Background Contemporary EUS-guided FNA techniques involve the use of a needle, with an air column within the lumen, with or without suction. We describe a novel technique with an aim to improve the ...quality of the aspirate. Objective To compare a novel “wet suction” technique (WEST) with the conventional FNA technique (CFNAT) of EUS-guided FNA using a 22-gauge FNA needle. Design Prospective, single-blind, and randomized trial. Setting Two large tertiary-care hospitals. Patients All consecutive adult patients presenting for EUS with possible FNA of solid lesions were offered the chance to participate in the study. Methods All lesions were sampled with the same needle by using alternating techniques. Patients were randomized to the WEST versus the CFNAT for the first pass. If the first pass was made with the WEST, the second pass was made with the CFNAT, and subsequent passes were made in an alternating manner by using the same sequence. All FNAs were performed using 22-gauge needles. Main Outcome Measurements Specimen adequacy, cellularity, and blood contamination of EUS-guided FNA aspirates graded on a predefined scale. Results The WEST yielded significantly higher cellularity in a cell block compared with the CFNAT, with a mean cellularity score of 1.82 ± 0.76 versus 1.45 ± 0.768 ( P < .0003). The WEST cell block resulted in a significantly better specimen adequacy of 85.5% versus 75.2% ( P < .035). There was no difference in the amount of blood contamination between the 2 techniques. Limitations Lack of cross check and grading by a second cytopathologist. Conclusion The novel WEST resulted in significantly better cellularity and specimen adequacy in cell blocks of EUS-guided FNA aspirate of solid lesions than the CFNAT.
BACKGROUND Bedaquiline is an oral antimycobacterial agent belonging to a new class of drugs called diarylquinolines. It has low equivalent minimal inhibitory concentrations for Mycobacterium ...tuberculosis and nontuberculous mycobacterial (NTM) lung disease, especially Mycobacterium avium complex (MAC) and Mycobacterium abscessus (Mab). Bedaquiline appears to be effective for the treatment of multidrug-resistant TB but has not been tested clinically for NTM disease. METHODS We describe a case series of off-label use of bedaquiline for treatment failure lung disease caused by MAC or Mab. Only patients whose insurance would pay for the drug were included. Fifteen adult patients were selected, but only 10 (six MAC, four Mab) could obtain bedaquiline. The 10 patients had been treated for 1 to 8 years, and all were on treatment at the start of bedaquiline therapy. Eighty percent had macrolide-resistant isolates (eight of 10). The patients were treated with the same bedaquiline dosage as that used in TB trials and received the best available companion drugs (mean, 5. 0 drugs). All patients completed 6 months of therapy and remain on bedaquiline. RESULTS Common side effects included nausea (60%), arthralgias (40%), and anorexia and subjective fever (30%). No abnormal ECG findings were observed with a mean corrected QT interval lengthening of 2. 4 milliseconds at 6 months. After 6 months of therapy, 60% of patients (six of 10) had a microbiologic response, with 50% (five of 10) having one or more negative cultures. CONCLUSIONS This small preliminary report demonstrates potential clinical and microbiologic activity of bedaquiline in patients with advanced MAC or Mab lung disease but the findings require confirmation with larger studies.
Background Probe-based confocal laser endomicroscopy (pCLE) is an emerging tool for in vivo imaging of the GI tract that requires the endoscopist to interpret microscopic images. The learning curve ...for interpretation of pCLE images is unknown. Objective To examine the learning curve of correctly identifying benign and neoplastic colorectal lesions by using pCLE and to evaluate the learning curve of obtaining high-quality images. Design Prospective, double-blind review of pCLE images of 76 colorectal lesions by using corresponding polypectomies as the reference standard. A training set of 20 images with known histology was first reviewed to standardize image interpretation, followed by blinded review of 76 unknown images. Setting Eleven endoscopists from 3 different endoscopy centers evaluated the images obtained by 1 endoscopist using the high-definition confocal probe. Patients Patients undergoing screening and surveillance colonoscopies. Intervention Intravenous fluorescein pCLE imaging of colorectal lesions followed by polypectomies. Main Outcome Measurements Accuracy of image interpretation with constructing learning curve for pCLE image interpretation and acquisition. Results Of the 76 colorectal lesions, 51 (67%) were neoplastic and 25 (33%) were benign, based on histopathology. Accuracy for the overall group was 63% for lesions 1 to 20, 64% for lesions 21 to 40, 79% for lesions 41 to 60, and 86% for lesions 61 to 76. The ability to obtain high-quality images was stable over the 76 cases. Limitations Small sample size and use of offline video sequences. Conclusions Accurate interpretation of pCLE images for predicting neoplastic lesions can be learned rapidly by a wide range of GI specialists. Furthermore, the ability to acquire high-quality pCLE images is also quickly learned.
Background and Aims Endoscopic therapy is the standard treatment for high-grade dysplasia and some cases of T1a esophageal adenocarcinoma (EAC), but it is not appropriate for deeply invasive disease. ...Data on the value of EUS for patient selection for endoscopic or surgical resection are conflicting. We investigated the outcome of esophageal EUS for the staging and treatment selection of patients with treatment-naive, premalignant Barrett’s esophagus (BE) and suspected superficial EAC. Methods We retrospectively reviewed consecutive patients who underwent EUS for staging of treatment-naive, suspected premalignant BE and superficial EAC from January 2006 to June 2014. All patients referred for endoscopic therapy routinely underwent EUS. Patients with esophageal masses, squamous cell cancers, previous neoadjuvant therapy, or unrelated pathologies were excluded. Each patient’s final diagnosis was verified by EMR, esophagectomy, or forceps biopsy sampling. Test characteristics of EUS were calculated. Results Three hundred thirty-five patients (mean age, 68 years; 86% male) with BE, a Prague C mean of 2.8 cm, and a Prague M mean of 4.5 cm were staged (pT0, 78% 6% nondysplastic, 24% low-grade dysplasia, 42% high-grade dysplasia; pT1a, 14%; pT1b, 7%; and pT2, 1%). Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy for patient selection to endoscopic (T1aN0 or less) or surgical therapy with EUS TN staging were 50%, 93%, 40%, 95%, and 90%, respectively. Comparable rates were achieved for patients with nodular BE. Overstaging occurred in 7% of patients, and EUS selected 11% for incorrect treatment modalities compared with pathologic staging. Conclusions This study confirms the limited value of EUS suggested in the latest American College of Gastroenterology guidelines for BE management.
Background There are few randomized studies examining efficacy of snares and agents in EMR. Objective To compare the use of a combined needle and snare unit with injectate versus a spiral wire and ...injectate (primary); saline solution versus hydroxypropyl methylcellulose (secondary). Design Prospective, randomized, factorial, single center. Setting Tertiary-care academic medical center. Patients A total of 140 patients with large (>15 mm), sessile, colorectal polyps. Interventions Polyps randomized to either 1 of 2 snare types and 1 of 2 injectates. Main Outcome Measurements Primary—the Sydney resection quotient (SRQ), defined as the size of the polyp divided by the number of pieces resected and the amount of tissue per snare attempt. Secondary—procedure time, adverse events, residual neoplasia at follow-up. Results The SRQ was higher with the combined unit (median 13.8 mm vs 7.1 mm; P = .019); additionally, procedure time was less (median 6 vs 11 minutes; P < .001). Resection was considered complete after the EMR in 62% (42/68) with the combined needle and snare unit versus 51% (37/72; P = .22) with the spiral wire. Rates of adverse events were similar. Residual neoplasia was found at follow-up in 22% (10/46) with the combined needle and snare unit versus 21% (10/48; P = .89) with the spiral wire. There was no evidence of differences in outcomes by lifting agent. Limitations The SRQ is only a surrogate marker. Conclusion This study provides evidence that the integrated needle-snare may be superior to the snare alone for the removal of large, flat polyps. Additionally, the type of injectate appears to have no impact on outcome.
Background Cystic neoplastic lesions of the pancreas (CNLP) are increasingly detected and are associated with a potential for malignant transformation. Diagnostic assessment of these lesions is often ...limited by the cystic nature and focality of neoplastic progression of these lesions. EUS-guided FNA (EUS-FNA) of cyst fluid and exfoliated cells is one of the most accurate methods of diagnosis but still has limited sensitivity. A new, through-the-needle cytologic brush system has recently been approved for use during EUS evaluation of cystic lesions of the pancreas. Objective To evaluate the cytologic yield and safety profile of the new cytobrush compared with conventional FNA in evaluating CNLP. Design Ten consecutive patients with CNLP were included. All cysts were sampled by standard EUS-FNA (0.5 of cyst volume) followed by brush cytology, then by aspiration of the remaining fluid. Fluid samples were separately submitted (standard FNA and cytobrushings FNA) but were read by the same pathologist. Complications were assessed during the immediate postprocedure period (2-3 hours) and by a telephone call conducted approximately 30 days after the procedure to inquire about any new symptoms, including abdominal pain, melena, hematochezia, hematemesis, fever, nausea, and vomiting. Setting High-volume EUS referral center. Patients Ten consecutive patients with CNLP that measured at least 20 mm in maximal dimension were included. Main Outcome Measurements Cellularity and presence of diagnostic cells on the FNA. Results In 7 of 10 cases, the EchoBrush specimen was superior to FNA in terms of cellularity and detection of diagnostic cells. Two cases had complications: 1 major and 1 minor intracystic bleed. No infection or pancreatitis was observed. Limitations The interpreting pathologist for the case was not blinded to the results of either of the samples. In addition, this pilot study represents only a single-center experience. Conclusions This study suggests that brush cytology specimens obtained at the time of EUS are superior to conventional FNA because of the higher yield of epithelial cells. It is unclear whether bleeding is more common after EchoBrush sampling; however, caution should be taken in patients who require anticoagulation until further data are available.
Background According to the field effect theory, by detecting microvasculature changes such as early increase in blood supply (EIBS) in the surrounding tissue, neoplastic lesions can be identified ...from a distance. Objective To determine the feasibility and efficacy of a fiberoptic probe containing novel polarization gating spectroscopy technology to identify patients with pancreatic adenocarcinoma (PAC) by the field effect theory. Design Prospective cohort (pilot) study. Setting Outpatient tertiary care center. Patients Adult (≥18 years) patients undergoing EGD-EUS were screened. Patients with PAC were included in the “cancer” group and patients without PAC were included in the “control” group. We excluded patients with other known malignancies and gastroduodenal premalignant lesions. Interventions and Main Outcome Measures Spectroscopic measurements of EIBS variables, such as deoxyhemoglobin concentration (DHb) and mean blood vessel radius (BVR), were obtained from 5 periampullary locations. The Mann-Whitney rank sum test was used for the statistical analysis ( P ≤ .05). Results Fourteen patients (mean age 72 years, 79% male) in the cancer group and 15 patients (mean age 63 years, 60% male) in the control group were included in the final analysis. At the ampullary site, both DHb ( P = .001) and BVR ( P = .03) were higher in PAC patients than in the control subjects. The DHb alone (92% sensitivity, 86% specificity) or in combination with BVR (92% sensitivity, 79% specificity) can differentiate PAC from control subjects with high accuracy. Limitations Small sample size, unmatched control subjects. Conclusions Spectroscopic measurements of EIBS by fiberoptic probes are feasible. Preliminary evidence suggests that in vivo measurement of normal-appearing duodenal tissue can differentiate PAC patients from a distance with high accuracy.
Background and Aims EUS-guided FNA or biopsy sampling is widely practiced. Optimal sonographic visualization of the needle is critical for image-guided interventions. Of the several commercially ...available needles, bench-top testing and direct comparison of these needles have not been done to reveal their inherent echogenicity. The aims are to provide bench-top data that can be used to guide clinical applications and to promote future device research and development. Methods Descriptive bench-top testing and comparison of 8 commonly used EUS-FNA needles (all size 22 gauge): SonoTip Pro Control (Medi-Globe); Expect Slimline (Boston Scientific); EchoTip, EchoTip Ultra, EchoTip ProCore High Definition (Cook Medical); ClearView (Conmed); EZ Shot 2 (Olympus); and BNX (Beacon Endoscopic), and 2 new prototype needles, SonoCoat (Medi-Globe), coated by echogenic polymers made by Encapson. Blinded evaluation of standardized and unedited videos by 43 EUS endoscopists and 17 radiologists specialized in GI US examination who were unfamiliar with EUS needle devices. Results There was no significant difference in the ratings and rankings of these needles between endosonographers and radiologists. Overall, 1 prototype needle was rated as the best, ranking 10% to 40% higher than all other needles ( P < .01). Among the commercially available needles, the EchoTip Ultra needle and the ClearView needle were top choices. The EZ Shot 2 needle was ranked statistically lower than other needles (30%-75% worse, P < .001). Conclusions All FNA needles have their inherent and different echogenicities, and these differences are similarly recognized by EUS endoscopists and radiologists. Needles with polymeric coating from the entire shaft to the needle tip may offer better echogenicity.
Background Residual neoplasia after EMR of colorectal lesions is common. There is a critical need for imaging methods to accurately diagnose residual disease and to guide retreatment in real time. ...Objective The aim was to estimate and compare the accuracy of virtual chromoendoscopy (VCE) and probe-based confocal laser endomicroscopy (pCLE) for detection of residual neoplastic tissue at the site of prior EMR. Design Prospective, blind, pilot comparison of advanced endoscopic imaging (VCE and pCLE) by using matching histology as reference standard. Setting Three tertiary-care referral hospitals. Patients This study involved 92 participants who underwent follow-up colonoscopies for the evaluation of prior EMR sites within 1 year. Intervention The EMR scars were assessed during follow-up high-resolution colonoscopy by using VCE (narrow-band imaging/Fujinon Intelligent Color Enhancement FICE), and pCLE. Confocal videos of EMR scars were interpreted in real time and were also stored and reviewed offline, blinded to histopathology and endoscopic appearance. Tissue confirmation by biopsies or polypectomy/repeat EMR was performed in all cases. Main Outcome Measurements Sensitivity, specificity, and accuracy for VCE and pCLE alone and in combination against histopathology as the standard reference standard. Results Among 129 EMR scars, residual neoplasia was confirmed by histology in 29 sites (22%). For VCE, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy were 72%, 77%, 49%, 91%, and 77%, respectively, and were 97%, 77%, 55%, 99%, and 81% for pCLE ( P = .045 for sensitivity). When only EMR scars for which VCE and pCLE agreed on the diagnosis were analyzed (95/129 scars), the accuracy, sensitivity, specificity, PPV, and NPV of pCLE and VCE were 90%, 100%, 87%, 67%, and 100%, respectively. Limitations Small sample size, lack of power, involvement of highly experienced pCLE experts. Conclusion Confocal endomicroscopy significantly increases the sensitivity for detecting residual neoplasia after colorectal EMR compared with endoscopy alone. When confocal endomicroscopy is used in combination with VCE, the accuracy is extremely high, and sensitivity approaches that of histopathology. Together, they may reduce the need for histologic examination and allow a highly accurate on-table decision to treat again or not, thus avoiding unnecessary repeat procedures. (Clinical trial registration number: 00874263 .)
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