Riad R. Azar

Incidence of Sedation-Related Complications With Propofol Use During Advanced Endoscopic Procedures

BACKGROUND & AIMS Propofol is an effective sedative in advanced endoscopy. However, the incidence of sedation-related complications is unclear. We sought to define the frequency of sedation-related adverse events, particularly the rate of airway modifications (AMs), with propofol use during advanced endoscopy. We also evaluated independent predictors of AMs. METHODS Patients undergoing sedation with propofol for advanced endoscopic procedures, including endoscopic retrograde cholangiopancreatography, endoscopic ultrasound, and small-bowel enteroscopy, were studied prospectively. Sedative dosing was determined by a certified registered nurse anesthetist with the goal of achieving deep sedation. Sedation-related complications included AMs, hypoxemia (pulse oximetry [SpO(2)] < 90%), hypotension requiring vasopressors, and early procedure termination. AMs were defined as chin lift, modified face mask ventilation, and nasal airway. We performed a regression analysis to compare characteristics of patients requiring AMs (AM+) with those who did not (AM-). RESULTS A total of 799 patients were enrolled over 7 months. Procedures included endoscopic ultrasound (423), endoscopic retrograde cholangiopancreatography (336), and small-bowel enteroscopy (40). A total of 87.2% of patients showed no response to endoscopic intubation. Hypoxemia occurred in 12.8%, hypotension in 0.5%, and premature termination in 0.6% of the patients. No patients required bag-mask ventilation or endotracheal intubation. There were 154 AMs performed in 115 (14.4%) patients, including chin lift (12.1%), modified face mask ventilation (3.6%), and nasal airway (3.5%). Body mass index, male sex, and American Society of Anesthesiologists class of 3 or higher were independent predictors of AMs. CONCLUSIONS Propofol can be used safely for advanced endoscopic procedures when administered by a trained professional. Independent predictors of AMs included male sex, American Society of Anesthesiologists class of 3 or higher, and increased body mass index.

Acute pancreatitis after EUS-guided FNA of solid pancreatic masses: a pooled analysis from EUS centers in the United States

BACKGROUND The aim of this study was to determine the frequency and the severity of pancreatitis after EUS-guided FNA of solid pancreatic masses. A survey of centers that offer training in EUS in the United States was conducted. METHODS A list of centers in which training in EUS is offered was obtained from the Web site of the American Society for Gastrointestinal Endoscopy. Designated program directors were contacted via e-mail. The information requested included the number of EUS-guided FNA procedures performed for solid pancreatic masses, the number of cases of post-procedure pancreatitis, and the method for tracking complications. For each episode of pancreatitis, technical details were obtained about the procedure, including the location of the mass, the type of fine needle used, the number of needle passes, and the nature of the lesion. RESULTS Nineteen of the 27 programs contacted returned the questionnaire (70%). In total, 4909 EUS-guided FNAs of solid pancreatic masses were performed in these 19 centers over a mean of 4 years (range 11 months to 9 years). Pancreatitis occurred after 14 (0.29%): 95% CI[0.16, 0.48] procedures. At two centers in which data on complications were prospectively collected, the frequency of acute pancreatitis was 0.64%, suggesting that the frequency of pancreatitis in the retrospective cohort (0.26%) was under-reported (p=0.22). The odds that cases of pancreatitis would be reported were 2.45 greater for the prospective compared with the retrospective cohort (95% CI[0.55, 10.98]). The median duration of hospitalization for treatment of pancreatitis was 3 days (range 1-21 days). The pancreatitis was classified as mild in 10 cases, moderate in 3, and severe in one; one death (proximate cause, pulmonary embolism) occurred after the development of pancreatitis in a patient with multiple comorbid conditions. CONCLUSIONS EUS-guided FNA of solid pancreatic masses is infrequently associated with acute pancreatitis. The procedure appears to be safe when performed by experienced endosonographers. The frequency of post EUS-guided FNA pancreatitis may be underestimated by retrospective analysis.

Risk of post-ERCP pancreatitis with placement of self-expandable metallic stents

BACKGROUND There are conflicting data on the risk of post-ERCP pancreatitis (PEP) related to self-expandable metallic stents (SEMSs). OBJECTIVE To compare rates of PEP in patients who undergo biliary drainage with SEMSs or polyethylene stents (PSs). DESIGN Retrospective, cohort study. SETTING Tertiary-care medical center. PATIENTS This study involved patients undergoing ERCP for malignant biliary obstruction between January 2005 and October 2008. INTERVENTION First-time placement of a SEMS or PS for biliary decompression. MAIN OUTCOME MEASUREMENTS Early post-ERCP complications, particularly PEP. RESULTS We identified 544 eligible patients, 248 SEMSs (102 covered), and 296 PSs. The etiology of malignant biliary obstruction was similar between groups, with 55% from pancreatic cancer. The frequency of PEP was significantly higher in the SEMS group (7.3%) versus the PS group (1.3%) (OR 5.7 [95% CI, 1.9-17.1]). On univariate analysis, patient age of <40 years, a history of PEP, and at least 1 pancreatic duct injection were also significant predictors of PEP, whereas female sex and having pancreatic cancer were not. When significant variables were added to a multiple-predictor regression model, the odds of PEP from SEMS placement increased to 6.8 (95% CI, 2.2, 21.4). However, the frequency of PEP was similar between covered (6.9%) and uncovered (7.5%) SEMSs (OR 0.9 [CI, 0.3-2.4]). Purported SEMS-specific risk factors, including the use of cSEMSs, overlapping SEMSs, or having a biliary sphincterotomy were not found to be significant contributors to the higher risk. LIMITATIONS Retrospective design. CONCLUSION After we controlled for confounding variables, the frequency of PEP was significantly higher with placement of a SEMS compared with a PS. Rates of PEP were comparable with use of covered and uncovered SEMSs.

Stenting for malignant colonic obstruction: a comparison of efficacy and complications in colonic versus extracolonic malignancy

BACKGROUND Self-expandable metal stent placement for palliation of malignant colonic obstruction for colorectal cancer (CRC) is safe and efficacious. In contrast, outcomes of stent placement for extracolonic malignancy (ECM) are unclear. OBJECTIVE To compare the success and complication rates of colorectal stenting in patients with CRC versus those with ECM. DESIGN Retrospective chart review. SETTING Tertiary-care academic medical center. PATIENTS AND INTERVENTIONS Between September 2000 and December 2007, all patients with malignant colon obstruction in whom endoscopy was performed with the intention of placing a colonic metal stent. MAIN OUTCOME MEASUREMENTS Technical and clinical success rates, surgical interventions, and procedure-related complications. RESULTS Colonic stenting was performed for CRC in 34 patients and for ECM in 15 patients. Patients with CRC were more likely to have clinical success after all endoscopic therapy (94.1%) than those with ECM (20.0%) (P < .0001). Surgical diversion to relieve persistent obstructive symptoms was required in significantly more patients with ECM. Five patients with ECM (33.3%) had at least one complication, including 2 deaths, compared with 3 patients with CRC (8.8%) (P = .046). Only underlying ECM was predictive of failed colon stent placement by multivariate analysis (hazard ratio 21.0, P = .0013). A history of radiation therapy was the sole predictor of complications (hazard ratio 7.8, P = .048). LIMITATIONS Single institution, retrospective analysis, relatively small sample size. CONCLUSIONS Colon stenting for large-bowel obstruction from ECM is infrequently successful and is associated with a significantly higher risk of complications in comparison with patients with CRC.

Reliability of gross visual assessment of specimen adequacy during EUS-guided FNA of pancreatic masses

BACKGROUND In many centers, on-site cytopathologists are not available during EUS-guided FNA (EUS-FNA) examinations. Often, endosonographers request that technologists assess the adequacy of FNA by gross inspection of the slides. To date, there has not been a study that assessed the accuracy of experienced technologists in predicting tissue sampling adequacy by gross inspection before cytologic staining. OBJECTIVES To assess a grading system used by cytotechnologists and EUS technologists during gross inspection of FNA slides in reliably predicting specimen adequacy compared with the final cytologic diagnoses. DESIGN Prospective, double-blind, controlled study. SETTING Academic tertiary-referral center with a high-volume EUS practice. PATIENTS Fifty-one patients with a suspected solid pancreatic mass who were undergoing planned EUS-FNA. MAIN OUTCOME MEASUREMENTS The degree of correlation in the assessment of specimen adequacy as exhibited by a weighted kappa statistic between 2 groups of technologists and a board-certified cytopathologist. RESULTS FNA was performed in 37 cases with 234 individual slide specimens available for analysis. Only fair agreement was observed between cytotechnologists and EUS technologists versus final cytopathologic assessment of adequacy (kappa 0.20 and 0.19, respectively). The routine practice of 6 to 7 FNA passes yielded adequate tissue for assessment in 36 of 37 patients (97%). LIMITATIONS Interobserver variability, single center, and findings applicable only to solid pancreatic lesions. CONCLUSIONS Neither trained EUS technologists nor cytotechnologists were able to provide a reliable assessment of pancreatic-mass FNA adequacy by using gross visual inspection of the specimen on a slide. Rapid on-site cytopathology reduced the number of passes, ensured specimen adequacy, provided definitive diagnosis, and should be used in centers where available.

Obesity as a risk factor for sedation-related complications during propofol-mediated sedation for advanced endoscopic procedures

BACKGROUND There are limited data on the safety of anesthesia-assisted endoscopy by using propofol-mediated sedation in obese individuals undergoing advanced endoscopic procedures (AEPs). OBJECTIVE To study the association between obesity (as measured by body mass index [BMI]) and the frequency of sedation-related complications (SRCs) in patients undergoing AEPs. DESIGN Prospective cohort study. SETTING Tertiary referral center. PATIENTS A total of 1016 consecutive patients undergoing AEPs (BMI <30, 730 [72%]; 30-35, 159 [16%]; >35, 127 [12%]). INTERVENTION Monitored anesthesia sedation with propofol alone or in combination with benzodiazepines and/or opioids. MAIN OUTCOME MEASUREMENTS SRCs, airway maneuvers (AMs), hypoxemia, hypotension requiring vasopressors, and early procedure termination were compared across 3 groups. RESULTS There were 203 AMs in 13.9% of patients, hypoxemia in 7.3%, need for vasopressors in 0.8%, and premature termination in 0.6% of patients. Increasing BMI was associated with an increased frequency of AMs (BMI <30, 10.5%; 30-35, 18.9%; >35-26.8%; P < .001) and hypoxemia (BMI <30, 5.3%; 30-35, 9.4%; >35, 13.4%; P = .001); there was no difference in the frequency of need for vasopressors (P = .254) and premature termination of procedures (P = .401). On multivariable analysis, BMI (odds ratio [OR] 2.0; 95% CI, 1.3-3.1), age (OR 1.1; 95% CI, 1.0-1.1), and American Society of Anesthesiologists class 3 or higher (OR 2.4; 95% CI, 1.1-5.0) were independent predictors of SRCs. In obese individuals (n = 286), there was no difference in the frequency of SRCs in patients receiving propofol alone or in combination (P = .48). LIMITATIONS Single tertiary center study. CONCLUSIONS Although obesity was associated with an increased frequency of SRCs, propofol sedation can be used safely in obese patients undergoing AEPs when administered by trained professionals.

Endoscopic Ultrasound for Early Stage Esophageal Adenocarcinoma: Implications for Staging and Survival

BACKGROUND Patients often receive induction therapy based on endoscopic ultrasound (EUS)-identified nodal spread (N1) or deep tumor invasion (T3), although controversy exists regarding the role of induction therapy for early stage disease. We aim to evaluate the reliability of EUS in identifying early stage disease and the subsequent impact on treatment and outcomes. METHODS We retrospectively studied 149 patients who underwent EUS and esophagectomy for adenocarcinoma between January 2000 and December 2008. Computed tomography (CT) was performed in all patients, whereas positron emission tomography (PET) was performed in 91%. Clinical stage (c), pathologic stage (p), operative mortality, and survival were recorded. RESULTS Unanticipated pathologic nodal disease was similar in patients with cT1N0 and cT2N0 tumors (6/25 [24%] versus 7/18 [38.8%]; p=0.6). Among the 18 cases of cT2N0 disease, 9 (50%) were pathologically staged as T1N0, 8 (44%) were upstaged to pT3N0-1, and 1 (6%) was pT2N0. One case of cT1N0 tumor (4%) was upstaged to pT3N0. Among patients with cT1-2N0 tumors, 5-year disease-free survival for the group that was appropriately staged was 89.8% versus 39.9% for the group that had a higher pathologic stage than their clinical stage (ie, >T2N0) (p<0.001). Operative mortality for patients with cT1-2N0 tumors was 0/43 (0%), which was no different from that in the higher clinical stage groups with (1/37, 2.7%) or without (2/68, 2.9%) induction therapy (p=0.5). Multivariate analysis identified marked/intense uptake on staging PET (odds ratio, 5.76, 95%; confidence interval, 1.25 to 26.52; p=0.021) to be a factor predictive of upstaging of cT1-2N0 tumors. CONCLUSIONS Current staging techniques are inadequate for predicting T1-2N0 disease in esophageal adenocarcinoma. Survival is excellent with operation alone in patients with tumors appropriately staged as T1-2N0, although patients with tumors upstaged to greater than T2N0 have significantly worse survival. Other preoperative factors such as PET uptake may help select patients with cT1-2N0 tumors that will be upstaged at resection.

The Clinical Impact of Immediate On-Site Cytopathology Evaluation During Endoscopic Ultrasound-Guided Fine Needle Aspiration of Pancreatic Masses: A Prospective Multicenter Randomized Controlled Trial

Objectives:Observational data on the impact of on-site cytopathology evaluation (OCE) during endoscopic ultrasonography-guided fine needle aspiration (EUS–FNA) of pancreatic masses have reported conflicting results. We aimed to compare the diagnostic yield of malignancy and proportion of inadequate specimens between patients undergoing EUS–FNA of pancreatic masses with and without OCE.Methods:In this multicenter randomized controlled trial, consecutive patients with solid pancreatic mass underwent randomization for EUS–FNA with or without OCE. The number of FNA passes in the OCE+ arm was dictated by the on-site cytopathologist, whereas seven passes were performed in OCE− arm. EUS–FNA protocol was standardized, and slides were reviewed by cytopathologists using standardized criteria for cytologic characteristics and diagnosis.Results:A total of 241 patients (121 OCE+, 120 OCE−) were included. There was no difference between the two groups in diagnostic yield of malignancy (OCE+ 75.2% vs. OCE− 71.6%, P=0.45) and proportion of inadequate specimens (9.8 vs. 13.3%, P=0.31). Procedures in OCE+ group required fewer EUS–FNA passes (median, OCE+ 4 vs. OCE− 7, P<0.0001). There was no significant difference between the two groups with regard to overall procedure time, adverse events, number of repeat procedures, costs (based on baseline cost-minimization analysis), and accuracy (using predefined criteria for final diagnosis of malignancy). There was no difference between the two groups with respect to cytologic characteristics of cellularity, bloodiness, number of cells/slide, and contamination.Conclusions:Results of this study demonstrated no significant difference in the diagnostic yield of malignancy, proportion of inadequate specimens, and accuracy in patients with pancreatic mass undergoing EUS–FNA with or without OCE.

A Screening Instrument for Sleep Apnea Predicts Airway Maneuvers in Patients Undergoing Advanced Endoscopic Procedures

BACKGROUND & AIMS Among patients undergoing advanced endoscopy, unrecognized obstructive sleep apnea (OSA) could predict sedation-related complications (SRCs) and the need for airway maneuvers (AMs). By using an OSA screening tool, we sought to define the prevalence of patients at high risk for OSA and to correlate OSA with the frequency of AMs and SRCs. METHODS We enrolled 231 consecutive patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) (n = 176) and endoscopic ultrasound (n = 55). Propofol-based sedation and patient monitoring were performed by a nurse anesthetist and an anesthesiologist. A previously validated screening tool for OSA (STOP-BANG) was used to identify patients at high risk for OSA (score, > or =3 of 8; SB+) or low risk (SB-). AMs were defined as a chin lift, modified mask ventilation, nasal airway, bag-mask ventilation, and endotracheal intubation. SRCs were defined as any duration of pulse oximetry less than 90%, systolic blood pressure less than 90 mm Hg, apnea, or early procedure termination. RESULTS The prevalence of SB+ was 43.3%. The frequency of hypoxemia was significantly higher among patients with SB+ than SB- (12.0% vs 5.2%; relative risk [RR], 1.83; 95% confidence interval [CI], 1.32-2.54). The rate of AMs was also significantly higher among SB+ (20.0%) compared with SB- (6.1%) patients (RR, 1.8; 95% CI, 1.3-2.4). These rates remained significant after adjusting for American Society of Anesthesiologists class 3 or higher (RR, 1.70; 95% CI, 1.28-2.2 for AMs; RR, 1.63; 95% CI, 1.19-2.25 for hypoxemia). Each element of the STOP-BANG was reported more commonly in SB+ patients (P < .0001 for each comparison). CONCLUSIONS A significant number of patients undergoing advanced endoscopic procedures are at risk for OSA. AMs and hypoxemia occur at an increased frequency in these patients.

Diagnosis and management of GI stromal tumors by EUS-FNA: a survey of opinions and practices of endosonographers

BACKGROUND There is no consensus regarding the best management strategy for diagnosing and treating GI stromal tumors (GISTs). OBJECTIVE Our purpose was to examine the practice patterns of endosonographers in diagnosing and managing GISTs, particularly features of GISTs suggestive of malignancy, features that prompt surgical referral, and surveillance patterns. DESIGN An invitation to complete an online survey was e-mailed to all 413 members of the American Society for Gastrointestinal Endoscopy EUS Special Interest Group. RESULTS A total of 134 (32%) members responded; 59% of respondents use EUS features combined with FNA findings to diagnose GIST, and 89% consider a c-kit-positive stain on FNA most suggestive of GIST. However, 60% would diagnose GIST when cytologic samples are insufficient for diagnosis, and 40% would diagnose GIST if cytologic samples are sufficient but c-kit is negative. A total of 92% use size as the main criterion to distinguish benign from malignant GISTs, and 90% refer lesions >5 cm for surgery. For lesions not resected, 70% survey annually, 19% less than annually, 10% more than annually, and 1% do not survey. LIMITATIONS The opinions of the respondents do not necessarily reflect the opinions and practices of endosonographers nationwide. There are inherent limitations to an online multiple-choice survey, including low response rates. CONCLUSIONS There are substantial practice variations in diagnosing, resecting, and surveying GISTs. A majority of our survey respondents have made the diagnosis of GIST without FNA confirmation. Size >5 cm is the feature used most to predict malignancy and to prompt surgical referral. Surveillance practices for unresected GISTs are variable. Evidence is needed to establish practice guidelines in this area.