Goff Septotomy Is a Safe and Effective Salvage Biliary Access Technique Following Failed Cannulation at ERCP.

BACKGROUND: Biliary cannulation is readily achieved in > 85% of patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). When standard cannulation techniques fail, salvage techniques utilized include the needle knife precut, double wire technique, and Goff septotomy. METHODS: Records of patients undergoing ERCP from 2005 to 2016 were retrospectively examined using a prospectively maintained endoscopy database. Patients requiring salvage techniques for biliary access were analyzed together with a control sample of 20 randomly selected index ERCPs per study year. Demographic and clinical variables including indications for ERCP, cannulation rates, and adverse events were collected. RESULTS: A total of 7984 patients underwent ERCP from 2005 to 2016. Biliary cannulation was successful in 94.9% of control index ERCPs, 87.2% of patients who underwent Goff septotomy (significantly higher than for all other salvage techniques, p ≤ 0.001), 74.5% of patients in the double wire group and 69.6% of patients in the needle knife precut group. Adverse event rates were similar in the Goff septotomy (4.1%) and index ERCP control sample (2.7%) groups. Adverse events were significantly higher in the needle knife group (27.2%) compared with all other groups. CONCLUSIONS: This study represents the largest study to date of Goff septotomy as a salvage biliary access technique. It confirms the efficacy of Goff septotomy and indicates a safety profile similar to standard cannulation techniques and superior to the widely employed needle knife precut sphincterotomy. Our safety and efficacy data suggest that Goff septotomy should be considered as the primary salvage approach for failed cannulation, with needle knife sphincterotomy restricted to Goff septotomy failures.

When Experts Fail: Use of a Short Turning Radius Colonoscope Facilitates Successful Completion of Colonoscopy in Patients with Bowel Fixity.

BACKGROUND: Rates of incomplete colonoscopy in non-expert settings range up to 13%. Expert colonoscopists can complete ~ 95% colonoscopies when other endoscopists fail; however, a small number remain incomplete even in expert hands, typically due to bowel fixity. AIMS: Pentax Retroview™ (EC-3490TLi) is a new slim colonoscope with a short turning radius (STR) and greater tip deflection (210°), which allows easy maneuverability across sharply angulated/fixed colonic bends. We evaluated the utility of this colonoscope for completing colonoscopies that fail even in the hands of expert colonoscopists. METHODS: Retrospective chart review was performed, and main outcomes measured included cecal intubation rate, lesions detected, dosage of sedation used, and complications. RESULTS: Using the STR colonoscope, complete colonoscopy to the cecum was possible in 34/37 patients (91.9%). No loss of lumen/blind advancement was necessary in any of the procedures. No adverse events occurred. Among the completed colonoscopies, 6/34 (17.6%) patients had adenomas, all proximal to the site of prior failure, including one advanced adenoma. All failures (n = 3, 8.1%) had a history of cancer surgeries, with peritoneal carcinomatosis/extensively fixed/frozen bowel (two patients) and an additional diverticular stricture with colo-vesical fistula (one patient). CONCLUSION: STR colonoscope facilitates completion of a high proportion (91.9%) of colonoscopies that previously failed in expert hands. Its STR allows easy maneuverability across segments of sharp angulation with bowel fixity without need for blind advancement. The use of this colonoscope led to the detection of adenomas in 17.6% of patients, all proximal to the site of prior failed colonoscopy.

Radiation Training, Radiation Protection, and Fluoroscopy Utilization Practices Among US Therapeutic Endoscopists.

BACKGROUND: Fluoroscopy use during ERCP exposes patients and providers to deleterious effects of radiation. Formal training in fluoroscopy/radiation protection is not widely emphasized during therapeutic endoscopy training, and radiation use during GI endoscopy has not previously been characterized in the USA. In this study, we evaluated radiation training, fluoroscopy use patterns, and radiation protection practices among US therapeutic endoscopists. METHODS: An anonymous electronic survey was distributed to US therapeutic endoscopists, and responses were analyzed using descriptive statistics. State-specific requirements for fluoroscopy utilization were determined from state radiologic health branches. RESULTS: A total of 159 endoscopists (response rate 67.8%) predominantly those working in university hospitals (69.2%) with > 5 years of experience performing ERCP (74.9%) completed the questionnaire. Although the majority of endoscopists (61.6%) reported that they personally controlled fluoroscopy during ERCP, most (56.6%) had not received training on operating their fluoroscopy system. Only a minority (18-31%) of all respondents reported consistently utilizing modifiable fluoroscopy system parameters that minimize patient radiation exposure (pulsed fluoroscopy, frame rate modification or collimation). Endoscopists appear to undertake adequate personal radiation protective measures although use of a dosimeter was not consistent in half of respondents. The majority of states (56.8%) do not have any stated requirement for certification of non-radiologist physicians who intend to operate fluoroscopy. CONCLUSIONS: Most US gastroenterologists performing ERCP have not received formal training in operating their fluoroscopy system or in minimizing radiation exposure to themselves and to their patients. Such formal training should be included in all therapeutic endoscopy training programs, and fluoroscopy system-specific training should be offered at all hospitals.

A prospective evaluation of radiation-free direct solitary cholangioscopy for the management of choledocholithiasis.

BACKGROUND AND AIMS: Endoscopy has replaced many radiologic studies for the GI tract. However, ERCP remains a hybrid endoscopic-fluoroscopic procedure, which limits its portable delivery, creates delays because of fluoroscopy room unavailability, and exposes patients and providers to radiation. We evaluated fluoroscopy/radiation-free management of patients with noncomplex choledocholithiasis using direct solitary cholangioscopy (DSC). METHODS: Patients underwent fluoroscopy-free biliary cannulation, sphincterotomy, and then cholangioscopy to establish location and number/size of stones and to document distance from ampulla to bifurcation to guide balloon advancement. Stones were extracted using a marked balloon catheter advanced to the bifurcation and inflated to the bile duct diameter, documented on prior imaging. Repeat cholangioscopy was performed to confirm stone clearance. RESULTS: Fluoroscopy-free biliary cannulation was successful in all 40 patients (100%). Advanced cannulation techniques were required in 5 patients. Papillary balloon dilation was performed in 8 patients and electrohydraulic lithotripsy in 3 patients. Discrete stones were visualized in 31 patients and stone debris/sludge in 8 patients. Fluoroscopy-free stone/debris/sludge extraction was successful in all these patients. Brief fluoroscopy was used in 2 patients (5%) to confirm stone clearance. No stone/debris/sludge was noted in 1 patient. Mild pancreatitis was noted in 2 patients (5%) and bleeding in 1 (2.5%). CONCLUSIONS: This study establishes the feasibility of fluoroscopy/radiation-free, cholangioscopic management of noncomplex choledocholithiasis with success and adverse event rates similar to standard ERCP. DSC represents a significant procedural advance in the management of biliary disorders that does not need to be confined to the fluoroscopy suite and can be reimagined as bedside procedures in emergency department or intensive care unit settings. (Clinical trial registration number: NCT03074201.).

Evolution in the utilization of biliary interventions in the United States: results of a nationwide longitudinal study from 1998 to 2013.

BACKGROUND AND AIMS: Bile duct surgery (BDS), percutaneous transhepatic cholangiography (PTC), and ERCP are alternative interventions used to treat biliary disease. Our aim was to describe trends in ERCP, BDS, and PTC on a nationwide level in the United States. METHODS: We used the National Inpatient Sample to estimate age-standardized utilization trends of inpatient diagnostic ERCP, therapeutic ERCP, BDS, and PTC between 1998 and 2013. We calculated average case fatality, length of stay, patient demographic profile (age, gender, payer), and hospital characteristics (hospital size and metropolitan status) for these procedures. RESULTS: Total biliary interventions decreased over the study period from 119.8 to 100.1 per 100,000. Diagnostic ERCP utilization decreased by 76%, and therapeutic ERCP utilization increased by 35%. BDS rates decreased by 78% and PTC rates by 24%. ERCP has almost completely supplanted surgery for the management of choledocholithiasis. Fatality from ERCP, BDS, and PTC have all decreased, whereas mean length of stay has remained stable. The proportion of Medicare-insured, Medicaid-insured, and uninsured patients undergoing biliary procedures has increased over time. Most of the increase in therapeutic ERCP and decrease in BDS occurred in large, metropolitan hospitals. CONCLUSIONS: Although therapeutic ERCP utilization has increased over time, the total volume of biliary interventions has decreased. BDS utilization has experienced the most dramatic decrease, possibly a consequence of the increased therapeutic capacity and safety of ERCP. ERCPs are now predominantly therapeutic in nature. Large urban hospitals are leading the shift from surgical to endoscopic therapy of the biliary system.

Adenosine triphosphate bioluminescence for bacteriologic surveillance and reprocessing strategies for minimizing risk of infection transmission by duodenoscopes.

BACKGROUND AND AIMS: Recent outbreaks of duodenoscope-transmitted infections underscore the importance of adequate endoscope reprocessing. Adenosine triphosphate (ATP) bioluminescence testing allows rapid evaluation of endoscopes for bacteriologic/biologic residue. In this prospective study we evaluate the utility of ATP in bacteriologic surveillance and the effects of endoscopy staff education and dual cycles of cleaning and high-level disinfection (HLD) on endoscope reprocessing. METHODS: ATP bioluminescence was measured after precleaning, manual cleaning, and HLD on rinsates from suction-biopsy channels of all endoscopes and elevator channels of duodenoscopes/linear echoendoscopes after use. ATP bioluminescence was remeasured in duodenoscopes (1) after re-education and competency testing of endoscopy staff and subsequently (2) after 2 cycles of precleaning and manual cleaning and single cycle of HLD or (3) after 2 cycles of precleaning, manual cleaning, and HLD. RESULTS: The ideal ATP bioluminescence benchmark of <200 relative light units (RLUs) after manual cleaning was achieved from suction-biopsy channel rinsates of all endoscopes, but 9 of 10 duodenoscope elevator channel rinsates failed to meet this benchmark. Re-education reduced RLUs in duodenoscope elevator channel rinsates after precleaning (23,218.0 vs 1340.5 RLUs, P < .01) and HLD (177.0 vs 12.0 RLUs, P < .01). After 2 cycles of manual cleaning/HLD, duodenoscope elevator channel RLUs achieved levels similar to sterile water, with corresponding negative cultures. CONCLUSIONS: ATP testing offers a rapid, inexpensive alternative for detection of endoscope microbial residue. Re-education of endoscopy staff and 2 cycles of cleaning and HLD decreased elevator channel RLUs to levels similar to sterile water and may therefore minimize the risk of transmission of infections by duodenoscopes.

Endometriosis mimicking colonic stromal tumor.

Endometriosis is defined as the presence of endometrial glands and stroma at extra-uterine sites; it is a common disease affecting women of reproductive age. Endometrial tissue can implant itself to various organs, including the gastrointestinal tract, and can cause significant gastrointestinal symptoms. These ectopic endometrial tissue implants are usually located in the pelvis but can be present almost anywhere in the body. Endometriosis seems to be the most frequent cause of chronic pelvic pain in women of reproductive age and may cause prolonged suffering and disability that negatively affect health-related quality of life. We report a case in a generally healthy young female patient who presented for evaluation of diarrhea.

Outcomes of endoscopic treatment of second recurrences of large nonpedunculated colorectal adenomas.

BACKGROUND AND AIMS: Piecemeal endoscopic mucosal resection (EMR) of large nonpedunculated colorectal adenomas is associated with significant recurrence rates. After salvage endoscopic treatment of recurrences, there is a significant rate of second recurrences. There is a paucity of data on the efficacy and safety of continued endoscopic treatment after a second recurrence. METHODS: Consecutive patients with recurrent adenomas after initial piecemeal EMR of nonpedunculated colorectal adenomas >2 cm were reviewed. We assessed the feasibility, safety and efficacy of continued endoscopic treatment in these patients. RESULTS: Sixty-four patients with 70 recurrent lesions were identified. All were retreated endoscopically. Follow-up colonoscopy (mean interval 6.4 months) was performed on 62/70 lesions (89 %), and a second recurrence was found in 21/62 (34 %). One patient underwent surgery for a circumferential adenoma of the ileocecal valve. The other 20 lesions were treated endoscopically. Follow-up colonoscopy was performed on 15/20 (75 %) and demonstrated a third recurrence in 3/15 (20 %). One was a deep T1 cancer; curative surgery was performed. The other two patients each had one additional endoscopic treatment and both had no recurrence on subsequent colonoscopy. There were two complications: Both were delayed bleeds after treatment of the first recurrence. A mean of 1.3 endoscopic procedures was required to achieve a cure (range 1-3) for recurrent adenomas after piecemeal EMR. CONCLUSION: Endoscopic treatment of patients with second recurrences is safe and effective, but is associated with a significant rate of additional recurrences. Continued endoscopic treatment of patients with multiple recurrences is associated with high cure rates, low complication rates and a low risk of progression to malignancy.

Direct costs of care for hepatocellular carcinoma in patients with hepatitis C cirrhosis.

BACKGROUND: Hepatitis C virus (HCV) is the commonest cause of hepatocellular carcinoma (HCC) in the United States. The benefits of HCV therapy may be measured in part by the prevention of HCC and other complications of cirrhosis. The true cost of care of the HCV patient with HCC is unknown. METHODS: One hundred patients were randomly selected from a cohort of all HCC patients with HCV at a US transplant center between 2003 and 2013. Patients were categorized by the primary treatment modality, Barcelona class, and ultimate transplant status. Costs included the unit costs of procedures, imaging, hospitalizations, medications, and all subsequent care of the HCC patient until either death or the end of follow-up. Associations with survival and cost were assessed in multivariate regression models. RESULTS: Overall costs included a median of $176,456 (interquartile range [IQR], $84,489-$292,192) per patient or $6279 (IQR, $4043-$9720) per patient-month of observation. The median costs per patient-month were $7492 (IQR, $5137-$11,057) for transplant patients and $4830 for nontransplant patients. The highest median monthly costs were for transplant patients with Barcelona A4 disease ($11,349) and patients who received chemoembolization whether they underwent transplantation ($10,244) or not ($8853). Transarterial chemoembolization and radiofrequency ablation were independently associated with a 28% increase and a 22% decrease in costs, respectively, with adjustments for the severity of liver disease and Barcelona class. CONCLUSIONS: These data represent real-world estimates of the cost of HCC care provided at a transplant center and should inform economic studies of HCV therapy.

Prospective assessment of consensus criteria for evaluation of patients with suspected choledocholithiasis.

BACKGROUND AND AIM: American Society for Gastrointestinal Endoscopy (ASGE) guidelines have proposed criteria to stratify patients into low, intermediate and high risk of choledocholithiasis. The criteria include variables that are readily available in clinical practice. The objective of the present study was to prospectively assess the accuracy of these criteria. METHODS: A prospective observational cohort study was conducted at Beth Israel Deaconess Medical Center. All adult patients referred for endoscopic retrograde cholangiopancreatography (ERCP) with suspected choledocholithiasis were considered for inclusion. ASGE criteria were applied, and each patient was categorized as high, intermediate or low risk for choledocholithiasis. Presence of stone at ERCP served as criteria standard. RESULTS: During the study period, 402 patients met study inclusion criteria and 336 were reported in the final analysis. Of the 244 patients in the high risk for choledocholithiasis group, 185 were found to have stones at ERCP (75.8%, 95% CI 70.2-80.1%). Of the 92 patients in the intermediate risk for choledocholithiasis group, 45 had stones at ERCP (48.9%, 95% CI 38.8-59.1%); P-value for difference between groups = 0.001. Diagnostic accuracy for choledocholithiasis in the high-risk group was 69.05%, and for the intermediate group was 39.95%. Presence of choledocholithiasis on pre-ERCP imaging (OR: 3.6; 95% CI 2.2-6.0; P < 0.01), and bilirubin >1.8 but <4 mg/dL (OR: 1.69; 95% CI 1.0-2.8; P < 0.04) were the strongest predictors of choledocholithiasis. No additional variable that improved accuracy of ASGE criteria was identified. CONCLUSION: ASGE criteria stratify patients by risk for choledocholithiasis and can be used in routine clinical practice.

Multicenter Study Assessing Physician Recommendations Regarding the Continuation of Aspirin and/or NSAIDs Prior to Gastrointestinal Endoscopy.

BACKGROUND: In 2009 the American Society for Gastrointestinal Endoscopy (ASGE) guidelines advised that both aspirin and NSAIDs be continued prior to low-risk gastrointestinal endoscopic procedures. We sought to determine physician knowledge regarding these guidelines. METHODS: A survey questionnaire was developed based on the ASGE guidelines. Physicians were queried about whether they would continue/stop aspirin in a patient with cardiac disease and in a patient taking NSAIDs for arthritis whether they would continue/stop NSAIDs prior to endoscopy. The survey was administered at three academic medical centers. Demographic information: level of training, board certification, teaching trainees, percentage of time in clinical practice, year of medical school graduation, and location of medical school were all reviewed. The primary outcome was number of questions answered correctly and predictors of correct responses. RESULTS: The survey was administered to 941 participants with 12 declining to participate, while 80% (740/929) of the subjects completed the survey; 20% (150/740) respondents answered both questions correctly and 42% (310/740) answered one question correctly. There was no significant difference between institutions (p = 0.6) or between attendings and trainees (p = 0.75). Multivariate predictors of correct answers were self-reported familiarity with the guideline (-0.029; 95% CI -0.003 to -0.056, p < 0.031), level of training (0.050; 95% CI 0.012-0.088, p = 0.010), and specialty (0.108; 95% CI 0.058-0.159, p < 0.0001). Finally, there was an inverse, linear relationship between postgraduate year and percent questions correct. CONCLUSION: Physician knowledge of guidelines regarding the use of aspirin and NSAIDs prior to endoscopy is suboptimal. Interventions are necessary to improve knowledge of the current pre-procedure guidelines.

A Multi-Center Prospective Derivation and Validation of a Clinical Prediction Tool for Severe Clostridium difficile Infection.

BACKGROUND AND AIMS: Prediction of severe clinical outcomes in Clostridium difficile infection (CDI) is important to inform management decisions for optimum patient care. Currently, treatment recommendations for CDI vary based on disease severity but validated methods to predict severe disease are lacking. The aim of the study was to derive and validate a clinical prediction tool for severe outcomes in CDI. METHODS: A cohort totaling 638 patients with CDI was prospectively studied at three tertiary care clinical sites (Boston, Dublin and Houston). The clinical prediction rule (CPR) was developed by multivariate logistic regression analysis using the Boston cohort and the performance of this model was then evaluated in the combined Houston and Dublin cohorts. RESULTS: The CPR included the following three binary variables: age ≥ 65 years, peak serum creatinine ≥ 2 mg/dL and peak peripheral blood leukocyte count of ≥ 20,000 cells/µL. The Clostridium difficile severity score (CDSS) correctly classified 76.5% (95% CI: 70.87-81.31) and 72.5% (95% CI: 67.52-76.91) of patients in the derivation and validation cohorts, respectively. In the validation cohort, CDSS scores of 0, 1, 2 or 3 were associated with severe clinical outcomes of CDI in 4.7%, 13.8%, 33.3% and 40.0% of cases respectively. CONCLUSIONS: We prospectively derived and validated a clinical prediction rule for severe CDI that is simple, reliable and accurate and can be used to identify high-risk patients most likely to benefit from measures to prevent complications of CDI.

Current knowledge of antibiotic prophylaxis guidelines regarding GI open-access endoscopic procedures is inadequate.

BACKGROUND: The American Heart Association (AHA) guidelines from 2007 and the American Society for Gastrointestinal Endoscopy (ASGE) guidelines from 2008 recommended against antibiotic prophylaxis before GI endoscopic procedures to prevent bacterial endocarditis. OBJECTIVE: To determine physician knowledge regarding these guidelines and to identify physician subgroups for which knowledge was suboptimal. DESIGN: A survey questionnaire was developed based on AHA and ASGE guidelines regarding antibiotics before endoscopy. Physicians were queried about 10 theoretical scenarios as to whether or not they would recommend before-procedure antibiotics. SETTING: The survey was administered at 3 academic medical centers. PARTICIPANTS: Attending physicians and trainees in primary care and subspecialties. INTERVENTIONS: Survey. MAIN OUTCOME MEASUREMENTS: Percentage of the survey questions answered correctly and predictors of correct response. RESULTS: The survey was administered to 941 participants of whom 12 declined to participate. Eighty percent (n=740/929) of participants completed the survey. The median number of correct answers was 70% (interquartile range [IQR] 50%-90%) and was similar at each institution (P=.6). A total of 7.3% (n=54) of respondents answered all questions correctly. There was no significant difference in correct responses between attending physicians and trainees or between study centers (median 7, IQR 5-9; P=.75). Gastroenterologists were more likely to answer questions correctly than other subspecialists or primary care physicians (P<.0001). On multivariate analysis, physician knowledge correlated directly with self-reported familiarity with guidelines (0.21; 95% confidence interval [CI], 0.08-0.34; P=.002) and specialty (0.56; 95% CI, 0.30-0.82; P<.001) and inversely with year of medical school graduation (0.22; 95% CI, 0.07-0.37; P=.005). LIMITATIONS: Survey study that used theoretical scenarios. CONCLUSION: Physician knowledge of guidelines regarding antibiotic use before endoscopy is suboptimal. Further interventions are needed to improve the knowledge of before-procedure guidelines.

A meta-analysis on efficacy and safety: single-balloon vs. double-balloon enteroscopy.

BACKGROUND AND AIM: Double-balloon enteroscopy (DBE) and single-balloon enteroscopy (SBE) are new techniques capable of providing deep enteroscopy. Results of individual studies comparing these techniques have not been able to identify a superior strategy. Our aim was to systematically pool all available studies to compare the efficacy and safety of DBE with SBE for evaluation of the small bowel. METHODS: Databases were searched, including PubMed, Embase, and the Cochrane Central Register of Controlled Trials. The main outcome measures were complete small-bowel visualization, diagnostic yield, therapeutic yield, and complication rate. Statistical analysis was performed using Review Manager (RevMan version 5.2). Meta-analysis was performed using fixed-effect or random-effect methods, depending on the absence or presence of significant heterogeneity. We used the χ(2) and I(2) test to assess heterogeneity between trials. Results were expressed as risk ratios (RR) or mean differences with 95% confidence intervals (CI). RESULTS: Four prospective, randomized, controlled trials with a total of 375 patients were identified. DBE was superior to SBE for visualization of the entire small bowel [pooled RR = 0.37 (95% CI: 0.19-0.73; P = 0.004)]. DBE and SBE were similar in ability to provide diagnosis [pooled RR = 0.95 (95% CI: 0.77-1.17; P = 0.62)]. There was no significant difference between DBE and SBE in therapeutic yield [pooled RR = 0.78 (95% CI: 0.59-1.04; P = 0.09)] and complication rate [pooled RR = 1.08 (95% CI: 0.28-4.22); P = 0.91]. CONCLUSIONS: DBE was superior to SBE with regard to complete small bowel visualization. DBE was similar to SBE with regard to diagnostic yield, ability to provide treatment and complication rate, but these results should be interpreted with caution as they is based on very few studies and the overall quality of the evidence was rated as low to moderate, due to the small sample size.