Thomas J. Savides

Endoscopic ultrasound–guided fine-needle aspiration biopsy using linear array and radial scanning endosonography

BACKGROUND Endoscopic ultrasound (EUS) accurately stages gastrointestinal malignancies but is less able to differentiate between neoplastic and inflammatory processes. EUS-guided fine-needle aspiration (EUS FNA) has been reported useful for obtaining a diagnosis in suspected gastrointestinal lesions. We report our entire experience with EUS FNA using both radial and linear array endosonography, including our diagnostic accuracy and complication rate. METHODS Two hundred eight consecutive patients (119 men, 89 women) referred for EUS evaluation of suspected gastrointestinal or mediastinal masses underwent EUS-guided FNA. We performed EUS FNA using radial scanning or linear array endosonography and a 23 gauge, 4 cm needle or a 22 gauge, 12 cm needle. Data collected included lesion types, number of passes, complications, and diagnostic accuracy. RESULTS Two hundred eight lesions were targeted, with a total of 705 FNA passes (mean 3.39 passes/patient). Overall diagnostic accuracy for our study population was 87% with a 89% sensitivity and 100% specificity. The diagnostic accuracy for each subgroup was 95% for mediastinal lymph node, 85% for intra-abdominal lymph node, 85% for pancreatic, 84% for submucosal, and 100% for perirectal masses. EUS FNA provided an adequate specimen in 90% of patients. The FNA results were similar for both types of endosonography. We observed immediate complications in 2% (4 of 208) of patients. All complications occurred with EUS FNA of pancreatic lesions and consisted of bleeding and pancreatitis in 2 patients each. For EUS FNA of pancreatic masses there was a 1.2% (2 of 121) risk of pancreatitis, 1% (1/121) risk of severe bleeding, and risk of death in less than 1%. CONCLUSIONS EUS-guided FNA appears to be technically feasible, safe, and accurate for obtaining diagnostic tissue of suspicious gastrointestinal and mediastinal lesions and provides important preoperative information.

Endoscopic Ultrasonography, Fine-Needle Aspiration Biopsy Guided by Endoscopic Ultrasonography, and Computed Tomography in the Preoperative Staging of Non-Small-Cell Lung Cancer: A Comparison Study

Accurate staging of non-small-cell lung cancer plays a crucial role in determining the treatment options available to patients with this disease. The preoperative documentation of metastasis to the mediastinal lymph nodes has therapeutic implications that have traditionally focused on palliation but more recently have included neoadjuvant strategies [1, 2]. Metastasis to the mediastinal lymph nodes occurs in nearly half of all patients with non-small-cell lung cancer. The development of mediastinal metastasis is probably the most frequent deterrent to cure, even when the presentation is localized. If metastasis involves contralateral or large, bulky (>1.5 to 2.0 cm) subcarinal lymph nodes, surgery alone may not be curative [3-9]. As a result of recent revisions to the staging systems for lung cancer, ipsilateral mediastinal and subcarinal lymph node involvement is now classified as potentially resectable, N2 disease; contralateral mediastinal lymph node involvement (N3 disease) precludes resection [10-12]. Computed tomography of the chest is the current method by which mediastinal lymphadenopathy is detected in non-small-cell lung cancer. However, its sensitivity for detection of metastasis to the lymph nodes varies; accuracy in previous studies has ranged from 52% to 88% [13-23]. This inconsistency has been attributed to the variable correlation of lymph node size with the presence of malignancy. When enlarged contralateral or ipsilateral mediastinal lymph nodes are seen on computed tomography of the chest, standard practice is to determine more accurate staging by performing aspiration biopsy of the lymph node with computed tomographic guidance; bronchoscopy; or, less commonly, a transthoracic approach. If these procedures are unsuccessful, open biopsy is performed by using mediastinoscopy or limited thoracotomy [24-26]. If contralateral lymph nodes are positive for malignancy, surgical resection of the primary tumor is contraindicated. The development of endoscopic ultrasonography has now made it possible to visualize, with high resolution, not only the gastrointestinal tract but also surrounding structures. Endoscopic ultrasonography has been shown to be superior to computed tomography in evaluating lymph nodes for metastases in esophageal, gastric, and pancreatic cancer [27-29]. Promising results for detecting posterior mediastinal lymph nodes in patients with lung cancer suggest a possible role for endoscopic ultrasonography in staging lymph nodes in patients with non-small-cell lung cancer [30-36]. Fine-needle aspiration biopsy guided by endoscopic ultrasonography was recently reported to further improve the accuracy of endoscopic ultrasonography in predicting malignancy of gastrointestinal masses, with rates as high as 87% to 91% [37-42]. We previously reported the results of endoscopic ultrasonography in 17 patients with lung cancer. This method was very accurate for detecting mediastinal lymphadenopathy; the overall accuracy was 71% compared with 41% for computed tomography (P = 0.032) [43]. During the initial study, however, fine-needle aspiration biopsy guided by endoscopic ultrasonography was not available. The goal of the present study was to prospectively evaluate the accuracy of endoscopic ultrasonography alone, endoscopic ultrasonography-guided fine-needle aspiration biopsy, and computed tomography of the chest in detecting mediastinal lymph node metastasis in patients with non-small-cell lung cancer. Methods Patient Selection The study sample consisted of all patients presenting to the Indiana University Thoracic Oncology Program between July 1993 and June 1995 with a diagnosis of non-small-cell lung cancer. The study was approved by the institutional review board, and all enrolled patients gave informed consent. Patients were excluded if they had documented unresectable disease (that is, distant metastasis or locally advanced staged disease [stage III b]) as shown on computed tomography of the chest or if they had a serious medical illness and a life expectancy of less than 1 year. All patients underwent initial preoperative intravenous contrast-enhanced computed tomography of the chest; the axial technique was used in 60% of patients, and the spiral technique was used in 40%. Computed tomography was done at the referring hospital or Indiana University Medical Center; the scans were read at Indiana University Medical Center by a senior attending radiologist who has recognized expertise in this area and used currently accepted radiographic techniques to stage the tumor. The radiologists determination of the benign or malignant nature of each lymph node was recorded on a preoperative computed tomography lymph node map; the American Thoracic Society mediastinal staging map (Figure 1) was used to describe the location of each node [12]. Any patient who had a questionably enlarged mediastinal lymph node (>1 cm in diameter) and was considered a surgical candidate was then scheduled for endoscopic ultrasonography. Figure 1. American Thoracic Society scheme for mapping mediastinal lymphadenopathy by anatomic location, as seen from behind with endoscopic ultrasonography. Endoscopic Ultrasonography Endoscopic ultrasonography was performed in an outpatient setting on all patients by one of three experienced endosonographers; the radial scanning echoendoscope (GFUM-20, Olympus America, Melville, New York) or the linear-array scanning echoendoscope (FG32UA, Pentax, Orangeburg, New York) was used for all procedures. When done by an experienced operator, endoscopic ultrasonography is similar to standard upper endoscopy both in technique and duration of the procedure. When fine-needle aspiration biopsy is performed, the procedure is slightly prolonged. Patients were sedated with meperidine and midazolam, the doses of which were titrated to achieve adequate conscious sedation. The instrument was advanced into the stomach, and the celiac axis was imaged. The probe was then withdrawn to the gastroesophageal junction and slowly withdrawn at 1-cm intervals. Images were obtained with 7.5- and 12-MHz frequencies at each interval. All imaged mediastinal lymph nodes were mapped by location according to the American Thoracic Society classification scheme [12]. From these data, an objective assessment was made as to whether the mediastinal lymphadenopathy detected by endoscopic ultrasonography was benign or possibly malignant according to the following previously reported criteria for malignancy: round shape; sharp, distinct borders; hypoechoic texture; and a short-axis diameter greater than 5 mm [36-39]. Malignancy was suspected if all of these criteria were present. All patients who were studied before the availability of endoscopic ultrasonography-guided fine-needle aspiration biopsy underwent surgical resection, and endoscopic ultrasonographic findings were correlated to surgical pathologic findings. Patients who were studied after the advent of fine-needle aspiration biopsy and were found to have no suspicious lymph nodes by endoscopic ultrasonography were directly referred for surgery because there was no indication for aspiration biopsy. Endoscopic Ultrasonography-Guided Fine-Needle Aspiration Biopsy Endoscopic ultrasonography-guided aspiration biopsy became available after the first 17 patients were enrolled in our pilot study. All posterior mediastinal lymph nodes that were suspicious for malignant involvement according to the endoscopic ultrasonographic criteria were noted; selected nodes underwent biopsy during the same procedure. Many of the patients had more than one suspicious lymph node. We performed biopsy only on the most suspicious lymph node, which would have the greatest effect on clinical staging (that is, determination of whether the metastasis was contralateral or subcarinal). This technique for ultrasonography-guided aspiration biopsy was initially developed for use with the linear-array instrument (Figure 2) and is described elsewhere [40-42]. We recently reported a similar technique that uses a radial scanning echoendoscope (Figure 3) [37]. Ultrasonography-guided aspiration biopsy involves the insertion of an aspiration catheter needle device through the accessory channel port of the echoendoscope; the needle is then deployed into the lymph node to be sampled under endoscopic ultrasonographic guidance. Aspiration biopsy is done by introducing a specially designed fine-needle aspiration catheter system that consists of a 4-cm long, 23-gauge needle attached to a 180-cm long, 5-French aspiration catheter (Wilson-Cook, Winston-Salem, North Carolina); in and out movements of the catheter are used while the operator firmly grasps the catheter at the point at which it enters the accessory port. Figure 2. A mediastinal lymph node as imaged with the linear-array endoscopic ultrasonography system. arrow Figure 3. Endoscopic ultrasonographic image obtained from the radial scanning instrument showing a large hypoechoic, oval subcarinal lymph node (LN) suspicious for metastatic involvement. Preliminary cytologic findings were obtained during fine-needle aspiration biopsy by a cytopathologist who was present during the procedure. Before the sample was reviewed, Diff-Quik stain (Harleco, Gibbstown, New Jersey) was applied to the slide that contained the deposited specimen. Additional passes were made until a positive cytologic result or a negative result on an adequate tissue sample was obtained [37]. Patients who were considered eligible for surgical resection after staging by computed tomography and endoscopic ultrasonography (that is, patients with a negative result on aspiration biopsy of contralateral or bulky subcarinal lymph nodes or those with nodes that seemed to be benign according to endoscopic ultrasonographic criteria) underwent thoracotomy for pulmonary resection with ipsilateral mediastinal and subcarinal lymph node dissection. During mediastinal dissection, each lymph node was placed in th

Echocardiographic and clinical predictors for outcome of elective cardioversion of atrial fibrillation

Previous studies have suggested that success of elective direct-current cardioversion for atrial fibrillation (AF) can be predicted from clinical features and M-mode echocardiographic left atrial diameter. We evaluated clinical variables as well as M-mode and 2-dimensional echocardiographic measurements of atrial size in 85 patients undergoing electrical cardioversion for AF. Of 65 patients who were initially converted to sinus rhythm, 45 (69%) and 38 (58%) remained in sinus rhythm at 1 and 6 months, respectively. No historical feature predicted initial success, although patients with cardiomyopathy or pulmonary disease underlying their AF had significantly lower success rates compared with those having other etiologies. Furthermore, no M-mode or 2-dimensional echocardiographic measurements of atrial size predicted initial success of cardioversion. Maintenance of sinus rhythm at 1 month was related to short duration of AF before cardioversion (less than 3 months vs greater than 12 months, p less than 0.05). Left atrial area and long axis dimension by 2-dimensional echocardiography were significantly larger in patients remaining in sinus rhythm than in those who had reverted to AF at 1 month (28 +/- 7 vs 24 +/- 5 cm2 and 65 +/- 9 vs 59 +/- 8 mm, respectively, both p less than 0.05), but overlap was great. No significant difference in atrial dimensions was noted at 6-month follow-up. It appears that, although no clinical or echocardiographic variable predicts initial success for cardioversion of AF, duration of AF does predict maintenance of sinus rhythm 1 month after initial success.(ABSTRACT TRUNCATED AT 250 WORDS)

Circumferential ablation of Barrett's esophagus that contains high-grade dysplasia: a U.S. multicenter registry

BACKGROUND The management strategies for Barretts esophagus (BE) that contains high-grade dysplasia (HGD) include intensive endoscopic surveillance, photodynamic therapy, thermal ablation, EMR, and esophagectomy. OBJECTIVE To assess the safety and effectiveness of endoscopic circumferential balloon-based ablation by using radiofrequency energy for treating BE HGD. DESIGN Multicenter U.S. registry. SETTING Sixteen academic and community centers; treatment period from September 2004 to March 2007. PATIENTS Patients with histologic evidence of intestinal metaplasia (IM) that contained HGD confirmed by at least 2 expert pathologists. A prior EMR was permitted, provided that residual HGD remained in the BE region for ablation. INTERVENTION Endoscopic circumferential ablation with follow-up esophageal biopsies to assess the histologic response to treatment. OUTCOMES Histologic complete response (CR) end points: (1) all biopsy specimen fragments obtained at the last biopsy session were negative for HGD (CR-HGD), (2) all biopsy specimens were negative for any dysplasia (CR-D), and (3) all biopsy specimens were negative for IM (CR-IM). RESULTS A total of 142 patients (median age 66 years, interquartile range [IQR] 59-75 years) who had BE HGD (median length 6 cm, IQR 3-8 cm) underwent circumferential ablation (median 1 session, IQR 1-2). No serious adverse events were reported. There was 1 asymptomatic stricture and no buried glands. Ninety-two patients had at least 1 follow-up biopsy session (median follow-up 12 months, IQR 8-15 months). A CR-HGD was achieved in 90.2% of patients, CR-D in 80.4%, and CR-IM in 54.3%. LIMITATIONS A nonrandomized study design, without a control arm, a lack of centralized pathology review, ablation and biopsy technique not standardized, and a relatively short-term follow-up. CONCLUSIONS Endoscopic circumferential ablation is a promising modality for the treatment of BE that contains HGD. In this multicenter registry, the intervention safely achieved a CR for HGD in 90.2% of patients at a median of 12 months of follow-up.

Natural orifice surgery: initial clinical experience

BackgroundNatural orifice translumenal endoscopic surgery (NOTES) has moved quickly from preclinical investigation to clinical implementation. However, several major technical problems limit clinical NOTES including safe access, retraction and dissection of the gallbladder, and clipping of key structures. This study aimed to identify challenges and develop solutions for NOTES during the initial clinical experience.MethodsUnder an Institutional Review Board (IRB)-approved protocol, patients consented to a natural orifice operation for removal of either the gallbladder or the appendix via either the vagina or the stomach using a single umbilical trocar for safety and assistance.ResultsNine transvaginal cholecystectomies, one transgastric appendectomy, and one transvaginal appendectomy have been completed to date. All but one patient were discharged on postoperative day 1 as per protocol. No complications occurred.ConclusionThe limited initial evidence from this study demonstrates that NOTES is feasible and safe. The addition of an umbilical trocar is a bridge allowing safe performance of NOTES procedures until better instruments become available. The addition of a flexible long grasper through the vagina and a flexible operating platform through the stomach has enabled the performance of NOTES in a safe and easily reproducible manner. The use of a uterine manipulator has facilitated visualization of the cul de sac in women with a uterus to allow for safe transvaginal access.

Guidelines for credentialing and granting privileges for endoscopic ultrasound

Abstract This is one of a series of statements discussing the utilization of gastrointestinal endoscopy in common clinical situations. In preparing this guideline, a MEDLINE literature search was performed, and additional references were obtained from the bibliographies of the identified articles and from recommendations of expert consultants. When little or no data exist from well-designed prospective trials, emphasis is given to results from large series and reports from recognized experts. Guidelines for the appropriate use of endoscopy are based on a critical review of the available data and expert consensus. Controlled clinical studies are needed to clarify aspects of this statement and revision may be necessary as new data appear. Clinical considerations may justify a course of action at variance from these recommendations.

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.

Stent-induced pancreatic ductal and parenchymal changes: correlation of endoscopic ultrasound with ERCP

BACKGROUND Polyethylene pancreatic duct stents induce morphologic changes of the pancreatic duct in the majority of patients. This study was undertaken to determine if parenchymal abnormalities are present in patients undergoing short-term pancreatic duct stenting and to correlate these findings with the pancreatogram obtained at stent removal. METHODS Twenty-five patients underwent pancreatic duct stenting and had an endoscopic ultrasound evaluation of the pancreas at stent removal. The pancreatograms were evaluated at stent removal for ductal irregularity, narrowing, and side branch changes. Endoscopic ultrasound was used to assess for differences in the echo characteristics of the pancreatic parenchyma around the stent compared with the rest of the gland. RESULTS Of the 16 patients evaluated by ERCP at stent removal, 9 (56%) had 1 or more new ductographic changes. Endoscopic ultrasound identified parenchymal changes in the stented region in 17 of 25 patients (68%). Four patients who had parenchymal changes in the stented region on endoscopic ultrasound at stent removal had a follow-up study at a mean time of 16 months. Two patients had (new) changes suggestive of focal chronic pancreatitis in the stented region. CONCLUSION Short-term pancreatic duct stenting induced both ductal and parenchymal changes in more than 50% of patients. Chronic pancreatitis may be a consequence of pancreatic duct stenting.

Quality of colonoscopy withdrawal technique and variability in adenoma detection rates (with videos)

BACKGROUND Studies suggest that endoscopist-related factors such as colonoscopy withdrawal time are important in determining the adenoma detection rate (ADR). OBJECTIVE To determine the importance of withdrawal technique in differentiating among endoscopists with varying ADRs. DESIGN Prospective, multicenter study. SETTING Five academic tertiary-care medical centers. PARTICIPANTS This study involved 11 gastroenterology faculty endoscopists. INTERVENTION A retrospective review of screening colonoscopies was performed to categorize endoscopists into low, moderate, and high ADR groups. Video recordings were randomly obtained for each endoscopist on 20 (10 real, 10 sham) withdrawals during colonoscopies performed for average-risk colorectal cancer screening. Three blinded reviewers assigned withdrawal technique scores (total of 75 points) on 110 video recordings. A separate reviewer recorded withdrawal times. MAIN OUTCOME MEASUREMENTS Withdrawal technique scores and withdrawal times. RESULTS Mean (± standard deviation [SD]) withdrawal technique scores were higher in the moderate (62 ± 2.5) and high (59.5 ± 3) ADR groups compared with the low (40.8±3) ADR group (P = .002). Mean (± SD) withdrawal times were 6.3 ± 1.8 minutes (low ADR), 10.2 ± 1.5 minutes (moderate ADR), and 8.2 ± 1.8 minutes (high ADR) (P = .29). A comparison of the withdrawal times and technique scores of the two individual endoscopists with the lowest and highest ADRs did not find a significant difference in withdrawal times (6.6 ± 1.7 vs 7.4 ± 1.7 minutes) (P = .36) but did find a nearly 2-fold difference in technique scores (36.2 ± 9 vs 62.8 ± 9.9) (P = .0001). LIMITATIONS Not adequately powered to detect small differences in withdrawal times. CONCLUSION Withdrawal technique is an important indicator that differentiates between endoscopists with varying ADRs. It is possible that withdrawal technique is equal to, if not more important than, withdrawal time in determining ADRs.

Per-oral endoscopic myotomy white paper summary.

Achalasia is an uncommon esophageal motility disorder in which there is selective loss of inhibitory neurons resulting in loss of peristalsis and failure of adequate relaxation of the lower esophageal sphincter (LES) in response to food bolus. There is no current curative treatment that reverses the pathophysiology of achalasia. The treatment options are aimed at improving the passage of solids and liquids through the gastroesophageal junction (GEJ). The traditional treatment options include surgical myotomy and endoscopic methods that disrupt or weaken the LES, such as endoscopic balloon dilation and botulinum toxin injection (BI). Per-Oral Endoscopic Myotomy (POEM) represents a Natural Orifice Translumenal Endoscopic Surgery (NOTES ) approach to Heller myotomy. Preliminary data suggest that this minimally invasive endoscopic procedure may achieve clinical results similar to those of surgical myotomy. As part of the annual Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR ) meeting held in Chicago in July 2012, a conference was organized to collaboratively review POEM and develop a consensus document on the current status of POEM. An International POEM Survey (IPOEMS) was designed and conducted by the session moderators as part of this NOSCAR initiative to attempt to supplement the scant published literature with current data from POEM early adopters. The survey, which has now been published in This article is being published simultaneously in both Gastrointestinal Endoscopy and Surgical Endoscopy.