Contamination Rates in Duodenoscopes Reprocessed Using Enhanced Surveillance and Reprocessing Techniques: A Systematic Review and Meta-Analysis

Background/Aims@#Multiple outbreaks of multidrug-resistant organisms have been reported worldwide due to contaminated duodenoscopes. In 2015, the United States Food and Drug Administration recommended the following supplemental enhanced surveillance and reprocessing techniques (ESRT) to improve duodenoscope disinfection: 1. microbiological culture, 2. ethylene oxide sterilization, 3. liquid chemical sterilant processing system, and 4. double high-level disinfection. A systematic review and metaanalysis was performed to assess the impact of ESRT on the contamination rates. @*Methods@#A thorough and systematic search was performed across several databases and conference proceedings from inception until January 2021, and all studies reporting the effectiveness of various ESRTs were identified. The pooled contamination rates of post-ESRT duodenoscopes were estimated using the random effects model. @*Results@#A total of seven studies using various ESRTs were incorporated in the analysis, which included a total of 9,084 post-ESRT duodenoscope cultures. The pooled contamination rate of the post-ESRT duodenoscope was 5% (95% confidence interval [CI]: 2.3%–10.8%, inconsistency index [I2]=97.97%). Pooled contamination rates for high-risk organisms were 0.8% (95% CI: 0.2%–2.7%, I2=94.96). @*Conclusions@#While ESRT may improve the disinfection process, a post-ESRT contamination rate of 5% is not negligible. Ongoing efforts to mitigate the rate of contamination by improving disinfection techniques and innovations in duodenoscope design to improve safety are warranted.

Incidence and Significance of Biliary Stricture in Chronic Pancreatitis Patients Undergoing Extracorporeal Shock Wave Lithotripsy for Obstructing Pancreatic Duct Stones

Background/Aims@#This study assessed the significance of biliary stricture in symptomatic chronic pancreatitis patients requiring extracorporeal shock wave lithotripsy (ESWL) and endoscopic retrograde cholangiopancreatography (ERCP) to remove obstructing pancreatic calculi. @*Methods@#A total of 97 patients underwent ESWL followed by ERCP to remove pancreatic calculi between October 2014 and October 2017 at Virginia Mason Medical Center. Significant biliary stricture (SBS) was defined as a stricture with upstream dilation on computed tomography scan or magnetic resonance cholangiopancreatography scans accompanied by cholestasis and/or cholangitis. SBS was initially managed by either a plastic stent or fully covered self-expandable metallic stent (fcSEMS). If the stricture did not resolve, the stent was replaced with either multiple plastic stents or another fcSEMS. Data were collected by retrospectively reviewing the medical records. @*Results@#Biliary strictures were noted in approximately one-third of patients (34/97, 35%) undergoing ESWL for pancreatic calculi. Approximately one-third of the biliary strictures (11/34, 32%) were SBS. Pseudocysts were more frequently found in those with SBS (36% vs 8%, p=0.02), and all pseudocysts in the SBS group were located in the pancreatic head. The initial stricture resolution rates with fcSEMSs and plastic prostheses were 75% and 29%, respectively. The overall success rate for stricture resolution was 73% (8/11), and the recurrence rate after initial stricture resolution was 25% (2/8). @*Conclusions@#Although periductal fibrosis is the main mechanism underlying biliary stricture development in chronic pancreatitis, inflammation induced by obstructing pancreatic calculi, including pseudocysts, is an important contributing factor to SBS formation during the acute phase.

Outcomes of Infected versus Symptomatic Sterile Walled-Off Pancreatic Necrosis Treated with a Minimally Invasive Therapy

BACKGROUND/AIMS: Acute pancreatitis complicated by walled-off necrosis (WON) is associated with high morbidity and mortality, and if infected, typically necessitates intervention. Clinical outcomes of infected WON have been described as poorer than those of symptomatic sterile WON. With the evolution of minimally invasive therapy, we sought to compare outcomes of infected to symptomatic sterile WON. METHODS: We performed a retrospective cohort study examining patients who were undergoing dual-modality drainage as minimally invasive therapy for WON at a high-volume tertiary pancreatic center. The main outcome measures included mortality with a drain in place, length of hospital stay, admission to intensive care unit, and development of pancreatic fistulae. RESULTS: Of the 211 patients in our analysis, 98 had infected WON. The overall mortality rate was 2.4%. Patients with infected WON trended toward higher mortality although not statistically significant (4.1% vs 0.9%, p=0.19). Patients with infected WON had longer length of hospitalization (29.8 days vs 17.3 days, p<0.01), and developed more spontaneous pancreatic fistulae (23.5% vs 7.8%, p<0.01). Multivariate analysis showed that infected WON was associated with higher odds of spontaneous pancreatic fistula formation (odds ratio, 2.65; 95% confidence interval, 1.20 to 5.85). CONCLUSIONS: This study confirms that infected WON has worse outcomes than sterile WON but also demonstrates that WON, once considered a significant cause of death, can be treated with good outcomes using minimally invasive therapy.

Efficacy and safety of sofosbuvir-based regimens for treatment in chronic hepatitis C genotype 1 patients with moderately impaired renal function

BACKGROUND/AIMS: Treatment of chronic hepatitis C virus (HCV) infection in patients with chronic kidney disease (CKD) is essential. The availability of sofosbuvir (SOF) has dramatically improved overall HCV cure rates, however there is insufficient data regarding its use in patients with CKD. We evaluated SOF in patients with hepatitis C genotype 1 (G1) and moderately impaired renal function. METHODS: We retrospectively reviewed all patients treated with a SOF-based regimen from December 2013 through September 2015 at Virginia Mason Medical Center. Data was then collected for HCV G1 patients with stage 3 CKD. RESULTS: A total of 28 patients with HCV G1 and stage 3 CKD were treated with a SOF-based regimen. Twenty-one patients had stage 3A CKD (estimated glomerular filtration rate [eGFR] 45–60 mL/min/1.73m2) and 7 patients had stage 3B CKD (eGFR 30–45 mL/min/1.73m2). The overall rate of sustained virologic response (SVR) 12 weeks after completion of therapy (SVR12) was 85.7% (24/28). SVR12 in stage 3A CKD patients was 81.0% (17/21) and in stage 3B CKD patients, SVR12 was 100% (7/7). Based on the treatment regimen used, the SVR12 was 81.8% (9/11), 92.3% (12/13), and 75.0% (3/4) for SOF/ledipasvir (LDV), SOF/simeprevir (SIM), and SOF/pegylated interferon (PEG)/ribavirin (RBV), respectively. Greater than 30% reduction eGFR was observed in 4 out of 28 patients. CONCLUSIONS: SOF-based regimens resulted in high SVR12 rates in patients with moderately impaired renal function. During therapy, HCV patients with CKD should be carefully monitored for worsening renal function.

Real-World Single-Center Experience with Sofosbuvir-Based Regimens for the Treatment of Chronic Hepatitis C Genotype 1 Patients

BACKGROUND/AIMS: The approval of sofosbuvir (SOF), a direct-acting antiviral, has revolutionized the treatment of chronic hepatitis C virus (HCV). METHODS: We assessed the sustained virological response (SVR) of SOF-based regimens in a real-world single-center setting for the treatment of chronic HCV genotype 1 (G1) patients. This was a retrospective review of chronic HCV G1 adult patients treated with a SOF-based regimen at Virginia Mason Medical Center between December 2013 and August 2015. RESULTS: The cohort comprised 343 patients. Patients received SOF+ledipasvir (LDV) (n=155), SOF+simeprevir (SIM) (n=154), or SOF+peginterferon (PEG)+ribavirin (RBV) (n=34). Of the patients, 50.1% (n=172) had cirrhosis. The SVR rate was 92.2% for SOF/LDV, 87.0% for SOF/SIM, and 82.4% for SOF/PEG/RBV. Compared with the cirrhotic patients, the patients without cirrhosis had a higher SVR (96.8% vs 85.5%, p=0.01, SOF/LDV; 98.2% vs 80.6%, p=0.002, SOF/SIM; 86.4% vs 75.0%, p=0.41, SOF/PEG/RBV). In this study, prior treatment experience adversely affected the response rate in subjects treated with SOF/PEG/RBV. CONCLUSIONS: In this single-center, real-world setting, the treatment of chronic HCV G1 resulted in a high rate of SVR, especially in patients without cirrhosis.

Endoscopic approaches to afferent and Roux-en-Y limb obstruction

Afferent limb syndrome can be seen following Billroth II gastric resection, Whipple procedure with duodenojejunostomy, or in association with an obstructed Roux-en-Y limb following hepaticojejunostomy. This syndrome classically presents with jaundice or cholangitis but may also be associated with abdominal pain alone or pancreatitis, especially in patients with surgically created pancreaticojejunostomies. Obstructions may be a consequence of benign or malignant disorders. Historically treated with surgery or percutaneous transhepatic biliary drainage, this review describes currently applied and evolving endoscopic techniques to include balloon dilation, double pigtail plastic stent placement, and insertion of self-expandable metal stents or lumen-apposing stents.

Impact of Sigmoidoscopy and Colonoscopy on Colorectal Cancer Incidence and Mortality: An Evidence-Based Review of Published Prospective and Retrospective Studies

Screening for colorectal cancer (CRC) using sigmoidoscopy or colonoscopy is now common in many developed countries. This concise, evidence-based review looks at the impact of sigmoidoscopy or colonoscopy screening on CRC incidence, CRC mortality and overall mortality. Data from controlled retrospective and prospective (observational or randomized) studies have generally shown that sigmoidoscopy and colonoscopy, whether for diagnostic, screening or surveillance purposes, are associated with a significant reduction in CRC incidence and CRC mortality. The data on their impact on overall mortality is much more limited, with most studies unable to report a reduction in overall mortality. The results of three meta-analyses have confirmed these conclusions. As expected, sigmoidoscopy has a predominant effect on left-sided CRC, although some studies have shown modest effects on right-sided colon cancer as well. Most studies on colonoscopy have demonstrated that the protective effect applies to both right and left-sided cancer, although the protection seemed better on the left side. Despite the introduction of other screening and diagnostic modalities for the colon, such as computed tomography colonography and colonic capsule endoscopy, lower endoscopy will continue to be an important mode of screening for CRC and evaluating the colon.

Double Balloon Enteroscopy in a North American Setting: A Large Single Center 5-year Experience

BACKGROUND/AIMS: Double balloon enteroscopy (DBE) allows both diagnosis and therapeutic maneuvers in the small bowel. Its use was pioneered in Europe and Asia but there remains a relative paucity of literature from North America. Our aim in this study was to determine diagnostic and therapeutic yield in a North American setting. METHODS: A five-year retrospective analysis of all patients undergoing DBE at a single tertiary care North American hospital was performed. RESULTS: Four-hundred fifty-seven procedures, 265 anterograde and 192 retrograde, were performed on 335 patients. The most common indications were obscure gastrointestinal bleeding, small bowel obstruction, and suspected masses and mucosal abnormalities. Total enteroscopy was achieved in 19 of the 89 patients who had both anterograde and retrograde procedures. Overall diagnostic yield in the determination of cause of symptoms or previous imaging was 52%. The most common causes of obscure bleeding were small bowel ulcers (10%), vascular lesions (25%) and neoplasms (10%). The most common causes of small bowel obstruction were strictures, some of which underwent dilation. Other therapeutic interventions included polypectomy, retrieval of retained capsules, stent retrievals and percutaneous enteral jejunostomy tube placement. Overall complication rates were very low (0.6%) and included medication reaction (n=1), scope dysfunction (n=1) and perforation (n=1). CONCLUSIONS: DBE can be performed safely and with good diagnostic yield in a single referral center in North America.

The Society for Gastrointestinal Intervention. Are We, as an Organization of Disparate Disciplines, Cooperative or Competitive?

This is the Fourth Annual Meeting of the Society for Gastrointestinal Intervention, a multi-disciplinary group of practitioners committed to a minimally invasive approach to both the diagnosis and treatment of digestive disorders. The key concepts are minimally invasive and multi-disciplinary which can be construed as practicing in parallel with occasional lines of procedural and clinical interaction or inter-disciplinary in which patients are acutely cared for by a team, with treatments tailored to the patient and not the discipline that touches the patient first. In reality, many of us exist in both worlds. Most universities and large clinics are structured in departments along traditional training lines. As such, Interventional Radiology is housed in the Radiology Department, Laparoscopic Surgery (and potentially NOTES), as a component of the General Surgery Division, and Therapeutic Endoscopy usually resides within a gastroenterology structural framework. These divisions have historically been kept separate by multiple forces: salaries and budgets usually reside in a larger division. As a group, the amount of practice devoted to GI disorders is variable (for instance, minimally invasive surgeons may approach the adrenal glands or lung lesions in some institutions and interventional radiologists often sample tissue in multiple areas outside the GI tract, and by virtue of access to the vascular tree, can stent, embolize, or TPA almost any area of the body), as well as inherent differences in our individual abilities to access organs. I have already mentioned that angiographic capabilities allow the interventional radiologist access to virtually every GI organ and those capabilities allow therapeutic options for bleeding, tumor embolization, stenting of stenotic lesions, and formation of intravascular shunts. As such, there is very limited interdisciplinary competition here although capsule endoscopy as well as double and single balloon enteroscopy have improved the endoscopist's diagnostic and potential therapeutic reach. However, many of these diagnostic triumphs for obscure or massive GI bleed are simply to tattoo lesions that require surgical removal by laparoscopic or traditional surgery. Cooperation. However, there are potential competitive areas in the treatment of GI vascular lesions also. Whereas endoscopic band ligation has supplanted EVS, splenic devascularization, and most shunting procedures for patients with esophageal varices, endoscopic techniques have had less long-term success with glue injection for gastric varices. Multiple randomized, prospective trials have suggested therapeutic primacy of TIPS with embolization of recalcitrant vessels as an option or back-up. Despite this, therapeutic endoscopists have learned valuable lesions from our IR colleagues and studies are underway using endoscopically injected coils in addition to cyanoacrylate in an attempt to improve acute and long-term bleeding control. Nor is there any major competition in the treatment of primary or metastatic liver tumors by chemoembolization, RF current, or other thermal modalities, although selected patients with single lesions or multiple lesions isolated to a single lobe may be better handled surgically if there is curative intent. Finally, there is little IR, and progressively less, surgical competition for the treatment of high-grade dysplasia or superficial malignancies in the setting of Barrett's esophagus which are adequately treated in most patients by mucosectomy, RF ablation, or cryotherapy but require direct mucosal visualization to direct this therapy. The same has proven true for many years for colorectal polyps, superficial gastric cancers, and ampullary adenomas that had historically all been treated with major surgical resections. Still, there are many patients with advanced lesions who are good operative candidates who should be approached with conventional or minimally invasive surgery with the intent of operative cure. Cooperative, not competitive. The potential for competition between disciplines comes in mundane situations and clinical settings that have historically been "owned" by a single discipline. On the one hand, placement of PEGS and PEJs, initially done endoscopically, can be done with equal facility and occasional failure, by endoscopists and interventional radiologists, reserving failed attempts for minimally invasive surgery. What resources are utilized with these three methods? Are there advantages to defining the mucosa of the gut lumen in all, or even a subset of patients? By way of contrast, acute cholecystectomy tubes in high surgical risk patients have usually been the domain of the radiologist, although I described transcystic duct gallbladder decompression endoscopically 2(1/2) decades ago. With the advent of new devices delivered under EUS control, the gallbladder will now be readily accessible endoscopically. What does this mean both for the acutely ill patient without a window to approach their gallbladder radiologically? Will this play a bit part and a cooperative technique to expand our therapeutic armamentarium or will it become competitive therapeutically not only for IR but for minimally invasive surgeons? The same may be said for EUS's ability to inject genes, caustics, or chemo-therapeutic agents into organs adjacent to the lumen. What is the role of TNFerade injection into unresectable pancreatic cancers and the role of absolute alcohol or Taxitol to treat cystic neoplasms of the pancreas? The real issue of competition or cooperation between the disciplines comes when treating patients with unresectable and obstructing GI neoplasms, from my perspective. The latter may occur almost anywhere in the GI tract but, of course, are more commonly noted proximally (esophagus, stomach, duodenum) and distally (left colon) as well as proximal and distal biliary obstructions. Recognizing that the occasional mid-small bowel and many proximal colon lesions are better handled with an endoscopic approach because of loss of vector force and difficulty pushing a catheter through large diameter, acutely angulated lumens, all others are fair game from my perspective. To my knowledge, although there are studies demonstrating the superiority of SEMS over open or laparoscopic bypass for malignant gastric outlet obstruction insofar as return of gut function, hospitalization time, and resource utilization, there are no studies demonstrating the superiority of one discipline or another in the placement of SEMS. Nor have cost data emerged suggesting the superiority of one technique over another from a cost standpoint. Unless or until we have such studies, this suggests to me that institutional interest and expertise should play a major role in how these unfortunate patients have continuity of their GI tract re-established. The situation is a bit more complex in pancreaticobiliary malignancy. There are 2 prospective randomized trials (level 1 evidence) that suggest that patients with proximal strictures (Bismuth II-IV) in conjunction with bile duct and gallbladder cancer, respectively, may be more successfully stented percutaneously and certainly it is easier to deliver brachytherapy or PDT under protocol to these patients who have indwelling external drains. In contrast, there are no data, positive or negative, to suggest that PTBD is a preferable treatment for distal biliary malignant obstruction, and in most parts of the world, the endoscopic approach has supplanted the percutaneous one just as metal stents have replaced plastic prostheses to preclude recurrent bouts of stent dysfunction and need for additional ERCP. The question posed at the beginning of this syllabus contribution: Are we competitive or cooperative? The answer is obviously both but, hopefully, our choice of treatment should depend less on who touches the patient first and more on skill sets within an institution and what is the best treatment for this particular individual. The importance of the SGI is technical and informational cross-fertilization. If your university or clinic will not allow blurring of training barriers to put therapeutic endoscopists, minimally invasive surgeons, and interventional radiologists together as a department or institute, you can nevertheless work together as a team in the best interest of your patients.