EUS-guided coil injection therapy in the management of gastric varices: the first U.S. multicenter experience (with video).

BACKGROUND AND AIMS: Despite the significant morbidity associated with gastric variceal bleeding, there is a paucity of high-quality data regarding optimal management. EUS-guided coil injection therapy (EUS-COIL) has recently emerged as a promising endoscopic modality for the treatment of gastric varices (GV), particularly compared with traditional direct endoscopic glue injection. Although there are data on the feasibility and safety of EUS-COIL in the management of GV, these have been limited to select centers with particular expertise. The aim of this study was to report the first U.S. multicenter experience of EUS-COIL for the management of GV. METHODS: This retrospective analysis included patients with bleeding GV or GV at risk of bleeding who underwent EUS-COIL at 10 U.S. tertiary care centers between 2018 and 2022. Baseline patient and procedure-related information was obtained. EUS-COIL entailed the injection of .018 inch or .035 inch hemostatic coils using a 22-gauge or 19-gauge FNA needle. Primary outcomes were technical success (defined as successful deployment of coil into varix under EUS guidance with diminution of Doppler flow), clinical success (defined as cessation of bleeding if present and/or absence of bleeding at 30 days' postintervention), and intraprocedural and postprocedural adverse events. RESULTS: A total of 106 patients were included (mean age 60.4 ± 12.8 years; 41.5% female). The most common etiology of GV was cirrhosis (71.7%), with alcohol being the most common cause (43.4%). Overall, 71.7% presented with acute GV bleeding requiring intensive care unit stay and/or blood transfusion. The most common GV encountered were isolated GV type 1 (60.4%). A mean of 3.8 ± 3 coils were injected with a total mean length of 44.7 ± 46.1 cm. Adjunctive glue or absorbable gelatin sponge was injected in 82% of patients. Technical success and clinical success were 100% and 88.7%, respectively. Intraprocedural adverse events (pulmonary embolism and GV bleeding from FNA needle access) occurred in 2 patients (1.8%), and postprocedural adverse events occurred in 5 (4.7%), of which 3 were mild. Recurrent bleeding was observed in 15 patients (14.1%) at a mean of 32 days. Eighty percent of patients with recurrent bleeding were successfully re-treated with repeat EUS-COIL. No significant differences were observed in outcomes between high-volume (>15 cases) and low-volume (<7 cases) centers. CONCLUSIONS: This U.S. multicenter experience on EUS-COIL for GV confirms high technical and clinical success with low adverse events. No significant differences were seen between high- and low-volume centers. Repeat EUS-COIL seems to be an effective rescue option for patients with recurrent bleeding GV. Further prospective studies should compare this modality versus other interventions commonly used for GV.

Correlation of Gastrointestinal Symptoms at Initial Presentation with Clinical Outcomes in Hospitalized COVID-19 Patients: Results from a Large Health System in the Southern USA.

BACKGROUND: We aimed to understand the association of gastrointestinal (GI) symptoms at initial presentation with clinical outcomes during COVID-19 hospitalization. METHODS: This retrospective, multicenter cohort study included consecutive hospitalized COVID-19 patients from a single, large health system. The presence of GI symptoms was assessed at initial presentation and included one or more of the following: nausea, vomiting, diarrhea and abdominal pain. Patients were divided into three cohorts: Only GI symptoms, GI and non-GI symptoms and only non-GI symptoms. The primary outcome was association of GI symptoms with mortality. Secondary outcomes included prevalence of GI symptoms and survival analysis. RESULTS: A total of 1672 COVID-19 patients were hospitalized (mean age: 63 ± 15.8 years, females: 50.4%) in our system during the study period. 40.7% patients had at least one GI symptom (diarrhea in 28.3%, nausea/vomiting in 23%, and abdominal pain in 8.8% patients), and 2.6% patients had only GI symptoms at initial presentation. Patients presenting with GI symptoms (with or without non-GI symptoms) had a lower mortality rate compared to patients presenting with only non-GI symptoms (20% vs. 26%; p < 0.05). The time from hospitalization to being discharged was less for patients presenting with only GI symptoms (7.4 days vs. > 9 days, p < 0.0014). After adjusting for other factors, the presence of GI symptoms was not associated with mortality (p > 0.05). CONCLUSION: Among a hospitalized COVID-19 positive Southern US population, 41% patients presented with either diarrhea, nausea, vomiting or abdominal pain initially. The presence of GI symptoms has no association with in-hospital all-cause mortality.

Digestive Manifestations in Patients Hospitalized With Coronavirus Disease 2019.

BACKGROUND & AIMS: The prevalence and significance of digestive manifestations in coronavirus disease 2019 (COVID-19) remain uncertain. We aimed to assess the prevalence, spectrum, severity, and significance of digestive manifestations in patients hospitalized with COVID-19. METHODS: Consecutive patients hospitalized with COVID-19 were identified across a geographically diverse alliance of medical centers in North America. Data pertaining to baseline characteristics, symptomatology, laboratory assessment, imaging, and endoscopic findings from the time of symptom onset until discharge or death were abstracted manually from electronic health records to characterize the prevalence, spectrum, and severity of digestive manifestations. Regression analyses were performed to evaluate the association between digestive manifestations and severe outcomes related to COVID-19. RESULTS: A total of 1992 patients across 36 centers met eligibility criteria and were included. Overall, 53% of patients experienced at least 1 gastrointestinal symptom at any time during their illness, most commonly diarrhea (34%), nausea (27%), vomiting (16%), and abdominal pain (11%). In 74% of cases, gastrointestinal symptoms were judged to be mild. In total, 35% of patients developed an abnormal alanine aminotransferase or total bilirubin level; these were increased to less than 5 times the upper limit of normal in 77% of cases. After adjusting for potential confounders, the presence of gastrointestinal symptoms at any time (odds ratio, 0.93; 95% CI, 0.76-1.15) or liver test abnormalities on admission (odds ratio, 1.31; 95% CI, 0.80-2.12) were not associated independently with mechanical ventilation or death. CONCLUSIONS: Among patients hospitalized with COVID-19, gastrointestinal symptoms and liver test abnormalities were common, but the majority were mild and their presence was not associated with a more severe clinical course.

Safety and efficacy of EUS-guided coil and glue injection for the primary prophylaxis of gastric variceal hemorrhage.

BACKGROUND AND AIMS: Gastric variceal bleeding (GVB) is associated with high morbidity and mortality. EUS-guided coil and cyanoacrylate (CYA) injection (EUS-CCI) has been shown to be an effective therapy in acute bleeding and secondary prophylaxis; however, there is a paucity of data on primary prophylaxis. METHODS: In this single-center observational study, adult patients with high-risk gastric varices (GV; size >10 mm or cherry red spot) without prior bleeding underwent EUS-CCI for the primary prophylaxis of GVB between June 2009 and December 2019. The primary outcome was post-treatment GVB. RESULTS: Eighty patients with a mean variceal size of 22.5 ± 9.4 mm and a mean length of follow-up of 3.0 ± 2.4 years were included. The etiology of portal hypertension was cirrhosis in 71 patients (88.7%) and noncirrhotic in 9 (11.3). The mean model for end-stage liver disease score was 12.3 ± 3.7 in patients with cirrhosis. The mean coil number was 1.5 (range, 1-3) and mean glue volume injected 2 mL (range, .5-5). Technical success was achieved in 100%, 96.7% had EUS confirmation of GV obliteration, and 67.7% were obliterated with 1 treatment session. Post-treatment GVB occurred in 2 patients (2.5%) and adverse events in 4 (4.9%). No deaths related to GVB occurred, and emergent transjugular intrahepatic shunts were not needed during the follow-up period. CONCLUSIONS: In patients with high-risk GV, EUS-CCI for primary prophylaxis is highly effective at preventing GVB with a low rate of adverse events. Primary prophylaxis of high-risk GV with coil and CYA glue injection should be considered in centers with the appropriate expertise.

Effectiveness of combination endoscopic therapy for colonic anastomotic leaks.

BACKGROUND: Colonic anastomotic leaks are associated with significant morbidity and mortality. Whereas small case series suggest that fully covered self-expandable metal stents (FCSEMS) are effective, no larger studies have examined the impact of combination endoscopic therapy on colonic anastomotic leaks. METHODS: Our retrospective cohort study reviewed 51 patients undergoing endoscopic therapy for colonic anastomotic leaks between 2011 and 2018. Patients receiving combination therapy involving FCSEMS plus local closure (n = 24) were compared with patients receiving FCSEMS alone (n = 18) or endoscopic suturing alone (n = 9). The primary outcomes were technical and clinical success (resolution of leak, removal of percutaneous drains, avoidance of surgical reoperation, and reversal of temporary diversion). RESULTS: Clinical success was achieved in 55 % of patients. Clinical success was achieved in 18/24 patients (75 %) with combination therapy compared with 6/18 patients receiving FCSEMS alone (33 %, adjusted risk ratio [RR] 2.16, 95 % confidence interval [CI] 1.10 - 4.24; P = 0.02) and 4 /9 patients undergoing endoscopic suturing alone (44 %, RR 1.91, 95 %CI 0.84 - 4.31; P = 0.10). Stent migration occurred in 40 % of patients. CONCLUSIONS: This large series demonstrates that combination therapy was associated with a higher rate of clinical success, and future prospective studies are warranted.

Advances in Biliary Access.

PURPOSE OF REVIEW: Bile duct cannulation using conventional techniques fails in up to 16% of endoscopic retrograde cholangiopancreatography (ERCP) procedures. Advanced techniques to gain biliary access include ERCP-based maneuvers, and newer endoscopic ultrasound (EUS)-guided interventions. In this article, we review the evidence supporting the use of various ERCP and EUS techniques for biliary access, as well as studies comparing these different techniques. RECENT FINDINGS: In comparative studies, biliary access after failed conventional cannulation was more successful with EUS-rendezvous compared to precut papillotomy. EUS-guided drainage compares favorably with percutaneous drainage with respect to clinical success, safety profile, and cost-efficiency. Recent randomized trials comparing EUS to ERCP drainage in malignant obstruction have found similar success rates between these techniques. EUS-guided techniques compare favorably to ERCP-based methods for biliary access and drainage. The advent of newer technologies to facilitate interventional EUS may further change current treatment approaches.

Histologic Analysis of Endoscopic Ultrasound-Guided Through the Needle Microforceps Biopsies Accurately Identifies Mucinous Pancreas Cysts.

BACKGROUND & AIMS: It is a challenge to accurately assess pancreatic cystic lesions (PCLs) and determine their risk. We compared the yield of tissue acquired with endoscopic ultrasound (EUS)-guided microforceps (through the needle tissue biopsy [TTNB]) with that of samples collected by EUS-guided fine-needle-aspiration (EUS-FNA), and the accuracy of analyses of each sample type in the diagnosis of mucinous PCLs. METHODS: We performed a prospective open-label study of 114 consecutive adults (56.1% women; mean age, 64.2 y) undergoing EUS-FNA evaluation of PCLs (mean size, 35 mm) at 7 centers, from June 20, 2016, through August 31, 2018. Samples were collected from each cyst by FNA and microforceps; samples collected by FNA were analyzed by cytology and samples collected by TTNB were analyzed by histology. Acquisition yield was defined as the percentage of specimens collected that were adequate for cytologic or histologic analysis. Diagnoses of mucinous cysts were made based on identification of pancreatic mucinous epithelium by cytology analysis of FNA samples or histologic analysis of TTNB samples. Surgical specimens were used as the reference standard when available. RESULTS: The EUS-guided microforceps were successfully inserted into 97.4% (111 of 114) of PCLs. Tissue acquisition yield was significantly higher with TTNB (95 of 114; 83.3%) than FNA (43 of 114; 37.7%) (P < .001). Sixty-one PCLs were determined to be mucinous based on TTNB analysis (53.5%) vs 11 with FNA analysis (9.6%) (P < .001). Among PCLs categorized as equivocal, based on the level of carcinoembryonic antigen, TTNB analysis found 50% (41 of 82) to be mucinous and FNA analysis found 8.5% (7 of 82) to be mucinous (P < .001). Findings from analyses of samples collected by TTNB were 100% concordant with findings from histologic analysis of surgical specimens (14 of 14), whereas only 3 of 14 findings from analysis of samples collected by FNA were in agreement with findings from surgical specimens (21.4%) (P < .001). Four of 5 mucinous PCLs with advanced neoplasia (80%) were detected with TTNB compared with none with FNA (P = .04). Self-limited intracystic bleeding occurred in 7 patients (6.1%), and acute pancreatitis in 6 patients (5.3%). CONCLUSIONS: In a multicenter prospective study of patients undergoing EUS-FNA for evaluation of PCLs, we found TTNB collection of tissues for histologic analysis to be safe and feasible, with an acquisition yield of 83.3%. Histologic analysis of samples collected by TTNB identified a larger proportion of mucinous PCLs compared with cytologic analysis of samples collected by FNA-even among samples categorized as equivocal, based on the level of carcinoembryonic antigen. More samples collected by TTNB than FNA were found to have advanced neoplasia. Clinicaltrials.gov no: NCT02979509.

EUS-Guided Choledochoduodenostomy for Distal Malignant Biliary Obstruction Using Electrocautery-Enhanced Lumen-Apposing Metal Stents: First US, Multicenter Experience.

BACKGROUND AND AIMS: EUS-guided biliary drainage has emerged as a technique to enable endobiliary drainage in failed ERCP. A newer model, lumen-apposing metal stents (LAMS), with a cautery-enhanced delivery system became available in the USA in late 2015. This cautery-tipped version may facilitate EUS-guided choledochoduodenostomy (EUS-CD), but data using this model are lacking. METHODS: We reviewed outcomes of attempted EUS-CD using cautery-enhanced LAMS from 6, US centers. The following data were collected: patient and procedure details, technical success, adverse events, clinical success (resolution of jaundice or improvement in bilirubin > 50%), and biliary re-interventions. RESULTS: EUS-CD was attempted in 67 patients (mean age 68.8) with malignant obstruction after failed ERCP between September 2015 and April 2018. EUS-CD was technically successful in 64 (95.5%). A plastic or metal stent was inserted through the lumen of the deployed LAMS in 50 of 64 (78.1%) patients to maintain a non-perpendicular LAMS axis into the bile duct. Adverse events occurred in 4 (6.3%) and included: abdominal pain (n = 2), peritonitis that responded to antibiotics (n = 1), and bleeding requiring transfusion (n = 1). Among 40 patients with follow-up of > 4 weeks, clinical success was achieved in 100%. Biliary re-interventions for obstruction were needed in 7(17.5%), in 3 of 6 (50.0%) that underwent EUS-CD with LAMS alone versus 4 of 34 (5%) with LAMS plus an axis-orienting stent (p = 0.02). CONCLUSION: EUS-CD using LAMS with cautery-enhanced delivery systems has high technical and clinical success rates, with a low rate of adverse events. Inserting an axis-orienting stent through the lumen of the LAMS may reduce the need for biliary re-interventions.

Suboptimal Agreement Among Cytopathologists in Diagnosis of Malignancy Based on Endoscopic Ultrasound Needle Aspirates of Solid Pancreatic Lesions: A Validation Study.

BACKGROUND & AIMS: Despite the widespread use of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) to sample pancreatic lesions and the standardization of pancreaticobiliary cytopathologic nomenclature, there are few data on inter-observer agreement among cytopathologists evaluating pancreatic cytologic specimens obtained by EUS-FNA. We developed a scoring system to assess agreement among cytopathologists in overall diagnosis and quantitative and qualitative parameters, and evaluated factors associated with agreement. METHODS: We performed a prospective study to validate results from our pilot study that demonstrated moderate to substantial inter-observer agreement among cytopathologists for the final cytologic diagnosis. In the first phase, 3 cytopathologists refined criteria for assessment of quantity and quality measures. During phase 2, EUS-FNA specimens of solid pancreatic lesions from 46 patients were evaluated by 11 cytopathologists at 5 tertiary care centers using a standardized scoring tool. Individual quantitative and qualitative measures were scored and an overall cytologic diagnosis was determined. Clinical and EUS parameters were assessed as predictors of unanimous agreement. Inter-observer agreement (IOA) was calculated using multi-rater kappa (κ) statistics and a logistic regression model was created to identify factors associated with unanimous agreement. RESULTS: The IOA for final diagnoses, based on cytologic analysis, was moderate (κ = 0.56; 95% CI, 0.43-0.70). Kappa values did not increase when categories of suspicious for malignancy, malignant, and neoplasm were combined. IOA was slight to moderate for individual quantitative (κ = 0.007; 95% CI, -0.03 to -0.04) and qualitative parameters (κ = 0.5; 95% CI, 0.47-0.53). Jaundice was the only factor associated with agreement among all cytopathologists on multivariate analysis (odds ratio for unanimous agreement, 5.3; 95% CI, 1.1-26.89). CONCLUSIONS: There is a suboptimal level of agreement among cytopathologists in the diagnosis of malignancy based on analysis of EUS-FNA specimens obtained from solid pancreatic masses. Strategies are needed to refine the cytologic criteria for diagnosis of malignancy and enhance tissue acquisition techniques to improve diagnostic reproducibility among cytopathologists.

Endoscopic ultrasound-guided biliary access versus precut papillotomy in patients with failed biliary cannulation: a retrospective study.

Background and aims Precut papillotomy is widely used after failed biliary cannulation. Endoscopic ultrasound (EUS)-guided biliary access techniques are newer methods to facilitate access and therapy in failed cannulation. We evaluated the impact of EUS-guided biliary access on endoscopic retrograde cholangiopancreatography (ERCP) success and compared these techniques to precut papillotomy. Patients and methods We retrospectively compared two ERCP cohorts. One cohort consisted of biliary ERCPs (n = 1053) attempted in patients with native papillae and surgically unaltered anatomy in whom precut papillotomy and/or EUS-guided biliary access were routinely performed immediately after failed cannulation. This cohort was compared with a similar ERCP cohort (n = 1062) in which only precut papillotomy was available for failed cannulation. The following outcomes were compared: conventional cannulation success, rates of attempted advanced access techniques (precut or EUS), precut success, EUS-guided biliary access success, and ERCP failure rates. Results Although conventional cannulation success, rates of attempted advanced access technique (precut or EUS), and precut success were similar, the ERCP failure rate was lower when both EUS-guided biliary access and precut were available (1.0 % [95 % confidence interval (CI) 0.4 - 1.6]), compared with when only precut was possible for failed access (3.6 % [95 %CI 2.5 - 4.7]; P < 0.001). Success for EUS-guided biliary access (95.1 % [95 %CI 89.7 - 100]) was significantly higher than for precut (75.3 % [95 %CI 68.2 - 82.4]; P < 0.001), and mainly due to superiority in malignant obstruction (93.5 % vs. 64 %; P < 0.001). Conclusions EUS-guided biliary access decreases the rate of therapeutic biliary ERCP failure. Our results support the use of EUS-guided biliary access to optimize single-session ERCP success. In experienced hands, these techniques appear as effective, if not more so, than precut papillotomy.

Feasibility of nonradiation EUS-based ERCP in patients with uncomplicated choledocholithiasis (with video).

BACKGROUND AND AIMS: ERCP inherently involves radiation exposure. Nonradiation ERCP has been described in pregnancy. Theoretically, the same techniques could be applied to the general population. We prospectively assessed the feasibility of nonradiation, EUS-based ERCP in nonpregnant patients with choledocholithiasis. METHODS: Consecutive patients referred for ERCP for choledocholithiasis were recruited over a 1-year period. Patients providing study consent underwent the following procedural protocol. First, EUS was performed to verify the presence, size, and number of stones. Second, biliary cannulation was attempted without fluoroscopy for a maximum of 10 minutes. Selective cannulation was based on deep insertion with visible bile in the catheter on aspiration. Third, for stone removal, sphincterotomy was performed and stones were removed using a basket or balloon. The number of stones exiting the papilla was matched to the number seen on EUS. Finally, once the duct was deemed clear by the endoscopist, a final occlusion cholangiogram and ductal sweep served as the reference standard for confirmation of stone clearance. RESULTS: Nonradiation ERCP was attempted in 31 patients. Cannulation without fluoroscopy was successful in 26 patients (84%). Complete stone removal without fluoroscopy was achieved in all 26 of these cases. The 5 patients with failed nonfluoroscopic cannulation required double guidewire (n = 2) or precut papillotomy (n = 3) for deep biliary access and subsequent stone clearance. One patient who required precut papillotomy for access developed moderate post-ERCP pancreatitis (3%). CONCLUSIONS: Nonradiation, EUS-based ERCP for uncomplicated choledocholithiasis appears to be successful and safe. (Clinical trial registration number: NCT01678391.).

Underwater EMR of adenomas of the appendiceal orifice (with video).

BACKGROUND AND AIMS: EMR of adenomas involving the appendiceal orifice (AO) is controversial because of a high risk of perforation and incomplete resection. We evaluated the feasibility, safety, and outcomes of underwater EMR (UEMR) without submucosal injection for the treatment of adenomas involving the AO. METHODS: This was a prospective, observational study of a standardized UEMR technique without submucosal injection for adenomas involving the AO in 27 consecutive patients meeting inclusion and exclusion criteria. Surveillance colonoscopy included biopsy sampling of the EMR site and base of the AO. Main outcome measurements include technical success, histology, resection time, adverse events, and follow-up data. RESULTS: Over 42 months, UEMR of adenomas involving the AO (rim, 5 patients; inside, 22 patients) was attempted in 27 consecutive patients. Median adenoma size was 15 mm (range, 8 to 50). UEMR was successful in 24 patients (89%). Four patients were referred to surgery, 3 with UEMR failure because of an inability to exclude the adenoma extending into the appendix at the index procedure and 1 with invasive adenocarcinoma in the UEMR specimen. The median resection time was 3 minutes (range, 1 to 75). Adverse events consisted of postpolypectomy syndrome in 2 patients (7%). There was no perforation, bleeding requiring transfusion, or appendicitis. Final histology was tubular adenoma (7), tubulovillous adenoma (4), sessile serrated adenoma (15), and invasive adenocarcinoma (1). Twenty-one of 23 patients (91%), not referred to surgery, had follow-up colonoscopy with biopsy sampling of the resection site after a median of 29 weeks (range, 12 to 139) after resection. Residual adenoma was found in 2 of 21 patients (10%). CONCLUSION: On an intention-to-treat basis, UEMR without submucosal injection enabled safe and complete endoscopic resection of AO lesions. Close surveillance for residual or recurrence is warranted. ( CLINICAL TRIALS REGISTRATION NUMBER: NCT01750619.).

EUS-guided treatment of gastric fundal varices with combined injection of coils and cyanoacrylate glue: a large U.S. experience over 6 years (with video).

BACKGROUND AND AIMS: Conventional endoscopic treatment of gastric fundal varices (GFV) with cyanoacrylate (CYA) glue may be complicated by embolization and rebleeding. We evaluated the long-term outcomes of EUS-guided injection of coils and CYA glue for therapy of GFV. METHODS: A retrospective chart review of patients treated for GFV was performed. The main outcomes measured were hemostasis, obliteration on surveillance EUS, post-treatment bleeding rate, and adverse events. RESULTS: From March 2009 to 2015, 152 patients with GFV were treated. Seven (5%) had active hemorrhage, 105 (69%) had recent bleeding, and 40 (26%) were treated for primary prophylaxis. Treatment was technically successful in 151 patients (>99%). Mean number of coils was 1.4 (range, 1-4 coils), and mean volume of CYA was 2 mL (range, 0.5-6). Follow-up was available for 125 patients with treated GFV (mean, 436 days; range, 30-2043). Among 100 patients with follow-up EUS examinations, complete obliteration (on Doppler study) of GFV was confirmed in 93 (93%). Post-treatment bleeding from obliterated GFV occurred in 3 of 93 patients (3%). Twenty-five patients who had clinical and/or EGD follow-up had 3 post-treatment bleeding episodes after a median follow-up of 324 days (range, 41-486). Among the 40 patients treated for primary prophylaxis, 28 underwent follow-up EUS and 27 (96%) had confirmed obliteration. Mild postprocedure abdominal pain occurred in 4 of 125 patients (3%), and clinical signs of pulmonary embolization were seen in 1 patient (1%). Another 4 of 125 patients (3%) presented with minor delayed upper GI bleeding from coil/glue extrusion. CONCLUSIONS: EUS-guided combined coil and CYA glue injection of high-risk GFV appears to be highly effective for hemostasis in active bleeding and primary and secondary bleeding prophylaxis. Once obliteration was achieved, post-treatment bleeding from GFV occurred in only 3% during long-term follow-up. Combination therapy appears safe and may reduce the risk of CYA embolization.

EUS-guided drainage of peripancreatic fluid collections and necrosis by using a novel lumen-apposing stent: a large retrospective, multicenter U.S. experience (with videos).

BACKGROUND AND AIMS: EUS-guided drainage of peripancreatic fluid collection (PFC) (pancreatic pseudocyst [PP] or walled-off necrosis [WON]) by using a novel lumen-apposing, fully covered, self-expandable metal stent (LAMS) has been promising, but few of these data are from the United States. The aim of this study was to evaluate clinical outcomes and safety of EUS-guided drainage of pancreatic pseudocysts and WON by using the LAMS. METHODS: We conducted a multicenter, retrospective study on 82 patients with symptomatic PFC who underwent EUS-guided drainage by using the LAMS at 4 U.S. tertiary care centers. Outcomes evaluated included successful placement of the LAMS, the number of patients in whom complete resolution of PPs or WON was achieved, the number of procedures performed per patient to achieve PFC resolution, and adverse events. RESULTS: The mean size of the PFC was 11.8 cm. LAMSs were successfully placed in 80 patients (97.5%). Twelve patients had PP and 68 had WON. The median stent in-dwelling time was 2 months (range 1-3 months). Endoscopic debridement with the LAMS in WON was performed in 54 patients. The patency of the stent was maintained in 98.7% of the patients (77/78). There was spontaneous dislodgment of 2 LAMSs. Successful endoscopic therapy by using the LAMS was successful in 12 of 12 patients (100%) with PP compared with 60 of 68 patients (88.2%) with WON. All stents were endoscopically removed from all patients after peripancreatic fluid collection (PFC) resolution. There was 1 PFC recurrence during the 3-month median follow-up period. Procedure-related adverse events occurred in 8 patients (9.8%), and included stent maldeployment (n = 2), and self-limited bleeding (n = 6). In 1 patient with stent maldeployment gastric perforation developed, and the patient underwent surgical repair. CONCLUSION: EUS-guided drainage of PFCs by using the novel LAMS has high technical and long-term success rates. Due to its ease of use, the LAMSs may simplify and streamline EUS-guided management of PFCs, particularly for the endoscopic debridement of WON, and may help in its widespread adoption as an alternative to surgery.

Endoscopic resection is cost-effective compared with laparoscopic resection in the management of complex colon polyps: an economic analysis.

BACKGROUND AND AIMS: Endoscopic resection (ER) is an efficacious treatment for complex colon polyps (CCPs). Many patients are referred for surgical resection because of concerns over procedural safety, incomplete polyp resection, and adenoma recurrence after ER. Efficacy data for both resection strategies are widely available, but a paucity of data exist on the cost-effectiveness of each modality. The aim of this study was to perform an economic analysis comparing ER and laparoscopic resection (LR) strategies in patients with CCP. METHODS: A decision analysis tree was constructed using decision analysis software. The 2 strategies (ER vs LR) were evaluated in a hypothetical cohort of patients with CCPs. A hybrid Markov model with a 10-year time horizon was used. Patients entered the model after colonoscopic diagnosis at age 50. Under Strategy I, patients underwent ER followed by surveillance colonoscopy at 3 to 6 months and 12 months. Patients with failed ER and residual adenoma at 12 months were referred for LR. Under Strategy II, patients underwent LR as primary treatment. Patients with invasive cancer were excluded. Estimates regarding ER performance characteristics were obtained from a systematic review of published literature. The Centers for Medicare & Medicaid Services (2012-2013) and the 2012 Healthcare Cost and Utilization Project databases were used to determine the costs and loss of utility. We assumed that all procedures were performed with anesthesia support, and patients with adverse events in both strategies required inpatient hospitalization. Baseline estimates and costs were varied by using a sensitivity analysis through the ranges. RESULTS: LR was found to be more costly and yielded fewer quality-adjusted life-years (QALYs) compared with ER. The cost of ER of a CCP was $5570 per patient and yielded 9.640 QALYs. LR of a CCP cost $18,717 per patient and yielded fewer QALYs (9.577). For LR to be more cost-effective, the thresholds of 1-way sensitivity analyses were (1) technical success of ER for complete resection in <75.8% of cases, (2) adverse event rates for ER > 12%, and (3) LR cost of <$14,000. CONCLUSIONS: Our data suggest that ER is a cost-effective strategy for removal of CCPs. The effectiveness is driven by high technical success and low adverse event rates associated with ER, in addition to the increased cost of LR.

The Clinical Utility of Evaluating the Luminal Upper Gastrointestinal Tract During Linear Endoscopic Ultrasonography.

BACKGROUND: The clinical utility of performing esophagogastroduodenoscopy (EGD) before linear endoscopic ultrasonography (L-EUS) to evaluate the luminal upper gastrointestinal (GI) tract is not well established. GOALS: The study was aimed to determine the prevalence of clinically meaningful luminal abnormalities (any luminal finding requiring further evaluation with mucosal biopsy or initiation of treatment) in patients undergoing L-EUS. The study also sought to compare the ability of the gastroscope and the linear echoendoscope in identifying these lesions. STUDY: A prospective, multicenter cohort study enrolled patients undergoing L-EUS for nonluminal indications. All patients underwent EGD followed by L-EUS by 2 different endoscopists. The second endoscopist was blinded to the results of the initial EGD. The identification of clinically meaningful luminal lesions and quality of endoscopic visualization of the upper GI tract were measured. RESULTS: In the cohort of 175 patients, 52 (29.7%) patients had clinically meaningful luminal findings seen in the upper GI tract. There was no significant difference in the number of clinically meaningful lesions identified on EGD and L-EUS (25.1% vs. 22.9%, P=0.39). No significant difference was found in the miss rate of clinically meaningful lesions between the 2 modalities (EGD: 4.5% vs. EUS: 6.9%, P=0.39). CONCLUSIONS: A substantial minority of patients undergoing L-EUS for nonluminal indications will have clinically meaningful luminal findings. The endoscopic evaluation of the luminal upper GI tract can be adequately achieved using the linear echoendoscope.

Safety and efficacy of endoscopic ultrasound-guided drainage of pancreatic fluid collections with lumen-apposing covered self-expanding metal stents.

BACKGROUND & AIMS: Plastic stents, placed via endoscopy to drain pancreatic fluid collections (PFCs), require repeat access. Covered metal stents are larger in diameter and can be inserted in a single step, but can migrate. We evaluated the safety and efficacy of a lumen-apposing, covered, self-expanding metal stent (LACSEMS) for PFC drainage. METHODS: We performed a prospective study of the outcomes of stent placement in 33 patients (18 men; age, 53 ± 14 y; 28 with chronic pancreatitis) with symptomatic pancreatic pseudocysts and walled-off necrosis (≥ 6 cm with ≥ 70% fluid content). Subjects were enrolled at 7 tertiary care centers (6 in the United States and 1 in Europe) from October 2011 through August 2013. Cystenterostomies were created based on endoscopist preference. Safety outcomes included infection, bleeding, perforation, tissue injury, and stent migration. Efficacy end points included LACSEMS placement, patency, and removal, as well as 50% or more reduction in PFCs. RESULTS: The mean size of the patients' PFCs was 9 ± 3.3 cm. LACSEMSs were placed successfully via endoscopic ultrasound guidance in 30 patients (91%); the remaining 3 patients received 2 double-pigtail stents. One subject could not be evaluated because of a pseudoaneurysm. In the patients receiving LACSEMS, PFCs resolved in 27 of 29 (93%). Overall, PFCs resolved in 30 of 33 patients (91%). Endoscopic debridement through the LACSEMS was conducted in 11 subjects. Complications (15%) included abdominal pain (n = 3), spontaneous stent migration, back pain (n = 1), access-site infection, and stent dislodgement (n = 1). CONCLUSIONS: LACSEMS were placed successfully in 91% of subjects with PFCs. Overall, 93% had PFC resolution. Advantages of LACSEMSs over other stents include single-step deployment and the ability to perform endoscopic debridement with minimal stent migration. Clinicaltrials.gov: NCT01419769.

Attempted underwater en bloc resection for large (2-4 cm) colorectal laterally spreading tumors (with video).

OBJECTIVE: To evaluate the feasibility and outcomes of attempted underwater en bloc resection (UEBR) of large colorectal laterally spreading tumors (LSTs). DESIGN: Prospective, observational study. SETTING: Tertiary academic referral center. PATIENTS: Fifty patients meeting the inclusion and exclusion criteria. INTERVENTIONS: Standardized UEBR technique involving attempted en bloc resection without submucosal injection by using a large 33-mm snare. MAIN OUTCOME MEASUREMENTS: Complete endoscopic en bloc resection, histologic complete resection, procedure time, adverse events, and follow-up data. RESULTS: Over 13 months, UEBR was attempted in 50 patients (median age, 68 years) with 53 LSTs 2 to 4 cm in size. The median LST size was 30 mm (range 20-40 mm). The median procedure and resection times were 38 minutes (range 17-87 minutes) and 3 minutes (range 1-32 minutes), respectively. Complete endoscopic en bloc resection with the 33-mm snare was successful in 29 of 53 lesions (55%). Of these, histology showed neoplasia-free margins in 79%. Final histology was tubular adenoma (n = 26), sessile serrated adenoma (n = 10), tubulovillous adenoma (n = 14), villous adenoma (n = 2), and intramucosal carcinoma (n = 1). Adverse events (4%) were delayed bleeding in 1 and abdominal pain in 1 patient each. There were no perforations. Forty patients with a total of 43 adenomas had follow-up colonoscopy with biopsies of the resection site after a median of 31 weeks (range 7-71 weeks) after resection. Residual adenoma was found in 2 of 43 (5%). LIMITATIONS: Single-center, limited follow-up. CONCLUSION: On an intention-to-treat basis, complete endoscopic en bloc resection was achieved in 55% of lesions with complete histologic resection verified in 79% of the en bloc specimens. UEBR without submucosal injection appears safe. Refinements are needed to improve UEBR success rates.

Protective association of colonoscopy against proximal and distal colon cancer and patterns in interval cancer.

BACKGROUND: The protective effect of colonoscopy against proximal colorectal cancer is variable and depends on the detection and complete removal of precancerous polyps. OBJECTIVE: To estimate the efficacy of colonoscopy in a medical center with open-access screening colonoscopy since 1998. DESIGN: Nested case-control study with incidence density sampling. SETTING: University-affiliated Veterans Affairs Medical Center. PATIENTS: Colorectal cancer (CRC) cases and control subjects selected from screening age patients matched by age, gender, and date of first primary care visit. MAIN OUTCOME MEASUREMENT: Colonoscopy preceding the CRC diagnosis date. RESULTS: A total of 20.2% of CRC cases had a colonoscopy in the preceding 10 years compared with 49.0% of control subjects (adjusted odds ratio [aOR], 0.20; 95% confidence interval [CI], 0.11-0.34). Colonoscopy was strongly associated with decreased odds of both distal CRC (aOR, 0.16; 95% CI, 0.07-0.34) and proximal CRC (aOR, 0.26; 95% CI, 0.11-0.58). The fraction of cases attributed to interval cancers was 10.5%. Missed lesions predominantly localized to the cecum and rectum, and recurrent lesions clustered in the hepatic flexure. Cecal intubation rate was 93% (98% in adequately prepped patients), and the adenoma detection rate was 45.2% in the control group. LIMITATIONS: Single-center, retrospective case-control design. CONCLUSION: In an open access colonoscopy program characterized by a high cecal intubation rate and adenoma detection rate, colonoscopy was strongly associated with reduced odds of both distal and proximal CRC. Among interval cancers, missed lesions clustered in the cecum and rectum and recurrent lesions in the hepatic flexure.