Sphincter of Oddi manometry does not predispose to post-ERCP acute pancreatitis

BACKGROUND: Sphincter of Oddi manometry is helpful in selecting patients with sphincter of Oddi dysfunction who will respond to sphincterotomy. However, studies have shown that sphincter of Oddi manometry is associated with a high risk of post-procedure pancreatitis. The primary objective of this study was to evaluate the safety of sphincter of Oddi manometry in patients with sphincter of 2Oddi dysfunction. The secondary objective was to determine the risk factors for post-ERCP pancreatitis in patients with sphincter of Oddi dysfunction. METHODS: Data were collected retrospectively for 268 patients who had elective ERCP performed at 3 tertiary care medical centers between 1996 and 2000. Consecutive patients with suspected sphincter of Oddi dysfunction formed the case group; the control group consisted of patients with bile duct stone. The case group was further subclassified into group A, patients who underwent sphincter of Oddi manometry followed by immediate ERCP, and group B, patients who had ERCP without manometry. The rate of post-ERCP acute pancreatitis was compared between case and control groups. RESULTS: Twenty-seven percent of patients in the case group with suspected sphincter of Oddi dysfunction developed acute pancreatitis compared with 3.2% of patients in the control group with bile duct stone (p<0.001). There was no significant difference in the rate of acute pancreatitis in patients with sphincter of Oddi dysfunction who underwent sphincter of Oddi manometry and ERCP compared with patients with sphincter of Oddi dysfunction who had ERCP without sphincter of Oddi manometry (odds ratio 0.72: 95% CI[0.08, 9.2]). Multivariable logistic regression analysis showed that biliary sphincterotomy (p=0.006) and pancreatography (p=0.03) were independent predictors of acute pancreatitis. CONCLUSIONS: Patients with suspected sphincter of Oddi dysfunction are at higher risk of post-ERCP acute pancreatitis. Sphincter of Oddi manometry by itself does not appear to predispose to this complication.     

Complications of endoscopic sphincterotomy: can heparin prevent acute pancreatitis after ERCP?

BACKGROUND: An exploratory analysis of a prospective study of risk factors for acute pancreatitis after ERCP combined with endoscopic sphincterotomy showed that the frequency of acute pancreatitis was lower in patients who received heparin compared with patients not treated with heparin. The study was continued to further analyze the effect of heparin on the frequency of acute pancreatitis. METHODS: Potential risk factors for acute pancreatitis and outcomes were evaluated prospectively for all ERCP procedures with endoscopic sphincterotomy performed between September 1994 and December 1998. The results were analyzed by univariate and multivariate methods to determine risk factors for complications. Heparin was administered to 32.9% of the patients (heparin group [HEP group], n = 268) for various clinical reasons (low-molecular-weight heparin, n = 208, unfractionated heparin n = 60). A group of 547 patients who did not receive heparin served as control patients (CON group). RESULTS: Eight hundred fifteen patients underwent ERCP with endoscopic sphincterotomy; acute pancreatitis occurred in 6.4% (n = 52). The frequency of acute pancreatitis was significantly lower in the HEP group versus the CON group in the final multivariate model, which included significant risk factors for acute pancreatitis (HEP group: 3.4%, 9/268 vs. CON group: 7.9%, 43/547; p = 0.005). HEP did not increase the risk of hemorrhage (HEP group: 1.1%, 3/268, 2 severe, none fatal vs. CON group: 2.0%, 11/547, 3 severe, 2 fatal). HEP (p = 0.005; OR 0.3: 95% CI [0.16, 0.73]) and the number of risk factors present (p = 0.0001; OR 2.5: 95% CI [1.80, 3.50]) influenced the frequency of acute pancreatitis independently. CONCLUSIONS: Heparin was significantly associated with an extremely low frequency of post-ERCP pancreatitis without increasing the risk of hemorrhage after endoscopic sphincterotomy. Because this effect could not be attributed to other known or suspected confounders, our conclusion was that heparin administration before ERCP reduces the risk of pancreatitis.     

A Multicenter, Randomized, Controlled Trial to Evaluate the Effect of Prophylactic Octreotide on ERCP-Induced Pancreatitis

Eight-four patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) were randomized to receive 100 micrograms of octreotide intravenously immediately prior to ERCP, and 100 micrograms subcutaneously 45 min after the initial dose, or placebo. Amylase, lipase, and glucose were measured and clinical assessment was performed before, and 2 and 24 h after, ERCP. We define clinical pancreatitis as the combination of elevated amylase or lipase with abdominal pain and tenderness. Interim analysis in 84 patients revealed an 11% incidence of clinical pancreatitis in the control group and 35% in the treatment group (p < 0.01). There were no differences in either group with respect to sphincterotomy, gender, age, duration of ERCP, number of cannulations of the pancreatic duct, degree of duct injection, or the volume of contrast injected. Analysis of group differences stratified by sphincterotomy revealed the following: 1) In patients who did not undergo a sphincterotomy, there was a significantly higher rate of pancreatitis in the treatment group [10/17 (59%) versus 1/17 (6%) RR 10.0 (95% CI 1.4-69.8)]. 2) Sphincterotomy reduced the rate of pancreatitis in patients who received octreotide from 10/17 (59% no sphincterotomy), to 3/20 (15% sphincterotomy) (p = 0.01), which equals the rate in patients who received placebo and underwent sphincterotomy [4/25 (16%)]. 3) Although the incidence of pancreatitis was higher in the treatment group, octreotide may reduce the severity of pancreatitis measured by the number of days NPO (Wilcoxon rank sum, p = 0.02), length of stay after ERCP (p = 0.13), the number of days of pain (p = 0.11), and the degree of amylase elevation (p = 0.04). We conclude that: 1) Octreotide appears to increase the incidence of pancreatitis when given prophylactically for diagnostic ERCP. 2) Although pancreatitis was more common in the octreotide group, it was less severe than the placebo group. 3) Sphincterotomy may afford protection against pancreatitis in patients who received octreotide. 4) We cannot recommend the use of prophylactic octreotide during diagnostic or therapeutic ERCP.     

Biliary sphincterotomy reduces the risk of acute gallstone pancreatitis recurrence in non-candidates for cholecystectomy

BackgroundPopulation aging and comorbidity are leading to an increase in patients unfit for cholecystectomy.AimsTo evaluate whether endoscopic biliary sphincterotomy after a first episode of acute gallstone pancreatitis reduces the risk of pancreatitis recurrence and gallstone-related events in non-surgical candidates.MethodsRetrospective study of patients admitted for a first episode of acute gallstone pancreatitis rejected for cholecystectomy between 2013–2018. The role of endoscopic sphincterotomy was evaluated by adjusting for age, severity of pancreatitis, and presence of choledocholithiasis.ResultsWe included 247 patients (mean age 80 ± 12 years; Charlson index: 5; severity of pancreatitis: 72% mild). Sphincterotomy was performed in 23.9%. Recurrence of pancreatitis occurred in 17.4% patients (median follow-up: 426 days). The one-year cumulative incidence of a new episode of pancreatitis was 1.8% (95% confidence interval [CI]: 0.2–12%) and 23% (95% CI: 17–31%) in patients with and without sphincterotomy, respectively (p = 0.006). In multivariate analysis, sphincterotomy showed a protective role for recurrence of pancreatitis (adjusted hazard ratio [HR]: 0.29, 95% CI: 0.08–0.92, p = 0.037) and for any gallstone-related event (HR 0.46, 95% CI: 0.21–0.98, p = 0.043).ConclusionsEndoscopic biliary sphincterotomy reduced the risk of gallstone pancreatitis recurrence and other biliary-related disorders in patients with a first episode of pancreatitis non-candidates for cholecystectomy.     

Interleukin 10 reduces the incidence of pancreatitis after therapeutic endoscopic retrograde cholangiopancreatography

BACKGROUND & AIMS: Prophylactic administration of interleukin (IL)-10 decreases the severity of experimental pancreatitis. Prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis in humans is a unique model to study the potential role of IL-10 in this setting. METHODS: In a single-center, double-blind, randomized, placebo-controlled study, the effect of a single injection of 4 microg/kg (group 1) or 20 microg/kg (group 2) IL-10 was compared with that of placebo (group 0), all administered 30 minutes before therapeutic ERCP. The primary endpoint was the effect of IL-10 on serum levels of amylases and lipases measured 4, 24, and 48 hours after ERCP. The secondary objective was to evaluate changes in plasma cytokines (IL-6, IL-8, tumor necrosis factor) at the same time points and the incidence of acute pancreatitis in the 3 groups. Subjects undergoing a first therapeutic ERCP were eligible for inclusion. RESULTS: A total of 144 patients were included. Seven were excluded based on intention to treat (n = 1) or per protocol (n = 6). Forty-five, 48, and 44 patients remained in groups 0, 1, and 2, respectively. The 3 groups were comparable for age, sex, underlying disease, indication for treatment, type of treatment, and plasma levels of C-reactive protein (CRP), cytokines, and hydrolases at baseline. No significant difference was observed in CRP, cytokine, and hydrolase plasma levels after ERCP. Forty-three patients developed hyperhydrolasemia (18 in group 0, 14 in group 1, and 11 in group 2; P = 0.297), and 19 patients developed acute clinical pancreatitis (11 in group 0, 5 in group 1, 3 in group 2; P = 0.038). Two severe cases were observed in the placebo group. No mortality related to ERCP was observed. Logistic regression identified 3 independent risk factors for post-therapeutic ERCP pancreatitis: IL-10 administration (odds ratio [OR], 0.46; 95% confidence interval [95% CI], 0.22-0.96; P = 0.039), pancreatic sphincterotomy (OR, 5.04; 95% CI, 1.53-16.61; P = 0.008), and acinarization (OR, 8.19; 95% CI, 1.83-36.57; P = 0.006). CONCLUSIONS: A single intravenous dose of IL-10, given 30 minutes before the start of the procedure, independently reduces the incidence of post-therapeutic ERCP pancreatitis.     

A national study of cardiopulmonary unplanned events after GI endoscopy

BACKGROUND: Cardiopulmonary unplanned events (CUE) related to conscious sedation constitute a major proportion of GI endoscopy-associated complications. OBJECTIVES: Our purpose was to study the incidence of CUE during GI endoscopy and to determine factors that may predict CUE. DESIGN: Retrospective CORI (Clinical Outcomes Research Initiative) database review. PATIENTS: Undergoing GI endoscopy under conscious sedation. MAIN OUTCOME MEASUREMENT: CUE associated with GI endoscopy. RESULTS: Data on 324,737 unique procedures (EGD, 140,692; colonoscopy, 174,255; ERCP, 6092; and EUS, 3698) performed with the patient under conscious sedation were analyzed. Unplanned events were reported in 1.4% of procedures; 0.9% were associated with CUE. Rates of CUE with EGD, colonoscopy, ERCP, and EUS were 0.6%, 1.1%, 2.1%, and 0.9%, respectively. Multiple logistic regression revealed patient age (odds ratio [OR] 1.02, 95% CI 1.01-1.02) and ASA class were significant predictors of CUE (OR compared with ASA I: ASA II 1.05, 95% CI 0.95-1.16; ASA III 1.8, 95% CI 1.6-2.0, ASA IV 3.2, 95% CI 2.5-4.1, ASA V 7.5; 95% CI 3.2-17.6). Inpatient procedures were associated with higher CUE (OR 1.5, 95% CI 1.3-1.7). Compared with universities, nonuniversity sites (OR 1.2, 95% CI 1.1-1.4) and Veterans Administration Medical Centers (OR 1.4, 95% CI 1.2-1.5) had significantly higher CUE. Use of supplemental oxygen during a procedure was associated with significantly more CUE (OR 1.2, 95% CI 1.1-1.3). Involvement of a trainee with a procedure was also associated with higher CUE (OR 1.3, 95% CI 1.1-1.4). LIMITATIONS: Retrospective review of data entered voluntarily by endoscopists not trained on CORI data entry. CONCLUSIONS: During GI endoscopy with conscious sedation, patient's age, higher ASA grade, inpatient status, trainee participation, and routine use of oxygen are associated with a higher incidence of CUE.     

Efficacy of postprocedure administration of gabexate mesylate in the prevention of post-ERCP pancreatitis: a randomized, controlled, multicenter study

BACKGROUND AND OBJECTIVE: Gabexate mesylate reduces the incidence of post-ERCP pancreatitis. Patient-related risk factors associated with pancreatitis can be identified before ERCP, but the procedure-related factors are recognized only at the end of the procedure. This study's aim was to evaluate whether gabexate mesylate administered after ERCP reduces the incidence of pancreatitis. DESIGN: Randomized, prospective, double-blind, multicenter trial. SETTING: Tertiary care centers. PATIENTS AND INTERVENTION: A total of 608 patients undergoing ERCP were treated with gabexate mesylate 500 mg within 1 hour before ERCP (group A, 203 patients) or within 1 hour after ERCP (group B, 203), or with saline solution (group C, 202). MAIN OUTCOME MEASUREMENTS: The incidence and severity of pancreatitis and hyperamylasemia, as well as factors associated with the development of pancreatitis. RESULTS: The groups were similar for demographic characteristics, indications to ERCP, risk factors for pancreatitis, and therapeutic procedures. The incidence of pancreatitis was 3.9% in group A, 3.4% in group B, and 9.4% in group C (P<.01). Two patients (in groups A and C) developed necrotizing pancreatitis, and 1 died. Hyperamylasemia occurred in 23.6% in groups A and B, and in 24.7% in group C. Levels of amylase, the incidence of abdominal pain, and other complications occurred similarly. Female sex (odds ratios [OR] 2.7, 95% CI 1.2-5.9) and difficult cannulation (OR 5.6, 95% CI 2.6-12.3) were independently associated with pancreatitis. CONCLUSIONS: The administration of gabexate mesylate after ERCP protects against the development of pancreatitis similarly to the preprocedure administration. Factors associated with pancreatitis were mainly recognized after ERCP. We suggest administering gabexate mesylate after ERCP only in those patients recognized to be at risk of developing pancreatitis.     

Value of initial chest radiographs for predicting clinical outcomes in patients with severe acute respiratory syndrome

PURPOSE: To determine whether the initial chest radiograph is helpful in predicting the clinical outcome of patients with severe acute respiratory syndrome (SARS). METHODS: Of 343 patients who met the World Health Organization's case definition of probable SARS and who had been admitted to a regional hospital in Hong Kong, 201 patients had laboratory evidence of SARS coronavirus infection. The initial frontal chest radiographs of these 201 patients were assessed in a blinded fashion by 3 radiologists; individual findings were accepted if at least 2 of the radiologists concurred. Independent predictors of an adverse outcome, defined as the need for assisted ventilation, death, or both, were identified by multivariate analysis. RESULTS: Bilateral disease and involvement of more than two zones on the initial chest radiograph were associated with a higher risk of liver impairment and poor clinical outcome. Forty-two patients (21%) developed an adverse outcome. Multivariate analysis showed that lung involvement of more than two zones (odds ratio [OR] = 7.0; 95% confidence interval [CI]: 2.7 to 17.9), older age (OR for each decade of life = 1.5; 95% CI: 1.1 to 2.0), and shortness of breath on admission (OR = 2.8; 95% CI: 1.1 to 7.4) were independent predictors of an adverse outcome. CONCLUSION: Frontal chest radiographs on presentation may have prognostic value in patients with SARS.     

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.     

Post-ERCP pancreatitis

Pancreatitis remains the most common severe complication of endoscopic retrograde cholangiopancreatography (ERCP). Detailed information about the findings of previous studies concerning post-ERCP pancreatitis has not been utilized sufficiently. The purpose of the present article was to present guidelines for the diagnostic criteria of post-ERCP pancreatitis, and its incidence, risk factors, and prophylactic procedures that are supported by evidence. To achieve this purpose, a critical examination was made of the articles on post-ERCP pancreatitis, based on the data obtained by research studies published up to 2009. At present, there are no standardized diagnostic criteria for post-ERCP pancreatitis. It is appropriate that post-ERCP pancreatitis is defined as acute pancreatitis that has developed following ERCP, and its diagnosis and severity assessment should be made according to the diagnostic criteria and severity assessment of the Japanese Ministry of Health, Labour and Welfare. The incidence of acute pancreatitis associated with diagnostic and therapeutic ERCP is 0.4–1.5 and 1.6–5.4%, respectively. Endoscopic papillary balloon dilation is associated with a high risk of acute pancreatitis compared with endoscopic sphincterotomy. It was made clear that important risk factors include dysfunction of the Oddi sphincter, being of the female sex, past history of post-ERCP pancreatitis, and performance of pancreaticography. Temporary prophylactic placement of pancreatic stents in the high-risk group is useful for the prevention of post-ERCP pancreatitis [odds ratio (OR) 3.2, 95% confidence interval (CI) 1.6–6.4, number needed to treat (NNT) 10]. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) is associated with a reduction in the development of post-ERCP pancreatitis (OR 0.46, 95% CI 0.32–0.65). Single rectal administration of NSAIDs is useful for the prevention of post-ERCP pancreatitis [relative risk (RR) 0.36, 95% CI 0.22–0.60, NNT 15] and decreases the development of pancreatitis in both the low-risk group (RR 0.29, 95% CI 0.12–0.71) and the high-risk group (RR 0.40, 95% CI 0.23–0.72) of post-ERCP pancreatitis. As for somatostatin, a bolus injection may be most useful compared with short- or long-term infusion (OR 0.271, 95% CI 0.138–0.536, risk difference 8.2%, 95% CI 4.4–12.0%). The usefulness of gabexate mesilate was not apparent in any of the following conditions: acute pancreatitis (control 5.7 vs. 4.8% for gabexate mesilate), hyperamylasemia (40.6 vs. 36.9%), and abdominal pain (1.7 vs. 8.9%). Formulation of diagnostic criteria for post-ERCP pancreatitis is needed. Temporary prophylactic placement of pancreatic stents in the high-risk group offers the most promise as a means of preventing post-ERCP pancreatitis. As for pharmacological attempts, there are high expectations concerning NSAIDs because they are excellent in terms of cost-effectiveness, ease of use, and safety. There was no evidence of effective prophylaxis with the use of protease inhibitors, especially gabexate mesilate.     

Prophylaxis of ERCP-related pancreatitis: a randomized, controlled trial of somatostatin and gabexate mesylate.

BACKGROUND & AIMS: It still is debated whether post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis can be prevented by administering either somatostatin or gabexate mesylate. The aim of the study is to assess the efficacy of a 6.5-hour infusion of somatostatin or gabexate mesylate in preventing ERCP-related complications. METHODS: In a double-blind multicenter trial, 1127 patients undergoing ERCP were randomly assigned to intravenous administration of somatostatin (750 microg; n = 351), gabexate mesylate (500 mg; n = 381), or placebo (saline; n = 395). The drug infusion started 30 minutes before and continued for 6 hours after endoscopy. Patients were evaluated clinically, and serum amylase levels were determined at 4, 24, and 48 hours after endoscopy. RESULTS: No significant differences in incidences of pancreatitis, hyperamylasemia, or abdominal pain were observed among the placebo (4.8%, 32.6%, and 5.3%, respectively), somatostatin (6.3%, 26.8%, and 5.1%, respectively), and gabexate mesylate groups (5.8%, 31.5%, and 6.3%, respectively). Univariate analysis of patient characteristics and endoscopic maneuvers showed that a Freeman score >1 (P < 0.0001), >/=3 pancreatic injections (P < 0.00001), and precut sphincterotomy (P = 0.01) were significantly associated with post-ERCP pancreatitis. At multiple logistic regression analysis, >/=3 pancreatic injections (odds ratio [OR], 1.95; 95% confidence interval [CI], 1.45-2.63) and a Freeman score >1 (OR, 1.47; 95% CI, 1.11-1.94) retained their predictive power. CONCLUSIONS: Long-term (6.5-hr) administration of either somatostatin or gabexate mesylate is ineffective for the prevention of post-ERCP pancreatitis. Pancreatic injury seems to be related to difficulty in common bile duct access.     

Pharmacologic treatment can prevent pancreatic injury after ERCP: a meta-analysis

BACKGROUND: The identification of therapeutic agents that can prevent the pancreatic injury after endoscopic retrograde cholangiopancreatography (ERCP) is of considerable importance. METHODS: We performed a meta-analysis including 28 clinical trials on the use of somatostatin (12 studies), octreotide (10 studies), and gabexate mesilate (6 studies) after ERCP. Outcome measures evaluated were the incidence of acute pancreatitis, hyperamylasemia, and pancreatic pain. Three analyses were run separately: for all available studies, for randomized trials only, and for only those studies published as complete reports. RESULTS: When all available studies were analyzed, somatostatin and gabexate mesilate were significantly associated with improvements in all three outcomes. Odds ratios (OR) for gabexate mesilate were 0.27 (95% CI [0.13, 0. 57], p = 0.001) for acute pancreatitis, 0.66 (95% CI [0.48, -0.89], p = 0.007) for hyperamylasemia, and 0.33 (95% CI [0.18, 0.58], p = 0. 0005) for post-procedural pain. Somatostatin reduced acute pancreatitis (OR 0.38: 95% CI [0.22, 0.65], p < 0.001), pain (OR 0. 24: 95% CI [0.14, 0.42], p < 0.001), and hyperamylasemia (OR 0.65: 95% CI [0.48, 0.90], p = 0.008). Octreotide was associated only with a reduced risk of post-ERCP hyperamylasemia (OR 0.51: 95% CI [0.31, 0.83], p = 0.007) but had no effect on acute pancreatitis and pain. The statistical significance of data did not change after analyzing randomized trials only or studies published as complete reports. For each considered outcome, the publication bias assessment and the number of patients that need to be treated to prevent one adverse effect were, respectively, higher and lower for somatostatin than for gabexate mesilate. CONCLUSIONS: The pancreatic injury after ERCP can be prevented with the administration of either somatostatin or gabexate mesilate, but the former agent is more cost-effective. Additional studies comparing the efficacy of short-term infusion of somatostatin versus gabexate mesilate in patients at high risk for post-ERCP complications seem warranted.     

Predictors of clinical outcome and radiologic progression in patients with neuropsychiatric manifestations of systemic lupus erythematosus

PURPOSE: We sought to identify the predictors of clinical outcome and of the evolution of cerebral abnormalities in patients with neuropsychiatric systemic lupus erythematosus (SLE). SUBJECTS AND METHODS: Thirty-two patients with SLE (including 14 with the antiphospholipid syndrome) who had been hospitalized with primary neuropsychiatric disease were observed prospectively for at least 2 years. Laboratory and clinical characteristics and data from magnetic resonance imaging (MRI) studies obtained during the hospitalization and 2 years later were evaluated. We ascertained nonreversible or new MRI changes and clinical outcomes, including neuropsychiatric events, during follow-up. RESULTS: Cranial MRI scans on admission were abnormal in 26 (81%) of the 32 patients. Patients with the antiphospholipid syndrome were more likely to have focal cerebral white matter lesions (odds ratio [OR] = 12, 95% confidence interval [CI]: 2.0 to 72). After 2 years, neuropsychiatric deficits substantially improved in 22 (69%) of the patients, stabilized in 6 (19%), and deteriorated in 4 (12%). The number of prior neuropsychiatric events was associated with persistent MRI lesions (OR = 4.8 per each event, 95% CI: 1.1 to 21) and unfavorable clinical outcome (OR = 4.3 per each event, 95% CI: 1.4 to 13) at 2 years. The antiphospholipid syndrome also predicted an unfavorable clinical outcome at 2 years (OR = 11, 95% CI: 1.7 to 65). CONCLUSIONS: Among patients with SLE who have neuropsychiatric disease, prior neuropsychiatric events and the antiphospholipid syndrome increase the risk of adverse outcomes.     

Prognostic value of global myocardial performance indices in acute myocardial infarction: comparison to measures of systolic and diastolic left ventricular function

STUDY OBJECTIVES: Assessment of global myocardial performance by a single index (ie, the myocardial performance index [MPI]) has been suggested as an appealing alternative to the individual assessment of systolic and diastolic left ventricular (LV) function We sought to test the prognostic value of MPI in comparison to clinical characteristics and echocardiographic parameters of LV filling and ejection in acute myocardial infarction (AMI). PATIENTS: Four hundred seventeen consecutive patients with AMI were examined within 24 h of hospital admission. INTERVENTIONS: Doppler echocardiographic measures of systolic, diastolic, and global myocardial performance were assessed within 24 h of hospital admission. In addition to MPI (ie, the sum of the isovolumic time intervals divided by ejection time), we determined the isovolumic/heterovolumic time ratio, which expresses the time "wasted" by the myocardium to generate and decrease LV pressure without moving blood. RESULTS: The end points of the study at 30 days were death (4.7%), congestive heart failure (23%), and recurrent infarction (4.8%), and occurred in 109 patients, who were compared as group B to 314 patients without an event (group A). Multivariate analysis identified only age (odds ratio [OR], 1.04; 95% confidence interval [CI], 1.02 to 1.07), LV ejection fraction (LVEF) < or = 40% (OR, 3.82; 95% CI, 2.15 to 6.87), and E-wave deceleration time (EDT) of < or = 130 ms (OR, 2.29; 95% CI, 1.0 to 5.21) as independent predictors of adverse events. CONCLUSION: LVEF and EDT are powerful and independent echocardiographic predictors of poor outcome following AMI, and are superior to indexes of global LV performance. Both parameters should be taken into consideration when deciding about the management of these patients.     

Changes in hospital admissions across Europe: 1995-2003. Results from the EuroSIDA study

OBJECTIVES: To describe changes in the proportions of patients admitted to hospital and the duration of admission during the month of March between 1995 and 2003 and to describe the factors related to admission for 9802 patients from EuroSIDA, a pan-European, observational cohort study. METHODS: Generalized estimating equations were used to determine changes over time in the proportion of patients admitted and the median duration of admission. Logistic regression was used to determine factors related to admission in March 1995, March 1998 and March 2001. RESULTS: The proportion of patients admitted during March declined from 7.4% in 1995 to 2.6% in 2003. After adjustment, the estimated reduction in the proportion of patients admitted was 5.5% per year [95% confidence interval (CI) 2.5-8.5%; P=0.0004], a 26% reduction. The median duration of hospital admission declined by 58% from 12 days in 1995 [interquartile range (IQR) 5-19 days] to 5 days in 2003 (IQR 3-12 days), a significant decline of 0.7 days per year after adjustment (95% CI 0.5-0.9 days; P=0.031). Patients with a lower CD4 lymphocyte count, and with an AIDS diagnosis made within the 3 months prior to March, all had increased odds of admission during March 1995, 1998 or 2001. In March 2001, patients whose treatment regimen was changed as a consequence of toxicities had increased odds of admission [odds ratio (OR) 2.34; 95% CI 1.26-4.37; P=0.0074]. In addition, patients who were hepatitis C virus-positive during March 2001 (OR 1.66; 95% CI 1.02-2.68; P=0.041) had increased odds of admission. CONCLUSIONS: There has been a considerable decline in both the proportion of patients admitted to hospital and the median duration of the stay. Patients with hepatitis C had increased odds of admission, but there was little evidence of an increase in admissions among patients taking highly active antiretroviral therapy (HAART) associated with serious adverse events, although longer follow up is required.     

Emergency room risk stratification of patients with chest pain without ST segment elevation

OBJECTIVES: To investigate the prognostic factors in patients who come to the emergency room with chest pain but without ST segment elevation. PATIENTS AND METHOD: 743 consecutive patients were evaluated by recording clinical history, electrocardiogram and troponin I determination, and early (<24 h) exercise testing was done for the low-risk subgroup of patients (n=203). All patients were followed during 3 months for major events (acute myocardial infarction or death). RESULTS: Major events occurred in 71 patients (9.6%). Multivariate analysis (C statistic=0.79; 95% CI 0.73-0.84; p=0.0001) identified the following predictors: age > or =72 years (OR=1.7; 95% CI, 1.0-2.9; p=0.05), insulin-dependent diabetes mellitus (OR=2.9; 95% CI, 1.5-5.4; p=0.001), previous ischemic heart disease (OR=1.9; 95% CI, 1.1-3.2; p=0.02), ST depression (OR=2.1; 95% CI, 1.2-3.8; p=0.01) and troponin I elevation (OR=2.9; 95% CI, 1.5-5.3; p=0.001). These five predictors were used to construct a risk score based on their odds ratios, which allowed event rate stratification by quartiles of the score: 0-2 points (1.6% events), 3-4 points (8.1% events), 5-7 points (11.9% events) and > or =8 points (26.2% events); p=0.0001. No patient with negative findings in the early exercise testing had major events. CONCLUSIONS: In patients with chest pain, the combination of clinical, electrocardiographic and biochemical data available on admission to the emergency service allows rapid prognostic stratification. Early exercise testing is advisable for the final stratification of low risk patients.     

A prospective study of complications of endoscopic retrograde cholangiopancreatography and endoscopic ultrasound in an ambulatory endoscopy center.

BACKGROUND AND AIMS: Our aim was to assess the safety of endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS) in an ambulatory endoscopy center (AEC). METHODS: Complications occurring in consecutive patients undergoing ERCP or EUS from March 2003 to February 2004 at our AEC were recorded prospectively. Comprehensive complications were defined as consensus criteria plus other adverse events: use of reversal agents, unplanned hospital admission, hospitalization beyond planned 23-hour observation, unplanned emergency department or primary care provider visit, and 30-day mortality. RESULTS: A total of 497 patients (median age, 57 y; 82% American Society of Anesthesiologists class II or III) underwent 685 procedures. Monitored or general anesthesia was used in 25% of EUS and 50% of ERCP procedures. ERCP interventions were as follows: biliary or pancreatic stenting (N = 168), stone extraction (N = 70), sphincterotomy (N = 62), sphincter of Oddi manometry (N = 53), other (N = 66). EUS indications were as follows: known or suspected pancreatic mass (N = 103), upper-gastrointestinal mass/submucosal lesion (N = 71), luminal malignancy staging (N = 40), other (N = 96); 52% had EUS fine-needle aspiration. There was follow-up evaluation in 94% of the patients. There were 43 comprehensive ERCP complications (12.9%), 18 (5.4%) of these fit consensus criteria: pancreatitis (N = 14), cholangitis (N = 2), and perforation (N = 2). There were 9 comprehensive EUS complications (2.9%), 2 (.7%) of these fit consensus criteria: pancreatitis (N = 1) and bleeding (N = 1). Other adverse events for ERCP and EUS were as follows: prolongation of 23-hour observation (N = 14), emergency room visits (N = 3), primary care physician visits (N = 6), use of reversal agents (N = 3), unplanned admissions (N = 2), infection (N = 3), and death (N = 1). CONCLUSIONS: ERCP and EUS can be performed in an AEC, provided mechanisms for admission and anesthesia support are in place. The assessment of comprehensive complications is more reflective of adverse events related to ERCP and EUS than consensus criteria alone.     

Pancreatic stent insertion: consequences of failure and results of a modified technique to maximize success

BACKGROUND: Increasingly, pancreatic stents are being placed to prevent post-ERCP pancreatitis. However, guidewire and stent placement may fail if the duct is small or tortuous, potentially exacerbating the risk. This study assessed the impact of unsuccessful pancreatic stent placement on complications and the efficacy of a modified technique for stent insertion when pancreatic ductal anatomy makes stent insertion technically difficult. METHODS: Technical variables and 30-day complications of consecutive therapeutic ERCPs, including attempted major papilla pancreatic stent insertion were prospectively studied. Success rates for pancreatic stent placement were compared for a 1-year period during which conventional deep guidewire insertion was used and another 1-year period in which a modified technique was used as needed in patients with ductal anatomy that made stent placement technically difficult. In the modified technique, a short (2-3 cm) small diameter (3F-5F) stent was placed over a 0.018-in nitinol-tipped guidewire, passed as little as 1 to 2 cm beyond the pancreatic sphincter. RESULTS: In 225 high-risk therapeutic ERCPs, pancreatitis occurred after the procedure in two of 3 (66.7%) patients in whom pancreatic stent insertion failed vs. 32 of 222 (14.4%) patients with successful insertion (p=0.06). Severe pancreatitis occurred only after unsuccessful stent insertion. Significant multivariate risk factors for post-ERCP pancreatitis were unsuccessful pancreatic stent insertion (odds ratio 16.1: 95% CI[1.3, 200]), sphincter of Oddi dysfunction (odds ratio 3.2: 95% CI[1.4, 7.5]), and prior post-ERCP pancreatitis (odds ratio 3.2: 95% CI[1.4, 7.1]). The following were not risk factors: performance of pancreatic, biliary, or needle-knife pre-cut sphincterotomy; number of pancreatic contrast injections; and difficult cannulation. Stent placement was unsuccessful in 3 (3.2%) of 93 attempts during the 1-year period in which a conventional technique was used vs. none of 132 attempts in a subsequent year in which the modified technique was used. CONCLUSIONS: Failed attempts at pancreatic stent placement are associated with an extremely high risk of post-ERCP pancreatitis. Success can be consistently achieved by use of a modified technique.     

MORE ACCURATE PREDICTION OF POST‐ERCP PANCREATITIS BY 4‐H SERUM LIPASE LEVELS THAN AMYLASE LEVELS

Background: The aim of the present study was to evaluate and compare 4‐h post‐endoscopic retrograde cholangiopancreatography (ERCP) hyperamylasemia and hyperlipasemia as predictors of post‐ERCP pancreatitis. Methods: We reviewed 1631 consecutive cases consisting of 910 cases of diagnostic ERCP and 721 cases of therapeutic ERCP. Pancreatitis was diagnosed when abdominal pain persisted for 24 h after ERCP and the pain was associated with high serum amylase level and/or lipase level. Results: Pancreatitis developed in 69 (4.2%) of the 1631 cases. The receiver‐operator characteristic (ROC) curve of both the 4‐h amylase level and the 4‐h lipase level after diagnostic ERCP showed good test performance, with area under the curve of 0.88 (95% CI: 0.85–0.91) and 0.94 (95% CI: 0.92–0.96), respectively. The ROC of both the 4‐h amylase level and the 4‐h lipase level after therapeutic ERCP also showed good test performance, with an area under the curve of 0.92 (95% CI: 0.90–0.93) and 0.96 (95% CI: 0.94–0.97), respectively. The optimal cut‐off value for lipase after both diagnostic and therapeutic ERCP was 10‐fold the upper limit of the normal range. The serum lipase value after both diagnostic ERCP (P = 0.025) and therapeutic ERCP (P = 0.035) was a more effective predictor of post‐ERCP pancreatitis based on the areas under the ROC curve than was the serum amylase value. Conclusions: The 4‐h post‐ERCP lipase value is more useful for predicting pancreatitis after both diagnostic and therapeutic ERCP.     

Systematic evaluation of complications related to endoscopy in a training setting: A prospective 30-day outcomes study

BACKGROUND: The 30-day frequency of negative outcomes after outpatient endoscopy performed by gastroenterology fellows is unknown. METHODS: Questionnaires were mailed to 1000 consecutive patients 30 days after endoscopy to evaluate procedure-related negative outcomes (serious and minor adverse events) and patient satisfaction. Serious adverse events were defined as follows: oversedation requiring administration of a reversal agent, and those that resulted in a physician visit, emergency department visit, admission to the hospital, or death. Minor adverse events were defined as all problems other than serious adverse events that patients related to their endoscopic procedure. RESULTS: The 30-day frequency of negative outcomes in the 869 patients who responded was 14.3%, of which 0.6% were serious and 13.7% were minor adverse events. The frequency of negative outcomes was 17.1% for EGD, 15.0% for colonoscopy, 24.4% for combined EGD and colonoscopy, and 7.8% for flexible sigmoidoscopy. One hundred percent of the serious adverse events were known to us, but only 16.0% of minor adverse events (p < 0.001). Multiple logistic regression identified midazolam dose (OR for each 1 mg increase in dose 4.5; 95% CI [2.7, 7.3]; p < 0.001), treatment with warfarin (OR 3.0; 95% CI [1.4, 6.2]; p = 0.003), comorbid disease (OR 2.1; 95% CI [1.3, 3.4]; p = 0.001), endoscopy performed in July or August (OR 2.0; 95% CI [1.1,3.7]; p = 0.02), and age (OR for each 1 year increase in age 1.03; 95% CI [1.01, 1.05]; p = 0.01) as independent predictors of negative outcomes. There was a significant association between negative outcomes and decreased patient satisfaction, and patients who reported negative outcomes were less likely to agree to endoscopy in the future. CONCLUSIONS: Serious adverse events were rare after endoscopy performed by gastroenterology fellows. Contacting patients 30 days after outpatient endoscopy significantly improved the detection of negative outcomes. Although the majority of negative outcomes were minor, these adverse events were associated with decreased patient satisfaction.