The ERCP-related lawsuit: "Best avoid it!".
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Cholangiopancreatography, Endoscopic Retrograde↗
Biomedical subjects
James T Frakes
Publications and source records attributed to James T Frakes.
The ambulatory endoscopy center (AEC): what it can do for your gastroenterology practice.
Endoscopy accounts for most of the gastroenterologist's professional time and revenue. The thoughtful gastroenterologist in practice must understand the potential sites of service for endoscopy, including either the hospital endoscopy unit or an ambulatory endoscopy center (whether an office endoscopy suite or a licensed, certified, and accredited ambulatory surgery center). Out-of-hospital endoscopy centers have advantages for patients, including convenience, efficiency, economy, and more pleasant surroundings than the hospital. Payers appreciate improved access and reduced costs. For gastrointestinal practices, ambulatory endoscopy centers, particularly ambulatory surgery centers, provide significant advantages, including enhanced reimbursement and cost management, control, efficiency and convenience, quality control, opportunities for clinical research, and marketing and competitive strengths.
Ambulatory Care Facilities↗
Risk factors for post-ERCP pancreatitis: a prospective multicenter study.
OBJECTIVES: Pancreatitis is the most common and serious complication of diagnostic and therapeutic ERCP. The aim of this study is to examine the potential patient- and procedure-related risk factors for post-ERCP pancreatitis in a prospective multicenter study. METHODS: A 160-variable database was prospectively collected by a defined protocol on patients undergoing diagnostic or therapeutic ERCP at 15 centers in the Midwest Pancreaticobiliary Group and participating in a randomized controlled study evaluating whether prophylactic corticosteroids will reduce the incidence of post-ERCP pancreatitis. Data were collected prior to the procedure, at the time of procedure, and 24-72 h after discharge. Post-ERCP pancreatitis was diagnosed and its severity graded according to consensus criteria. RESULTS: Of the 1,115 patients enrolled, diagnostic ERCP with or without sphincter of Oddi manometry (SOM) was performed in 536 (48.1%) and therapeutic ERCP in 579 (51.9%). Suspected sphincter of Oddi dysfunction (SOD) was the indication for the ERCP in 378 patients (33.9%). Pancreatitis developed in 168 patients (15.1%) and was graded mild in 112 (10%), moderate in 45 (4%), and severe in 11(1%). There was no difference in the incidence of pancreatitis or the frequency of investigated potential pancreatitis risk factors between the corticosteroid and placebo groups. By univariate analysis, the incidence of post-ERCP pancreatitis was significantly higher in 19 of 30 investigated variables. In the multivariate risk model, significant risk factors with adjusted odds ratios (OR) were: minor papilla sphincterotomy (OR: 3.8), suspected SOD (OR: 2.6), history of post-ERCP pancreatitis (OR: 2.0), age <60 yr (OR: 1.6), > or =2 contrast injections into the pancreatic duct (OR: 1.5), and trainee involvement (OR: 1.5). Female gender, history of recurrent idiopathic pancreatitis, pancreas divisum, SOM, difficult cannulation, and major papilla sphincterotomy (either biliary or pancreatic) were not multivariate risk factors for post-ERCP pancreatitis. CONCLUSION: This study emphasizes the role of patient factors (age, SOD, prior history of post-ERCP pancreatitis) and technical factors (number of PD injections, minor papilla sphincterotomy, and operator experience) as the determining high-risk predictors for post-ERCP pancreatitis.
Adult↗
Ambulatory endoscopy centers: what the interviewing fellow needs to know.
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Ambulatory Surgical Procedures↗
Oral allopurinol does not prevent the frequency or the severity of post-ERCP pancreatitis.
BACKGROUND: Pancreatitis is the most common major complication of ERCP. Efforts have been made to identify pharmacologic agents capable of reducing its incidence and severity. The aim of this trial was to determine whether prophylactic allopurinol, an inhibitor of oxygen-derived free radical production, would reduce the frequency and severity of post-ERCP pancreatitis. Methods A total of 701 patients were randomized to receive either allopurinol or placebo 4 hours and 1 hour before ERCP. A database was prospectively collected by a defined protocol on patients who underwent ERCP. Standardized criteria were used to diagnose and grade the severity of postprocedure pancreatitis. RESULTS: The groups were similar with regard to patient demographics and to patient and procedure risk factors for pancreatitis. The overall incidence of pancreatitis was 12.55%. It occurred in 46 of 355 patients in the allopurinol group (12.96%) and in 42 of 346 patients in the control group (12.14%; p = 0.52). The pancreatitis was graded mild in 7.89%, moderate in 4.51%, and severe in 0.56% of the allopurinol group, and mild in 6.94%, moderate in 4.62%, and severe in 0.58% of the control group. There was no significant difference between the groups in the frequency or the severity of pancreatitis. CONCLUSIONS: Prophylactic oral allopurinol did not reduce the frequency or the severity of post-ERCP pancreatitis.
Administration, Oral↗
Does prophylactic administration of corticosteroid reduce the risk and severity of post-ERCP pancreatitis: a randomized, prospective, multicenter study.
BACKGROUND: Pancreatitis is the most common major complication of diagnostic and therapeutic ERCP. There have been continuing efforts to identify a pharmacologic agent capable of reducing the frequency and severity of this complication. On the basis of several case reports, experimental data, and knowledge of their mechanism of action, corticosteroids might be effective in this regard. The aim of this randomized, double-blind, controlled trial was to determine whether prophylactic, orally administered corticosteroid reduces the frequency and/or severity of post-ERCP pancreatitis. METHODS: A total of 1115 patients were randomized to receive either prednisone (40 mg) or a placebo orally 15 hours and 3 hours before ERCP. A 160 variable database was prospectively collected according to a defined protocol on patients undergoing diagnostic or therapeutic ERCP at 15 centers in the Midwest Pancreaticobiliary Group. Standardized criteria were used to diagnose and grade the severity of postprocedure pancreatitis. RESULTS: The overall frequency of pancreatitis was 15.07%. It occurred in 92 of 555 patients in the corticosteroid group (16.6%), and in 76 of 560 patients in the control group (13.6%; p = 0.19). The pancreatitis was mild in 10.04%, moderate in 4.04%, and severe in 0.99%. There was no difference between the groups with regard to the severity of pancreatitis. Moreover, the groups were similar with regard to age, gender, body mass index, frequency of prior pancreatitis, type of procedure performed (diagnostic or therapeutic), difficulty of cannulation, frequency of pre-cut sphincterotomy, pancreatic sphincterotomy, sphincter of Oddi dysfunction, sphincter of Oddi manometry, pancreatic acinarization, chronic pancreatitis, number of pancreatic duct injections, and bile duct diameter. CONCLUSION: Prophylactic orally administered corticosteroid did not reduce the frequency or severity of post-ERCP pancreatitis.
Administration, Oral↗
Outpatient endoscopy. The case for the ambulatory surgery center.
Since the late 1970s, there has been a dramatic shift of GI endoscopy services from the inpatient to the outpatient setting. Outpatient GI endoscopy has migrated from the hospital endoscopy unit to the office and then on to the EASC. This evolution has been brought about by many forces, including the drive for health care cost containment, a desire for enhanced service, cost pressure on physicians, and demands for quality assurance. Although there are advantages and disadvantages to each of the outpatient settings (see Tables 5 and 6), the EASC seems to offer the most value to patients, payers, and physician owners. That value is defined as good outcomes, excellent service, and reasonable cost. Those attributes of the EASC that are most important in guaranteeing this value are physician control, time efficiency, convenience, and adequate reimbursement. The endoscopic ambulatory surgery center seems to be the best environment for delivering endoscopic services. The office AEC can only approach the attractiveness of an EASC when restrictive certificate-of-need laws prevent the development of an EASC; when groups lack a critical number of endoscopists to support an EASC (at least three endoscopists with a potential procedure volume of 1200 to 1800 procedures per year [11]); when excess office capacity and personnel can be used for the office AEC; and, perhaps most importantly, when there is an ability to secure favorable contracts for facility payment from private health plans to the office endoscopy center. The evolution of EASCs over three decades has demonstrated many advantages to patients, physicians, and payers. Although further questions and challenges are inevitable, EASCs can adapt quickly and deliver value. The author believes the future is deservedly bright for such facilities.
Ambulatory Surgical Procedures↗
A corporate partner in the endoscopic ambulatory surgery center. Is it worth the cost?
In the preceding article of this two-part polemic on the advisability of a corporate partner in the endoscopic ambulatory surgery center (EASC), the advantages of such a partner were discussed and criteria given for judging its performance. Alternatives to the corporate partner were discussed. In that article, the corporate partnership in the EASC is a positive development yielding many benefits and few disadvantages to the physicians and the center. In this article, the balance tilts the other way.
Ambulatory Surgical Procedures↗