Comparison of endoscopic ultrasound-guided fine-needle biopsy versus fine-needle aspiration for genomic profiling and DNA yield in pancreatic cancer: a randomized crossover trial.

BACKGROUND: National guidelines recommend genomic profiling of tumor tissue to guide precision therapy. We compared the specimen adequacy for genomic profiling and yield of DNA between endoscopic ultrasound (EUS)-guided fine-needle biopsy (FNB) and EUS-guided fine-needle aspiration (FNA). METHODS: In our tandem, randomized controlled trial, consecutive patients undergoing EUS for evaluation of pancreatic masses underwent both conventional EUS-FNA with a 25-gauge needle and paired EUS-FNB (19 or 22-gauge needle), with the order randomized (EUS-FNA first followed by EUS-FNB, or vice versa). A minimum of one pass with each needle was obtained for histology. Second and third passes were performed to collect DNA. Specimens were evaluated by a cytopathologist blinded to the needle type. Specimen adequacy for genomic profiling was calculated based on FoundationOne clinical diagnostic (CDx) adequacy requirements. We compared the adequacy for genomic profiling DNA (quantity) and histology yields with both needles. RESULTS: Analysis included 50 patients (25 men; mean age 68 [standard deviation (SD) 13] years), with a mean lesion size of 38 (SD 17) mm; 37 lesions (74 %) were pancreatic ductal adenocarcinoma (PDAC). The mean DNA concentrations in PDAC by FNB and FNA needles were 5.930 (SD 0.881) µg/mL vs. 3.365 (SD 0.788) µg/mL, respectively (P = 0.01). The median standardized histology score per pass with EUS-FNB was 5 (sufficient for histology) and for EUS-FNA was 2 (enough for cytology). Specimen adequacy for genomic profiling and yield of DNA was significantly higher with FNB than with FNA needles. CONCLUSIONS: In this study, adequacy for genomic profiling, DNA, and histology yield were considerably superior using an EUS-FNB needle compared with an EUS-FNA needle.

Fine-needle aspiration of pancreatic cystic lesions: a randomized study with long-term follow-up comparing standard and flexible needles.

BACKGROUND: Pancreatic cystic lesions (PCLs) are increasingly found on cross-sectional imaging, with the majority having a low risk for malignancy. The added value of fine-needle aspiration (FNA) in risk stratification remains unclear. We evaluated the impact of three FNA needles on diagnostic accuracy, clinical management, and the ability to accrue fluid for tumor markers. METHODS: A multicenter prospective trial randomized 250 patients with PCLs ≥ 13 mm 2:1:1 to 19G Flex, 19G, and 22G needles with crossover for repeated FNA procedures. Diagnostic accuracy was established at 2-year follow-up, with the final diagnosis from surgical histopathology or consensus diagnosis by experts based sequentially on clinical presentation, imaging, and aspirate analysis in blinded review. RESULTS: Enrolled patients (36 % symptomatic) had PCLs in the head (44 %), body (28 %), and tail (26 %). Percentage of cyst volume aspirated was 78 % (72 % - 84 %) for 19G Flex, 74 % (64 % - 84 %) for 22G, and 73 % (63 % - 83 %) for 19G (P = 0.84). Successful FNA was significantly higher for 19G Flex (89 % [82 % - 94 %]) and 22G (82 % [70 % - 90 %]) compared with 19G (75 % [63 % - 85 %]) (P = 0.02). Repeated FNA was required more frequently in head/uncinate lesions than in body and tail (P < 0.01). Diagnostic accuracy of the cyst aspirate was 84 % (73 % - 91 %) against histopathology at 2-year follow-up (n = 79), and 77 % (70 % - 83 %) against consensus diagnosis among nonsurgical cases (n = 171). Related serious adverse events occurred in 1.2 % (0.2 % - 3.5 %) of patients. CONCLUSIONS: Our study results demonstrate a statistically significant difference among the three needles in the overall success rate for aspiration, but not in the percentage of cyst volume aspirated. Flexible needles may be particularly valuable in sampling cystic PCLs in the pancreatic head/uncinate process.

Methylated DNA in Pancreatic Juice Distinguishes Patients With Pancreatic Cancer From Controls.

BACKGROUND & AIMS: Precursors of pancreatic cancer arise in the ductal epithelium; markers exfoliated into pancreatic juice might be used to detect high-grade dysplasia (HGD) and cancer. Specific methylated DNA sequences in pancreatic tissue have been associated with adenocarcinoma. We analyzed these methylated DNA markers (MDMs) in pancreatic juice samples from patients with pancreatic ductal adenocarcinomas (PDACs) or intraductal papillary mucinous neoplasms (IPMNs) with HGD (cases), and assessed their ability to discriminate these patients from individuals without dysplasia or with IPMNs with low-grade dysplasia (controls). METHODS: We obtained pancreatic juice samples from 38 patients (35 with biopsy-proven PDAC or pancreatic cystic lesions with invasive cancer and 3 with HGD) and 73 controls (32 with normal pancreas and 41 with benign disease), collected endoscopically from the duodenum after secretin administration from February 2015 through November 2016 at 3 medical centers. Samples were analyzed for the presence of 14 MDMs (in the genes NDRG4, BMP3, TBX15, C13orf18, PRKCB, CLEC11A, CD1D, ELMO1, IGF2BP1, RYR2, ADCY1, FER1L4, EMX1, and LRRC4), by quantitative allele-specific real-time target and signal amplification. We performed area under the receiver operating characteristic curve analyses to determine the ability of each marker, and panels of markers, to distinguish patients with HGD and cancer from controls. MDMs were combined to form a panel for detection using recursive partition trees. RESULTS: We identified a group of 3 MDMs (at C13orf18, FER1L4, and BMP3) in pancreatic juice that distinguished cases from controls with an area under the receiver operating characteristic value of 0.90 (95% CI, 0.83-0.97). Using a specificity cut-off value of 86%, this group of MDMs distinguished patients with any stage of pancreatic cancer from controls with 83% sensitivity (95% CI, 66%-93%) and identified patients with stage I or II PDAC or IPMN with HGD with 80% sensitivity (95% CI, 56%-95%). CONCLUSIONS: We identified a group of 3 MDMs in pancreatic juice that identify patients with pancreatic cancer with an area under the receiver operating characteristic value of 0.90, including patients with early stage disease or advanced precancer. These DNA methylation patterns might be included in algorithms for early detection of pancreatic cancer, especially in high-risk cohorts. Further optimization and clinical studies are needed.

Endoscopic scar assessment after colorectal endoscopic mucosal resection scars: when is biopsy necessary (EMR Scar Assessment Project for Endoscope (ESCAPE) trial).

OBJECTIVE: It is unclear whether endoscopic assessment of scars after colorectal endoscopic mucosal resection (EMR) has to include biopsies, even if endoscopy is negative. Vice versa, endoscopic diagnosis of recurrent adenoma may not require biopsy before endoscopic reinterventions. We prospectively analysed various endoscopic modalities in the diagnosis of recurrence following EMR. DESIGN: We conducted a prospective study of patients undergoing colonoscopy after EMR of large (≥20 mm) colorectal neoplasia. Endoscopists predicted recurrence and confidence level with four imaging modes: high-definition white light (WL) and narrow-band imaging (NBI) with and without near focus (NF). Separately, 26 experienced endoscopists assessed offline images. RESULTS: Two hundred and thirty patients with 255 EMR scars were included. The prevalence of recurrent adenoma was 24%. Diagnostic values were high for all modes (negative predictive value (NPV) ≥97%, positive predictive value (PPV) ≥81%, sensitivity ≥90%, specificity ≥93% and accuracy ≥93%). In high-confidence cases, NBI with NF had NPV of 100% (95% CI 98% to 100%) and sensitivity of 100% (95% CI 93% to 100%). Use of clips at initial EMR increased diagnostic inaccuracy (adjusted OR=1.68(95% CI 1.01 to 2.75)). In offline assessment, specificity was high for all imaging modes (mean: ≥93% (range: 55%-100%)), while sensitivity was significantly higher for NBI-NF (82%(72%-93%)%)) compared with WL (69%(38%-86%); p<0.001), WL-NF (68%(55%-83%); p<0.001) and NBI (71%(59%-90%); p<0.001). CONCLUSION: Our study demonstrates very high sensitivity and accuracy for all four imaging modalities, especially NBI with NF, for diagnosis of recurrent neoplasia after EMR. Our data strongly suggest that in cases of high confidence negative optical diagnosis based on NBI-NF, no biopsy is needed to confirm absence of recurrence during colorectal EMR follow-up. A high confidence positive optical diagnosis can lead to immediate resection of any suspicious area. In all cases of low confidence, biopsy is still required. TRIAL REGISTRATION NUMBER: NCT02668198.

Comparison of flexible endoscopic cricopharyngeal myectomy and myotomy approaches for Zenker diverticulum repair.

BACKGROUND AND AIMS: Incision of the cricopharyngeal (CP) muscle with flexible endoscopy is an important approach for Zenker diverticulum (ZD) repair with symptomatic resolution in approximately 90% of cases, but recurrence has been reported in up to 20%. We report our experience with a new endoscopic myectomy of the CP muscle and compare the outcome with conventional myotomy of ZD. METHODS: Our retrospective study included all patients with ZD who underwent endoscopic repair between August 1, 2014 and July 31, 2017. Conventional CP myotomy was defined as a vertical cut through the CP muscle. CP myectomy was defined as parallel excisions followed by snare resection at the CP resection base. Measurement of ZD size was based on barium esophagram and endoscopic estimation. Outcomes included ZD recurrence, improvement of dysphagia, and procedure adverse events. RESULTS: Sixty-four patients underwent endoscopic repair for ZD, 44 with CP myotomy and 20 with CP myectomy. Mean (standard deviation) size of ZD was 3.3 cm (1.0) and 3.8 cm (1.2) in the myotomy and myectomy cohorts, respectively (P = .11), and median procedure time was 50 and 56 minutes, respectively (P = .73). In the CP myotomy cohort, 10 patients (22.7%) had recurrence of ZD at a median of 19.1 months, whereas no recurrence was documented in the CP myectomy cohort (P = .02). This trend was also shown in multivariate analysis but was not statistically significant (P = .07). There was no statistical difference in improvement of dysphagia and adverse events. CONCLUSIONS: CP myectomy is a new endoscopic technique for ZD repair. In our experience, it was safe and well tolerated, with a high initial success rate and less ZD recurrence when compared with myotomy.

Selective application of fully covered biliary stents and narrow-diameter esophageal stents for proximal esophageal indications.

BACKGROUND: Proximal esophageal stents are poorly tolerated and have a high risk of complications. We report our experience using fully covered, biliary, self-expandable metal stents (B-SEMS) and narrow-diameter, esophageal, self-expandable metal stents (NDE-SEMS) for this group of patients. METHODS: 24 patients underwent placement of B-SEMS or NDE-SEMS for proximal esophageal lesions between 1 January 2011 and 31 July 2016. The outcomes included improvement of dysphagia, healing of fistulas, and adverse events. RESULTS: 10 patients received B-SEMS and 14 had NDE-SEMS. Median follow-up time was 11.5 months (range 0.5 - 62 months). In both cohorts, stents were left in place for a mean of 6 weeks. The dysphagia score decreased in 7 (70 %) and 10 (71.4 %) patients, and fistulas resolved in 3/5 (60.0 %) and 5/8 (62.5 %) patients with B-SEMS and NDE-SEMS, respectively. Stent migration occurred in three patients (30.0 %) with B-SEMS and five patients (35.7 %) with NDE-SEMS. CONCLUSIONS: Both stents were well tolerated and resulted in overall improvement of dysphagia in 70.8 % of patients. B-SEMS appeared to be more favorable for cervical esophageal lesions with narrower diameters, while NDE-SEMS may be better for more distal lesions.

Prophylactic Snare Tip Soft Coagulation and Its Impact on Adenoma Recurrence After Colonic Endoscopic Mucosal Resection.

BACKGROUND: Up to 20% of patients can have recurrence of adenomatous tissue at first surveillance study after colon endoscopic mucosal resection of large polyps. AIMS: To determine whether an educational intervention discussing thermal ablation of lateral margins of the mucosectomy site of post-endoscopic mucosal resection defect with snare tip soft coagulation (STSC) would decrease adenoma recurrence. METHODS: We performed a single-center quality improvement project from November 1, 2016, to November 30, 2017. Gastroenterologists underwent an educational intervention demonstrating the treatment of peripheral margins of mucosectomy site with STSC after standard mucosectomy technique. These cases (intervention group) were compared with consecutive procedures performed prior to commencement of the quality improvement study (pre-intervention group). Patients with large colorectal lesions (≥ 20 mm) were included. RESULTS: Of the 120 patients here included, overall demographics of the groups were similar and the most common histology was sessile serrated adenoma (study group 45% vs 32% control group). Adenoma recurrence on intervention group and pre-intervention group was 12% versus 30%; p = 0.01. On univariate analysis, biopsy prior to mucosectomy, intraprocedural bleeding, and application of STSC on mucosectomy defect were the strongest predictors of adenoma recurrence. Adenoma recurrence in the intervention group was significantly lower than in the pre-intervention group in both univariate (odds ratio, 0.3 [95% CI, 0.11-0.80]) and multivariate analyses (odds ratio, 0.2 [95% CI, 0.12-0.92]). CONCLUSIONS: The implementation of STSC of post-endoscopic mucosal resection peripheral defects is clinically feasible and significantly decreased adenoma recurrence.

Correction to: Endoscopic and surgical management of nonampullary duodenal neoplasms.

This article was updated to correct the author listing for Carlos Roberto Simons-Linares.

Endoscopic and surgical management of nonampullary duodenal neoplasms.

BACKGROUND: Sporadic nonampullary duodenal neoplasms (SNADN) can have malignant potential for which endoscopic and surgical resections are offered. We report combined gastroenterologic and surgical experience for treatment of SNADN, including endoscopic mucosal resection (EMR) and pancreas-preserving partial duodenectomy (PPPD). METHODS: We retrospectively reviewed 121 consecutive patients, who underwent 30 PPPDs and 91 EMRs for mucosal and submucosal SNADN. Decision to undergo EMR or surgical resection was based on expert endoscopist and surgeon discretion including multidisciplinary tumor board review. Main outcomes were recurrence rate of neoplasia and adverse events requiring hospital admission or prolonged care. EMRs were performed with submucosal lifting followed by snare resection. PPPD included total duodenectomy, supra-ampullary PPPD for neoplasms proximal to the ampulla, and infra-ampullary PPPD for lesions distal to the ampulla. Follow-up data were available for 65% of EMR and 73% of surgical patients. RESULTS: Surgically resected neoplasia was larger with more advanced neoplasia and submucosal lesions. En bloc resection was achieved in all surgical resections and in 53% of EMRs. Post-EMR, mucosal and submucosal neoplasia recurred in 32 and 0%, respectively, including five neoplasms (26%) after an initial negative esophagogastroduodenoscopy. All recurrences were treated endoscopically. Complications occurred in 14 endoscopically and eight surgically treated patients, none requiring surgical intervention. CONCLUSIONS: Post-EMR patients had higher recurrence of mucosal neoplasia, whereas submucosal neoplasms, mainly carcinoid, did not recur. Polyp size and positive resection margin were not associated with neoplasia recurrence. Patients with SNADN could benefit from a multidisciplinary approach to stratify the optimal treatment based on local expertise.

Role of EUS in patients with suspected Barrett's esophagus with high-grade dysplasia or early esophageal adenocarcinoma: impact on endoscopic therapy.

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.

Association Between Advances in High-Resolution Cross-Section Imaging Technologies and Increase in Prevalence of Pancreatic Cysts From 2005 to 2014.

BACKGROUND & AIMS: Increasingly, pancreatic cysts are discovered incidentally in patients undergoing cross-sectional imaging for nonpancreatic reasons. It is unclear whether this increase is caused by improved detection by progressively more sophisticated cross-sectional imaging techniques or by a true increase in prevalence. We aimed to determine the prevalence of incidental pancreatic cysts in patients undergoing magnetic resonance imaging (MRI) for nonpancreatic indications on successive, increasingly sophisticated MRI systems. Also, we compared prevalence based on the demographic characteristics of the patients. METHODS: We collected data from MRIs performed at the Mayo Clinic in Florida during the sample months of January and February, from 2005 to 2014. Each patient's clinical chart was reviewed in chronological order to include the first 50 MRIs of each year (500 total). Patients were excluded if they had pancreatic disease including cysts, pancreatic surgery, pancreatic symptoms, pancreatic indication for the imaging study, or previous abdominal MRIs. An expert pancreatic MRI radiologist reviewed each image, looking for incidental pancreatic cysts. RESULTS: Of the 500 patients analyzed, 208 patients (41.6%) were found to have an incidental cyst. A significant relationship was observed between pancreatic cysts and patient age (P < .0001), diabetes mellitus (P = .001), and nonpancreatic cancer (P = .01), specifically nonmelanoma skin cancer (P = .03) or hepatocellular carcinoma (P = .02). The multivariable model showed a strong association between hardware and software versions and detection of cysts (P < .0001); the old hardware detected pancreatic cysts in 30.3% of patients, whereas the newest hardware detected cysts in 56.3% of patients. CONCLUSIONS: Based on an analysis of data collected from 2005 through 2014, newer versions of MRI hardware and software corresponded with higher numbers of pancreatic cysts detected. Older age, diabetes, and the presence of nonpancreatic cancer (specifically nonmelanoma skin cancer and hepatocarcinoma) were also associated with the presence of cysts.

EUS-guided fine needle biopsy sampling using a novel fork-tip needle: a case-control study.

BACKGROUND AND AIMS: EUS-guided fine needle biopsy (FNB) sampling and FNA are important methods for obtaining core tissues and cytologic aspirates. To improve the specimen quality for pathologic evaluation, a novel EUS-FNB Shark Core (SC) needle has been designed to acquire core tissue during EUS procedures. We compared the histology yield of EUS-FNB sampling using the SC needle (EUS-FNB-SC) to EUS-FNA in patients who had solid pancreatic and nonpancreatic lesions. METHODS: This was a retrospective case-control study design. Between July 2012 and July 2015 all patients who had EUS-FNB-SC and EUS-FNA were reviewed through a hospital EUS database. Consecutive samples from EUS-FNB-SCs were matched in a 1:3 ratio by lesion site (eg, pancreatic head) and needle gauge (ie, 19 gauge, 22 gauge, 25 gauge) to recent random samples of EUS-FNA. The procedures were performed with rapid onsite evaluation. For study purposes specimen slides were evaluated by 2 cytopathologists for histologic yield using a standard scoring system (0 = no material, 1-2 = cytologic, 3-5 = histologic). The main objectives were to assess the histologic yield of the samples and compare the median number of passes required to obtain core tissue by using EUS-FNB-SC and EUS-FNA needles. RESULTS: Of the 156 patients included in study, 25% patients (n = 39) were in the EUS-FNB-SC group and 75% (n = 117) in the EUS-FNA group. According to standard scoring criteria for histology, the median histology score for EUS-FNA was 2 (sufficient for cytology but not histology) and for EUS-FNB-SC was 4 (sufficient for adequate histology). Ninety-five percent of the specimens obtained from the EUS-FNB-SC group were of sufficient size for histologic screening, compared with 59% from the EUS-FNA group (P = .01). The median number of passes required to achieve a sample was significantly lower in the EUS-FNB-SC group compared with the EUS-FNA group (2 passes vs 4 passes, P = .001). There was significant difference in the median number of passes to all lesion sites and needle gauges. CONCLUSIONS: The histology yield was significantly higher using the EUS-FNB-SC needle compared with the EUS-FNA needle. Additionally, fewer passes were required to obtain histology cores when using EUS-FNB-SC.

Endoscopic mucosal resection: learning curve for large nonpolypoid colorectal neoplasia.

BACKGROUND AND AIMS: Colorectal EMR for nonpolypoid neoplasia achieves better outcomes when performed by expert endoscopists. The time point at which the endoscopist achieves expert level remains to be defined. The objective of this study was to establish a learning curve of colorectal EMR for nonpolypoid neoplasia based on residual tissue on surveillance colonoscopy and adverse event rate. METHODS: Five hundred seventy-eight consecutive patients underwent EMR of colorectal neoplasia by 1 of 3 primary endoscopists between December 2004 and September 2013 in a tertiary academic center. Primary analyses focused on the largest lesion for patients with more than 1 lesion (median age, 69 years; median polyp size, 30 mm; 51% en bloc resection). Data on surveillance colonoscopy were available for 74%. Learning curves were calculated for each of the 3 main outcome measurements: the presence of residual neoplasia on surveillance colonoscopy, endoscopic assessment of incomplete EMR, and the occurrence of an immediate bleeding adverse event. RESULTS: Residual neoplasia on surveillance colonoscopy was present for 23.2% of patients, the rate of endoscopist-assessed incomplete EMR was 27.6%, and immediate bleeding adverse events occurred in 6.9% of patients. Although there was between-endoscopist variability, the overall rates of residual neoplasia and incomplete EMR decreased to below 20% to 25% after 100 EMRs; initial decreases in both rates were observed for earlier EMRs. Immediate bleeding adverse events occurred at a low frequency for each endoscopist across all EMRs. Perforation requiring surgical intervention occurred in 1 patient (0.2%). CONCLUSIONS: This study demonstrated that an unexpectedly high number of 100 colorectal EMR procedures for large nonpolypoid colorectal neoplasia are required to achieve a plateau phase for crucial outcomes.

Comparison of endoscopic treatment modalities for Barrett's neoplasia.

BACKGROUND: There are few data comparing endoscopic treatment outcomes for Barrett's esophagus (BE). OBJECTIVE: To compare treatment outcomes in BE patients treated with radiofrequency ablation (RFA), RFA after EMR, and porfimer sodium photodynamic therapy (Ps-PDT). DESIGN: Retrospective, observational study. SETTING: Single tertiary center between 2001 and 2013. PATIENTS: A total of 342 BE patients treated with RFA (n = 119), EMR+RFA (n = 98), and Ps-PDT (n = 125). MAIN OUTCOME MEASUREMENTS: Rates of complete remission of intestinal metaplasia (CRIM), BE recurrence, and adverse events. RESULTS: Baseline BE high-grade dysplasia (HGD) and adenocarcinoma were more common in the Ps-PDT group (89%) compared with the EMR-RFA (70%) and RFA (37%) groups. At a median follow-up of 14.2 months, 173 patients (50.6%) achieved CRIM. CRIM was significantly more common in Ps-PDT patients compared with RFA (P < .001) and EMR-RFA (P < .001) patients on multivariable analysis. In patients who achieved CRIM, the rates of subsequent BE recurrence were relatively similar among the 3 groups. Although the rates of bleeding were similar, strictures were less common in RFA patients (2.4%) compared with EMR-RFA (13.3%, P = .001) and Ps-PDT (10.4%, P =.043) patients. CONCLUSION: This study of endoscopic treatment for Barrett's dysplasia and neoplasia found that complete remission was achieved more often and more rapidly after Ps-PDT with similar disease recurrence rates compared with EMR or RFA. Adverse events were more common after EMR and Ps-PDT. Further studies are required to determine which ablation and resection techniques are ideally suited for each BE patient.

Gender differences in remission of esophageal intestinal metaplasia after radiofrequency ablation.

OBJECTIVES: Few studies have assessed the effect of gender on remission rates after radiofrequency ablation (RFA) of Barrett's esophagus (BE). We aim to assess the effect of gender on the time to achieve complete remission of intestinal metaplasia (CRIM) among patients with BE, who underwent RFA. METHODS: This was a retrospective, observational study using a large RFA database in a tertiary referral center. The primary outcome was time to CRIM compared between males and females. Covariates included age, race, smoking history, use of endoscopic mucosal resection (EMR), histology before RFA, and the number of RFA sessions. Time to CRIM (in months) was calculated using the Kaplan-Meier method and compared using the log-rank test. Multivariable Cox-proportional hazard models were used to assess for any association between time to CRIM and gender. RESULTS: Two hundred and fifty-seven patients, 11% (n=23) female, underwent RFA for BE between May 2005 and June 2012. Males and females were similar in mean age, race, smoking history, median BE length, history of EMR, and baseline histology. Median time to CRIM for females was longer than males (24 months (95% confidence interval (CI): 10.3-60.2) vs. 11.7 months (95% CI: 10-15), P=0.03). Using Cox-regression analysis, controlling for age, use of EMR, BE segment length, and the number of RFA sessions, female gender was associated with a 55% decrease in the rate of CRIM compared with that in males (hazard ratio=0.45 (95% CI: 0.25-0.82), P=0.009). CONCLUSIONS: Females take longer time to achieve CRIM when treated with RFA when compared with males of similar age and BE length.

Safety of esophageal EMR in elderly patients.

BACKGROUND: EMR is commonly used to remove suspicious esophageal lesions among patients with Barrett's esophagus (BE). BE primarily affects older patients. Yet, the safety profile of EMR in elderly patients has not been well-described. OBJECTIVE: We aimed to study the safety profile of EMR in elderly patients compared with younger patients. DESIGN: Retrospective, observational, descriptive study that used a prospective database. SETTING: Tertiary-care referral center. PATIENTS: A total of 136 patients who underwent esophageal EMR for BE. INTERVENTIONS: EMR with/without ablative therapy. MAIN OUTCOME MEASUREMENTS: The rate of adverse events, including bleeding, stricture formation, and perforation between elderly (aged ≥75 years) and younger (aged <75 years) patients. RESULTS: We identified 136 patients who underwent esophageal EMR who were followed-up in our clinic. Of those, 40% (n = 55) were aged ≥75 years (elderly group) and 60% (n = 81) were aged <75 years (younger group). There was no difference in rate of stricture formation or early or delayed bleeding when we compared elderly patients to younger patients. None of the patients had esophageal perforation. On multivariable logistic regression analysis, controlling for patient sex, EMR technique, and underlying pathology, older age was not associated with increased odds of adverse events (OR 0.88; 95% confidence interval, 0.42-1.9; P = .75). LIMITATIONS: Single-center experience. CONCLUSION: Rates of adverse events from EMR appear to be similar in elderly patients compared with younger patients. Overall, esophageal EMR seems to offer an acceptable safety profile in elderly patients.

International multicenter experience with an over-the-scope clipping device for endoscopic management of GI defects (with video).

BACKGROUND: The over-the-scope clip (OTSC) provides more durable and full-thickness closure as compared with standard clips. Only case reports and small case series have reported on outcomes of OTSC closure of GI defects. OBJECTIVE: To describe a large, multicenter experience with OTSCs for the management of GI defects. Secondary goals were to determine success rate by type of defect and type of therapy and to determine predictors of treatment outcomes. DESIGN: Multicenter, retrospective study. SETTING: Multiple, international, academic centers. PATIENTS: Consecutive patients who underwent attempted OTSC placement for GI defects, either as a primary or as a rescue therapy. INTERVENTIONS: OTSC placement to attempt closure of GI defects. MAIN OUTCOME MEASUREMENTS: Long-term success of the procedure. RESULTS: A total of 188 patients (108 fistulae, 48 perforations, 32 leaks) were included. Long-term success was achieved in 60.2% of patients during a median follow-up of 146 days. Rate of successful closure of perforations (90%) and leaks (73.3%) was significantly higher than that of fistulae (42.9%) (P < .05). Long-term success was significantly higher when OTSCs were applied as primary therapy (primary 69.1% vs rescue 46.9%; P = .004). On multivariate analysis, patients who had OTSC placement for perforations and leaks had significantly higher long-term success compared with those who had fistulae (OR 51.4 and 8.36, respectively). LIMITATIONS: Retrospective design and multiple operators with variable expertise with the OTSC device. CONCLUSION: OTSC is safe and effective therapy for closure of GI defects. Clinical success is best achieved in patients undergoing closure of perforations or leaks when OTSC is used for primary or rescue therapy. Type of defect is the best predictor of successful long-term closure.

Can endoscopic ultrasound distinguish between mediastinal benign lymph nodes and those involved by sarcoidosis, lymphoma, or metastasis?

BACKGROUND: Lymph nodes (LNs) echofeatures on endoscopic ultrasound (EUS) and concurrent fine needle aspiration (FNA) are alternatives to highly invasive approaches for etiologic diagnosis of mediastinal lymphadenopathy (MLAD). AIMS: To evaluate the efficacy of LNs echofeatures and FNA via EUS to distinguish benign LNs from LNs involved by sarcoidosis, lymphoma, and metastasis in non-lung cancer patients. METHODS: A retrospective review of patients who underwent EUS-FNA for MLAD was performed. Echofeatures of LNs including echogenicity, margins, shape, and LN size were recorded. Final diagnosis was made based on surgical sampling or clinical diagnosis with long-term follow-up. Only patients diagnosed as benign MLAD, sarcoidosis, lymphoma, and metastasis included. Diagnostic value of echofeatures and FNA was evaluated. RESULTS: Included were 162 patients with final diagnosis of benign (68), sarcoidosis (33), lymphoma (20), and metastasis (41). The median LN along axis in the benign group [20.5 mm (6-76)] was significantly shorter than in the metastasis [28 mm (9-82)] and sarcoidosis [27 mm (17-50)] groups (p < 0.05). The median LN short axis in the benign group [11 mm (2-50)] was significantly shorter than in the metastasis [17 mm (5-44)] and lymphoma [16 mm (7-47)] groups (p < 0.05). No other echofeatures showed a discriminant value among the groups. When performing FNA, the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of EUS-FNA were 73.7, 100, 100, 72.2, and 84.4 %, respectively. CONCLUSION: Although benign MLAD tend to be smaller than other etiologies, echofeatures of LNs are not reliable etiologic diagnostic approach to MLAD. Therefore, FNA is suggested when feasible. However, due to relatively low sensitivity, LNs with benign FNA results should be subjected to further work-up if they are clinically suspicious.