Prospective assessment of the effectiveness of standard high-level disinfection for echoendoscopes.

BACKGROUND AND AIMS: Duodenoscopes have been implicated in the transmission of multidrug-resistant organisms (MDROs). Echoendoscopes could potentially transmit infection. The aim of this study was to assess the effectiveness of standard high-level disinfection (HLD) for radial and linear echoendoscopes and to compare it with that of duodenoscopes. METHODS: We performed a prospective single-center study sampling echoendoscopes immediately before use, from the working channel (radial and linear echoendoscopes) and the transducer (radial echoendoscope) or elevator mechanism and transducer (linear echoendoscope). The primary outcome was the proportion of echoendoscopes with any culture showing ≥1 MDRO; secondary outcomes included bacterial growth >0 colony forming units (CFUs) and ≥10 CFUs on either sampling location. We compared these findings with duodenoscope cultures from the previously published DISINFECTS trial. RESULTS: During the study period, 101 echoendoscopes were sampled (n = 50 radial echoendoscopes, n = 51 linear echoendoscopes). No MDROs were recovered. Bacterial growth >0 CFUs was noted in 6% and ≥10 CFUs in 3% of all echoendoscopes. There was no significant difference in growth between radial and linear echoendoscopes (P = .4 for >0 CFU growth; P = .6 for ≥10 CFUs growth). The proportion of transducer and/or elevator mechanism positive for bacterial growth was significantly higher in duodenoscopes as compared with echoendoscopes (P = .02). CONCLUSIONS: After standard HLD, no echoendoscope showed MDRO growth, 6% showed >0 CFUs, and 3% showed ≥10 CFUs bacterial growth. Bacterial growth was higher in duodenoscopes at the level of the transducer and/or elevator mechanism when compared with echoendoscopes.

Intracardiac Echocardiography for Structural Heart and Electrophysiological Interventions.

PURPOSE OF REVIEW: With an increasing number of interventional procedures performed for structural heart disease and cardiac arrhythmias each year, echocardiographic guidance is necessary for safe and efficient results. The purpose of this review article is to overview the principles of intracardiac echocardiography (ICE) and describes the peri-interventional role of ICE in a variety of structural heart disease and electrophysiological interventions. RECENT FINDINGS: Both transthoracic (TTE) and transesophageal echocardiography have limitations. ICE provides the advantage of imaging from within the heart, providing shorter image distances and higher resolution. ICE may be performed without sedation and avoids esophageal intubation as with transesophageal echocardiography (TEE). Limitations of ICE include the need for additional venous access with possibility of vascular complications, potentially higher costs, and a learning curve for new operators. Data supports the use of ICE in guiding device closure of interatrial shunts, transseptal puncture, and electrophysiologic procedures. This paper reviews the more recent reports that ICE may be used for primary guidance or as a supplement to TEE in patients undergoing left atrial appendage (LAA) closure, interatrial shunt closure, transaortic valve implantation (TAVI), percutaneous mitral valve repair (PMVR), paravalvular leak (PVL) closure, aortic interventions, transcatheter pulmonary valve replacement (tPVR), ventricular septal defect (VSD), and patent ductus arteriosus (PDA) closure. ICE imaging technology will continue to expand and help improve structural heart and electrophysiology interventions.

Laparoscopic ultrasonography as an alternative to intraoperative cholangiography during laparoscopic cholecystectomy.

AIM: To assess the role of laparoscopic ultrasound (LUS) as a substitute for intraoperative cholangiography (IOC) during cholecystectomy. METHODS: We present a MEDLINE and PubMed literature search, having used the key-words "laparoscopic intraoperative ultrasound" and "laparoscopic cholecystectomy". All relevant English language publications from 2000 to 2016 were identified, with data extracted for the role of LUS in the anatomical delineation of the biliary tract, detection of common bile duct stones (CBDS), prevention or early detection of biliary duct injury (BDI), and incidental findings during laparoscopic cholecystectomy. Data for the role of LUS vs IOC in complex situations (i.e., inflammatory disease/fibrosis) were specifically analyzed. RESULTS: We report data from eighteen reports, 13 prospective non-randomized trials, 5 retrospective trials, and two meta-analyses assessing diagnostic accuracy, with one analysis also assessing costs, duration of the examination, and anatomical mapping. Overall, LUS was shown to provide highly sensitive mapping of the extra-pancreatic biliary anatomy in 92%-100% of patients, with more difficulty encountered in delineation of the intra-pancreatic segment of the biliary tract (73.8%-98%). Identification of vascular and biliary variations has been documented in two studies. Although inflammatory disease hampered accuracy, LUS was still advantageous vs IOC in patients with obscured anatomy. LUS can be performed before any dissection and repeated at will to guide the surgeon especially when hilar mapping is difficult due to fibrosis and inflammation. In two studies LUS prevented conversion in 91% of patients with difficult scenarios. Considering CBDS detection, LUS sensitivity and specificity were 76%-100% and 96.2%-100%, respectively. LUS allowed the diagnosis/treatment of incidental findings of adjacent organs. No valuable data for BDI prevention or detection could be retrieved, even if no BDI was documented in the reports analyzed. Literature analysis proved LUS as a safe, quick, non-irradiating, cost-effective technique, which is comparatively well known although largely under-utilized, probably due to the perception of a difficult learning curve. CONCLUSION: We highlight the advantages and limitations of laparoscopic ultrasound during cholecystectomy, and underline its value in difficult scenarios when the anatomy is obscured.

Endoscopic ultrasound sedation in the United Kingdom: Is life without propofol tolerable?

There is compelling evidence to support the quality, cost effectiveness and safety profile of non-anesthesiologist-administered propofol for endoscopic ultrasound (EUS). However in the United Kingdom, it is recommended that the administration and monitoring of propofol sedation for endoscopic procedures should be the responsibility of a dedicated and appropriately trained anaesthetist only. The majority of United Kingdom EUS procedures are performed with opiate and benzodiazepine sedation rather than anaesthetist led propofol lists due to anaesthetist resource availability. We sought to prospectively determine the tolerability and safety of EUS with benzodiazepine and opiate sedation in single United Kingdom centre. Two hundred consecutive patients undergoing either EUS or oesophago-gastroduodenoscopy (OGD) with conscious sedation were prospectively recruited with a 1:1 enrolment ratio. Patients completed questionnaires pre and post procedure detailing anticipated and actual pain experienced on a 1-10 visual analogue scale. Demographics, procedure duration, sedation doses and willingness to repeat the procedure were also recorded. EUS procedures lasted significantly longer than OGDs (15 min vs 6 min, P < 0.0001), however, there was no difference in anticipated pain scores between the groups (EUS 3.37/10 vs OGD 3.47/10, P = 0.46). Pain scores indicated EUS was better tolerated than OGD (1.16/10 vs 1.88/10, P = 0.03) although higher doses of sedation were used for EUS procedures. There were no complications identified in either group. We feel our study demonstrates that the tolerability of EUS with opiate and benzodiazepine sedation is acceptable.

Echoendoscopes.

Advances in echoendoscopes and their processors have significantly expanded the role of EUS and its clinical applications.The diagnostic and therapeutic capabilities of EUS continue to evolve and improve. EUS has made a large impact on patient care but comes with significant startup and maintenance costs. As improved technology continues to enhance image resolution while decreasing the size of EUS processors, use of endosonography will become more widespread. EUS will continue to be a vital part of patient care and complement currently available cross-sectional imaging.

A comparative evaluation of EUS-guided biliary drainage and percutaneous drainage in patients with distal malignant biliary obstruction and failed ERCP.

BACKGROUND AND AIM: Endoscopic ultrasound-guided biliary drainage (EGBD) may be a safe, alternative technique to percutaneous transhepatic biliary drainage (PTBD) in patients who fail ERCP. However, it is currently unknown how both techniques compare in terms of efficacy, safety, and cost. The aims of this study were to compare efficacy, safety, and cost of EGBD to that of PTBD. METHODS: Jaundiced patients with distal malignant biliary obstruction who underwent EGBD or PTBD after failed ERCP were included. Technical success, clinical success, and adverse events between the two groups were compared. RESULTS: A total of 73 patients with failed ERCP subsequently underwent EGBD (n = 22) or PTBD (n = 51). Although technical success was higher in the PTBD group (100 vs. 86.4 %, p = 0.007), clinical success was equivalent (92.2 vs. 86.4 %, p = 0.40). PTBD was associated with higher adverse event rate (index procedure: 39.2 vs. 18.2 %; all procedures including reinterventions: 80.4 vs. 15.7 %). Stent patency and survival were equivalent between both groups. Total charges were more than two times higher in the PTBD group (p = 0.004) mainly due to significantly higher rate of reinterventions (80.4 vs. 15.7 %, p < 0.001). CONCLUSION: EGBD and PTBD are comparably effective techniques for treatment of distal malignant biliary obstruction after failed ERCP. However, EGBD is associated with decreased adverse events rate and is significantly less costly due to the need for fewer reinterventions. Our results suggest that EGBD should be the technique of choice for treatment of these patients at institutions with experienced interventional endosonographers.

Linear endobronchial ultrasonography: a novelty turned necessity for mediastinal nodal assessment.

Linear endobronchial ultrasound was first described in 2003. Since then the technique has spread rapidly and has now become an established practice in many centres as the first-line mediastinal investigation for the diagnosis and staging of lung cancer. In combination with endoscopic ultrasound, the majority of the mediastinum can be assessed and this approach has been shown to have equivalent accuracy to surgical staging. This strategy is also cost-effective. New tissue processing techniques using liquid-based thin-layer cytology and cell blocks have increased diagnostic yield using immunohistochemical staining and molecular diagnostics. Several meta-analyses of case series and, more recently, randomised controlled trials have provided high-level evidence of efficacy leading to incorporation into national lung cancer staging guidelines. In addition, linear endobronchial ultrasound is increasingly used in the investigation of mediastinal lymphadenopathy for suspected sarcoidosis, tuberculosis and lymphoma. While undoubtedly endobronchial/endoscopic ultrasound has reduced the need for surgical staging in lung cancer, the latter still has an important role to play in certain scenarios. The challenge now facing clinicians is to learn to apply the appropriate test or sequence of tests in each patient while ensuring that operators are appropriately trained in order to ensure optimal outcomes.

Diagnostic endoscopic ultrasonography: assessment of safety and prevention of complications.

Endoscopic ultrasonography (EUS) has gained wide acceptance as an important, minimally invasive diagnostic tool in gastroenterology, pulmonology, visceral surgery and oncology. This review focuses on data regarding risks and complications of non-interventional diagnostic EUS and EUS-guided fine-needle biopsy (EUS-FNB). Measures to improve the safety of EUS und EUS-FNB will be discussed. Due to the specific mechanical properties of echoendoscopes in EUS, there is a low but noteworthy risk of perforation. To minimize this risk, endoscopists should be familiar with the specific features of their equipment and their patients' specific anatomical situations (e.g., tumor stenosis, diverticula). Most diagnostic EUS complications occur during EUS-FNB. Pain, acute pancreatitis, infection and bleeding are the primary adverse effects, occurring in 1% to 2% of patients. Only a few cases of needle tract seeding and peritoneal dissemination have been reported. The mortality associated with EUS and EUS-FNB is 0.02%. The risks associated with EUS-FNB are affected by endoscopist experience and target lesion. EUS-FNB of cystic lesions is associated with an increased risk of infection and hemorrhage. Peri-interventional antibiotics are recommended to prevent cyst infection. Adequate education and training, as well consideration of contraindications, are essential to minimize the risks of EUS and EUS-FNB. Restricting EUS-FNB only to patients in whom the cytopathological results may be expected to change the course of management is the best way of reducing the number of complications.

Outcome and complications of endoscopic ultrasound guided pancreatic pseudocyst drainage using combined endoprosthesis and naso-cystic drain.

BACKGROUND AND AIM: Endoscopic ultrasound guided pancreatic pseudocyst drainage (EUS-PPD) is increasingly being used for management of pancreatic pseudocysts. We evaluated the outcome and complications of EUS-PPD with modified combined technique by inserting both endoprosthesis and naso-cystic drain. METHODS: Forty patients referred between August 2007 and January 2010 for EUS-PPD were prospectively studied. EUS-PPD was attempted for symptomatic pancreatic pseudocysts which were; (i) resistant to conservative treatment, (ii) in contact with the gastric or duodenal wall on EUS and (iii) having no bulge seen on endoscopy. Controlled radial expansion wire guided balloon dilation of the puncture tract was performed followed by insertion of a 10 French double pigtail stent and 7-Fr naso-biliary drain. The early and late outcome and complications of EUS-PPD were analyzed. RESULTS: Thirty-two patients had non-infected and eight had infected pseudocysts. EUS-PPD was technically successful in all. Pseudocysts resolved completely in 39 patients, while one with infected pseudocyst underwent surgical resection for bleeding in the cyst. Naso-cystic drain was removed in 39 patients after median duration of 13 days. Thereafter, the double pigtail stent was removed in all cases after median duration of 10 weeks. Pseudocyst recurred in one patient requiring a second session of EUS-PPD. All 32 patients without cystic infection were successfully treated by EUS-PPD. Seven out of eight patients (87%) with cystic infection were successfully treated by EUS-PPD. CONCLUSION: Endoscopic ultrasound guided pancreatic pseudocyst drainage with modified combined technique is safe and is associated with high success rate.

Assessment of morbidity and mortality associated with EUS-guided FNA: a systematic review.

BACKGROUND: EUS-guided FNA (EUS-FNA) permits both morphologic and cytologic analysis of lesions within or adjacent to the GI tract. Although previous studies have evaluated the accuracy of EUS-FNA, little is known about the complications of EUS-FNA. Moreover, the frequency and severity of complications may vary from center to center and may be related to differences in individual experience. OBJECTIVE: To systematically review the morbidity and mortality associated with EUS-FNA. DESIGN: MEDLINE and EMBASE were searched to identify relevant English-language articles. MAIN OUTCOME MEASUREMENTS: EUS-FNA-specific morbidity and mortality rates. RESULTS: We identified 51 articles with a total of 10,941 patients who met our inclusion and exclusion criteria; the overall rate of EUS-FNA-specific morbidity was 0.98% (107/10,941). In the small proportion of patients with complications of any kind, the rates of pancreatitis (36/8246; 0.44%) and postprocedure pain (37/10,941; 0.34%) were 33.64% (36/107) and 34.58% (37/107), respectively. The mortality rate attributable to EUS-FNA-specific morbidity was 0.02% (2/10,941). Subgroup analysis showed that the morbidity rate was 2.44% in prospective studies compared with 0.35% in retrospective studies for pancreatic mass lesions (P=.000), whereas it was 2.33% versus 5.07% for pancreatic cysts (P=.036). LIMITATIONS: Few articles reported well-designed, prospective studies and few focused on overall complications after EUS-FNA. CONCLUSIONS: EUS-FNA-related morbidity and mortality rates are relatively low, and most associated events are mild to moderate in severity.

Prospective assessment of diagnostic utility and complications of endoscopic ultrasound-guided fine needle aspiration. Results from a newly developed academic endoscopic ultrasound program.

BACKGROUND: It is currently unknown whether a newly developed endoscopic ultrasound (EUS) program can produce results similar to those of experienced EUS centers. We therefore prospectively evaluated the diagnostic accuracy and major complications of EUS-guided fine needle aspiration (EUS-FNA) in a newly developed EUS program. METHODS: All procedures were performed by a single endosonographer in the presence of a cytopathologist. Reference standard for classification of final disease included: surgical resection, death from disease progression and repeat radiologic and/or clinical follow-up. Major complications were defined as oversedation, and those that resulted in a physician or emergency department visits, hospitalization, or death. RESULTS: 540 patients (median age 63 years, 77% white) underwent EUS-FNAs of 656 lesions: lymph nodes (LNs, n = 248), solid pancreatic masses (SPMs, n = 229), cystic pancreatic masses (CPM, n = 57), mural lesions (n = 41), bile duct/gallbladder (n = 28), liver (n = 17), mediastinum/lung (n = 17), adrenal (n = 15), spleen (n = 3) and kidney (n = 1). SPMs and bile duct/gallbladder lesions were more likely to have suspicious/atypical cytology when compared to other lesions (8.7 vs. 4.6%; p = 0.04) and required more passes to achieve a tissue diagnosis (p < 0.001). The overall sensitivity, specificity, PPV, NPV and accuracy of EUS-FNA was 91.7, 97.1, 98.1, 87.7 and 93.8%, respectively. Six patients (1.1%) (95% CI 0.4-2.4) experienced a major complication. One patient died shortly after the procedure due to preexisting pulmonary embolus (0.18%). CONCLUSION: EUS-FNA is highly accurate and safe in sampling a variety of peri-intestinal organs and lymph nodes. With adequate third-tier training, a newly developed program can produce results similar to those from expert EUS centers.

[Risk management: relationship with the patient's relatives, who does what?]. / Gestione del rischio: rapporto con i familiari, chi fa cosa?

Risk management is the systematic process of identification, evaluation and treatment of current and potential risks. In the last decades it has acquired a significant importance also in the medical field, where it aims to increase patient' safety, to reduce adverse events and costs, thus improving patients' outcomes. Gastrointestinal endoscopy is a clinical field where operative procedures are carried out; some of them may have complications, which can lead to legal cases; among such techniques endoscopic ultrasonography is acceptably safe. The aim of the article is to highlight some aspects of the risk management which are related with the patient's relatives, in the field of endoscopic ultrasonography: from the gathering of the case history to the required information for a safe discharge. Communication skills and attention given to the information process, can allow the reduction of clinical risks for patients undergoing endoscopic procedures.

Frequency of bacteremia after linear EUS of the upper GI tract with and without FNA.

BACKGROUND: Few data are available concerning the frequency of bacteremia after diagnostic EUS or EUS-guided FNA. This study was undertaken to provide these data and to determine whether present guidelines for prophylactic administration of antibiotics to prevent endocarditis during upper endoscopy are applicable to EUS and EUS-guided FNA. METHODS: A total of 100 patients who were to undergo diagnostic EUS of the upper-GI tract and 50 who were to have upper-GI EUS-guided FNA were enrolled in this prospective study. Blood cultures were obtained before and within 5 minutes after the conclusion of the procedure. In case of bacterial growth, patients were observed for at least 3 days for signs of infection. RESULTS: After diagnostic EUS, significant bacteremia was found in two patients with esophageal carcinoma (2%: 95% CI[0%, 4.8%]) and after EUS-guided FNA in two patients (4%: 95% CI[0%, 9.6%]). The difference was not statistically significant. None of these patients developed clinical signs of infection. Risk factors predisposing to bacteremia could not be identified. CONCLUSION: The frequency of bacteremia after EUS, with and without FNA, is within the range of that for diagnostic upper endoscopy. Therefore, the same recommendations for prophylactic administration of antibiotics to prevent endocarditis may be applied in patients undergoing EUS and EUS-guided FNA. The role of esophageal cancer as a predisposing factor to EUS-associated infection remains uncertain.

Prospective risk assessment of bacteremia and other infectious complications in patients undergoing EUS-guided FNA.

BACKGROUND: There are few data regarding the risk of bacteremia with EUS-guided FNA. This study prospectively evaluated the frequency of bacteremia and other infectious complications after EUS-guided FNA. METHODS: Patients referred for EUS-guided FNA of the upper GI tract lesions were considered for enrollment. Patients were excluded if there was an indication for preprocedure administration of antibiotics based on ASGE guidelines, had taken antibiotics within the prior 7 days, or if they had a pancreatic cystic lesion. Blood cultures were obtained immediately before the procedure, after routine endoscopy/radial EUS, and 15 minutes after EUS-guided FNA. RESULTS: Fifty-two patients underwent EUS-guided FNA at 74 sites (mean 1.4 sites/patient) totaling 266 passes of the fine needle (mean 5.1 FNA/patient). Coagulase negative Staphylococcus was grown in cultures from 3 patients (5.8%; 95% CI [1%, 15%]) and was considered a contaminant. Three patients (5.8%; 95% CI [1%, 15%]) developed bacteremia: Streptococcus viridans (n = 2), unidentified gram-negative bacillus (n = 1). No signs or symptoms of infection developed in any patient. CONCLUSION: EUS-guided FNA of solid lesions in the upper GI tract should be considered a low-risk procedure for infectious complications that does not warrant prophylactic administration of antibiotics for prevention of bacterial endocarditis.

Cost-minimization analysis of alternative diagnostic approaches in a modeled patient with non-small cell lung cancer and subcarinal lymphadenopathy.

OBJECTIVE: To evaluate the costs of alternative diagnostic evaluations of enlarged subcarinal lymph nodes (SLNs) in modeled patients with non-small cell lung cancer (NSCLC). METHODS: A cost-minimization model was used to compare 5 diagnostic approaches in the evaluation of enlarged SLNs in modeled patients with NSCLC. Values for the test performance characteristics and prevalence of malignancy in patients with SLN were obtained from the medical literature. The target population was adult patients known or suspected to have NSCLC with SLNs with a short axis length of at least 10 mm on thoracic computed tomography (CT). RESULTS: The lowest-cost diagnostic work-up was by initial evaluation with endoscopic ultrasonography-guided fine-needle aspiration (EUS FNA) biopsy ($11,490 per patient) compared with mediastinoscopy (with biopsy) ($13,658), transbronchial FNA biopsy ($11,963), CT-guided FNA biopsy ($13,027), and positron emission tomography ($12,887). The results were sensitive to rate of SLN metastases and EUS FNA sensitivity. The EUS FNA biopsy remained least costly if the probability of SLN metastases exceeded 24% or EUS FNA sensitivity was higher than 76%. Primary mediastinoscopy was the most economical if not. CONCLUSIONS: Which testing strategy is least costly for SLN evaluation in a modeled patient with NSCLC may be determined by the pretest probability of nodal metastases. Use of EUS FNA biopsy minimizes the cost of diagnostic evaluation in most cases.

Endoscopic ultrasonography versus cholangiography for the diagnosis of choledocholithiasis.

BACKGROUND: Choledocholithiasis is a major source of morbidity among patients undergoing cholecystectomy for symptomatic gallstones. There is no consensus on the best approach to diagnosing bile duct stones. We compared the safety, accuracy, diagnostic yield, and cost of EUS- and ERCP-based approaches. METHODS: Sixty-four consecutive pre- and post-cholecystectomy patients referred for endoscopic retrograde cholangiopancreatography (ERCP) for suspected choledocholithiasis were prospectively evaluated in a blinded fashion. All were stratified into risk groups using predefined criteria. Endoscopic ultrasonography (EUS) and ERCP were sequentially performed by two endoscopists. RESULTS: The success rates of EUS and ERCP were 98% and 94%, respectively. The accuracy of EUS for diagnosing choledocholithiasis was 94%. EUS provided an additional or alternative diagnosis to bile duct stones in 21% of patients. The complication rate of EUS was significantly lower than diagnostic ERCP. An EUS-based strategy costs less than diagnostic ERCP in patients with low, moderate, or intermediate risk. CONCLUSIONS: EUS is comparably accurate, but safer and less costly than ERCP for evaluating patients with suspected choledocholithiasis. It is useful in patients with an increased risk of having common bile duct stones based on clinical criteria and those with contraindications for or prior unsuccessful ERCP. EUS may enable selective performance of ERCP and improve the cost-effectiveness of diagnosing choledocholithiasis.

Endosonography-guided fine-needle aspiration biopsy: diagnostic accuracy and complication assessment.

BACKGROUND & AIMS: Endosonography-guided fine-needle aspiration biopsy (EUS-FNA) permits cytological confirmation of EUS findings. A multicenter prospective evaluation of EUS-FNA for primary diagnosis, staging, and/or follow-up purposes was undertaken. METHODS: EUS-FNA was performed in 457 patients with 554 lesions. Clinical (n = 218) or histopathologic (n = 256) confirmation was available in 192 lymph nodes, 145 extraluminal masses, 115 gastrointestinal wall lesions, and 22 cystic lesions. RESULTS: EUS-FNA sensitivity, specificity, and accuracy was 92%, 93%, and 92% for lymph nodes, 88%, 95%, and 90% for extraluminal masses, and 61%, 79%, and 67% for gastrointestinal wall lesions, respectively. The sensitivity and accuracy for lymph nodes and extraluminal masses was superior to that for gastrointestinal wall lesions. When EUS-FNA was compared with EUS size criteria in lymph node evaluation, specificity (93% vs. 24%) and accuracy (92% vs. 69%) were superior, whereas sensitivity (92% vs. 86%) was similar. The accuracy of EUS-FNA in patients with previously failed biopsy procedures was 81% (73 of 90). Five nonfatal complications occurred for a rate of 0.5% (95% confidence interval, 0.1%-0.8%) in solid lesions vs. 14% (95% confidence interval, 6%-21%) in cystic lesions. CONCLUSIONS: EUS-FNA accurately and safely evaluates solid peri-intestinal lesions and improves lymph node staging accuracy.

Clinical implications of endoscopic ultrasound: the American Endosonography Club Study.

BACKGROUND: Despite increased clinical use of endoscopic ultrasound (EUS), there are little data regarding complications of EUS or its impact on patient management. METHODS: A prospective multicenter study was completed to evaluate clinical outcomes of EUS. Before each EUS examination the endosonographer recorded further theoretical patient management plans as if EUS was unavailable. After the EUS, endosonographers recorded actual management plans based on EUS results. The actual management plan after EUS was compared to the theoretical management before EUS. Complications were assessed in short-term follow-up. RESULTS: Four hundred twenty-eight subjects were enrolled. Of subjects able to be evaluated, EUS changed the treatment plan in 74%. Management changes of major importance occurred in 120 patients (31% of subjects able to be evaluated) and included decisions regarding surgery (62 patients), decisions regarding nonsurgical invasive management (36 patients), and decisions regarding further follow-up (22 patients). When there was a change in management, the change was to less costly, risky, or invasive management in 55%, to more costly/risky/invasive in 37%, and to equally costly/risky/invasive in 8%. Short-term follow-up was completed in 81% of subjects, with six complications identified (1.7%). Three complications were mild, two were moderate, one severe, and none fatal. CONCLUSIONS: (1) Changes in management plan may occur in the majority of patients based on EUS results. (2) The management changes are often of major importance with regard to health care costs and safety, and are more often in the direction of less costly, risky, and invasive management. (3) EUS is safe in experienced hands.