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.

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.

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.

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.

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.

Plastic biliary stent patency in patients with locally advanced pancreatic adenocarcinoma receiving downstaging chemotherapy.

BACKGROUND: Plastic stents in patients with biliary obstruction caused by pancreatic adenocarcinoma are typically exchanged at 3-month intervals. Plastic stents may have reduced durability in patients receiving chemotherapy. OBJECTIVE: To determine the duration of plastic biliary stent patency in patients undergoing chemotherapy for pancreatic adenocarcinoma. DESIGN: Retrospective, multicenter cohort study. SETTING: Three tertiary academic referral centers. PATIENTS: A total of 173 patients receiving downstaging chemotherapy for locally advanced or borderline resectable pancreatic adenocarcinoma from 1996 to 2013. INTERVENTIONS: Placement of 10F or larger plastic biliary stents. MAIN OUTCOME MEASUREMENTS: Primary outcome was overall duration of stent patency. Secondary outcomes included the incidence of premature stent exchange (because of cholangitis or jaundice) and hospitalization rates. RESULTS: A total of 233 plastic stents were placed, and the overall median duration of stent patency was 53 days (interquartile range [IQR] 25-99 days). Eighty-seven stents were removed at the time of surgical resection, and 63 stents were exchanged routinely per protocol. The remaining 83 stent exchanges were performed for worsening liver function test results, jaundice, or cholangitis, representing a 35.6% rate of premature stent exchange. The median stent patency duration in the premature stent exchange group was 49 days (IQR 25-91 days) with a 44.6% hospitalization rate. The overall rate of cholangitis was 15.0% of stent exchanges, occurring a median of 56 days after stent placement (IQR 26-89 days). LIMITATIONS: Retrospective study. CONCLUSIONS: Plastic biliary stents placed during chemotherapy/chemoradiation for pancreatic adenocarcinoma have a shorter-than-expected patency duration, and a substantial number of patients will require premature stent exchange. Consideration should be given to shortening the interval for plastic biliary stent exchange.

Suck-ligate-unroof-biopsy by using a detachable 20-mm loop for the diagnosis and therapy of small subepithelial tumors (with video).

BACKGROUND: The diagnosis and therapy of subepithelial tumors (SETs) can be challenging. OBJECTIVE: Proof-of-concept evaluation of the suck-ligate-unroof-biopsy (SLUB) technique for small (<2 cm), non-pedunculated SETs. DESIGN: Pilot feasibility study. SETTING: Tertiary-care referral center. PATIENTS: Twenty-three patients (median age 60 years) meeting the inclusion criteria after preliminary EUS. INTERVENTION: SET ligation was performed with a detachable 20-mm loop deployed through an 18-mm diameter, soft, oblique, transparent, cap attachment. The SLUB technique comprised (1) suction to draw the SET into the cap; (2) ligation below the SET, confirmation by repeat EUS; (3) unroofing of the overlying mucosa with a needle-knife; and (4) biopsy specimens taken from the exposed tumor. MAIN OUTCOME MEASUREMENTS: Technical success, histology and/or immunohistochemistry yield, adverse events, completeness of resection. RESULTS: SLUB was attempted on 24 SETs and was technically successful in all. Location was the stomach (n = 19), small bowel (n = 1), colon (n = 2), and rectum (n = 2). Median size by EUS was 10 mm (range 6-15 mm). Biopsy specimens provided an immunohistologic diagnosis in all cases: GI stromal tumor (n = 5), leiomyoma (n = 8), carcinoid tumor (n = 5), Vanek's tumor (n = 2), granuloma (n =1), and pancreatic heterotopia (n = 3). Follow-up endoscopy and EUS in 13 patients showed well-healed scars with no residual tumor, including all 9 patients with premalignant neoplastic lesions. The only adverse event was self-limited pain in 2 patients. LIMITATIONS: Single center, single operator, small sample size. CONCLUSIONS: Loop ligation of small, non-pedunculated SETs is feasible by using a cap attachment for suction. Unroofing after ligation is safe and provides sufficient tissue for immunohistochemistry. Ligation combined with unroofing appears to lead to complete ablation by ischemia and tumor enucleation.

EUS-FNA is superior to ERCP-based tissue sampling in suspected malignant biliary obstruction: results of a prospective, single-blind, comparative study.

BACKGROUND: Both EUS and ERCP sampling techniques may provide tissue diagnoses in suspected malignant biliary obstruction. However, there are scant data comparing these 2 methods. OBJECTIVE: To compare EUS-guided FNA (EUS-FNA) and ERCP tissue sampling for the diagnosis of malignant biliary obstruction. DESIGN: Prospective, comparative, single-blind study. SETTING: Tertiary center. PATIENTS: Fifty-one patients undergoing same-session EUS and ERCP for the evaluation of malignant biliary obstruction over a 1-year period. INTERVENTIONS: EUS-FNA and ERCP tissue sampling with biliary brush cytology and intraductal forceps biopsies. MAIN OUTCOME MEASUREMENTS: Diagnostic sensitivity and accuracy of each sampling method compared with final diagnoses. RESULTS: EUS-FNA was more sensitive and accurate than ERCP tissue sampling (P < .0001) in 51 patients with pancreatic cancers (n = 34), bile duct cancers (n = 14), and benign biliary strictures (n = 3). The overall sensitivity and accuracy were 94% and 94% for EUS-FNA, and 50% and 53% for ERCP sampling, respectively. EUS-FNA was superior to ERCP tissue sampling for pancreatic masses (sensitivity, 100% vs 38%; P < .0001) and seemed comparable for biliary masses (79% sensitivity for both) and indeterminate strictures (sensitivity, 80% vs 67%). LIMITATIONS: Single-center study. CONCLUSION: EUS-FNA is superior to ERCP tissue sampling in evaluating suspected malignant biliary obstruction, particularly for pancreatic masses. EUS-FNA appears similar to ERCP sampling for biliary tumors and indeterminate strictures. Given the superior performance characteristics of EUS-FNA and the higher incidence of pancreatic cancer compared with cholangiocarcinoma, EUS-FNA should be performed before ERCP in all patients with suspected malignant biliary obstruction. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT01356030.).

The Bethesda ERCP Skills Assessment Tool (BESAT) can reliably differentiate endoscopists of different experience levels.

Background and study aims The Bethesda ERCP Skill Assessment Tool (BESAT) is a video-based assessment tool of technical endoscopic retrograde cholangiopancreatography (ERCP) skill with previously established validity evidence. We aimed to assess the discriminative validity of the BESAT in differentiating ERCP skill levels. Methods Twelve experienced ERCP practitioners from tertiary academic centers were asked to blindly rate 43 ERCP videos using the BESAT. ERCP videos consisted of native biliary cannulation and sphincterotomy and were recorded from 10 unique endoscopists of various ERCP experience (from advanced endoscopy fellow to > 10 years of ERCP experience). Inter-rater reliability, discriminative validity, and internal structure validity were subsequently assessed. Results The BESAT was found to reliably differentiate between endoscopists of varying levels of ERCP experience with experienced ERCPists scoring higher than novice ERCPists in 11 of 13 (85%) instrument items. Inter-rater reliability for BESAT items ranged from good to excellent (intraclass correlation range: 0.86 to 0.93). Internal structure validity was assessed with item-total correlations ranging from 0.53 to 0.83. Conclusions Study findings demonstrate that the BESAT, a video-based ERCP skill assessment tool, has high inter-rater reliability and has discriminative validity in differentiating novice from expert ERCP skill. Further investigations are needed to determine the role of video-based assessment in improving trainee learning curves and patient outcomes.

Retract-ligate-unroof-biopsy: a novel approach to the diagnosis and therapy of large nonpedunculated stromal tumors (with video).

BACKGROUND: We report a novel technique of retract-ligate-unroof-biopsy (RLUB) for the diagnosis and treatment of large nonpedunculated upper GI stromal tumors originating from the muscularis propria. OBJECTIVE: Proof-of-concept evaluation of the RLUB technique. DESIGN: Pilot and feasibility study. SETTING: Tertiary care center. PATIENTS: Sixteen patients (median age 71 years) fulfilling the following inclusion criteria: poor surgical candidates with lesions that are broad based with a benign appearance, originating from the muscularis propria, size 2 cm or larger. INTERVENTIONS: A double-channel endoscope was used to simultaneously retract the stromal tumor while advancing an endoloop beyond the tumor for ligation. The overlying tissue was incised ("unroofed") to expose and partially enucleate the tumor, and multiple biopsy samples were obtained. After unroofing, an additional endoloop was placed below the previous one by using the loop-over-loop technique to reinforce enucleation and ischemic ablation. MAIN OUTCOME MEASUREMENTS: Successful ligation, immunohistochemistry and mitotic index yield, therapeutic ablation, adverse events. RESULTS: Technical success was achieved in 13 of 16 patients (81%). Immunohistology of biopsy specimens: GI stromal tumor (n = 10), leiomyoma (n = 3). Twelve of 13 patients (92%) with follow-up (median 22 weeks, range 1-82.5 weeks) had confirmed tumor ablation by endoscopy and EUS. One patient with partial resolution was re-treated, but was subsequently lost to follow-up. Delayed bleeding occurred in 2 patients that required hospitalization and blood transfusions, both successfully controlled with repeat endolooping. One patient reported transient pain. LIMITATIONS: Single center, single operator, small sample size. CONCLUSIONS: The RLUB technique is feasible as a platform for full-thickness treatment of stromal tumors. Limitations encountered included technical challenges and delayed bleeding. Further developmental work is needed.

"Underwater" EMR of sporadic laterally spreading nonampullary duodenal adenomas (with video).

BACKGROUND: EMR for the treatment of duodenal adenomas is challenging due to a thin wall and rich vascularity. OBJECTIVE: To evaluate a novel technique of "underwater" EMR without prior submucosal injection for the removal of large (≥2 cm) laterally spreading nonampullary duodenal adenomas. DESIGN: Prospective, observational study. SETTING: Tertiary academic referral center. PATIENTS: Twelve patients (median age, 60 years) meeting the inclusion criteria. INTERVENTIONS: Piecemeal EMR technique after sterile water submersion when using a double-channel endoscope. MAIN OUTCOME MEASUREMENTS: Technical success, adverse events, completeness of resection on follow-up endoscopy. RESULTS: Median adenoma size was 35 mm (25% greater than one-half circumference, 50% equal to one-third to one-half circumference, and 25% less than one-third circumference). Median procedure time was 65 minutes (range, 32-151). Final histology was tubular adenoma (7), tubulovillous adenoma (1), villous adenoma (3), and high-grade dysplasia (1). Eleven patients (92%) met the primary endpoint (technical success) and all patients met the secondary endpoint (completeness of resection). Median interval until follow-up endoscopy was 16 weeks (range, 11-56). Adverse events were as follows: delayed bleeding (3 patients, of whom 2 required transfusions), water intoxication syndrome manifested by altered mental status and hyponatremia (1), and stricture formation (1) that responded to balloon dilation. No perforation or postresection abdominal pain was found. LIMITATIONS: Single operator, single center, small sample size, limited follow-up. CONCLUSION: Underwater EMR for large sessile duodenal adenomas has high success rates for complete removal. The risk of delayed bleeding is significant, and precautions are needed when infusing a large volume of fluid into the GI tract.

Endosonography-guided transmural drainage of pancreatic pseudocysts using an exchange-free access device: initial clinical experience.

BACKGROUND: Endosonography (EUS)-guided transmural pseudocyst drainage is a multistep procedure currently performed with different "off-the-shelf" accessories developed for other applications. Multiple device exchanges over-the-wire is time consuming and risks loss of wire access. This report describes the technical feasibility and outcomes for EUS-guided drainage of pancreatic fluid collections using a novel exchange-free device developed for translumenal therapy. METHODS: Between April and November 2010, 14 patients (9 men; mean age, 49.9 years) with pancreatic fluid collection (mean size, 102 mm) underwent 16 EUS-guided drainage procedures using the exchange-free access device at a single tertiary care center. The trocar of the exchange-free device was used to gain pseudocyst access. The dual-balloon catheter then was advanced over the trocar, followed by inflation of the (first) anchor balloon. Cyst contents were sampled, and contrast was injected to define the pseudocyst anatomy. The first guidewire was inserted into the cyst cavity. The cystenterostomy tract was dilated to 10 mm with the (second) dilation balloon, followed by a second guidewire insertion. The exchange-free access device was removed, leaving the two guidewires in place for two double-pigtail stents. RESULTS: The procedure was technically successful for all the patients. No acute procedure-related complications occurred. Late complications included a symptomatic leak in a patient who underwent drainage of a pancreatic uncinate pseudocyst from the second duodenum, a self-limited transfusion-dependent bleed after transbulbar drainage, and symptomatic pseudocyst infection. CONCLUSION: Pseudocyst access, cystenterostomy tract dilation, and placement of two guidewires for dual stent drainage are technically feasible using an exchange-free access device. The device has the potential to standardize, simplify, and streamline EUS-guided pseudocyst drainage with a single instrument. Comparative studies with alternative tools and methods for pseudocyst drainage are warranted.

Randomized trial of standard versus magnetic endoscope imaging colonoscopes for unsedated colonoscopy.

BACKGROUND: Unsedated colonoscopy has potential benefits, including decreased costs and decreased risks. OBJECTIVE: To determine whether patient comfort during unsedated colonoscopy can be improved through the use of a magnetic endoscopic imaging (MEI) colonoscope compared with a standard colonoscope. DESIGN: Prospective, patient-blinded, randomized, controlled trial. SETTING: San Francisco Veterans Affairs Medical Center. PATIENTS: Veterans undergoing outpatient screening or surveillance colonoscopy. INTERVENTIONS: Use of a standard or MEI colonoscope during unsedated colonoscopy. MAIN OUTCOME MEASUREMENT: The primary outcome variable was patient perception of pain using a 7-point scale. The secondary endpoint was patient willingness to undergo a future unsedated colonoscopy. RESULTS: Of the 160 patients enrolled, 140 completed an unsedated colonoscopy in the study protocol. In a per-protocol analysis, the mean and median pain score was 3.12 (standard deviation 1.22) and 4 (interquartile range 2-4) for the standard colonoscope group and 3.06 (standard deviation 1.13) and 3 (interquartile range 2-4) for the MEI group, where 3 was mild pain (P = not significant). Overall, 80% of subjects were willing to undergo a future unsedated colonoscopy for screening or surveillance. In an intention-to-treat analysis, 80% of subjects (64/80) in the standard colonoscope arm and 79% in the MEI arm (63/80) were willing to undergo a future unsedated colonoscopy (P = not significant). LIMITATIONS: Single-center study of mostly male veterans. CONCLUSIONS: This patient-blinded, randomized, controlled trial did not demonstrate any difference in patient perception of pain or willingness to undergo unsedated examinations when using the MEI versus the conventional colonoscope. Unsedated colonoscopy is generally feasible and well tolerated and is associated with high patient satisfaction rates.