Uzma D. Siddiqui

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.

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.

Wireless capsule endoscopy

Over the last decade, WCE has established itself as a valuable test for imaging the small intestine. It is a safe and relatively easy procedure to perform that can provide valuable information in the diagnosis of small-bowel conditions. Its applications still remain limited within the esophagus and colon. Future developments may include improving visualization within the esophagus and developing technologies that may allow manipulation of the capsule within the GI tract and biopsy capabilities.

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.

Endoscopic submucosal dissection

ESD is an established effective treatment modality for premalignant and early-stage malignant lesions of the stomach, esophagus, and colorectum. Compared with EMR, ESD is generally associated with higher rates of en bloc, R0, and curative resections and a lower rate of local recurrence. Oncologic outcomes with ESD compare favorably with competing surgical interventions, and ESD also serves as an excellent T-staging tool to identify noncurative resections that will require further treatment. ESD is technically demanding and has a higher rate of adverse events than most endoscopic procedures including EMR. As such,sufficient training is critical to ensure safe conduct and high-quality resections. A standardized training model for Western endoscopists has not been clearly established,but will be self-directed and include courses, animal model training, and optimally an observership at an expert center.Numerous dedicated ESD devices are now available in the United States from different manufacturers. Although the use of ESD in the United States is increasing, issues related to technical difficulty, limited training opportunities and mentors, risk of adverse events, long procedure duration,and suboptimal reimbursement may limit ESD adoption in the United States to a modest number of academic referral centers for the foreseeable future.

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.

Prevalence and Impact of Diarrhea on Health-related Quality of Life in Hiv-infected Patients in the Era of Highly Active Antiretroviral Therapy

Objectives Before the introduction of highly active antiretroviral therapy (HAART), the majority of HIV-infected patients experienced diarrhea. The aims of this study were to compare the prevalence of diarrhea among HIV-infected and uninfected patients in the HAART era, and to evaluate the impact of diarrhea on health-related quality of life (HRQOL). Methods Diarrheal symptoms experienced by 163 consecutive HIV-infected patients and 253 HIV-seronegative control subjects were ascertained using a validated questionnaire. The HRQOL of these patients was assessed using the Medical Outcomes Study (MOS) SF-36 and MOS-HIV Health surveys. Results Among the 163 HIV-infected patients, the median CD4 cell count was 370 cells/mm3 and 150 individuals were taking HAART. Significantly, more HIV-infected subjects reported having 3 or more bowel movements daily within the past 7 days than did HIV-seronegative subjects (28.2% vs. 7.1%, P<0.001), even after adjusting for potential confounding variables (odds ratios=6.65; 95% confidence intervals, 3.36-13.17). In addition, diarrhea was significantly more common in HIV-infected patients than in control subjects when assessed by several other criteria. HIV-infected patients reported significantly worse HRQOL across all domains of the MOS SF-36 as compared with control subjects. Among HIV-infected patients, individuals with diarrhea had significantly worse HRQOL in nearly all domains of the MOS-HIV as compared with those without diarrhea. Conclusions Diarrhea remains an important clinical problem in HIV-infected patients and is associated with significant impairments in HRQOL. It is important that healthcare providers specifically evaluate their HIV-infected patients for diarrhea so that these symptoms may be optimally managed.

Tissue adhesives: cyanoacrylate glue and fibrin sealant

The ASGE Technology Committee provides reviews of existing, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Evidence-based methodology is used, performing a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported adverse events of a given technology. Both are supplemented by accessing the “related articles” feature of PubMed and by scrutinizing pertinent references cited by the identified studies. Controlled clinical trials are emphasized, but in many cases, data from randomized, controlled trials are lacking. In such cases, large case series, preliminary clinical studies, and expert opinions are used. Technical data are gathered from traditional and Web-based publications, proprietary publications, and informal communications with pertinent vendors. Technology Status Evaluation Reports are drafted by 1 or 2 members of the ASGE Technology Committee, reviewed and edited by the Committee as a whole, and approved by the Governing Board of the ASGE. When financial guidance is indicated, the most recent coding data and list prices at the time of publication are provided. For this review, the MEDLINE database was searched through August 2012 for relevant articles by using the key words cyanoacrylate, cyanoacrylate glue, cyanoacrylate and gastroenterology, cyanoacrylate and endoscopy, fibrin glue, fibrin sealant, tissue glue and endoscopy. Technology Status Evaluation Reports are scientific reviews provided solely for educational and informational purposes. Technology Status Evaluation Reports are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment.

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.

Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution: A Randomized Clinical Trial

IMPORTANCE Endoscopic placement of multiple plastic stents in parallel is the first-line treatment for most benign biliary strictures; it is possible that fully covered, self-expandable metallic stents (cSEMS) may require fewer endoscopic retrograde cholangiopancreatography procedures (ERCPs) to achieve resolution. OBJECTIVE To assess whether use of cSEMS is noninferior to plastic stents with respect to stricture resolution. DESIGN, SETTING, AND PARTICIPANTS Multicenter (8 endoscopic referral centers), open-label, parallel, randomized clinical trial involving patients with treatment-naive, benign biliary strictures (N = 112) due to orthotopic liver transplant (n = 73), chronic pancreatitis (n = 35), or postoperative injury (n = 4), who were enrolled between April 2011 and September 2014 (with follow-up ending October 2015). Patients with a bile duct diameter less than 6 mm and those with an intact gallbladder in whom the cystic duct would be overlapped by a cSEMS were excluded. INTERVENTIONS Patients (N = 112) were randomized to receive multiple plastic stents or a single cSEMS, stratified by stricture etiology and with endoscopic reassessment for resolution every 3 months (plastic stents) or every 6 months (cSEMS). Patients were followed up for 12 months after stricture resolution to assess for recurrence. MAIN OUTCOMES AND MEASURES Primary outcome was stricture resolution after no more than 12 months of endoscopic therapy. The sample size was estimated based on the noninferiority of cSEMS to plastic stents, with a noninferiority margin of -15%. RESULTS There were 55 patients in the plastic stent group (mean [SD] age, 57 [11] years; 17 women [31%]) and 57 patients in the cSEMS group (mean [SD] age, 55 [10] years; 19 women [33%]). Compared with plastic stents (41/48, 85.4%), the cSEMS resolution rate was 50 of 54 patients (92.6%), with a rate difference of 7.2% (1-sided 95% CI, -3.0% to ∞; P < .001). Given the prespecified noninferiority margin of -15%, the null hypothesis that cSEMS is less effective than plastic stents was rejected. The mean number of ERCPs to achieve resolution was lower for cSEMS (2.14) vs plastic (3.24; mean difference, 1.10; 95% CI, 0.74 to 1.46; P < .001). CONCLUSIONS AND RELEVANCE Among patients with benign biliary strictures and a bile duct diameter 6 mm or more in whom the covered metallic stent would not overlap the cystic duct, cSEMS were not inferior to multiple plastic stents after 12 months in achieving stricture resolution. Metallic stents should be considered an appropriate option in patients such as these. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01221311.