One- or two-operator techniques for oesophago-gastro-duodenoscopy in unsedated patients: A comparative prospective randomized study.

BACKGROUND: The standard oesophago-gastro-duodenoscopy procedure is performed with a single endoscopist (SE). Nurse-assisted (NA) oesophago-gastro-duodenoscopies have not yet been studied. We aimed to evaluate the efficacy of an NA endoscopy compared to an SE endoscopy. METHODS: A prospective, single-center, randomized trial, in which 500 adult patients were divided into two groups. In the first group, patients underwent an endoscopy with an SE. In the second group, the endoscopy was performed with an NA. The ease of the procedure (scores 1-4; 1 difficult, 2 satisfactory, 3 easy, 4 veryeasy), evaluation of patient satisfaction (scores 1-4; 1 uncomfortable, 2 satisfactory, 3 comfortable, 4 verycomfortable), total time of the procedure and vocal cord observation were determined as quality indicators. RESULTS: Mean patient satisfaction scores in groups 1 and 2 were 2.98±0.79 and 3.11±0.78, respectively (p=0.043), with uncomfortable ratings in 5.2% vs 4%, satisfactory in 16.8% vs 13.2%, comfortable in 53.2% vs 50.4%, and very comfortable in 24.8% vs 32.4% of patients in groups 1 and 2, respectively. Retching rates during the procedure were 54.4% and 45.2% (p=0.040) in groups 1 and 2, respectively. No differences were seen in vocal cord observation (54.4% vs 56.0%), total procedure time (2.35±1.56 vs 2.41±1.48min) and easy score (3.26±0.603 vs 3.25±0.64) in groups 1 and 2 for the procedures. Very easy, easy, satisfactory, and difficult ratings were given by 33.6% vs 34.8%, 60.4% vs 56.4%, 4.8% vs 7.6% and 1.2% vs 1.2% of groups 1 and 2, respectively. CONCLUSIONS: Compared with the conventional method, the assisted endoscopic technique provides more comfort and less gag reflex without increasing the processing time or difficulty of performing the procedure.

Upper gastrointestinal bleeding due to duodenum diverticulum: a challenge for the endoscopist.

An 80-year-old female with a mechanic mitral valve treated with acenocumarol was admitted to the hospital due to tarry stools over the last two days and hemoglobin levels of 5.6 g/dl. She had not biliary pathology. An emergency esophagogastroduodenoscopy showed lots of fresh clots over the second part of the duodenum that seemed to come from the major papilla. A duodenoscopy was performed in order to obtain a direct view, showing a huge clot near the papilla. Its removal with a polypectomy snare revealed a large duodenum diverticulum with little saculations inside, one of which showed a visible, actively bleeding vessel. Sclerosis with epinephrine was performed and subsequently, two through-the-scope Cook® 11 mm clips were placed, achieving the cessation of the hemorrhage. Several attempts with different clips were needed since they were separated by the elevator nail of the duodenoscope. No complications developed during the procedure or once anticoagulation was restarted.

Complications of endoscopically placed duodenal stents for malignant duodenal outlet obstruction.

BACKGROUND: Endoscopically placed duodenal stents are commonly performed procedures for palliation of obstruction due to malignancy. A relatively small number of studies highlight the potential complications of this procedure, and to date no data have been published in New Zealand specifically addressing this issue. We aimed to retrospectively review complications from duodenal stents at our center and factors associated with the complications. METHOD: We retrospectively reviewed our endoscopy reporting system, Provation MD, for patients who underwent endoscopic duodenal stenting between 1 April 2010 and 31 March 2020. We searched the system for the keywords 'prosthesis or stent', 'duodenal mass or tumour' and 'duodenal stenosis or stricture'. Their clinical records were reviewed. Patients were included if they had a duodenal stent inserted to relieve a malignant duodenal obstruction. Patients were excluded if the obstruction was due to a benign pathology or if the obstruction was proximal to duodenum. Patient demographics, the type of stent used and any stent-related complications were recorded. Previous radiotherapy to chest or abdomen was also recorded. RESULTS: We identified 61 patients who underwent palliative endoscopic duodenal stenting. The overall complication rate was 15% (9/61), with five cases of stent migration, two cases of perforation and two cases of late tumour ingrowth requiring re-stenting. Three out of five stent-migration cases had non-obstructive lesions. Both the cases of perforation had previous radiotherapy. CONCLUSION: Duodenal stenting can be performed safely in most patients with malignant duodenal obstruction. The complication rate was found to be higher among the 60-69 age group, the New Zealand Maori/Pacific Islander ethnic group, patients with Niti-S stent and those with duodenal adenocarcinoma as the primary diagnosis, but these higher rates were not found to be statistically significant. Larger studies are required to assess factors associated with complication rates.

Low recurrence rate after endoscopic resection in non-ampullary duodenal lesions: A 16-year single-center retrospective study.

ABSTRACT: Endoscopic resection (ER) for non-ampullary duodenal lesions (NADLs) is technically more difficult than lesions of the stomach. However, endoscopic treatment of duodenal lesions has been increasingly performed in recent years. This study aimed to evaluate the efficacy and safety of ER for NADLs.Patients who underwent ER for NADLs between 2004 and 2019 were retrospectively reviewed. Clinical and pathologic features of the lesions including the clinical outcomes and adverse events were analyzed.The study included 80 patients with NADLs. The mean age of patients was 59.3 years (22-80 years), the mean size of the lesion was 8.8 ±â€Š7.0 mm, and the mean procedure time was 13.2 ±â€Š11.2 min. Half (40/80) of the lesions were in the duodenal bulb including the superior duodenal angle. Final histological data showed 56 adenomas (70.5%), 13 Brunner gland tumors (16.2%), and 4 pyloric gland tumors (5.0%). The final diagnoses of 5 lesions after ER showed higher-grade dysplasia compared to pre-ER biopsy findings. The en bloc resection rate was 93.8% (75/80), and the complete resection rate with clear margins was 90.0% (72/80). Micro-perforation occurred in 2 of 80 patients and was successfully treated with conservative treatment. There were no cases of delayed bleeding. The mean follow-up period was 27.0 months (2-119 months) with no cases of recurrence.ER may be an effective treatment for NADLs with favorable long-term outcomes. However, the possibility of perforation complications should always be considered during ER.

Duodenoscope as a Vector for Transmission.

Elevator-based endoscope-related infections from patient cross-contamination is a multifactorial problem related to device design, maintenance, and function, with additional risk incurred from a high-level disinfection process that lacks quality controls. This article reviews the historical context for these outbreaks, technical aspects of scope design contributing to this risk, and innovations in endoscope technology that have the potential to overcome these shortcomings. Also reviewed are interim solutions and the data that support use of some of these interventions. Still needed are a validated manufacturer-recommended schedule for routine duodenoscope and echoendoscope maintenance with reprocessing protocols that can be implemented in endoscopy units.

Recent Actions by the US Food and Drug Administration: Reducing the Risk of Infection from Reprocessed Duodenoscopes.

In addition to technological advancements, engagement and collaboration among the wider community of stakeholders will be beneficial toward reducing the risk of infection from reprocessed duodenoscopes. Such a community can raise awareness of the importance of duodenoscope cleaning, work to improve reprocessing training, identify the most pressing unanswered questions that merit further research, and develop tools that can be used by health care facilities to improve the quality of reprocessing at their sites. The Food and Drug Administration looks forward to working with the community to further reduce the risk of infections from reprocessed duodenoscopes.

Society Guidelines-Where Is the Consensus?

With reports of ongoing duodenoscope contamination and pathogen transmission despite strict adherence to manufacturer reprocessing instructions, professional societies continue to release updated recommendations. Despite general guideline similarities, there are differences. Although adherence to guidelines does not entirely eliminate pathogen contamination or transmission, it is critical to strictly adhere to updated guidelines for maximum risk reduction. In the United States, the Food and Drug Administration and Centers for Disease Control and Prevention continue to offer updates regarding improved duodenoscope reprocessing techniques and endoscope design. This article critically analyzes currently available national and international duodenoscope reprocessing guidelines.

Can Early 'Shallow' Needle-knife Papillotomy be the First Choice in ERCP?

PURPOSE: Needle-knife sphincterotomy, known as 'precut' is recommended as the second option in the case of difficult cannulation due to its potential higher complication (bleeding and perforation) rates. The aim of this study was to present our experience on early shallow needle-knife papillotomy (eSNKP) as the first-line choice independently of standard technique with or without difficult cannulation. MATERIALS AND METHODS: A total of 70 patients underwent therapeutic endoscopic retrograde cholangiopancreatography. A standard eSNKP and guidewire cannulation technique was routinely preferred as a first-line intervention. Deep biliary cannulation rate and timing were recorded, as well as intraoperative and postoperative complication rates. RESULTS: Successful deep biliary cannulation was performed in 66 (94.3%) patients during the first procedure. In 4 patients (5.7%), the procedure was terminated due to failed cannulation and repeated successfully after 72 hours. Minor complications were observed in 3 (4.3%) patients. No mortality was seen. CONCLUSION: eSNKP is a safe, time-saving, and effective technique as the first-line of endoscopic retrograde cholangiopancreatography for common bile duct cannulation.

Clinical outcomes of iatrogenic upper gastrointestinal endoscopic perforation: a 10-year study.

BACKGROUND: Upper gastrointestinal endoscopic examination is a relatively safe procedure; however, all endoscopic procedures are invasive and are associated with a risk of iatrogenic perforation. To evaluate clinical outcomes of iatrogenic upper gastrointestinal endoscopic perforation. Factors associated with surgical management or mortality were analyzed. METHODS: Between November 2008 and November 2018, the medical records of 149,792 upper gastrointestinal endoscopic procedures were evaluated. The mechanisms of perforations were categorized as electrocoagulation-induced or blunt trauma-induced injuries. The incidence and clinical outcomes of iatrogenic perforations based on the types of procedures performed were evaluated. RESULTS: Iatrogenic endoscopic perforations occurred in 28 cases (0.019%). Iatrogenic perforation-related mortality occurred in 3 patients. The iatrogenic perforation rate based on the types of procedures performed was as follows: diagnostic endoscopy = 0.002%, duodenal endoscopic mucosal resection = 0.9%, esophageal endoscopic submucosal dissection = 10.7%, gastric endoscopic submucosal dissection = 0.2%, endoscopic self-expandable metal stent insertion for malignant esophageal obstruction = 0.1%, duodenoscope-induced injury = 0.02%, endoscopic sphincterotomy = 0.08%, and ampullectomy = 6.8%. All electrocoagulation-induced perforations (n = 21) were managed successfully (15 cases of endoscopic closure, 5 cases treated conservatively, and 1 case treated surgically). Three patients died among those with blunt trauma-induced perforations (n = 7). The factors associated with surgical management or mortality were old age, poor performance status (Eastern Cooperative Oncology Group score ≥ 1), advanced malignancy, and blunt trauma. CONCLUSIONS: Most cases of electrocoagulation-induced iatrogenic perforations can be treated using endoscopic clips. If endoscopic closure fails for blunt trauma-induced perforations, prompt surgical management is mandatory.

Endoscopic management of duodenal levodopa-carbidopa therapy of advanced Parkinson's disease.

BACKGROUND: treatment of intraduodenal levodopa using percutaneous endoscopic gastrostomy is an alternative therapy in patients with advanced Parkinson's disease. There are few studies that have evaluated the endoscopic aspects of this technique. OBJECTIVES: to describe our experience and adverse events regarding this technique in advanced Parkinson's disease. METHOD: a retrospective study was performed from January 2007 to January 2019 in a tertiary healthcare center. RESULTS: thirty-seven patients aged 65.1 ± 10.3 years were included in the study, 21 were male and the disease duration was ten years (1-26). The median follow-up was 16 months (1-144). The device was successfully placed in all cases. The persistence rate with the PEG-D at the end of follow-up was 62.2%. The system was removed in 14 patients, seven due to neurological impairment, four because of the decision of the patient and three due to related events. Fifty-nine adverse events occurred in 23 patients (62.2%, 0.63 per patient-year), four of which were severe (8.1%, 0.05 per patient-year). Minor adverse events included 14 (37.8%) related to the stoma, six (16.2%) to the gastric tube and 15 (40.5%) to the duodenal tube. Forty-four system replacements were performed in 20 patients (54.1%, 0.52 per patient-year). Male sex, age over 70 and a higher comorbidity index were associated with a greater likelihood of persistence of the system (OR: 0.14, 95% CI: 0.03-0.62; OR: 0.52, 95% CI: 0.32-0.86; OR: 0.16, 95% CI: 0.03-0.99, respectively). No predictors of adverse events associated with PEG-D were identified. CONCLUSIONS: percutaneous endoscopic gastrostomy for the continuous delivery of duodenal levodopa is a highly effective technique. Adverse events are common, although most are resolved by endoscopy.

Short- and long-term outcomes of endoscopically treated superficial non-ampullary duodenal epithelial tumors.

BACKGROUND: It is widely recognized that endoscopic resection (ER) of superficial non-ampullary duodenal epithelial tumors (SNADETs) is technically challenging and may carry high risks of intraoperative and delayed bleeding and perforation. These adverse events could be more critical than those occurring in other levels of the gastrointestinal tract. Because of the low prevalence of the disease and the high risks of severe adverse events, the curability including short- and long-term outcomes have not been standardized yet. AIM: To investigate the curability including short- and long-term outcomes of ER for SNADETs in a large case series. METHODS: This retrospective study included cases that underwent ER for SNADETs at our university hospital between March 2004 and July 2017. Short-term outcomes of ER were measured based on en bloc and R0 resection rates as well as adverse events. Long-term outcomes included local recurrence detected on endoscopic surveillance and disease-specific mortality in patients followed up for ≥ 12 mo after ER. RESULTS: In the study, 131 patients with 147 SNADETs were analyzed. The 147 ERs consisted of 136 endoscopic mucosal resections (EMRs) (93%) and 11 endoscopic submucosal dissections (ESDs) (7%). The median tumor diameter was 10 mm. The pathology diagnosis was adenocarcinoma (56/147, 38%), high-grade intraepithelial neoplasia (44/147, 30%), or low-grade intraepithelial neoplasia (47/147, 32%). The R0 resection rate was 68% (93/136) in the EMR group and 73% (8/11) in the ESD group, respectively. Cap-assisted EMR (known as EMR-C) showed a higher rate of R0 resection compared to the conventional method of EMR using a snare (78% vs 62%, P = 0.06). No adverse event was observed in the EMR group, whereas delayed bleeding, intraoperative perforation, and delayed perforation in 3, 3, and 5 patients occurred in the ESD group, respectively. One patient with perforation required emergency surgery. In the 43 mo median follow-up period, local recurrence was found in four EMR cases and all cases were treated endoscopically. No patient died due to tumor recurrence. CONCLUSION: Our findings suggest that ER provides good long-term outcomes in the patients with SNADETs. EMR is likely to become the safe and reliable treatment for small SNADETs.

Purse-string sutures using novel endoloops and repositionable clips for the closure of large iatrogenic duodenal perforations with single-channel endoscope: a multicenter study.

BACKGROUND: Serious complications due to perforation restrict the development of duodenal endoscopic treatment. The key stage for remediation is the successful endoscopic closure to prevent peritonitis and the need for surgical intervention. This report aimed to present a new simple method for the closure of large iatrogenic duodenal perforations with purse-string sutures using the novel endoloops and repositionable clips through a single-channel endoscope. METHODS: A total of 23 patients with iatrogenic duodenal perforations ≥ 1 cm were retrospectively studied who were presently treated by purse-string sutures using the novel endoloops and the repositionable hemostasis clips with the single-channel endoscope at four institutes. During and after the procedure, a 20-gauge needle was used to relieve the pneumoperitoneum or subcutaneous emphysema. Finally, a gastroduodenal decompression tube was placed. RESULTS: The median maximum diameter of iatrogenic duodenal perforations was 1.65 cm (range 1.0-3.0 cm). Complete endoscopic closure of all 23 perforations was achieved. No patient had severe complications such as peritonitis. The wounds were healed and no obvious duodenal stricture was observed in all cases after 3 months. CONCLUSION: Purse-string sutures using the novel endoloops and repositionable endoclips through single-channel endoscope were feasible, effective and easy methods for the closure of large duodenal iatrogenic perforations.

Current Status and Challenges of Endoscopic Treatments for Duodenal Tumors.

BACKGROUND: Superficial tumors of the duodenum, other than ampullary tumors, have been traditionally considered rare. However, reports of this kind of tumor have increased in recent times, and the demand for minimally invasive treatments have also increasing. SUMMARY: Adenomas and intramucosal carcinomas are target lesions for treatment. A preoperative diagnosis has not been established, but unnecessary biopsies increase the difficulty of treatment and should be avoided. Cold snare polypectomy, endoscopic mucosal resection (EMR), and underwater EMR are treatment options for small lesions. Endoscopic submucosal dissection enables secure resection even for large lesions, but it is technically demanding and associated with a higher complication rate. After endoscopic resections, exposure of digestive juices is believed to cause delayed complications. To prevent these complications, several closing and covering methods are proposed, with favorable clinical results. Key message: A treatment method should be chosen based on each patient's situation. With any of the treatment methods, post-resection measures are required to prevent delayed complications. Secure closure of resection wounds seems promising.

Duodenoscope-Associated Infections: Update on an Emerging Problem.

The duodenoscope is among the most complex medical instruments that undergo disinfection between patients. Transmission of infection by contaminated scopes has remained a challenge since its inception. Notable risk factors for pathogen transmission include non-adherence to disinfection guidelines, encouragement of biofilm deposition due to complex design and surface defects and contaminated automated endoscope reprocessors. The most common infections following endoscopy are endogenous infections involving the patient's own gut flora. Exogenous infections, on the other hand, are associated with contaminated scopes and can theoretically be prevented by effective reprocessing. Pseudomonas aeruginosa is currently the most common organism isolated from contaminated endoscopes. Of note, reports of multidrug-resistant duodenoscopy-associated outbreaks have surfaced recently, many of which occurred despite adequate reprocessing. The FDA and CDC currently recommend comprehensive cleaning followed with at least high-level disinfection for reprocessing of flexible GI endoscopes. Reports of duodenoscope-related outbreaks despite compliance with established guidelines have prompted professional and government bodies to revisit existing guidelines and offer supplementary recommendations for duodenoscope processing. For the purposes of this review, we identified reports of duodenoscope-associated infections from 2000 till date. For each outbreak, we noted the organisms isolated, the number of cases reported, any possible explanations of contamination, and the measures undertaken to end each outbreak. We have also attempted to present an overview of recent developments in this rapidly evolving field.

Duodenoscopy: an amplifier of cross-transmission during a carbapenemase-producing Enterobacteriaceae outbreak in a gastroenterology pathway.

Carbapenemase-producing Klebsiella pneumoniae (OXA-48 CPE) were identified in five patients who underwent an endoscopy with the same duodenoscope in October 2015. The endoscope was the only epidemiological link between these cases. A transient contamination of the duodenoscope following a failure in the disinfection process may have been the cause of transmission.

Current Status of Endoscopic Resection for Superficial Nonampullary Duodenal Epithelial Tumors.

BACKGROUND: Endoscopic resection (ER) is becoming the first choice of treatment for treating superficial nonampullary duodenal epithelial tumors (SNADETs), but ER procedures for SNADETs remain challenging because of the difficulty experienced in maneuvering the endoscope toward the thin duodenal wall, which results in a high rate of adverse events. Although several ER methods were used to overcome these technical difficulties and complications, ER methods for SNADETs are not standardized. A new technique, underwater endoscopic mucosal resection (UEMR), was developed recently in a western country, and its usefulness was reported. Beginning in 2014, we were the first to use UEMR for SNADETs in Japan. Thus, in our experience, we would propose an indication of the various ER methods for SNADETs according to the lesion size. SUMMARY: Endoscopic mucosal resection (EMR) and UEMR were effective and safe for small lesions (≤20 mm), but for large lesions (>20 mm), piecemeal removal of lesion by EMR and UEMR had high incidence of recurrence and adverse events. Especially, piecemeal EMR could cause delayed perforation. Cold snare polypectomy was useful for small lesions (≤10 mm), but further study of its recurrence is warranted. Endoscopic submucosal dissection (ESD) achieved a high complete resection rate regardless of the lesion size, but its rate of adverse events, including morbid complications, was high. Thus, after ESD for large lesions, secure prevention method for adverse events, such as closure of the wound by laparoscopic-endoscopic cooperative surgery, should be required. Key Messages: ER methods for treating SNADETs were proposed based on the lesion size. For large lesions, prophylactic methods for adverse events should be implemented.

Safety and Effectiveness of an Endoscopically Placed Duodenal-Jejunal Bypass Device (EndoBarrier®): Outcomes in 114 Patients.

BACKGROUND: The duodenal-jejunal bypass liner (DJBL) is an endoscopically placed device designed to achieve weight loss and improve glycemic control in obese patients. Previous studies report promising results but typically included small patient numbers and short follow-up. This study aims to determine the safety and effectiveness of the device. METHODS: Study design: A series of all patients treated by the DJBL at our institutions. OUTCOME MEASUREMENTS: Weight loss, biochemical measures, complications. RESULTS: Between July 2012 and March 2015, 114 consecutive patients were treated for a mean 51.1 weeks (standard deviation (SD) 19.9 weeks). Mean total body weight change from baseline was 12.0 kg (SD 8.5 kg, p < 0.001). Mean percent total body weight loss (%TWL) was 10.5% (SD 7.3%). Mean HbA1c was not significantly improved, but of 10 patients on insulin, 4 ceased insulin and 4 reduced insulin dosages. There was a significant decrease in hemoglobin and total cholesterol and a significant increase in serum alkaline phosphatase. Seventy-four percent of patients experienced at least one adverse event, some of them serious including 6 device obstructions, 5 gastrointestinal hemorrhages, 2 liver abscesses, and 1 acute pancreatitis. Seventy-four percent of patients experienced weight gain after removal with a mean 4.5 ± 6.1 kg (p < 0.0001) within the first 6 months after explantation. CONCLUSIONS: The DJBL provides significant but highly variable weight loss. Glycemic control was variable. Most insulin-requiring T2DM patients ceased or reduced insulin. Most patients experience an adverse event and most regain significant weight after device removal. Major adverse events can occur, including the potentially life-threatening complications of hepatic abscess and gastrointestinal hemorrhage.