (EGJ). Even though commercially available since 2009, FLIP utilization remains low, partly due to lack of consensus in methodology and interpretation. Therefore, we aimed to analyze the influence of concurrent endoscopy on FLIP measurements. METHODS: In this single-center study, we reviewed data from 93 patients undergoing FLIP for symptomatic esophageal motility disorders between 2016 and 2018. During sedated endoscopy, we measured luminal values (distensibility, cross-sectional area (CSA), and balloon pressure) at the EGJ and distal esophagus using 30, 40, and 50 mL distension volumes, with and without concurrent endoscope presence. All recorded values were compared at the various distension volumes between the two measurements using a Wilcoxon rank sum test. KEY RESULTS: There was a significant difference in distensibility and CSA with index distension volume (40 mL) at the EGJ comparing the two measurements: Lower median distensibility was 2.1 mm2  mm Hg-1 in the group with concurrent inserted endoscope, respectively, 3.4 mm2  mm Hg-1 without endoscope (P < .001), and median CSA was 86.0 resp. 110.0 mm2 (P < .001). No significant difference could be found in the measurements of the distal esophagus. CONCLUSIONS & INFERENCES: Our results show a significant difference in FLIP measurements with and without endoscope presence. This underlines the importance of establishing a consensus of a standardized FLIP protocol to define normal luminal values and guiding future FLIP diagnostic studies.

The Endoscopy Patient as a Vector and Victim.

Patient and procedural factors can increase the risk of infectious adverse events during endoscopy. Prophylactic antibiotic use must be judicious and individualized in the era of antibiotic resistance. New and emerging procedures require high-quality studies to elucidate appropriate risk profiles.

Prognostic factors in patients with advanced extrahepatic cholangiocarcinoma: A single center experience.

Extrahepatic cholangiocarcinoma (ECC) is an aggressive malignancy causing a lot of fatalities and comorbidities. Endoscopic biliary stenting (EBS) is mostly needed for ECC. In this study, we aimed to investigate the prognostic factors for the overall survival (OS) and the factors predicting the patients eligible for chemotherapy after EBS in ECC.We retrospectively screened 153 advanced ECC patients who underwent EBS for jaundice to make the patients eligible for chemotherapy. Patient's clinical and laboratory parameters were recorded. OS was estimated by the Kaplan-Meier method. All parameters were assessed by binary logistic regression analysis to predict which patients are eligible for chemotherapy.The median OS of all patients was 12.0 months (10.1-13.8). The median OS of the patients treated with chemotherapy was 13.0 months (12.0-14.0), while it was 4.0 months (2.3-5.7) for patients unable for chemotherapy after EBS. Albumin, aspartate aminotransferase (ALT) and carbohydrate antigen 19-9 (CA 19-9) values were independent prognostic factors for OS. Higher albumin and lower prothrombin time (PT) levels were independent parameters to predict the patients eligible for chemotherapy after EBS.Being suitable for chemotherapy was the main determinant for prolonged survival and albumin and PT levels were independent predictors for chemotherapy eligibility after EBS. Albumin, ALT, and CA 19-9 values were independent prognostic factors for OS in ECC.

Infection prevention in NOTES.

Prevention of infection during natural orifice translumenal endoscopic surgery (NOTES) was identified as one of the most important challenges for translumenal surgery. Does infection prevention during NOTES warrant such attention? This article summarizes the accumulated data about septic complications during translumenal surgery.

Transnasal endoscopic retrograde chalangiopancreatography using an ultrathin endoscope: a prospective comparison with a routine oral procedure.

AIM: To investigate if transnasal endoscopic retrograde cholangiopancreatography (n-ERCP) using an ultrathin forward-viewing scope may overcome the disadvantages of conventional oral ERCP (o-ERCP) related to the large-caliber side-viewing duodenoscope. METHODS: The study involved 50 patients in whom 25 cases each were assigned to the o-ERCP and n-ERCP groups. We compared the requirements of esophagogastroduodenoscopy (EGD) prior to ERCP, rates and times required for successful cannulation into the pancreatobiliary ducts, incidence of post-procedure hyperamylasemia, cardiovascular parameters during the procedure, the dose of a sedative drug, and successful rates of endoscopic naso-biliary drainage (ENBD). RESULTS: Screening gastrointestinal observations were easily performed by the forward-viewing scope and thus no prior EGD was required in the n-ERCP group. There was no significant difference in the rates or times for cannulation, or incidence of hyperamylasemia between the groups. However, the cannulation was relatively difficult in n-ERCP when the scope appeared U-shape under fluoroscopy. Increments of blood pressure and the amount of a sedative drug were significantly lower in the n-ERCP group. ENBD was successfully performed succeeding to the n-ERCP in which mouth-to-nose transfer of the drainage tube was not required. CONCLUSION: n-ERCP is likely a well-tolerable method with less cardiovascular stress and no need of prior EGD or mouth-to-nose transfer of the ENBD tube. However, a deliberate application is needed since its performance is difficult in some cases and is not feasible for some endoscopic treatments such as stenting.

Unsedated ultrathin upper endoscopy is better than conventional endoscopy in routine outpatient gastroenterology practice: a randomized trial.

AIM: to compare the feasibility and patients' tolerance of esophagogastroduodenoscopy (EGD) using a thin endoscope with those of conventional oral EGD and to determine the optimal route of introduction of small-caliber endoscopes. METHODS: One hundred and sixty outpatients referred for diagnostic EGD were randomly allocated to 3 groups: conventional (C)-EGD (9.8 mm in diameter), transnasal (TN)-EGD and transoral (TO)-EGD (5.9 mm in diameter). Pre-EGD anxiety was measured using a 100-mm visual analogue scale (VAS). After EGD, patients and endoscopists completed a questionnaire on the pain, nausea, choking, overall discomfort, and quality of the examination either using VAS or answering some questions. The duration of EGD was timed. Blood oxygen saturation (SaO2) and heart rate (HR) were monitored during EGD. RESULTS: Twenty-one patients refused to participate in the study. The 3 groups were well-matched for age, gender, experience with EGD, and anxiety. EGD was completed in 91.1% (41/45), 97.5% (40/41), and 96.2% (51/53) of cases in TN-EGD, TO-EGD, and C-EGD groups, respectively. TN-EGD lasted longer (3.11 +/- 1.60 min) than TO-EGD (2.25 +/- 1.45 min) and C-EGD (2.49 +/- 1.64 min) (P<0.05). The overall tolerance was higher (P<0.05) and the overall discomfort was lower (P<0.05) in TN-EGD group than in C-EGD group. EGD was tolerated "better than expected" in 73.2% of patients in TN-EGD group and 55% and 39.2% of patients in TO-EGD and C-EGD groups, respectively (P<0.05). Endoscopy was tolerated "worst than expected" in 4.9% of patients in TN-EGD group and 17.5% and 23.5% of patients in TO-EGD and C-EGD groups, respectively (P<0.05). TN-EGD caused mild epistaxis in one case. The ability to insufflate air, wash the lens, and suction of the thin endoscope were lower than those of conventional instrument (P<0.001). All biopsies performed were adequate for histological assessment. CONCLUSION: Diagnostic TN-EGD is better tolerated than C-EGD. Narrow-diameter endoscope has a level of diagnostic accuracy comparable to that of conventional gastroscope, even though some technical characteristics of these instruments should be improved. Transnasal EGD with narrow-diameter endoscope should be proposed to all patients undergoing diagnostic EGD.

Capsule endoscopy: a comprehensive review.

The development of wireless capsule endoscopy (CE) has been a significant technologic advancement for the non-invasive visual evaluation of the entire small bowel and esophagus. The capsule endoscope is disposable and measures 11 x 26 mm. There are two capsule endoscopes currently available: PillCam ESO and PillCam SB for the evaluation of the esophagus and the small bowel, respectively. The PillCam ESO has two cameras on each end and captures images 7 frames per second per each camera, while the PillCam SB has one camera and captures images at a rate of 2 frames per second. Both capsule endoscopes transmit the image data using a radiofrequency signal to a recording device worn on the patient's waist. Once image acquisition is completed, the data from the recording device is downloaded to a computer workstation and analyzed by a gastroenterologist. Common indications for the small bowel CE include obscure gastrointestinal bleeding (OGIB), suspected Crohn disease (CD), as well as other suspected small bowel pathologies, while indications for the esophageal CE include screening of Barrett esophagus and esophageal varices. Small bowel CE appears to be more sensitive in the evaluation of OGIB and small bowel CD compared with other conventional radiological and endoscopic modalities. Preliminary results for the esophageal CE reveal good accuracy for screening of both Barrett and esophageal varices. CE is well tolerated by most patients, requires no sedation, and carries few side effects. One of the complications of CE is capsule retention; however, a patency capsule system has been developed, which can indicate whether an obstructing lesion is present before CE is performed. Finally, there are preliminary data suggesting that a new capsule endoscope for the colon may be useful in the evaluation of patients for colon polyps and possibly, screening for colon cancer.

Iatrogenic Gastrointestinal Perforation Following Therapeutic Endoscopic Procedures: Management and Outcome.

The aim of this study was to analyze the location, the cause and treatment of iatrogenic gastrointestinal perforations following therapeutic endoscopic procedures. Perforation occurred in 12 patients out of 3,389, giving cases occurred intraoperatively or postoperatively. Among them, 6 cases were closed by titanium clipping and 1 case by purse string suture. In another case after cap-assisted endoscopic mucosal resection (EMRC), attempted titanium clipping failed, emergency surgery had to be performed. One each case, after Argon plasma coagulation (APC) and case after endoscopic piecemeal mucosal resection (EPMR), recovered well spontaneously. In two cases, titanium clips fell off endoscopic mucosal resection (EMR) resulting in delayed perforation, required surgery. Key factors for preventing and managing the perforation of endoscopic treatment, include the choice of endoscopic approach, processing method of perforation, detail processing in endoscopic therapy, proficient degree of operators and psychological quality.

Follow-up and management of patients exposed to a flawed automated endoscope washer-disinfector in a digestive diseases unit.

The possible transmission of pathogens to 236 persons exposed to an endoscope processed in a flawed automated endoscope washer-disinfector in a gastrointestinal endoscopy unit was investigated. During 6 months, 197 patients (83.5%) were followed up, and no cases of acute human immunodeficiency virus, hepatitis C virus, or hepatitis B virus infection were observed. This event created the conditions for improvements in safety procedures.