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1.  Predicting the likelihood of a persistent bile duct stone in patients with suspected choledocholithiasis: accuracy of existing guidelines and the impact of laboratory trends 
Gastrointestinal endoscopy  2015;82(1):88-93.
Existing guidelines aim to stratify the likelihood of choledocholithiasis in order to guide the use of ERCP versus a lower risk diagnostic study such as EUS, magnetic resonance cholangiopancreatography (MRCP), or intraoperative cholangiography.
To assess the performance of existing guidelines in predicting choledocholithiasis and to determine if trends in laboratory parameters improve diagnostic accuracy.
Retrospective cohort study.
Tertiary-care hospital.
Hospitalized patients presenting with suspected choledocholithiasis over a 6 year period.
Assessment of the American Society for Gastrointestinal Endoscopy (ASGE) guidelines, its component variables, and laboratory trends in predicting choledocholithiasis.
The presence of choledocholithiasis confirmed by EUS, MRCP, or ERCP.
One hundred seventy-nine (35.9%) of the 498 eligible patients met ASGE high-probability criteria for choledocholithiasis on initial presentation. Of those, 99 subjects (56.3%) had stone/sludge on subsequent confirmatory test. Among cases not meeting high-probability criteria on presentation, 111 (34.8%) had a stone/sludge. The overall accuracy of the guidelines in detecting choledocholithiasis was 62.1% (47.4% sensitivity, 73% specificity) based upon data available at presentation. The accuracy was unchanged when incorporating the second set of liver chemistries obtained after admission (63.2%), suggesting that laboratory trends did not improve performance.
retrospective study; inconsistent timing of second set of biochemical markers.
In our cohort of patients, existing choledocholithiasis guidelines lacked diagnostic accuracy, likely resulting in overuse of ERCP. Incorporation of laboratory trends did not improve performance. Additional research focused on risk stratification is necessary toward the goal of eliminating unnecessary diagnostic ERCP.
PMCID: PMC4469613  PMID: 25792387
2.  Intraprocedural Quality in Endoscopic Retrograde Cholangiopancreatography: A Meta-Analysis 
The American journal of gastroenterology  2013;108(11):10.1038/ajg.2013.217.
In 2006, the American College of Gastroenterology (ACG)/the American Society for Gastrointestinal Endoscopy (ASGE) Taskforce on Quality in Endoscopy published quality indicators for the major gastrointestinal procedures. Our primary aim was to use the published literature to assess current endoscopic retrograde cholangiopancreatography (ERCP) intraprocedural performance and compare it to the targets set by the ACG/ASGE taskforce. Our secondary aim was to determine whether performance varies across different health-care settings (academic and community), study designs (prospective and retrospective), and trainee participation.
A PubMed and EMBASE literature search from 1/1/2006 to 2/1/2013 was conducted. Articles were selected based on title, abstract, full text, and reporting of success rates for the intraprocedural quality indicators. Success rates, represented as numerical proportions, were collected from each study. For each success rate, a standard error and a 95% confidence interval (CI) was calculated. A random-effects meta-analysis model was used to weight each study, and a cumulative, weighted success rate (or effect size) for each indicator was determined. Random-effects meta-regression was then used to examine the impact of study setting, design, and trainee involvement on each quality indicator.
A total of 8,005 articles were initially retrieved. Following the application of predefined criteria, 52 articles remained. The cumulative, weighted bile duct cannulation success rate was 89.3% (95% CI 0.866–0.919); pancreatic duct cannulation was 85.0% (95% CI 0.813–0.886); precut utilization rate was 10.5% (95% CI 0.087–0.123); common bile duct stone extraction rate was 88.3% (95% CI 0.825–0.941); and the rate of successful biliary stenting below the common bile duct bifurcation was 97.5% (95% CI 0.967–0.984). Subgroup analysis with meta-regression showed no statistically significant differences between academic and community settings, prospective and retrospective study designs, and trainee participation on success across bile duct cannulation, precut utilization, and common bile duct stone extraction (insufficient observations/variance for pancreatic duct cannulation and biliary stent placement).
ERCP intraprocedural quality is in good standing. On the basis of this analysis, the two targets that could be potentially revised are precut utilization and biliary stenting. This analysis was confined to the published literature and therefore, in general, reflects the ERCP performance of institutions, primarily academic, that are conducting clinical research. Thus, it is difficult to generalize this performance assessment to the broader ERCP community as a whole.
PMCID: PMC3840532  PMID: 23877349
3.  Sphincter of Oddi dysfunction and bile duct microlithiasis in acute idiopathic pancreatitis 
Although there are numerous causes of acute pancreatitis, an etiology cannot always be found. Two potential etiologies, microlithiasis and sphincter of Oddi dysfunction, are discussed in this review. Gallbladder microlithiasis, missed on transcutaneous ultrasound, is reported as the cause of idiopathic acute pancreatitis in a wide frequency range of 6%-80%. The best diagnostic technique for gallbladder microlithiasis is endoscopic ultrasound although biliary crystal analysis and empiric cholecystectomy remain as reasonable options. In contrast, in patients who are post-cholecystectomy, bile duct microlithiasis does not appear to have a role in the pathogenesis of acute pancreatitis. Sphincter of Oddi dysfunction is present in 30%-65% of patients with idiopathic acute recurrent pancreatitis in whom other diagnoses have been excluded. It is unclear if this sphincter dysfunction was the original etiology of the first episode of pancreatitis although it appears to have a causative role in recurring episodes since sphincter ablation decreases the frequency of recurrent attacks. Unfortunately, this conclusion is primarily based on small retrospective case series; larger prospective studies of the outcome of pancreatic sphincterotomy for SOD-associated acute pancreatitis are sorely needed. Another problem with this diagnosis and its treatment is the concern over potential procedure related complications from endoscopic retrograde cholangiopancreatography (ERCP), manometry and pancreatic sphincterotomy. For these reasons, patients should have recurrent acute pancreatitis, not a single episode, and have a careful informed consent before assessment of the sphincter of Oddi is undertaken.
PMCID: PMC2689403  PMID: 18286682
Sphincter of Oddi dysfunction; Microlithiasis; Idiopathic pancreatitis
4.  Does Rectal Indomethacin Eliminate the Need for Prophylactic Pancreatic Stent Placement in Patients Undergoing High-Risk ERCP? Post hoc Efficacy and Cost-Benefit Analyses Using Prospective Clinical Trial Data 
A recent large-scale randomized controlled trial (RCT) demonstrated that rectal indomethacin administration is effective in addition to pancreatic stent placement (PSP) for preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk cases. We performed a post hoc analysis of this RCT to explore whether rectal indomethacin can replace PSP in the prevention of PEP and to estimate the potential cost savings of such an approach.
We retrospectively classified RCT subjects into four prevention groups: (1) no prophylaxis, (2) PSP alone, (3) rectal indomethacin alone, and (4) the combination of PSP and indomethacin. Multivariable logistic regression was used to adjust for imbalances in the prevalence of risk factors for PEP between the groups. Based on these adjusted PEP rates, we conducted an economic analysis comparing the costs associated with PEP prevention strategies employing rectal indomethacin alone, PSP alone, or the combination of both.
After adjusting for risk using two different logistic regression models, rectal indomethacin alone appeared to be more effective for preventing PEP than no prophylaxis, PSP alone, and the combination of indomethacin and PSP. Economic analysis revealed that indomethacin alone was a cost-saving strategy in 96% of Monte Carlo trials. A prevention strategy employing rectal indomethacin alone could save approximately $150 million annually in the United States compared with a strategy of PSP alone, and $85 million compared with a strategy of indomethacin and PSP.
This hypothesis-generating study suggests that prophylactic rectal indomethacin could replace PSP in patients undergoing high-risk ERCP, potentially improving clinical outcomes and reducing healthcare costs. A RCT comparing rectal indomethacin alone vs. indomethacin plus PSP is needed.
PMCID: PMC3947644  PMID: 23295278
5.  Can patient and pain characteristics predict manometric sphincter of Oddi dysfunction in patients with clinically suspected sphincter of Oddi dysfunction? 
Gastrointestinal endoscopy  2014;79(5):765-772.
Biliopancreatic-type postcholecystectomy pain, without significant abnormalities on imaging and laboratory test results, has been categorized as “suspected” sphincter of Oddi dysfunction (SOD) type III. Clinical predictors of “manometric” SOD are important to avoid unnecessary ERCP, but are unknown.
To assess which clinical factors are associated with abnormal sphincter of Oddi manometry (SOM).
Prospective, cross-sectional.
A total of 214 patients with suspected SOD type III underwent ERCP and pancreatic SOM (pSOM; 85% dual SOM), at 7 U.S. centers (from August 2008 to March 2012) as part of a randomized trial.
Pain and gallbladder descriptors, psychosocial/functional disorder questionnaires.
Main Outcome Measurements
Abnormal SOM findings. Univariate and multivariate analyses assessed associations between clinical characteristics and outcome.
The cohort was 92% female with a mean age of 38 years. Baseline pancreatic enzymes were increased in 5%; 9% had minor liver enzyme abnormalities. Pain was in the right upper quadrant (RUQ) in 90% (48% also epigastric); 51% reported daily abdominal discomfort. Fifty-six took narcotics an average of 33 days (of the past 90 days). Less than 10% experienced depression or anxiety. Functional disorders were common. At ERCP, 64% had abnormal pSOM findings (34% both sphincters, 21% biliary normal), 36% had normal pSOM findings, and 75% had at least abnormal 1 sphincter. Demographic factors, gallbladder pathology, increased pancreatobiliary enzymes, functional disorders, and pain patterns did not predict abnormal SOM findings. Anxiety, depression, and poorer coping were more common in patients with normal SOM findings (not significant on multivariate analysis).
Patient and pain factors and psychological comorbidity do not predict SOM results at ERCP in suspected type III SOD. (Clinical Trial registration number: NCT00688662.) (Gastrointest Endosc 2014;79:765-72.)
PMCID: PMC4409681  PMID: 24472759
6.  Challenges in planning and initiating a randomized clinical study of sphincter of Oddi dysfunction 
Gastrointestinal endoscopy  2010;72(5):986-991.
Sphincter of Oddi dysfunction (SOD) is a controversial topic, especially in patients with no objective findings on laboratory or imaging studies (SOD type III). The value of ERCP manometry with sphincterotomy is unproven and carries significant risks.
To describe the process of planning and initiating a randomized sham-controlled study to establish whether patients with SOD respond to sphincter ablation, and whether the outcomes are predicted by the pain patterns, presence or absence of other functional GI or psychosocial problems, or the results of manometry.
Planning a trial to establish which patients with “suspected SOD” (if any) respond to endoscopic sphincter ablation.
Meetings and correspondence by a planning group of gastroenterologists and clinical research specialists hosted at the Medical University of South Carolina.
Clarifying subject characteristics and inclusion and exclusion criteria.
Defining the questionnaires, therapies, randomizations, and numbers of subjects required by outcome measures. Defining the metrics of success and failure.
The planning resulted in funding for the proposed study as a cooperative agreement with the National Institute of Diabetes and Digestive and Kidney Diseases.
Lack of data required several consensus decisions in designing the protocol.
The planning process was challenging, and some changes were needed after initiation.* (Clinical trial registration number: NCT00688662.) (Gastrointest Endosc 2010;72:986-91.)
PMCID: PMC4409682  PMID: 21034899
7.  CT colonography: Friend or foe of practicing endoscopists 
AIM: To investigate the perceived impact of computed tomographic colonography (CTC) on endoscopists’ current and future practice.
METHODS: A 21-question survey was mailed to 1570 randomly chosen American Society for Gastrointestinal Endoscopy (ASGE) members. Participants reported socio-demographics, colonoscopy volume, percentage of colonoscopies performed for screening, and likelihood of integration of CTC into their practice.
RESULTS: A total of 367 ASGE members (23%) returned the questionnaire. Respondents were predominantly male (> 90%) and white (83%) with an average age of 49 years. Most respondents (58%) had no plans to incorporate CTC into daily practice and only 7% had already incorporated CTC into daily practice. Private practice respondents were the least likely to incorporate this modality into their daily practice (P = 0.047). Forty-three percent of participants were willing to take courses on CTC reading, particularly those with the highest volume of colonoscopy (P = 0.049). Forty percent of participants were unsure of CTC’s impact on future colonoscopy volume while 21% and 18% projected a decreased and increased volume, respectively. The estimated impact of CTC volume varied significantly by age (P = 0.002). Respondents > 60 years felt that CTC would increase colonoscopy, whereas those < 40 years thought CTC would ultimately decrease colonoscopy.
CONCLUSION: Practicing endoscopists are not enthusiastic about the incorporation of CTC into their daily practice and are unsure of its future impact on their practice.
PMCID: PMC2998846  PMID: 21160651
Computed tomographic colonography; Virtual colonoscopy; Endoscopy; Colonoscopy; Screening; Colorectal cancer
8.  A survey of ampullectomy practices 
AIM: To investigate the endoscopic ampullectomy practices of expert biliary endoscopists.
METHODS: An anonymous survey was mailed to 79 expert biliary endoscopists to assess ampullectomy practices.
RESULTS: Forty six (58%) biliary endoscopists returned the questionnaire. Of these, 63% were in academia and in practice for an average of 16.4 years (± 8.6). Endoscopists performed an average of 1.1 (± 0.8) ampullectomies per month. Prior to ampullectomy, endoscopic ultrasound was “always” utilized by 67% of respondents vs “sometimes” in 31% of respondents. Empiric biliary sphincterotomy was not utilized uniformly, only 26% “always” and 37% “sometimes” performed it prior to resection. Fifty three percent reported “never” performing empiric pancreatic sphincterotomy prior to ampullectomy. Practitioners with high endoscopic retrograde cholangiopancreatography volumes were the most likely to perform a pancreatic sphincterotomy (OR = 10.9; P = 0.09). Participants overwhelmingly favored “always” placing a prophylactic pancreatic stent, with 86% placing it after ampullectomy rather than prior to resection (23%). Argon plasma coagulation was the favored adjunct modality (83%) for removal of residual adenomatous tissue. Practitioners uniformly (100%) preferred follow-up examination to be within 6 mo post-ampullectomy.
CONCLUSION: Among biliary experts, there is less variation in ampullectomy practices than is reflected in the literature.
PMCID: PMC2715973  PMID: 19630102
Endoscopic retrograde cholangiopancreatography; Ampullectomy; Papillectomy; Ampulla of Vater, Common bile duct neoplasms; Adenoma
9.  Patient compliance and suboptimal bowel preparation with split-dose bowel regimen in average-risk screening colonoscopy 
Gastrointestinal endoscopy  2014;79(5):811-820.e3.
Although split-dose bowel regimen is recommended in colon cancer screening and surveillance guidelines, implementation in clinical practice has seemingly lagged because of concerns of patient compliance.
To assess patient compliance with the split-dose bowel regimen and assess patient- and preparation process–related factors associated with compliance and bowel preparation adequacy.
Prospective survey cohort.
Tertiary care setting.
Average-risk patients undergoing colonoscopy for colorectal cancer screening between August 2011 and January 2013.
Main Outcome Measurements
Split-dose bowel regimen patient-reported compliance and bowel preparation adequacy with the Boston Bowel Preparation Scale score.
Surveys and Boston Bowel Preparation Scale score data were completed in 462 participants; 15.4% were noncompliant with the split-dose bowel regimen, and suboptimal bowel preparation (score < 5) was reported in 16% of all procedures. White (P = .009) and married (P = .01) subjects were least likely to be noncompliant, whereas Hispanic subjects and those who reported incomes of US$75,000 or less were most likely to be noncompliant (P = .004). Participants who were noncompliant with split-dosing were less likely to follow the other laxative instructions and more likely to have their colonoscopy appointment before 10:30 am. Compliance differed by bowel preparation type (P = .003, χ2 test), with those who used MiraLAX showing the highest compliance, followed by polyethylene glycol electrolyte solution and other bowel preparations. Noncompliance with split-dose bowel preparation (odds ratio 6.7; 95% confidence interval, 3.2–14.2) was the strongest predictor of suboptimal bowel preparation.
Patient self-report, performed at tertiary care center.
Overall, 1 in 7 patients do not comply with a split-dose bowel regimen. Ensuring compliance with the split-dose bowel regimen will reduce the risk of a suboptimal bowel preparation. (Gastrointest Endosc 2014;79:811-20.)
PMCID: PMC4107415  PMID: 24631492
10.  In Vivo and In Situ Evaluation of a Wireless Magnetoelastic Sensor Array for Plastic Biliary Stent Monitoring 
Biomedical microdevices  2013;15(3):509-517.
This paper presents the in vivo and in situ evaluation of a system that wirelessly monitors the accumulation of biliary sludge in a plastic biliary stent. The sensing element, located within the stent, is a passive array of magnetoelastic resonators that is queried by a wireless electromagnetic signal. The in vivo and in situ testing uses commercially-available plastic biliary stents, each enhanced with an array of ribbon sensors (formed from Metglas™ 2826MB). The sensor array is approximately 70 mm long and contains individual resonators that are 1 mm in width and have lengths of 10 mm, 14 mm, and 20 mm. The array is anchored into the 2.8 mm inner-diameter stent using a thermal staking technique. For the in situ testing, an instrumented stent is placed in various locations within the abdominal cavity of a female domestic swine carcass to evaluate the wireless range of the system; these results show that a wireless signal can be obtained from a range of at least 7.5 cm from a sensor array covered in bile. The in vivo testing includes the endoscopic implantation of an instrumented stent into the bile duct of a swine. After implantation, the swine was housed for a period of 4 weeks, during which the animal showed no ill effects and followed the expected growth curve from 29 kg to 42 kg. At the conclusion of the in vivo test, the animal was euthanized, and the instrumented stent explanted and examined. The results presented in this paper indicate that the monitoring system does not adversely affect the health of the animal and can feasibly provide sufficient wireless range after implantation.
PMCID: PMC3738268  PMID: 23460136
Implant; Resonant Sensors; Biliary Sludge; Mass Sensors; Viscosity Sensors
11.  A survey of expert follow-up practices after successful endoscopic eradication therapy for Barrett's esophagus with high-grade dysplasia and intramucosal adenocarcinoma 
Gastrointestinal endoscopy  2013;78(5):696-701.
Despite the increasing number of patients undergoing endoscopic therapy for Barrett's esophagus (BE) with high-grade dysplasia (HGD) or intramucosal cancer (IMC), there are few data to guide clinical decision making and research initiatives in the area of posttreatment follow-up.
We aimed to define expert practice patterns regarding follow-up after endoscopic treatment of BE with HGD and IMC.
Electronic survey.
Forty-eight endoscopists in the United States with expertise in BE endotherapy based on high-impact publications and national reputation.
A 21-item Web-based survey inquiring about post-BE endotherapy follow-up practices.
Of 48 expert endoscopists, 42 completed the survey. After successful treatment of BE with HGD or IMC, all experts perform surveillance upper endoscopy, most commonly at 3-month intervals in the first posttreatment year, every 6 months during the second year, and annually thereafter. None of the experts perform surveillance EUS after treatment of HGD, and only 19% perform EUS after treatment of IMC. After cancer eradication, only 36% of experts refer patients for CT, and 24% refer patients for positron emission tomography. Thirty-eight percent of experts refer patients for a surgical opinion when IMC extends into the muscularis mucosa; 100% refer when IMC extends into submucosa.
Not a consensus document; only U.S. experts included.
This study reports the follow-up practices of expert endoscopists after successful endotherapy for BE with HGD and IMC. Additional research is necessary to establish optimal surveillance intervals, the role of follow-up EUS, CT, and positron emission tomography, as well as the surgical implications of low-risk IMC extending into the muscularis mucosa.
PMCID: PMC3961573  PMID: 23711553
12.  Post-sphincterotomy bleeding: fully-covered metal stents for hemostasis 
F1000Research  2013;2:171.
Background/objectives: In endoscopic retrograde cholangiopancreatography, post-sphincterotomy bleeding (PSB) is a common complication of biliary sphincterotomy. Recently, the temporary placement of fully-covered metal stents (FCMS) into the biliary tree in order to achieve a tamponade effect has been described as an additional therapeutic option for PSB. The aim of this article is to review the literature on FCMS for hemostasis in PSB and update the treatment algorithm for this complication.
Methods: A PubMed literature search was conducted using the search terms post-sphincterotomy, bleeding, and stent. 33 articles were reviewed, along with their references, and four were found to describe the use of FCMS for hemostasis in PSB.
Results: A total of 21 patient cases were described in the four articles. All patients received FCMS for PSB hemostasis following the application and subsequent failure of traditional therapies (conventional pharmacologic injection, thermal or electrocoagulation, and mechanical therapy (balloon tamponade or endoclip)). Successful hemostasis was achieved in all patients through FCMS placement. No major complications were observed.   
Conclusion: These 21 cases demonstrate that FCMS are a viable therapeutic option for PSB.  It is reasonable to consider stent placement for patients in which traditional interventions fail in order to avoid the need for angiographic or surgical hemostasis.
PMCID: PMC3869479  PMID: 24555084
13.  A Randomized Trial of Rectal Indomethacin to Prevent Post-ERCP Pancreatitis 
The New England Journal of Medicine  2012;366(15):1414-1422.
Preliminary research suggests that rectally administered nonsteroidal antiinflammatory drugs may reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP).
In this multicenter, randomized, placebo-controlled, double-blind clinical trial, we assigned patients at elevated risk for post-ERCP pancreatitis to receive a single dose of rectal indomethacin or placebo immediately after ERCP. Patients were determined to be at high risk on the basis of validated patient- and procedure-related risk factors. The primary outcome was post-ERCP pancreatitis, which was defined as new upper abdominal pain, an elevation in pancreatic enzymes to at least three times the upper limit of the normal range 24 hours after the procedure, and hospitalization for at least 2 nights.
A total of 602 patients were enrolled and completed follow-up. The majority of patients (82%) had a clinical suspicion of sphincter of Oddi dysfunction. Post-ERCP pancreatitis developed in 27 of 295 patients (9.2%) in the indomethacin group and in 52 of 307 patients (16.9%) in the placebo group (P = 0.005). Moderate-to-severe pancreatitis developed in 13 patients (4.4%) in the indomethacin group and in 27 patients (8.8%) in the placebo group (P = 0.03).
Among patients at high risk for post-ERCP pancreatitis, rectal indomethacin significantly reduced the incidence of the condition. (Funded by the National Institutes of Health; number, NCT00820612.)
PMCID: PMC3339271  PMID: 22494121
14.  Radiation doses to ERCP patients are significantly lower with experienced endoscopists 
Gastrointestinal endoscopy  2010;72(1):58-65.
Patients undergoing ERCP receive nontrivial doses of radiation, which may increase their risk of developing cancer, especially young patients. Radiation doses to patients during ERCP correlate closely with fluoroscopy time.
The aim of this study was to determine whether endoscopist experience is associated with fluoroscopy time.
Retrospective analysis of a prospectively collected database.
Data from 69 providers from 6 countries.
9,052 entries of patients undergoing ERCP.
Main Outcome Measurements
Percent difference in fluoroscopy time associated with endoscopist experience and fellow involvement.
For procedure types that require less fluoroscopy time, compared with endoscopists who performed > 200 ERCPs in the preceding year, endoscopists who performed < 100 and 100 to 200 ERCPs had 104% (95% confidence interval [CI], 85%–124%) and 27% (95% CI, 20%–35%) increases in fluoroscopy time, respectively. Every 10 years of experience was associated with a 21% decrease in fluoroscopy time (95% CI, 19%–24%). For fluoroscopy-intense procedures, compared with endoscopists who performed > 200 ERCPs in the preceding year, endoscopists who performed < 100 and 100 to 200 ERCPs had 59% (95% CI, 39%–82%) and 11% (95% CI, 3%–20%) increases in fluoroscopy time, respectively. Every 10 years of experience was associated with a 20% decrease in fluoroscopy time (95% CI, 18%–24%).
Database used is a voluntary reporting system, which may not be generalizable. Data is self-reported and was not verified for accuracy.
Fluoroscopy time is shorter when ERCP is performed by endoscopists with more years of performing ERCP and a greater number of ERCPs in the preceding year. These findings may have important ramifications for radiation-induced cancer risk.
PMCID: PMC2906113  PMID: 20421102
15.  Prophylactic Pancreatic Duct Stents 
Gastroenterology & Hepatology  2008;4(4):251-253.
PMCID: PMC3093726  PMID: 21960906

Results 1-15 (15)