Association of covered metallic stents with cholecystitis and stent migration in malignant biliary stricture.

BACKGROUND AND AIMS: ERCP with self-expandable metallic stent (SEMS) placement provides reliable and durable relief of malignant biliary obstruction. Our objective was to compare efficacy and adverse outcomes between uncovered SEMSs (USEMSs) and covered SEMSs (CSEMSs). METHODS: A retrospective cohort study was performed of all consecutive patients who underwent ERCP with SEMS placement for the management of a malignant bile duct stricture. Comparative analyses on clinical success, patency duration, stent dysfunction, and adverse outcomes were performed. Univariate and multivariable analyses were performed to identify factors associated with stent dysfunction. RESULTS: Six hundred forty-five patients underwent SEMS placement for the management of malignant bile duct stricture from 2008 to 2016. CSEMSs and USEMSs had similar rates of clinical success in relief of bile duct obstruction (93.0% vs 92.1%, respectively; P = .69) and patency duration (546.7 vs 557.9 days, P = .14). Among those with an intact gallbladder, the incidence of acute cholecystitis was higher in the CSEMS group compared with the USEMS group (7.8% vs 1.2%; P < .001). In the multivariable analysis, CSEMS use was associated with increased risk of stent migration (hazard ratio, 10.7; 95% confidence interval, 4.1-27.7). CONCLUSIONS: CSEMSs and USEMSs have similar clinical success rates and patency durations in management of malignant bile duct stricture. CSEMSs, however, are associated with increased rates of migration and cholecystitis. Comparable efficacy and superior safety profile of USEMSs render a compelling argument for its place as the preferred choice of SEMSs in the management of malignant biliary stricture.

Initial Experience With High-Risk Patients Excluded From Clinical Trials: Safety of Short-Term Anticoagulation After Left Atrial Appendage Closure Device.

BACKGROUND: The implantation of left atrial appendage closure device (WATCHMAN, Boston Scientific, Natick, MA) is an alternative option to oral anticoagulation (OAC) for stroke prevention in atrial fibrillation. Patients require short-term OAC after implantation to avoid device thrombosis. The 2 clinical trials that assessed this device excluded patients thought not to be candidates for OAC. As such, little is known about the safety of this strategy in patients with previous major bleeding events. METHODS AND RESULTS: All 20 consecutive patients with history of spontaneous major bleeding while on OAC who had subsequently undergone WATCHMAN device implantation at our institution were included. A newly conceived multidisciplinary Atrial Fibrillation Stroke Prevention Center evaluated patients for candidacy for device implantation and subsequent antithrombotic therapy. The primary outcome was spontaneous major bleeding while receiving short-term postprocedural OAC. Median CHA2DS2-VASc and HAS-BLED scores were 5 (quartiles 5-6) and 5 (quartiles 4-5), respectively. Previous major bleeding events were major gastrointestinal bleeding, intracranial bleeding, spontaneous hemopericardium with cardiac tamponade, and hemarthrosis in 11, 7, 1, and 1 patients, respectively. None of the patients had spontaneous major bleeding during the course of OAC after device implantation. In 1 patient, OAC was discontinued after 40 days because of mechanical fall with head trauma resulting in subdural hematoma with no associated neurological deficits; this was managed conservatively. CONCLUSIONS: With careful multidisciplinary evaluation, a short course of OAC after WATCHMAN device implantation in patients with previous spontaneous major bleeding events is associated with low risk of recurrent spontaneous major bleeding.

Association of procedure length on outcomes and adverse events of endoscopic retrograde cholangiopancreatography.

OBJECTIVE: The aims of this study were to determine the effects of length of procedure on endoscopic retrograde cholangiopancreatography (ERCP) outcomes and adverse events. METHODS: All ERCP procedures, performed by experienced advanced endoscopists, in patients without prior papillary intervention from 2006 to 2008 were reviewed. Procedures were arbitrarily divided into two groups: shorter procedures (SP), with a duration shorter than the overall mean procedure length, and longer procedures (LP), with a duration longer than overall mean procedure length. Length of procedure was defined as the time from endoscope insertion to endoscope removal. RESULTS: Two hundred and ninety-five procedures were included in the analysis. Mean procedure length was 45.6 ± 30.1 min. One hundred and seventy-seven procedures (60%) were SP and 118 (40%) were LP. There were no differences between the groups with regard to patients' ages, genders, race, or trainee participation. SP cases were more likely to be biliary vs pancreatic or bi-ductal evaluations (P = 0.03). LP had significantly higher complexity scores (34% with >3 vs 13%; P = 0.046) and were more likely to require pre-cut papillotomy (39% vs 15%; P < 0.001). There was no significant difference between the groups in overall completion rates (91.5% LP vs 96% SP; P = 0.10) or adverse events (10.2% LP vs 6.2% SP; P = 0.21). However, LP cases were associated with higher rates of post-ERCP bleeding (4.2% vs 0.6%; P = 0.029). CONCLUSION: There was no significant difference in outcomes or overall adverse events between shorter and longer ERCP procedures. However, longer procedures were associated with higher procedure complexity, higher utilization of pre-cut technique, and increased risk of bleeding.

Effect of the time of day on the success and adverse events of ERCP.

BACKGROUND: Physician fatigue and decreased concentration have been proposed as causes of lower completion and adenoma detection rates in afternoon colonoscopies compared with morning colonoscopies. ERCP is a technically demanding and highly operator-dependent procedure, and its success may similarly be affected in the afternoon compared with the morning. OBJECTIVE: To compare cannulation success and adverse events between ERCP procedures performed in the morning and afternoon. DESIGN: Retrospective cohort study. SETTING: Tertiary referral center. PATIENTS: Patients with no previous papillary intervention who underwent ERCP at our institution between November 2006 and November 2008. MAIN OUTCOME MEASUREMENTS: Cannulation success, procedure completion rates, length of procedures, and adverse events. RESULTS: A total of 296 patients were studied; 114 patients (38.5%) underwent a procedure in the morning and 182 patients (61.5%) underwent a procedure in the afternoon. There were 139 male patients (47.0%). The mean patient age was 59.1 years. The deep cannulation success rate was 95.3% overall, with similar rates when performed in the morning (98.3%) and afternoon (94.0%) (P = .08). When the start time was evaluated as a continuous hour-by-hour variable, there was also no significant difference in deep cannulation success rates (P = .30). Procedure completion rates were similar in both groups (morning, 93.9%; 94.0%, afternoon; P = .97). Adverse events (8.8% for morning procedures vs 7.1% for afternoon procedures, P = .61) and length of procedures (40 minutes for morning procedures vs 40 minutes for afternoon procedures, P = .87) were also similar between the 2 groups. LIMITATIONS: Small sample size and retrospective study. CONCLUSIONS: The timing of ERCP, morning versus afternoon, does not seem to affect cannulation success, procedure completion rates, length of procedures, or adverse events.

Does anesthesiologist-directed sedation for ERCP improve deep cannulation and complication rates?

OBJECTIVES: While some gastroenterologists provide their own sedation for endoscopic retrograde cholangiopancreatography (ERCP), others utilize anesthesiologists. There is limited information comparing cannulation success and complication rates between these two approaches. Theoretically, anesthesiologist-directed sedation (ADS) may lead to an improved deep cannulation rate by virtue of using deeper and more constant levels of sedation and by removing the minute-by-minute medication management and physiologic monitoring responsibilities from the endoscopy team. AIMS: To compare ERCP deep cannulation success and complications between gastroenterologist-directed sedation (GDS) and ADS. METHODS: All ERCPs completed by senior advanced endoscopists at a tertiary referral center over a 2-year period were reviewed. During the first year, all ERCP sedation was performed with GDS utilizing a narcotic and a benzodiazepine. Due to a change in division policy and practice, during the second year, all ERCP sedation was provided by ADS. Patients with prior papillary interventions were excluded. Demographics, procedure indications, deep cannulation success, sedation provider, and procedural complications were recorded. RESULTS: A total of 367 patients were studied: 178 (48.5%) GDS and 189 (51.5%) ADS. There was no difference in the groups with respect to race, age, and gender. Four patients (2.3%) in the GDS group could not be sedated. There were two deaths, one in each group; one death was due to cholangitis/sepsis and the other was due to post-ERCP pancreatitis. The overall cannulation success rates were similar between the two groups (94.4% vs. 95.2%, P = 0.36). CONCLUSIONS: Deep ductal cannulation rates between GDS and ADS are similar.

Factors affecting the yield of brush cytology for the diagnosis of pancreatic and biliary cancers.

OBJECTIVE: Pancreatobiliary malignancies often present as biliary strictures. Biliary brush cytology is an established diagnostic technique in the investigation of such strictures. The main shortcoming of the test, however, is its low sensitivity. The aim of this was to identify factors associated with a positive yield on biliary brush cytology. METHODS: Consecutive patients who had brush cytology for investigation of biliary strictures from 2005 to 2007 were included. Association of several factors with a positive result on brush cytology was studied using univariable and multivariable logistic regression analyses. RESULTS: Two hundred eighty patients were evaluated. One hundred nineteen (42.5%) patients had a final diagnosis of malignancy; of whom, 55 had a positive brush cytology (sensitivity, 46%; specificity, 100%). On multivariable analysis, age (odds ratio [OR], 1.2; 95% confidence interval [CI], 1.06-10.4 per 5-year increase), total serum bilirubin levels (OR, 1.3; 95% CI, 1.01-1.6 per 5-unit increase), and presence of a mass on cross-sectional imaging (OR, 11.7; 95% CI 5.1-27.2) were independent predictors of a positive brush cytology result. CONCLUSIONS: Increasing age, higher serum bilirubin levels, and presence of a mass on cross-sectional imaging are independent factors associated with a positive result on biliary brush cytology. These findings suggest use of complementary tissue acquisition techniques in selected cases.

Cigarette smoking is independently associated with chronic pancreatitis.

BACKGROUND AND AIMS: It is not completely understood whether smoking contributes to chronic pancreatitis (CP). Past studies have included mostly patients with alcohol-related and severe CP. Our aim was to assess the relationship of smoking and CP adjusting for alcohol and other clinical risk factors. METHODS: A cross-sectional study was performed of patients referred to the pancreatic disease clinic in the past 2 years with abdominal pain and suspected CP. Patients were questioned on their smoking and alcohol habits. Patients underwent an etiological workup and diagnostic evaluation for early and late CP comprised of computed tomography scan and combined endoscopic ultrasound and secretin endoscopic pancreatic function test if indicated. Logistic regression was used to determine the association of current smoking with CP adjusting for other risk factors. RESULTS: The adjusted odds ratio (OR) for current smoking was 1.99 (95% CI 1.01, 3.91). Other significant predictors included consumption of > or =10 alcohol drinks/week, advancing age, history of acute pancreatitis, and the presence of another etiological factor. Smoking was also independently associated with exocrine insufficiency (OR 2.00, 95% CI 1.07, 3.75) and calcifications (OR 2.68, 95% CI 1.03, 6.94). CONCLUSION: Active cigarette smoking is associated with CP adjusting for alcohol and other risk factors. and IAP.

Combined endoscopic ultrasound and secretin endoscopic pancreatic function test in patients evaluated for chronic pancreatitis.

BACKGROUND: Endoscopic ultrasound and endoscopic secretin pancreatic function test may be combined in a single endoscopic session (EUS/ePFT) to diagnose chronic pancreatitis (CP). AIMS: Our primary aim was to assess the correlation and concordance of combined EUS and secretin ePFT bicarbonate results in suspected minimal change CP. METHODS: Radial EUS included scoring for nine criteria (normal<4 criteria) with endoscopic collection of duodenal samples at 15, 30, and 45 min after secretin stimulation (normal peak bicarbonate>or=80 mmol/l). RESULTS: Three hundred and two patients completed the EUS/ePFT (252 for suspected minimal change CP, 38 for established CP, 12 for painless steatorrhea). In patients evaluated for suspected minimal change CP, a moderate negative correlation was observed between endoscopic ultrasound score and peak bicarbonate (r=-0.38, P<0.001). The EUS and ePFT results were 76% concordant and 24% discordant. The ePFT was 85% sensitive and EUS was 100% sensitive for detecting patients with established calcific CP. The EUS/ePFT diagnosed CP in two of 12 of patients evaluated for painless steatorrhea or diarrhea with weight loss. CONCLUSIONS: The combined EUS/ePFT is feasible and safe. There is only moderate correlation and concordance of endoscopic ultrasound and endoscopic pancreatic function test results in patients with suspected minimal change CP. The EUS and ePFT results produce complimentary functional and structural information for the evaluation of CP.

Capnographic monitoring of respiratory activity improves safety of sedation for endoscopic cholangiopancreatography and ultrasonography.

BACKGROUND & AIMS: The Joint Commission on the Accreditation of Healthcare Organizations recommends ventilation monitoring during procedural sedation for gastrointestinal endoscopy. We sought to determine whether intervention, based on a microstream capnography-based ventilation monitoring system that has been shown to function as an early warning system for hypoxemia, would decrease hypoxemia during endoscopy. METHODS: Subjects undergoing elective endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasonography (EUS) under procedural sedation with a combination of opioid and benzodiazepine were randomly assigned to either a study arm in which the endoscopy team was blinded to capnography or an open arm in which the endoscopy team was prompted of capnographic changes. The primary end point was the occurrence of hypoxemia; secondary end points were the occurrences of severe hypoxemia, apnea, and oxygen supplementation. RESULTS: A total of 263 subjects were enrolled; 247 were analyzed for efficacy. The numbers of hypoxemic events in the blinded and open arms were 132 and 69, respectively (P < .001). Thirty-five percent of all hypoxemic events occurred with completely normal ventilation. Hypoxemia developed in 69% of patients in the blinded arm compared with 46% in the open arm (P < .001). Severe hypoxemia percentages in the blinded and open arms were 31% and 15% (P = .004), for apnea were 63% and 41% (P < .001), for oxygen supplementation were 67% and 52% (P = .02), and for recurrent hypoxemia after oxygen supplementation were 38% and 18% (P = .01), respectively. CONCLUSIONS: Capnographic monitoring of respiratory activity improves patient safety during procedural sedation for elective ERCP/EUS by reducing the frequency of hypoxemia, severe hypoxemia, and apnea.

Endoscopic therapy of recurrent acute pancreatitis.

Endoscopic therapy has emerged as an alternative to surgery for the subset of patients with acute recurrent pancreatitis whose disease is due to gallstones or other mechanical processes that obstruct the outflow of the pancreas. In this article, the authors review the specific situations in which endoscopic therapy might be useful in patients with acute recurrent pancreatitis.

Evaluation of duct-cell and acinar-cell function and endosonographic abnormalities in patients with suspected chronic pancreatitis.

BACKGROUND & AIMS: Endoscopic ultrasound (EUS) detects mild and severe structural abnormalities of the pancreas that correlate with fibrosis. Direct pancreatic function tests (PFTs) detect mild exocrine insufficiency associated with early fibrosis. The primary aim of this study was to compare EUS structural criteria with duct-cell and acinar-cell function. METHODS: Fifty patients evaluated for chronic pancreatitis underwent combined EUS and secretin endoscopic PFTs (ePFT) on day 1 and CCK ePFT on day 2. EUS images were videotaped and interpreted by consensus of 3 blinded expert reviewers. RESULTS: There were inverse correlations of EUS consensus score with both duct-cell bicarbonate secretion (R = -0.71, P < .001) and acinar-cell lipase secretion (R = -0.52, P < .001). With secretin ePFT as reference standard, EUS (>or=4 criteria) showed a sensitivity of 71% (95% confidence interval [CI], 53%-89%) and specificity of 92% (95% CI, 75%-99%). With CCK ePFT as reference standard, EUS had a sensitivity of 63% (95% CI, 43%-82%) and specificity of 85% (95% CI, 71%-98%). Main duct dilation, irregularity, calcifications, and visible side-branches were most predictive of exocrine insufficiency (positive predictive value >80% for both acinar- and duct-cell insufficiency). CONCLUSIONS: Acinar- and duct-cell function decreases as EUS structural abnormalities increase. EUS has fair sensitivity and very good specificity compared with secretin and CCK functional reference standards.

Surgical versus nonsurgical management of pancreatic pseudocysts.

GOALS: Compare patient characteristics and outcome and also physician referral patterns between surgically and nonsurgically managed patients with pancreatic pseudocysts. BACKGROUND: Treatment of pancreatic pseudocysts can be accomplished by surgical, endoscopic, or percutaneous procedures. The ideal treatment method has not yet been defined. PATIENTS: All patients treated for pancreatic pseudocyst between 1999 and 2005 were identified in our health services database. Patients were treated with surgical, endoscopic, and percutaneous drainage procedures at the discretion of the treating physician. Main outcome measures included complications, pseudocyst resolution, and treatment modality as a function of the treating physician's specialty. RESULTS: Thirty patients (49%) were treated surgically, 24 endoscopically (39%), and 7 (11%) with percutaneous drainage. The most common indications for treatment were symptoms of pain, and biliary or gastric outlet obstruction (81%). Patients treated surgically and endoscopically were similar in terms of age (49 vs. 52 y), mean cyst diameter (9.1 vs. 9.5 cm, P=0.74), incidence of chronic pancreatitis (50% vs. 32%, P=0.26) and complicated pancreaticobiliary disease (69% vs. 60%). There were no differences in complications (20% vs. 21%) or pseudocyst resolution (93.3% vs. 87.5%, P=0.39) between the surgical and endoscopic groups. There was no significant difference in the rate of surgical versus nonsurgical treatment in patients initially evaluated by surgeons versus nonsurgeons. CONCLUSIONS: Surgical and endoscopic interventions for pancreatic pseudocysts are equally safe and effective with percutaneous drainage playing a less important role. Endoscopic drainage should be considered for initial therapy in appropriate patients.

Findings on endoscopic retrograde cholangiopancreatography and pancreatic function test in suspected chronic pancreatitis and negative cross-sectional imaging.

BACKGROUND & AIMS: The diagnosis of chronic pancreatitis (CP) often relies on cross-sectional imaging, which may be insensitive for early disease. The aim of this study was to assess the utility of cholecystokinin pancreatic function test and endoscopic retrograde cholangiopancreatography (ERCP) for the diagnosis of CP in patients with negative or inconclusive cross-sectional imaging. METHODS: Consecutive patients with suspicion of CP and negative or inconclusive cross-sectional imaging (computerized tomography and magnetic resonance cholangiopancreatography) were evaluated with cholecystokinin-stimulated endoscopic pancreatic function test (ePFT) and ERCP. The setting was a referral center for difficult diagnostic scenarios. Pancreatograms were scored according to Cambridge classification (I-IV). The ePFT was used to determine the peak lipase concentration in pancreatic juice during timed duodenal aspiration. The gold standard for the diagnosis of CP was long-term clinical follow-up evaluation. RESULTS: Thirty-five patients met the study criteria. The median duration of follow-up evaluation was 7 years (25th, 75th percentiles: 3, 7). Twenty-four of the 35 patients were diagnosed with CP based on long-term follow-up evaluation with a clinical composite reference standard. The sensitivity, specificity, and positive and negative predictive values were 96%, 37%, 77%, and 80% for ePFT and 71%, 91%, 94%, and 59% for ERCP, respectively. A low peak lipase concentration on the initial ePFT was associated with development of steatorrhea during the follow-up period (P = .02). CONCLUSIONS: ePFT is a sensitive test for the diagnosis of patients with suspicion of CP and negative or inconclusive cross-sectional imaging. ERCP has modest sensitivity and high specificity for this purpose. A normal ePFT rules out CP with a high degree of certainty. An abnormal test result requires follow-up evaluation and diagnostic confirmation.

Predicting success of endoscopic aspiration for suspected pancreatic cystic neoplasms.

CONTEXT: Analysis of pancreatic cyst fluid can play a role in the management of asymptomatic cystic neoplasms. OBJECTIVE: Our aim was to determine whether cyst size or location can predict the success of cyst fluid collection and analysis. DESIGN: Review of prospective management protocol. SETTING: Tertiary care referral center. PATIENTS: Three-hundreds and 70 patients with suspected pancreatic cystic neoplasms evaluated over 6 years. INTERVENTIONS: Endoscopic ultrasound aspiration for up to 3 variables: cytology including extracellular mucin, CEA, and amylase. MAIN OUTCOME MEASURES: The number of variables obtained were compared with cyst size and location. RESULTS: The distribution of unilocular cystic lesions was: 125 (33.8%) head, 105 (28.4%) tail, 77 (20.8%) body, 37 (10.0%) uncinate and 13 (3.5%) multiple cysts. In addition, 13 (3.5%) patients had uncertain cyst location. There was no association between cyst location and number of variables obtained (P=0.148). An aspirate was obtained in 284 patients (76.8%) with a mean volume of 8.3 mL. There was a significant correlation between cyst size and volume aspirated (P<0.001). The number of variables obtained was significantly correlated with cyst size (P<0.001): 3 variables were obtained in 109 out of 284 (38.4%) with a median size of 3.0 cm. Logistic regression curves predict likelihood of success based on cyst size. An unsuccessful attempt at EUS aspiration for cysts occurred in 31 of the 284 cases (10.9%) with a median size of 1.5 cm. CONCLUSIONS: Successful endoscopic ultrasound aspiration of pancreatic cysts is independent of cyst location, but correlates with size, which can be useful in deciding which patients should undergo endoscopic ultrasound and aspiration.

Epidemiology of lower gastrointestinal bleeding.

Lower GI bleeding is a very broad topic, which can encompass situations from a small amount of red blood on tissue paper associated with formed brown stool, to life-threatening severe haemorrhage. Much of the literature on this topic focuses on acute bleeding necessitating hospitalisation and urgent intervention. The literature that is available focuses primarily on medical intervention and support, which will be covered in another review in this series. Causes for lower GI bleeding include diverticular disease, vascular ectasia, ischemic, inflammatory or infectious colitis, colonic neoplasia (including post polypectomy bleeding), anorectal causes (including haemorrhoids, fissures and rectal varices), and small bowel lesions (Crohn's, vascular ectasia, Meckel's diverticula, and small bowel tumours). Different clinical series identified these lesions in varying frequencies. Factors associated with the development of acute lower GI bleeding include advanced age and use of non-steroidal anti-inflammatory medication. Colonoscopy is the single most frequent intervention in evaluating all the patients with lower GI bleeding. Determining the precise impact of colonoscopy on the outcome of lower GI bleeding is difficult due to the retrospective nature of many studies, and the frequent inability to definitively establish the exact bleeding site.

A prospective crossover study comparing secretin-stimulated endoscopic and Dreiling tube pancreatic function testing in patients evaluated for chronic pancreatitis.

BACKGROUND: Direct pancreatic function tests (PFT) are conventionally performed with use of double-lumen "Dreiling" collection tubes. We have developed an endoscopic collection method (ePFT) that eases the performance of these tests. OBJECTIVE: Our aim was to compare the bicarbonate results obtained from the secretin ePFT and Dreiling PFT methods in patients evaluated for chronic pancreatitis. DESIGN: A prospective crossover design was used to compare the PFT methods. SETTING: Tertiary care referral center. PATIENTS AND INTERVENTIONS: Twenty-four patients undergoing an evaluation for chronic pancreatitis underwent the secretin-stimulated ePFT and Dreiling PFT methods on separate days. MAIN OUTCOME MEASUREMENTS: Duodenal fluid bicarbonate concentrations and estimated bicarbonate outputs were compared. RESULTS: The mean difference in peak bicarbonate concentration (Dreiling PFT minus ePFT) was 7 mEq/L (SD 20) and not statistically significant (P = .11). A good correlation in peak bicarbonate concentrations (r = 0.74, 95% CI, 0.48-0.88) and estimated bicarbonate output (r = 0.78, 95% CI, 0.54-0.90) was observed between the two PFT methods. LIMITATION: The sensitivities and specificities of the secretin ePFT and Dreiling PFT could not be compared because of the lack of a histologic gold standard. CONCLUSION: The secretin ePFT yields results similar to those of the Dreiling PFT in patients evaluated for chronic pancreatitis.

Comparison of endoscopic ultrasound and endoscopic retrograde pancreatography for the prediction of pancreatic exocrine insufficiency.

Endoscopic retrograde pancreatography (ERP) is a sensitive test for the early ductal changes of chronic pancreatitis. More recently, endoscopic ultrasound (EUS) has also been proposed as a sensitive structural test for chronic pancreatitis. Few studies have compared EUS and ERP using an external reference standard. Direct pancreatic function tests (PFT) are an acceptable reference standard for chronic pancreatitis since they detect mild exocrine insufficiency. Our aim was to compare structural abnormalities as revealed by ERP and EUS for the prediction of exocrine insufficiency. Eight-three patients who underwent EUS, ERP, and secretin PFT for the evaluation of pancreatitis were identified from our database. Exocrine insufficiency was defined as a secretin PFT peak bicarbonate concentration <80 mEq/l. Based on the number of abnormal sonographic criteria observed, EUS findings were categorized as normal (<2 criteria), mild (3-5 criteria) or severe (6-9 criteria or calcifications). ERP findings were categorized based on the Cambridge classification. ERP and EUS did not differ significantly in either sensitivity (72% vs 68%, P = 0.52) or specificity (76% vs 79%, P = 0.40). ERP and EUS were similarly associated with exocrine insufficiency both in the presence of minimal (OR 3.4 and 4.9, respectively) and severe structural changes (OR 12 and 24, respectively). We consider EUS to have a diagnostic accuracy for the structural diagnosis of early- and late-stage chronic pancreatitis similar to that of ERP.

Bispectral index monitoring of conscious sedation with the combination of meperidine and midazolam during endoscopy.

UNLABELLED: background & aims: Current practice guidelines strongly recommend differentiation of deep from moderate sedation during endoscopy. Standard methods of sedation monitoring are labor-intense. Bispectral index monitoring (BIS) is widely used during anesthesia, but its benefits during conscious sedation are controversial. Thus, we performed a prospective observational study to assess its ability for detecting deep sedation during endoscopy. METHODS: Patients presenting for elective outpatient endoscopy were monitored simultaneously with the Modified Observer's Assessment of Alertness and Sedation (MOAA/S) and BIS. A combination of a narcotic and benzodiazepine was used, with the target being moderate sedation and analgesia. Deep sedation was defined by MOAA/S score of 1-2 and BIS score of

Colonoscopy preparation: are our patients at risk?

Clinical studies are used to make generalizations about a population of interest. Bias can be defined as the systematic error in study design or implementation, leading to inaccurate generalizations about this population. There is a potential for bias in all of the clinical studies on sodium phosphate colonoscopy preparation, and this bias may lead to the differing conclusions regarding safety drawn by the authors. A review of some of the relevant literature is presented, as well as a discussion of propensity score analysis, a technique used to help clarify the causal pathway in nonrandomized studies. Based on the available information, it is reasonable to follow the recommendations contained in the consensus document of the American Society of Colon and Rectal Surgeons, American Society for Gastrointestinal Endoscopy, and Society of American Gastrointestinal and Endoscopic Surgeons regarding sodium phosphate colonoscopy preparation.

A phase II trial of accelerated multimodality therapy for locoregionally advanced cancer of the esophagus and gastroesophageal junction: the impact of clinical heterogeneity.

OBJECTIVES: This is a report of mature results from a phase II trial of an accelerated multimodality treatment program for locoregionally advanced cancer of the esophagus and gastroesophageal junction with a focus on the impact of clinical heterogeneity on outcomes. A split course of pre- and postoperative hyperfractionated radiation therapy and concurrent chemotherapy was used in an effort to limit perioperative mortality. METHODS: Eligibility required a diagnosis of esophageal or gastroesophageal junction cancer and an esophageal ultrasound stage of at least T3, N1, or M1A. Patients received a 12-day induction course of radiation (1.5 Gy twice a dose to a dose of 30 Gy) concurrent with 4-day continuous intravenous infusions of cisplatin (20 mg/m2 per day) and 5-fluorouracil (1000 mg/m2 per day) beginning on day 1. Surgery followed in 4 to 6 weeks followed 6 to 10 weeks later by a second, identical course of chemoradiotherapy. RESULTS: From October 1999 through March 2003, 93 patients were enrolled; 96% were white, 86% male, and 83% had adenocarcinoma. Resection was possible in 83 patients (89%) with 4 (5%) perioperative deaths. With a median follow up of 50 months (range, 34-72 months), the 3-year projected overall survival rate is 27.9%, freedom from recurrence 30.5%, and distant metastatic control 32.4%. Locoregional control in resected patients is 86%. Freedom from recurrence and distant control were significantly better in patients with 1) earlier pretreatment clinical stage, 2) earlier postinduction pathologic stage, 3) squamous cell cancer, and 4) a pathologic response. CONCLUSIONS: This accelerated multimodality treatment program is feasible and perioperative mortality proved acceptable. Despite excellent locoregional control, freedom from recurrence, and overall survival proved disappointing reflecting the frequency of distant metastases. Heterogeneity in patient populations makes comparisons with similar nonrandomized experiences problematic.