David E. Loren

Fully covered self-expanding metal stents versus lumen-apposing fully covered self-expanding metal stent versus plastic stents for endoscopic drainage of pancreatic walled-off necrosis: clinical outcomes and success

BACKGROUND AND AIMSnEndoscopic transmural drainage/debridement of pancreatic walled-off necrosis (WON) has been performed using double-pigtail plastic (DP), fully covered self-expanding metal stents (FCSEMSs), or the novel lumen-apposing fully covered self-expanding metal stent (LAMS). Our aim was to perform a retrospective cohort study to compare the clinical outcomes and adverse events of EUS-guided drainage/debridement of WON with DP stents, FCSEMSs, and LAMSs.nnnMETHODSnConsecutive patients in 2 centers with WON managed by EUS-guided debridement were divided into 3 groups: (1) those who underwent debridement using DP stents, (2) debridement using FCSEMSs, (3) debridement using LAMSs. Technical success (ability to access and drain a WON by placement of transmural stents), early adverse events, number of procedures performed per patient to achieve WON resolution, and long-term success (complete resolution of the WON without need for further reintervention at 6 months after treatment) were evaluated.nnnRESULTSnFrom 2010 to 2015, 313 patients (23.3% female; mean age, 53 years) underwent WON debridement, including 106 who were drained using DP stents, 121 using FCSEMSs, and 86 using LAMSs. The 3 groups were matched for age, cause of the pancreatitis, WON size, and location. The cause of the patients pancreatitis was gallstones (40.6%), alcohol (30.7%), idiopathic (13.1%), and other causes (15.6%). The mean cyst size was 102xa0mm (range, 20-510xa0mm). The mean number of endoscopy sessions was 2.5 (range, 1-13). The technical success rate of stent placement was 99%. Early adverse events were noted in 27 of 313 (8.6%) patients (perforation in 6, bleeding in 8, suprainfection in 9, other in 7). Successful endoscopic therapy was noted in 277 of 313 (89.6%) patients. When comparing the 3 groups, there was no difference in the technical success (Pxa0= .37). Early adverse events were significantly lower in the FCSEMS group compared with the DP and LAMS groups (1.6%, 7.5%, and 9.3%; Pxa0< .01). At 6-month follow-up, the rate of complete resolution of WON was lower with DP stents compared with FCSEMSs and LAMSs (81% vs 95% vs 90%; Pxa0= .001). The mean number of procedures required for WON resolution was significantly lower in the LAMS group compared with the FCSEMS and DP groups (2.2 vs 3 vs 3.6, respectively; Pxa0= .04). On multivariable analysis, DP stents remain the sole negative predictor for successful resolution of WON (odds ratio [OR], 0.18; 95% confidence interval, 0.06-0.53; Pxa0= .002) after adjusting for age, sex, and WON size. Although there was no significant difference between FCSEMSs and LAMSs for WON resolution, the LAMS was more likely to have early adverse events (OR, 6.6; Pxa0= .02).nnnCONCLUSIONSnEUS-guided drainage/debridement of WON using FCSEMSs and LAMSs is superior to DP stents in terms of overall treatment efficacy. The number of procedures required for WON resolution was significantly lower with LAMSs compared with FCSEMSs and DP stents.

Metal versus plastic for pancreatic pseudocyst drainage: clinical outcomes and success

BACKGROUNDnEndoscopic transmural drainage of pancreatic pseudocysts (PPs) by using double-pigtail (DP) plastic stents requires placement of multiple stents and can be restricted by inadequate drainage and leakage risk. Recently, the use of fully covered self-expanding metal stents (FCSEMSs) has been reported as an alternative to DP plastic stents.nnnOBJECTIVEnTo evaluate the clinical outcomes, success rate, and adverse events of EUS-guided drainage of PPs with DP plastic stents and FCSEMSs.nnnDESIGNnRetrospective cohort study.nnnSETTINGnTwo tertiary-care academic medical centers.nnnPATIENTSnThis study involved 230 patients (mean age, 52.6 years) with PPs who underwent EUS-guided transmural drainage including 118 that were drained by using DP plastic stents and 112 by using FCSEMSs. A transgastric approach was used in 210 patients (91%), and transduodenal drainage was performed in 20 patients (9%).nnnINTERVENTIONSnStent deployment under EUS guidance.nnnMAIN OUTCOME MEASUREMENTSnTechnical success, early adverse events, stent occlusion requiring reintervention, and long-term success.nnnRESULTSnAt 12-month follow-up after the initial procedure, complete resolution of PPs by using DP plastic stents was lower compared with those that underwent drainage with FCSEMSs (89% vs 98%; Pxa0= .01). Procedural adverse events were noted in 31% in the DP plastic stent group and 16% in the FCSEMS group (Pxa0= .006). On multivariable analysis, patients with plastic stents were 2.9 times more likely to experience adverse events (odds ratio 2.9; 95% confidence interval, 1.4-6.3).nnnLIMITATIONSnRetrospective study.nnnCONCLUSIONnIn patients with PPs, EUS-guided drainage by using FCSEMSs improves clinical outcomes and lowers adverse event rates compared with those drained with DP plastic stents.

A Large Multicenter Experience With Endoscopic Suturing for Management of Gastrointestinal Defects and Stent Anchorage in 122 Patients: A Retrospective Review.

Goals:To describe a multicenter experience using an endoscopic suturing device for management of gastrointestinal (GI) defects and stent anchorage. Background:Endoscopic closure of GI defects including perforations, fistulas, and anastomotic leaks as well as stent anchorage has improved with technological advances. An endoscopic suturing device (OverStitch; Apollo Endosurgery Inc.) has been used. Study:Retrospective study of consecutive patients who underwent endoscopic suturing for management of GI defects and/or stent anchorage were enrolled between March 2012 and January 2014 at multiple academic medical centers. Data regarding demographic information and outcomes including long-term success were collected. Results:One hundred and twenty-two patients (mean age, 52.6 y; 64.2% females) underwent endoscopic suturing at 8 centers for stent anchorage (n=47; 38.5%), fistulas (n=40; 32.7%), leaks (n=15; 12.3%), and perforations (n=20; 16.4%). A total of 44.2% underwent prior therapy and 97.5% achieved technical success. Immediate clinical success was achieved in 79.5%. Long-term clinical success was noted in 78.8% with mean follow-up of 68 days. Clinical success was 91.4% in stent anchorage, 93% in perforations, 80% in fistulas, but only 27% in anastomotic leak closure. Conclusions:Endoscopic suturing for management of GI defects and stent anchoring is safe and efficacious. Stent migration after stent anchoring was reduced compared with published data. Long-term success without further intervention was achieved in the majority of patients. The role of endoscopic suturing for repair of anastomotic leaks remains unclear given limited success in this retrospective study.

Comparison of FNA and fine-needle biopsy for EUS-guided sampling of suspected GI stromal tumors

BACKGROUND AND AIMSnSubepithelial lesions are found in about 1% of all EGD procedures, and GI stromal tumors are a type of subepithelial lesion commonly encountered. Although the majority of subepithelial lesions are benign, GI stromal tumors have malignant potential, making a definitive diagnosis important. Currently, the criterion standard for the diagnosis of GI stromal tumors is EUS-directed FNA (EUS-FNA). The definitive diagnosis of GI stromal tumors relies on immunohistochemical staining, which depends on enough tissue being submitted to the pathologist. Achieving adequate tissue acquisition from suspected GI stromal tumors by EUS-FNA remains a limitation. Advancements in needle design, however, have improved tissue acquisition and therefore may improve the definitive diagnosis of GI stromal tumors by EUS-FNA. The goal of this study is to compare a fine-needle biopsy (FNB) needle (SharkCore, Medtronics) with FNA needles in definitively diagnosing suspected GI stromal tumors.nnnMETHODSnThis is a retrospective, single-center study of consecutive patients with suspected GI stromal tumors by EUS characterization who underwent EUS-FNA or EUS-FNB.nnnRESULTSnA total of 106 patients (53 men, mean [± standard deviation {SD}] age 62.19 ± 16.33 years) were included in the study undergoing EUS-FNA or EUS-FNB of suspected GI stromal tumors. The needle size that was used most often was 22 gauge in both groups. The average size of the lesions was 27.68 ± 15.70xa0mm; 71.7% of lesions were located in stomach, 19.8% in the esophagus, 5.7% in the duodenum, and 2.8% in the rectosigmoid colon. Ninety-one patients underwent EUS-FNA and 15 patients underwent EUS-FNB. Adequate tissue was procured, allowing immunohistochemical staining in 59 (64.8%) patients in the FNA group and 15 (100%) patients in the FNB group; Pxa0= .006. A diagnosis was reached by immunohistochemical staining in 48 (52.7%) patients in the FNA group and 13 (86.7%) patients in the FNB group; Pxa0= .01. Tissue was insufficient to make a cytologic diagnosis in 22 (24.2%) patients in the FNA group compared with none in the FNB group; Pxa0= .03. Adequate tissue was procured on the first pass of the FNB needle in the majority of patients (83.3%), whereas only 23.5% of patients had adequate tissue on the first pass by the FNA needle, with a median of 3 passes; Pxa0= .00. Tissue was insufficient to perform immunohistochemical staining, and thus a diagnosis could not be confirmed before surgery in 8 of the 34 surgical patients in the FNA group. Ten of 15 patients in the EUS-FNB group underwent surgery, all of whom were correctly diagnosed by FNB. There were no reported immediate adverse events or technical difficulties in either group.nnnCONCLUSIONSnEUS-FNB by using a SharkCore needle for suspected GI stromal tumors is technically similar and equally safe as FNA, with better tissue acquisition, which was achieved with fewer needle passes and an improved diagnostic yield by immunohistochemical staining.

A Trial of Rectal Indomethacin to Prevent Post-ERCP Pancreatitis in Patients with Suspected Type 3 Sphincter of Oddi Dysfunction

In the original publication the surname of the co-author was misspelled on the initial submission. The correct spelling of name should be Satish Munigala. Also, the authors have re-evaluated the article after publication, for the statistics on patients that had undergone a biliary sphincterotomy in their study population. It was noticed that they had erroneously miscalculated the number of patients that had undergone a biliary sphincterotomy:

Effect of the time of day and queue position in the endoscopic schedule on the performance characteristics of endoscopic ultrasound-guided fine-needle aspiration for diagnosing pancreatic malignancies

Background and Objectives: Recent reports have indicated that the time of day may impact the detection rate of abnormal cytology on gynecologic cytology samples. The aim of this study was to determine if procedure time or queue position affected the performance characteristics of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) for diagnosing solid pancreatic malignancies. Patients and Methods: We conducted a retrospective study evaluating patients with solid pancreatic lesions in whom EUS-FNA was performed. Three timing variables were evaluated as surrogate markers for endoscopist fatigue: Procedure start times, morning versus afternoon procedures, and endoscopy queue position. Statistical analyses were performed to determine whether the timing variables predicted performance characteristics of EUS-FNA. Results: We identified 609 patients (mean age: 65.8 years, 52.1% males) with solid pancreatic lesions who underwent EUS-FNA. The sensitivity of EUS-FNA was 100% for procedures that started at 7 AM while cases that started at 4 PM had a sensitivity of 81%. Using start time on a continuous scale, each elapsed hour was associated with a 1.9% decrease in EUS-FNA sensitivity (P = 0.003). Similarly, a 10% reduction in EUS-FNA sensitivity was detected between morning and afternoon procedures (92% vs. 82% respectively, P = 0.0006). A linear regression comparing the procedure start time and diagnostic accuracy revealed a decrease of approximately 1.7% in procedure accuracy for every hour later a procedure was started. A 16% reduction in EUS-FNA accuracy was detected between morning and afternoon procedures (100% vs. 84% respectively, P = 0.0009). When the queue position was assessed, a 2.4% reduction in accuracy was noted for each increase in the queue position (P = 0.013). Conclusion: Sensitivity and diagnostic accuracy of EUS-FNA for solid pancreatic lesions decline with progressively later EUS starting times and increasing numbers of procedures before a given EUS, potentially from endoscopist fatigue and cytotechnologist fatigue.

Comparison of the diagnostic accuracy of three current guidelines for the evaluation of asymptomatic pancreatic cystic neoplasms.

Abstract Asymptomatic pancreatic cysts are a common clinical problem but only a minority of these cases progress to cancer. Our aim was to compare the accuracy to detect malignancy of the 2015 American Gastroenterological Association (AGA), the 2012 International Consensus/Fukuoka (Fukuoka guidelines [FG]), and the 2010 American College of Radiology (ACR) guidelines. We conducted a retrospective study at 3 referral centers for all patients who underwent resection for an asymptomatic pancreatic cyst between January 2008 and December 2013. We compared the accuracy of 3 guidelines in predicting high-grade dysplasia (HGD) or cancer in resected cysts. We performed logistic regression analyses to examine the association between cyst features and risk of HGD or cancer. A total of 269 patients met inclusion criteria. A total of 228 (84.8%) had a benign diagnosis or low-grade dysplasia on surgical pathology, and 41 patients (15.2%) had either HGD (nu200a=u200a14) or invasive cancer (nu200a=u200a27). Of the 41 patients with HGD or cancer on resection, only 3 patients would have met the AGA guidelines indications for resection based on the preoperative cyst characteristics, whereas 30/41 patients would have met the FG criteria for resection and 22/41 patients met the ACR criteria. The sensitivity, specificity, positive predictive value, negative predictive value of HGD, and/or cancer of the AGA guidelines were 7.3%, 88.2%, 10%, and 84.1%, compared to 73.2%, 45.6%, 19.5%, and 90.4% for the FG and 53.7%, 61%, 19.8%, and 88% for the ACR guidelines. In multivariable analysis, cyst size >3u200acm, compared to ⩽3u200acm, (odds ratio [OR]u200a=u200a2.08, 95% confidence interval [CI]u200a=u200a1.11, 4.2) and each year increase in age (ORu200a=u200a1.07, 95% CIu200a=u200a1.03, 1.11) were positively associated with risk of HGD or cancer on resection. In patients with asymptomatic branch duct-intraductal papillary mucinous neoplasms or mucinous cystic neoplasms who underwent resection, the prevalence rate of HGD or cancer was 15.2%. Using the 2015 AGA criteria for resection would have missed 92.6% of patients with HGD or cancer. The more “inclusive” FG and ACR had a higher sensitivity for HGD or cancer but lower specificity. Given the current deficiencies of these guidelines, it will be important to determine the acceptable rate of false-positives in order to prevent a single true-positive.

Subharmonic and Endoscopic Contrast Imaging of Pancreatic Masses: A Pilot Study

To use subharmonic imaging (SHI) to depict the vascularity of pancreatic masses compared to contrast‐enhanced endoscopic ultrasound (EUS) and pathologic results.

Influence of integrated molecular pathology test results on real-world management decisions for patients with pancreatic cysts: analysis of data from a national registry cohort

BackgroundIntegrated molecular pathology (IMP) approaches based on DNA mutational profiling accurately determine pancreatic cyst malignancy risk in patients lacking definitive diagnoses following endoscopic ultrasound imaging with fine-needle aspiration of fluid for cytology. In such cases, IMP ‘low-risk’ and ‘high-risk’ diagnoses reliably predict benign and malignant disease, respectively, and provide improved risk stratification for malignancy than a model of the 2012 International Consensus Guideline (ICG) recommendations. Our objective was to determine if initial adjunctive IMP testing influenced future real-world pancreatic cyst management decisions for intervention or surveillance relative to ICG recommendations, and if this benefitted patient outcomes.MethodsAnalysis of data from the previously described National Pancreatic Cyst Registry. Associations between real-world decisions (intervention vs. surveillance), ICG model recommendations (surgery vs. surveillance) and IMP diagnoses (high-risk vs. low-risk) were evaluated using 2 × 2 tables. Kaplan Meier and hazard ratio analyses were used to assess time to malignancy. Odds ratios (OR) for surgery decision were determined using logistic regression.ResultsOf 491 patients, 206 received clinical intervention at follow-up (183 surgery, 4 chemotherapy, 19 presumed by malignant cytology). Overall, 13xa0% (66/491) of patients had a malignant outcome and 87xa0% (425/491) had a benign outcome at 2.9xa0years’ follow-up. When ICG and IMP were concordant for surveillance/surgery recommendations, 83xa0% and 88xa0% actually underwent surveillance or surgery, respectively. However, when discordant, IMP diagnoses were predictive of real-world decisions, with 88xa0% of patients having an intervention when ICG recommended surveillance but IMP indicated high risk, and 55xa0% undergoing surveillance when ICG recommended surgery but IMP indicated low risk. These IMP-associated management decisions benefitted patient outcomes in these subgroups, as 57xa0% had malignant and 99xa0% had benign outcomes at a median 2.9xa0years’ follow-up. IMP was also more predictive of real-world decisions than ICG by multivariate analysis: OR 11.4 (95xa0% CI 6.0u2009−u200923.7) versus 3.7 (2.4u2009−u20095.8), respectively.ConclusionsDNA-based IMP diagnoses were predictive of real-world management decisions. Importantly, when ICG and IMP were discordant, IMP influence benefitted patients by increasing confidence in surveillance and surgery decisions and reducing the number of unnecessary surgeries in patients with benign disease.

Three-way comparative study of endoscopic ultrasound-guided transmural gallbladder drainage using lumen-apposing metal stents versus endoscopic transpapillary drainage versus percutaneous cholecystostomy for gallbladder drainage in high-risk surgical patients with acute cholecystitis: clinical outcomes and success in an International, Multicenter Study

BackgroundPercutaneous cholecystostomy tube (PTGBD), endoscopic retrograde cholangiopancreatography with transpapillary gallbladder drainage (TP), and endoscopic ultrasound-guided transmural gallbladder drainage (EGBD) using lumen-apposing metal stents (LAMS) have been offered for gallbladder decompression for acute cholecystitis in high-risk surgical patients. Yet, there are limited data comparing these therapies. Our aim was to compare the safety and efficacy of EGBD to TP and PTGBD for gallbladder drainage.MethodsWe retrospectively collected high-risk surgical patients from six centers with acute cholecystitis who underwent gallbladder drainage by EGBD, TP, or PTGBD. Data included technical success (gallbladder drainage), clinical success (acute cholecystitis resolution), adverse events (AE), and follow-up.ResultsFrom 2010 to 2016, 372 patients underwent gallbladder drainage, with 146 by PTGBD, 124 by TP, and 102 drained by EGBD. Technical (98% vs. 88% vs. 94%; pu2009=u20090.004) and Clinical (97% vs. 90% vs. 80%; pu2009<u20090.001) success rates were significantly higher with PTGBD and EGBD compared to TP. PTGBD group had statistically significantly higher number of complications as compared to EGBD and TP groups (2u200a0% vs. 2% vs. 5%; pu2009=u20090.01). Mean hospital stay in the EGBD group was significantly less than TP and PTGBD (16 vs. 18 vs. 19xa0days; pu2009=u20090.01), while additional surgical intervention was significantly higher in the PTGBD group compared to the EGBD and TP groups (49% vs. 4% vs. 11%; pu2009<u20090.0001).ConclusionsEGBD with LAMS is an effective and safer alternative to TP and PTGBD for treatment of patients with acute cholecystitis who cannot undergo surgery. EGBD with LAMS has significantly lower overall AEs, hospital stay, and unplanned admissions compared to PTGBD. Trial registration: ClinicalTrials.gov Identifier: NCT01522573.