ERCP improves mortality in acute biliary pancreatitis without cholangitis.

Background and study aims Acute pancreatitis (AP) is an increasingly common indication for hospitalization in the United States. The necessity for endoscopic retrograde cholangiopancreatography (ERCP) and the timing of ERCP in acute gallstone-related pancreatitis without cholangitis (AGPNC) is controversial. The aim of this study was to evaluate the association of ERCP and its performance during admission with mortality and length of stay (LOS) in patients with AGPNC. Patients and methods We queried the Nationwide Inpatient Sample (NIS) from 2004 to 2014 to identify all patients with admissions for gallstone AP. We excluded patients with chronic pancreatitis or concurrent cholangitis, and those who were transferred from elsewhere for treatment. Our primary outcome measure was inpatient mortality. Our secondary outcome measure was hospital length of stay (LOS). Results We identified 491,011 records eligible for analysis. Of the patients, 30.6 % (150,101) had AGPNC. There were 1.34 deaths per 100 admissions in patients with AGPNC. The average LOS was 5.88 (±â€Š6.38) days with a median stay of 4 days (range, 3-7). When adjusted for age, Elixhauser Comorbidity Index, and severe pancreatitis, patients with ERCP during admission were 43 % less likely to die. ERCP performed between Days 3 and 9 of hospitalization resulted in a significant mortality benefit. Among those who had ERCP, a shorter wait time for ERCP was associated with a shorter LOS after adjustment for demographics and severity of illness. Conclusion ERCP performed during inpatient admission for AGPNC was associated with decreased mortality. These data support early ERCP in patients with acute gallstone pancreatitis without cholangitis.

Efficacy of Endoscopic Submucosal Dissection for Superficial Gastric Neoplasia in a Large Cohort in North America.

BACKGROUND & AIMS: Endoscopic submucosal dissection (ESD) is a widely accepted treatment option for superficial gastric neoplasia in Asia, but there are few data on outcomes of gastric ESD from North America. We aimed to evaluate the safety and efficacy of gastric ESD in North America. METHODS: We analyzed data from 347 patients who underwent gastric ESD at 25 centers, from 2010 through 2019. We collected data on patient demographics, lesion characteristics, procedure details and related adverse events, treatment outcomes, local recurrence, and vital status at the last follow up. For the 277 patients with available follow-up data, the median interval between initial ESD and last clinical or endoscopic evaluation was 364 days. The primary endpoint was the rate of en bloc and R0 resection. Secondary outcomes included curative resection, rates of adverse events and recurrence, and gastric cancer-related death. RESULTS: Ninety patients (26%) had low-grade adenomas or dysplasia, 82 patients (24%) had high-grade dysplasia, 139 patients (40%) had early gastric cancer, and 36 patients (10%) had neuroendocrine tumors. Proportions of en bloc and R0 resection for all lesions were 92%/82%, for early gastric cancers were 94%/75%, for adenomas and low-grade dysplasia were 93%/ 92%, for high-grade dysplasia were 89%/ 87%, and for neuroendocrine tumors were 92%/75%. Intraprocedural perforation occurred in 6.6% of patients; 82% of these were treated successfully with endoscopic therapy. Delayed bleeding occurred in 2.6% of patients. No delayed perforation or procedure-related deaths were observed. There were local recurrences in 3.9% of cases; all occurred after non-curative ESD resection. Metachronous lesions were identified in 14 patients (6.9%). One of 277 patients with clinical follow up died of metachronous gastric cancer that occurred 2.5 years after the initial ESD. CONCLUSIONS: ESD is a highly effective treatment for superficial gastric neoplasia and should be considered as a viable option for patients in North America. The risk of local recurrence is low and occurs exclusively after non-curative resection. Careful endoscopic surveillance is necessary to identify and treat metachronous lesions.

EUS-guided pancreatic drainage: A steep learning curve.

BACKGROUND AND OBJECTIVE: EUS-guided pancreatic drainage (EUS-PD) is an efficacious, acceptable risk option for patients with pancreatic duct obstruction who fail conventional ERCP. The aim of this study was to define the learning curve (LC) for EUS-PD. METHODS: Consecutive patients undergoing EUS-PD by a single operator were included from a dedicated registry. Demographics, procedural info, adverse events, and follow-up data were collected. Nonlinear regression and cumulative sum (CUSUM) analyses were conducted for the LC. RESULTS: Fifty-six patients were included (54% of male, with a mean age of 58 years). Technical success was achieved in 47 patients (84%). Stent placement was antegrade in 36 patients (77%) and retrograde in 11 (23%). Clinical success was achieved in 46/47 (98%) patients who achieved technical success. Adverse events were seen in 13 patients (6 of whom did not achieve technical success) and included bleeding requiring embolization (n = 5), bleeding treated with clips peri-procedurally (n = 1), pancreatitis (n = 5), and a pancreatic fluid collection drained via EUS-drainage (n = 2). The median procedural time was 80 min (range 49-159 min). The CUSUM chart showed that 80-min procedural time was achieved at the 27th procedure. Durations further reduced 40th procedure onward, reaching a plateau indicating proficiency (nonlinear regression P < 0.0001). CONCLUSION: Endoscopists experienced in EUS-PD are expected to achieve a reduction in procedural time over successive cases, with efficiency reached at 80 min and a learning rate of 27 cases. Continued improvement is demonstrated with additional experience, with plateau indicating mastery suggested at the 40th case. EUS-PD is probably one of the hardest therapeutic endosonographic procedures to learn.

Optical coherence tomography of the pancreatic and bile ducts: are we ready for prime time?

Background and study aims First-generation optical coherence tomography (OCT) has been shown to increase diagnostic sensitivity for malignant biliary and pancreatic-duct strictures. A newer OCT imaging system, NVision Volumetric Laser Endomicroscopy (VLE), allows for in vivo cross-sectional imaging of the ductal wall at the microstructure level during endoscopic retrograde cholangiopancreatography (ERCP). The aim of this study was to identify and evaluate characteristics on OCT that are predictive of benign and malignant strictures. Patients and methods Consecutive patients from six centers who underwent OCT between September 2016 and September 2017 were included in a dedicated registry. OCT images were analyzed, and nine recurring characteristics were further assessed. Final diagnosis was based on histology and/or surgical pathology. Results 86 patients were included (49 % male, mean age 64.7). OCT was performed in the bile duct in 79 patients and the pancreatic duct in seven. Nine OCT characteristics were identified: dilated hypo-reflective structures (n = 7), onion-skin layering (n = 8), intact layering (n = 17), layering effacement (n = 25), scalloping (n = 20), thickened epithelium (n = 42), hyper-glandular mucosa (n = 13), prominent blood vessels (n = 6), and a hyper-reflective surface (n = 20). Presence of hyper-glandular mucosa, hyper-reflective surface and scalloping significantly increased the odds of malignancy diagnosis by 6 times more ( P  = 0.0203; 95 % CI 1.3 to 26.5), 4.7 times more ( P  = 0.0255; 95 % CI 1.2 to 18.0) and 7.9 times more ( P  = 0.0035; 95 % CI 1.97 to 31.8) respectively. Conclusion By providing in-vivo cross-sectional imaging of the pancreatic and biliary duct wall, OCT technology may improve sensitivity in diagnosing malignant strictures and provide standardizable criteria predictive of malignancy.

Endoscopic ultrasound-guided drainage of pancreatic walled-off necrosis using 20-mm versus 15-mm lumen-apposing metal stents: an international, multicenter, case-matched study.

BACKGROUNDS: Endoscopic ultrasound (EUS)-guided placement of lumen-apposing metal stents (LAMSs) has gained popularity for the treatment of pancreatic walled-off necrosis (WON). We compared the 20-mm and 15-mm LAMSs for the treatment of symptomatic WON in terms of clinical success and adverse events. METHODS: We conducted a retrospective, case-matched study of 306 adults at 22 tertiary centers from 04/2014 to 10/2018. A total of 102 patients with symptomatic WON who underwent drainage with 20-mm LAMS (cases) and 204 patients who underwent drainage with 15-mm LAMS (controls) were matched by age, sex, and drainage approach. Conditional logistic regression analysis was performed to compare clinical success (resolution of WON on follow-up imaging without reintervention) and adverse events (according to American Society for Gastrointestinal Endoscopy criteria). RESULTS: Clinical success was achieved in 92.2 % of patients with 20-mm LAMS and 91.7 % of patients with 15-mm LAMS (odds ratio 0.92; P = 0.91). Patients with 20-mm LAMS underwent fewer direct endoscopic necrosectomy (DEN) sessions (mean 1.3 vs. 2.1; P < 0.001), despite having larger WON collections (transverse axis 118.2 vs. 101.9 mm, P = 0.003; anteroposterior axis 95.9 vs. 80.1 mm, P = 0.01). There was no difference in overall adverse events (21.6 % vs. 15.2 %; P = 0.72) and bleeding events (4.9 % vs. 3.4 %; P = 0.54) between the 20-mm and 15-mm LAMS groups, respectively. CONCLUSIONS: The 20-mm LAMS showed comparable clinical success and safety profile to the 15-mm LAMS, with the need for fewer DEN sessions for WON resolution.

Endoscopic Therapy for Pancreatic Fluid Collections: A Definitive Management Using a Dedicated Algorithm.

BACKGROUND/AIMS:  Endoscopic ultrasonography (EUS)-guided drainage is the preferred approach for infected or symptomatic pancreatic fluid collections (PFCs). Here, we developed an algorithm for the management of pancreatitis complicated by PFCs and report on its effcacy and safety. METHODS: Between September 2011 and October 2017, patients were prospectively managed according to the algorithm. PFCs were classified as poorly organized fluid collections (POFCs), pancreatic pseudocysts (PPs), or walled-off pancreatic necrosis (WOPN). Clinical success was defined as a decrease in PFC size by ≥50% of the maximal diameter or to ≤2 cm. RESULTS:  A total of 108 patients (62% male; mean age, 53 years) were included: 13 had POFCs, 43 had PPs, and 52 had WOPN. Seventytwo patients (66%) required a pancreatic duct (PD) stent, whereas 65 (60%) received enteral feeding. A total of 103 (95%) patients achieved clinical success. Eight patients experienced complications including bleeding (n=6) and surgical intervention (n=2). Patients with enteral feeding were 3.4 times more likely to achieve resolution within 60 days (p=0.0421), whereas those with PD stenting was five times more likely to achieve resolution within 90 days (p=0.0069). CONCLUSION:  A high PFC resolution rate can be achieved when a dedicated algorithm encompassing EUS-guided drainage, PD stenting, and early enteral feeding is adopted.

Fully covered self-expanding metal stents for refractory pancreatic duct strictures in symptomatic chronic pancreatitis, US experience.

Background and study aims Fully covered self-expanding metal stents (FCSEMS) have been used to treat refractory pancreatic duct strictures. We aimed to evaluate the feasibility, safety, and efficacy of FCSEMS in chronic pancreatitis with refractory pancreatic duct strictures. Patients and methods This was a retrospective multicenter cases series of patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) with FCSEMS placement in the main pancreatic duct (MPD) at five tertiary care centers between February 2010 and June 2016. Primary endpoints were technical success, clinical success, and procedure-related morbidity. Secondary endpoints were pain relief at the end of follow-up and resolution of the pancreatic stricture on ERCP. Results Thirty-three patients with previously drained stents, 76 % of whom were male, underwent ERCP with FCSEMS placement. Mean duration of follow-up was 14 months. All of the patients had prior therapy. The technical success rate for FCSEMS placement was 100 % (n = 33) and the clinical success rate was 93 % (was n = 31). Stents were removed after a median duration of 14.4 weeks. After stent removal, the diameter of the narrowest MPD stricture had increased significantly from 1 mm to 4.5 mm ( P  < 0.001). There was a statistically significant improvement on the Visual Analogue Scale (VAS) from a median of 8.5 to 2.5. At the end of the study, (n = 27) 87.1 % of patients reported significant pain reduction with reduced narcotic use. Conclusion FCSEMS appeared to be a feasible, safe, and potentially effective Intervention in patients who had not responded to endoscopic therapy with plastic stents.

Practical Management of Indeterminate Biliary Strictures.

Indeterminate biliary strictures pose a diagnostic and therapeutic challenge. Although underlying malignancy is a primary concern, biliary strictures may result from benign processes. An accurate diagnosis is paramount to define the treatment strategy and minimize morbidity. The limitations of traditional endoscopic retrograde cholangiopancreatography-based tissue acquisition with cytology brushings are well-documented. Endoscopic retrograde cholangiopancreatography is generally unable to determine a stricture's etiology. Complementary advanced endoscopic imaging and multimodal tissue acquisition have evolved. Careful consideration of the clinical presentation, location of the stricture, and interpretation of imaging constitute the most optimal approach for diagnosis and management.

Discontinuation of proton pump inhibitor use reduces the number of endoscopic procedures required for resolution of walled-off pancreatic necrosis.

BACKGROUND AND OBJECTIVES: Endoscopic drainage/debridement of symptomatic walled off necrosis (WON) using lumen-apposing metal stents (LAMS) is both safe and effective. While endoscopic management of WON is the standard approach to treatment, the ideal concomitant medical therapy remains unclear. The purpose of this study was to further elucidate the effect of proton pump inhibitor (PPIs) therapy on the technical and clinical success of endoscopic treatment of WON. METHODS: Two hundred and seventy-two patients in 8 centers with WON managed by endoscopic drainage using LAMS were evaluated. Patients were followed for at least 6 months following treatment. The patients were divided into two groups: Those that used PPIs continuously during the therapy and those not on PPIs continuously during the interval of therapy. Outcomes included but were not limited to technical success, clinical success, number of procedures performed, and adverse events. RESULTS: From 2013 to 2016, 272 patients underwent WON drainage with successful transmural LAMS placement. The two groups were split evenly into PPI users and non-PPI users, and matched in regards to demographics, etiology of pancreatitis, WON size, and location. There was no difference in the technical success between the two groups (100% vs. 98.8%, P = 1), or in clinical success rates (78.7% vs. 77.9%). There was a significant difference in the required number of direct endoscopic necrosectomies to achieve clinical success in the PPI vs. non-PPI group (3.2 vs. 4.6 respectively, P < 0.01). There were significantly more cases of stent occlusion in the non-PPI group vs. PPI group (9.5% vs. 20.1% P = 0.012), but all other documented adverse events were not significantly different. CONCLUSION: Discontinuing PPIs during endoscopic drainage and necrosectomy of symptomatic WON appears to reduce the number of endoscopic procedures required to achieve resolution. Continuous PPI results in higher rates of early stent occlusion.

Single Fluid-Filled Intragastric Balloon Safe and Effective for Inducing Weight Loss in a Real-World Population.

BACKGROUND & AIMS: The Orbera intragastric balloon (OIB) is a single fluid-filled intragastric balloon approved for the induction of weight loss and treatment of obesity. However, little is known about the effectiveness and safety of the OIB outside clinical trials, and since approval, the Food and Drug Administration has issued warnings to health care providers about risk of balloon hyperinflation requiring early removal, pancreatitis, and death. We analyzed data on patients who have received the OIB since its approval to determine its safety, effectiveness, and tolerance in real-world clinical settings. METHODS: We performed a postregulatory approval study of the safety and efficacy of the OIB, and factors associated with intolerance and response. We collected data from the Mayo Clinic's database of patient demographics, outcomes of OIB placement (weight loss, weight-related comorbidities), technical aspects of insertion and removal, and adverse events associated with the device and/or procedure, from 8 centers (3 academic, 5 private, 4 surgeons, and 4 gastroenterologists). Our final analysis comprised 321 patients (mean age, 48.1 ± 11.9 y; 80% female; baseline body mass index, 37.6 ± 6.9). Exploratory multivariable linear and logistic regression analyses were performed to identify predictors of success and early balloon removal. Primary effectiveness outcomes were percentage of total body weight lost at 3, 6, and 9 months. Primary and secondary safety outcomes were rates of early balloon removal, periprocedural complications, dehydration episodes requiring intravenous infusion, balloon migration, balloon deflation or hyperinflation, pancreatitis, or other complications. RESULTS: Four patients had contraindications for placement at the time of endoscopy. The balloon was safely removed in all instances with an early removal rate (before 6 months) in 16.7% of patients, at a median of 8 weeks after placement (range, 1-6 mo). Use of selective serotonin or serotonin-norepinephrine re-uptake inhibitors at the time of balloon placement was associated with increased odds of removal before 6 months (odds ratio, 3.92; 95% CI, 1.24-12.41). Total body weight lost at 3 months was 8.5% ± 4.9% (n = 204), at 6 months was 11.8% ± 7.5% (n = 199), and at 9 months was 13.3% ± 10% (n = 47). At 6 months, total body weight losses of 5%, 10%, and 15% were achieved by 88%, 62%, and 31% of patients, respectively. Number of follow-up visits and weight loss at 3 months were associated with increased weight loss at 6 months (ß = 0.5 and 1.2, respectively) (P < .05). Mean levels of cholesterol, triglycerides, low-density lipoprotein, and hemoglobin A1c, as well as systolic and diastolic blood pressure, were significantly improved at 6 months after OIB placement (P < .05). CONCLUSIONS: In an analysis of a database of patients who received endoscopic placement of the OIB, we found it to be safe, effective at inducing weight loss, and to reduce obesity-related comorbidities in a real-world clinical population. Rates of early removal (before 8 weeks) did not differ significantly between clinical trials and the real-world population, but were affected by use of medications.

Endoscopic Sleeve Gastroplasty, Laparoscopic Sleeve Gastrectomy, and Laparoscopic Band for Weight Loss: How Do They Compare?

BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is a novel endobariatric procedure. Initial studies demonstrated an association of ESG with weight loss and improvement of obesity-related comorbidities. Our aim was to compare ESG to laparoscopic sleeve gastrectomy (LSG) and laparoscopic adjustable gastric banding (LAGB). METHODS: We included 278 obese (BMI > 30) patients who underwent ESG (n = 91), LSG (n = 120), or LAGB (n = 67) at our tertiary care academic center. Primary outcome was percent total body weight loss (%TBWL) at 3, 6, 9, and 12 months. Secondary outcome measures included adverse events (AE), length of stay (LOS), and readmission rate. RESULTS: At 12-month follow-up, LSG achieved the greatest %TBWL compared to LAGB and ESG (29.28 vs 13.30 vs 17.57%, respectively; p < 0.001). However, ESG had a significantly lower rate of morbidity when compared to LSG or LAGB (p = 0.01). The LOS was significantly less for ESG compared to LSG or LAGB (0.34 ± 0.73 vs 3.09 ± 1.47 vs 1.66 ± 3.07 days, respectively; p < 0.01). Readmission rates were not significantly different between the groups (p = 0.72). CONCLUSION: Although LSG is the most effective option for weight loss, ESG is a safe and feasible endobariatric option associated with low morbidity and short LOS in select patients.

Rapid Primary Care Follow-up from the ED to Reduce Avoidable Hospital Admissions.

INTRODUCTION: Hospital admissions from the emergency department (ED) now account for approximately 50% of all admissions. Some patients admitted from the ED may not require inpatient care if outpatient care could be optimized. However, access to primary care especially immediately after ED discharge is challenging. Studies have not addressed the extent to which hospital admissions from the ED may be averted with access to rapid (next business day) primary care follow-up. We evaluated the impact of an ED-to-rapid-primary-care protocol on avoidance of hospitalizations in a large, urban medical center. METHODS: We conducted a retrospective review of patients referred from the ED to primary care (Weill Cornell Internal Medicine Associates - WCIMA) through a rapid-access-to-primary-care program developed at New York-Presbyterian / Weill Cornell Medical Center. Referrals were classified as either an avoided admission or not, and classifications were performed by both emergency physician (EP) and internal medicine physician reviewers. We also collected outcome data on rapid visit completion, ED revisits, hospitalizations and primary care engagement. RESULTS: EPs classified 26 (16%) of referrals for rapid primary care follow-up as avoided admissions. Of the 162 patients referred for rapid follow-up, 118 (73%) arrived for their rapid appointment. There were no differences in rates of ED revisits or subsequent hospitalizations between those who attended the rapid follow-up and those who did not attend. Patients who attended the rapid appointment were significantly more likely to attend at least one subsequent appointment at WCIMA during the six months after the index ED visit [N=55 (47%) vs. N=8 (18%), P=0.001]. CONCLUSION: A rapid-ED-to-primary-care-access program may allow EPs to avoid admitting patients to the hospital without risking ED revisits or subsequent hospitalizations. This protocol has the potential to save costs over time. A program such as this can also provide a safe and reliable ED discharge option that is also an effective mechanism for engaging patients in primary care.