Harry R. Aslanian

EUS-guided FNA of solid pancreatic masses: a prospective, randomized trial comparing 22-gauge and 25-gauge needles

BACKGROUND There is a lack of prospective, randomized studies comparing the diagnostic yield and complication rates of 22-gauge and 25-gauge needles during EUS-FNA of solid pancreatic masses. OBJECTIVES Our primary aim was to compare the diagnostic yield of 22-gauge and 25-gauge needles. Secondary aims included determining the number of needle passes performed, ease of needle passage, and complications. DESIGN Prospective, randomized study. SETTING Tertiary referral centers at Yale University School of Medicine, New Haven, Connecticut, and Virginia Piper Cancer Institute, Minneapolis, Minnesota. PATIENTS Patients with a suspected solid pancreatic mass from February 2007 to June 2008 were enrolled. INTERVENTIONS Patients were randomized to EUS-FNA with a 22-gauge or 25-gauge needle. MAIN OUTCOME MEASUREMENTS A diagnostic result was defined as cytology findings positive for malignant cells. RESULTS A total of 131 patients were enrolled: EUS-FNA was performed with a 22-gauge needle in 64 patients and with a 25-gauge needle in 67 patients. Cytology was diagnostic in 120 (91.6%) of 131 patients overall: 56 (87.5%) of 64 with 22-gauge needles and 64 (95.5%) of 67 with 25-gauge needles (no statistically significant difference was found between the 2 groups; P=.18). A similar number of passes was performed in both arms (mean [SD] 2.6 [1.2] each; P=.96). There were no complications in either group. LIMITATION A larger number of patients is needed to determine small differences in diagnostic yield. CONCLUSIONS This is the first prospective, randomized trial comparing 22-gauge and 25-gauge needles in EUS-FNA of solid pancreatic masses. We achieved equally high diagnostic yields by using a similar number of passes, showing that 25-gauge needles are an effective alternative to 22-gauge needles.

Endoscopic ultrasound and fine-needle aspiration of unexplained bile duct strictures.

OBJECTIVES:The aim of this study was to assess the utility of endoscopic ultrasound (EUS) with fine-needle aspiration (FNA) in patients with unexplained common bile duct strictures after endoscopic retrograde cholangiopancreatography (ERCP) and intraductal tissue sampling.METHODS:Records were reviewed for all subjects undergoing EUS for evaluation of unexplained bile duct strictures at our institution. 40 subjects had either a final histologic diagnosis (24) or no evidence of malignancy after at least 1 yr of follow-up (16).RESULTS:The finding of a pancreatic head mass and/or an irregular bile duct wall had sensitivity for malignancy of 88%, specificity of 100%, positive predictive value of 100%, and negative predictive value of 84%. Bile duct wall thickness ≥3 mm had a sensitivity for malignancy of 79%, specificity of 79%, positive predictive value of 73%, and negative predictive value of 80%. Sensitivity of EUS FNA for malignancy was 47% with specificity 100%, positive predictive value 100%, and negative predictive value 50%.CONCLUSIONS:Sonographic features may be more sensitive than EUS FNA for diagnosis of unexplained bile duct strictures and include presence of a pancreatic mass, an irregular bile duct wall, or bile duct wall thickness > 3 mm. EUS FNA cytology is specific but insensitive for diagnosis. EUS improves the diagnosis of otherwise unexplained bile duct strictures.

A pilot study of in vivo identification of pancreatic cystic neoplasms with needle-based confocal laser endomicroscopy under endosonographic guidance

BACKGROUND AND STUDY AIMS Endoscopic ultrasound (EUS) with fine-needle aspiration (FNA) of pancreatic cystic lesions (PCL) is flawed by inadequate diagnostic yield. Needle-based confocal laser endomicroscopy (nCLE) utilizes a sub-millimeter probe that is compatible with an EUS needle and enables real-time imaging with microscopic detail of PCL. The aims of the In vivo nCLE Study in the Pancreas with Endosonography of Cystic Tumors (INSPECT) pilot study were to assess both the diagnostic potential of nCLE in differentiating cyst types and the safety of the technique. PATIENTS AND METHODS Eight referral centers performed nCLE in patients with PCL. Stage 1 defined descriptive terms for structures visualized by an off-line, unblinded consensus review. Cases were reviewed with a gastrointestinal pathologist to identify correlations between histology and nCLE. Stage 2 assessed whether the specific criteria defined in Stage 1 could identify pancreatic cystic neoplasms (PCN) including intraductal papillary mucinous neoplasms, mucinous cystic adenoma, or adenocarcinoma in an off-line blinded consensus review. RESULTS A total of 66 patients underwent nCLE imaging and images were available for 65, 8 of which were subsequently excluded due to insufficient information for consensus reference diagnosis. The presence of epithelial villous structures based on nCLE was associated with PCN (P=0.004) and provided a sensitivity of 59%, specificity of 100%, positive predictive value of 100 %, and negative predictive value of 50%. The overall complication rate was 9% and included pancreatitis (1 mild case, 1 moderate case), transient abdominal pain (n=1), and intracystic bleeding not requiring any further measures (n=3). CONCLUSIONS These preliminary data suggested that nCLE has a high specificity in the detection of PCN, but may be limited by a low sensitivity. The safety of nCLE requires further evaluation.

First assessment of needle-based confocal laser endomicroscopy during EUS-FNA procedures of the pancreas (with videos)

BACKGROUND Challenges in EUS-guided FNA (EUS-FNA) include sampling error, nondiagnostic cytology, and limited on-site cytological evaluation. A prototype needle-based confocal laser endomicroscopy (nCLE) probe is a submillimeter probe that provides real-time imaging at the microscopic level through the FNA needle. OBJECTIVE To evaluate the feasibility of nCLE during EUS-FNA of pancreatic lesions. DESIGN Feasibility study. SETTING Multicenter, tertiary care. PATIENTS Eighteen patients presenting for EUS-FNA. INTERVENTIONS Patients were injected with 2.5 mL of 10% fluorescein. The lesion was interrogated with the nCLE probe positioned at the tip of a 19-gauge FNA needle. MAIN OUTCOME MEASUREMENTS Device integrity, technical ease, safety, and image acquisition. RESULTS Cases included 16 cysts and 2 masses. There were no device malfunctions. Technical challenges were encountered in 6 of 18 attempts to image and reflected challenges with a postloading technique, the longer ferule tip, and a transduodenal approach. Technical feasibility to perform imaging with nCLE during a pancreatic EUS-FNA procedure was achieved in 17 of 18 cases. Ten cases had good to very good image quality. Two serious adverse events occurred; both were pancreatitis requiring hospitalization. LIMITATIONS Limited sample size, small number of patients with confirmed pathological diagnosis, lack of coregistered pathology and images. CONCLUSIONS nCLE in the pancreas is technically feasible via a 19-gauge needle under endosonographic guidance. Future studies will address identification of structures, diagnostic accuracy, and complication profiles. The rate of pancreatitis needs to be further clarified and mitigated.

Fellow involvement may increase adenoma detection rates during colonoscopy.

BACKGROUND:Adenoma detection rate (ADR) is increasingly used as a quality indicator for screening/surveillance colonoscopy. Recent investigations to identify factors that affect ADR have focused on the technical aspects of the procedure or the equipment.OBJECTIVE:To assess whether gastroenterology (GI) fellow participation during colonoscopy affects ADR.METHODS:This is a retrospective study of data prospectively collected on 309 patients enrolled in a different study not involving polyp detection. In total, 126 colonoscopies were performed by a GI attending alone, and 183 by a GI fellow supervised by one of the same four GI attendings.RESULTS:The ADR was significantly higher when a fellow was involved (37% vs 23%, P < 0.01), as was the total number of adenomas detected (0.56 per patient vs 0.30 per patient, P < 0.05). The percentage of patients with two and three or more adenomas was also higher for fellows versus attendings alone (13.1% vs 5.6%, and 6% vs 1.6%, respectively; P < 0.05), though there was no difference in the detection of advanced adenomas (7.1% vs 5.6%, P = 0.16). The adenomas detected when fellows participated were smaller (mean size 4.4 mm vs 5.8 mm, P < 0.05), and more likely to be sessile (80.6% vs 64.9%, P < 0.05). There were no significant differences in the age, gender, indication for colonoscopy, or procedure time for the two groups.CONCLUSIONS:In this retrospective study, fellow involvement in colonoscopy may increase not only the ADR, but also the detection of more subtle adenomas. Further investigation into whether this is a “fellow effect,” or simply a matter of more efficient visual scanning and recognition with two people, should be considered.

Pancreatic cancer: a comprehensive review and update.

The term pancreatic cancer encompasses both exocrine and endocrine tumors of the pancreas. More than 90% of pancreatic tumors originate from ductal epithelium and this reviewwill focus only on pancreatic ductal adenocarcinoma, which is commonly referred to as pancreatic cancer. The aim of this review is to update the primary practitioner on the epidemiology, genetics, risk factors, potential for screening, etiology, clinical presentation, diagnosis, and current medical and surgical management of pancreatic cancer.

Analysis of endoscopic management of occluded metal biliary stents at a single tertiary care center

BACKGROUND A significant number of self-expandable metal stents (SEMSs) placed to palliate malignant biliary obstruction will occlude. Few data exist as to what constitutes optimal management. OBJECTIVE Our purpose was to review the management and outcomes of patients with biliary SEMS occlusion. DESIGN AND SETTING Retrospective chart review at a single tertiary care hospital. PATIENTS From January 1999 to October 2005, a total of 90 patients had SEMSs placed for malignant biliary obstruction, and 27 of these occluded. MAIN OUTCOME MEASUREMENTS Technical success of treating SEMS occlusion, stent patency and need for reintervention, and incremental cost analysis. RESULTS A total of 60 ERCPs were performed to treat SEMS occlusions in 27 patients. The success rate was 95%; however, 52% of patients eventually required more than 1 intervention. Placing a second SEMS through the existing SEMS (n = 14) provided the lowest reocclusion rate (43% vs 55% and 100%), the longest time to reintervention (172 days vs 66 and 43 days, P = .03), and a trend toward longer survival (285 days vs 188 and 194 days) compared with plastic stent and mechanical balloon cleaning, respectively. Incremental cost analysis showed both uncovered SEMSs and plastic stents to be cost effective strategies. LIMITATIONS Small number of patients, retrospective study. CONCLUSIONS Treatment of biliary SEMS occlusion with SEMS insertion provides for longer patency and survival, decreases the number of subsequent ERCPs by 50% compared with plastic stents, and is cost-effective.

ASGE Technology Committee systematic review and meta-analysis assessing the ASGE Preservation and Incorporation of Valuable Endoscopic Innovations thresholds for adopting real-time imaging–assisted endoscopic targeted biopsy during endoscopic surveillance of Barrett’s esophagus

BACKGROUND AND AIMS Endoscopic real-time imaging of Barretts esophagus (BE) with advanced imaging technologies enables targeted biopsies and may eliminate the need for random biopsies to detect dysplasia during endoscopic surveillance of BE. This systematic review and meta-analysis was performed by the American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee to specifically assess whether acceptable performance thresholds outlined by the ASGE Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI) document for clinical adoption of these technologies have been met. METHODS We conducted meta-analyses calculating the pooled sensitivity, negative predictive value (NPV), and specificity for chromoendoscopy by using acetic acid and methylene blue, electronic chromoendoscopy by using narrow-band imaging, and confocal laser endomicroscopy (CLE) for the detection of dysplasia. Random effects meta-analysis models were used. Statistical heterogeneity was evaluated by means of I(2) statistics. RESULTS The pooled sensitivity, NPV, and specificity for acetic acid chromoendoscopy were 96.6% (95% confidence interval [CI], 95-98), 98.3% (95% CI, 94.8-99.4), and 84.6% (95% CI, 68.5-93.2), respectively. The pooled sensitivity, NPV, and specificity for electronic chromoendoscopy by using narrow-band imaging were 94.2% (95% CI, 82.6-98.2), 97.5% (95% CI, 95.1-98.7), and 94.4% (95% CI, 80.5-98.6), respectively. The pooled sensitivity, NPV, and specificity for endoscope-based CLE were 90.4% (95% CI, 71.9-97.2), 98.3% (95% CI, 94.2-99.5), and 92.7% (95% CI, 87-96), respectively. CONCLUSIONS Our meta-analysis indicates that targeted biopsies with acetic acid chromoendoscopy, electronic chromoendoscopy by using narrow-band imaging, and endoscope-based CLE meet the thresholds set by the ASGE PIVI, at least when performed by endoscopists with expertise in advanced imaging techniques. The ASGE Technology Committee therefore endorses using these advanced imaging modalities to guide targeted biopsies for the detection of dysplasia during surveillance of patients with previously nondysplastic BE, thereby replacing the currently used random biopsy protocols.

Variation in Aptitude of Trainees in Endoscopic Ultrasonography, Based on Cumulative Sum Analysis

BACKGROUND & AIMS Studies have reported substantial variation in the competency of advanced endoscopy trainees, indicating a need for more supervised training in endoscopic ultrasound (EUS). We used a standardized, validated, data collection tool to evaluate learning curves and measure competency in EUS among trainees at multiple centers. METHODS In a prospective study performed at 15 centers, 17 trainees with no prior EUS experience were evaluated by experienced attending endosonographers at the 25th and then every 10th upper EUS examination, over a 12-month training period. A standardized data collection form was used (using a 5-point scoring system) to grade the EUS examination. Cumulative sum analysis was applied to produce a learning curve for each trainee; it tracked the overall performance based on median scores at different stations and also at each station. Competency was defined by a median score of 1, with acceptable and unacceptable failure rates of 10% and 20%, respectively. RESULTS Twelve trainees were included in the final analysis. Each of the trainees performed 265 to 540 EUS examinations (total, 4257 examinations). There was a large amount of variation in their learning curves: 2 trainees crossed the threshold for acceptable performance (at cases 225 and 245), 2 trainees had a trend toward acceptable performance (after 289 and 355 cases) but required continued observation, and 8 trainees needed additional training and observation. Similar results were observed at individual stations. CONCLUSIONS A specific case load does not ensure competency in EUS; 225 cases should be considered the minimum caseload for training because we found that no trainee achieved competency before this point. Ongoing training should be provided for trainees until competency is confirmed using objective measures.

Nurse Observation During Colonoscopy Increases Polyp Detection: A Randomized Prospective Study

OBJECTIVES:To determine whether a second observer during colonoscopy increases adenoma detection.METHODS:Consecutive patients undergoing screening colonoscopy were prospectively randomized to routine colonoscopy or physician and nurse observation during withdrawal.RESULTS:Of 502 patients, 249 were randomized to routine colonoscopy, and 253 to physician plus nurse observation during withdrawal. A total of 592 polyps were detected, 40 identified by the endoscopy nurse only. With nurse observation, 1.32 polyps and 0.82 adenomas were found per colonoscopy, vs. 1.03 polyps and 0.64 adenomas in the routine group, demonstrating a 1.29-fold and a 1.28-fold increase in the average number of polyps and of adenomas detected, respectively. The overall adenoma detection rate (ADR) was 44.1%, with trends toward increased ADR and all-polyp detection rate with nurse observation.CONCLUSIONS:Nurse observation during colonoscopy resulted in an increase in the number of polyps and adenomas found per colonoscopy, along with a trend toward improved overall ADR and all-polyp detection rate.