Treatment of walled-off necrosis using lumen-apposing metal stents versus plastic stents: a systematic review and meta-analysis of data from randomized trials.

BACKGROUND: Walled-off necrosis (WON) is highly morbid disease most effectively managed by endoscopic drainage with lumen-apposing metal stents (LAMSs) or plastic stents, with or without necrosectomy. This meta-analysis compared the clinical outcomes of patients included in randomized trials treated using LAMSs or plastic stents. METHODS: The MEDLINE and EMBASE databases were searched to identify all data collected from randomized trials comparing LAMSs and plastic stents for the treatment of WON. The primary outcome measure was need for endoscopic necrosectomy. RESULTS: Three studies comprising 206 patients met inclusion criteria. Except for procedure duration, which was significantly shorter for LAMSs (standardized mean difference [SMD] -1.22, 95%CI -1.64 to -0.79), there was no significant difference in need for necrosectomy (38.5% vs. 41.2%; risk ratio [RR] 1.07, 95%CI 0.79-1.45), number of interventions (SMD -0.09, 95%CI -0.40 to 0.22), treatment success (90.7% vs. 94.5%; RR 0.96, 95%CI 0.87-1.06), recurrence (4.6% vs. 0.6%; RR 3.73, 95%CI 0.42-33.0), readmission (42.6% vs. 50.2%; RR 0.84, 95%CI 0.62-1.14), length of hospitalization (SMD -0.06, 95%CI -0.55 to 0.43), mortality (8.5% vs. 9.8%; RR 0.70, 95%CI 0.30-1.66), new-onset organ failure (10.6% vs. 14.6%; RR 0.72, 95%CI 0.16-3.32), bleeding (11.0% vs. 10.7%; RR 1.09, 95%CI 0.34-3.44), procedural adverse events (23.6% vs. 19.2%; RR 1.38, 95%CI 0.82-2.33), or overall costs (SMD -0.04, 95%CI -0.31 to 0.24) between LAMSs and plastic stents, respectively. CONCLUSIONS: Except for procedure duration, there is no significant difference in clinical outcomes for patients with WON treated using LAMSs or plastic stents.

Impact of endoprosthesis type on inflammatory response in patients undergoing endoscopic drainage of pancreatic fluid collections.

OBJECTIVE: To study the impact of endoprosthesis type on inflammatory response in patients undergoing endoscopic ultrasound (EUS)-guided drainage of pancreatic fluid collections (PFC). METHODS: Patients undergoing EUS-guided PFC drainage and treated using lumen-apposing metal stents (LAMS) or plastic endoprostheses constituted the study cohort. The primary outcome was the presence of systemic inflammatory response syndrome (SIRS) after index intervention. Secondary outcomes were persistent organ failure, new onset organ failure, duration of hospitalization, and treatment success. RESULTS: In all, 303 patients were treated using LAMS (n = 247) or plastic stents (n = 56). At 48 h postintervention, the presence of SIRS (25.0 vs. 14.2%, P = 0.047), new onset SIRS (10.0 vs. 1.8%, P = 0.017), and new organ failure (5.4 vs. 0.4%, P = 0.003) were significantly higher in the plastic stent cohort compared to LAMS. On multivariable logistic regression analysis, the use of plastic stents (odds ratio [OR] 2.7, 95% confidence interval [CI] 1.2-6.0, P = 0.014), patients receiving high-acuity care (OR 5.1, 95% CI 2.5-10.4, P < 0.001) and the presence of ≥33% of necrosis (OR 4.5, 95% CI 2.0-10.0, P < 0.001) were significantly associated with the presence of SIRS or new organ failure. While there was no significant difference in treatment success (96.4 vs. 95.5%, P = 0.77), duration of hospitalization was significantly longer for the plastic stent cohort (mean [standard deviation] 12.5 [17.8] vs. 7.9 [10.1] days, P = 0.009). CONCLUSIONS: Use of plastic stents as compared to LAMS was associated with a higher proportion of SIRS and new organ failure that prolonged hospital stay. Therefore, placement of LAMS is recommended in sick patients and those with ≥33% necrosis to minimize inflammatory response.

Outcomes of a Structured, Stepwise Approach to Endoscopic Necrosectomy.

BACKGROUND AND AIM: Despite the increasing number of procedures being performed, there is no consensus on the optimal approach to performing direct endoscopic necrosectomy (DEN), which is a labor-intensive, nonstandardized intervention. We prospectively validated the usefulness of a predefined, structured, stepwise approach to DEN with the objective of improving procedural efficiency and resource use. MATERIALS AND METHODS: A prospective study of patients with necrotizing pancreatitis who after endoscopic transluminal drainage did not have clinical improvement and required DEN. The study was undertaken in 2 phases. Phase I was a retrospective analysis of interventions performed using an unstructured, conventional approach. Median of 3 necrosectomy sessions (range, 2 to 3) were required to achieve 80% treatment success in 20 patients. On the basis of these observations, a structured approach that included 3 steps (debridement, necrosis extraction, and irrigation) was developed and validated prospectively in phase II in 39 patients. The main outcome was to compare procedural efficiency defined as a number of necrosectomy sessions to achieve treatment success. RESULTS: Although there was no significant difference in treatment success (phase I=80.0 vs. phase II=94.9%, P=0.17), the procedure was more efficient in phase II [median session, 2 (interquartile range=1 to 3) vs. 3 (interquartile range=2 to 3); P=0.003]. Multiple logistic regression analysis revealed that a structured, stepwise approach was associated with fewer necrosectomy sessions to achieve treatment success (odds ratio=4.7; 95% confidence interval=1.5-15.0; P=0.008) when adjusted for patient demographics, lab parameters, and disease characteristics. CONCLUSIONS: By decreasing the number of necrosectomy sessions, a structured, stepwise approach to endoscopic necrosectomy seems to improve procedural efficiency.

Superiority of endoscopic interventions over minimally invasive surgery for infected necrotizing pancreatitis: meta-analysis of randomized trials.

BACKGROUND AND AIM: Infected necrotizing pancreatitis is a highly morbid disease managed by minimally invasive surgical (MIS) or endoscopy-based interventions. This meta-analysis compared the clinical outcomes of patients treated using either approach. METHODS: MEDLINE and EMBASE databases were searched to identify all randomized trials that compared MIS and endoscopy-based interventions for treatment of infected necrotizing pancreatitis. Main outcome measure was to compare rates of complications or death during 6-month follow-up. RESULTS: Three studies involving 184 patients met inclusion criteria. While there was no significant difference in mortality (14.5% vs. 16.1%, risk ratio [RR] = 1.02, P = 0.963), new onset multiple organ failure (5.2% vs. 19.7%, RR = 0.34, P = 0.045), enterocutaneous fistula/perforation (3.6% vs. 17.9%, RR = 0.34, P = 0.034) and pancreatic fistula (4.2% vs. 38.2%, RR = 0.13, P < 0.001) were significantly lower for endoscopic interventions compared to MIS. There was no significant difference in intraabdominal bleeding, endocrine or exocrine pancreatic insufficiency between cohorts. Length of hospital stay was significantly shorter for endoscopy (standardized mean difference, -0.41, P = 0.010). CONCLUSIONS: An endoscopy-based treatment approach, as compared to minimally invasive surgery, significantly reduces complications in patients with infected necrotizing pancreatitis.

Impact of Disconnected Pancreatic Duct Syndrome on the Endoscopic Management of Pancreatic Fluid Collections.

OBJECTIVE: To study the effect of disconnected pancreatic duct syndrome (DPDS) on endoscopic management of pancreatic fluid collections (PFCs). BACKGROUND: Data on the impact of DPDS in patients undergoing endoscopic treatment of PFCs are limited. METHODS: Retrospective study of patients undergoing endoscopic drainage of PFCs from 2003 to 2015. If treatment response was suboptimal following initial endoscopic or endoscopic ultrasound-guided transmural drainage, hybrid interventions (endoscopic ultrasound-guided multigate/dual modality technique, endoscopic/percutaneous sinus tract necrosectomy) were performed. Transmural stents were left permanently in situ in DPDS patients from 2008 onwards. Main outcome measures were to evaluate the effect of DPDS on need for hybrid treatment, reinterventions, rescue surgery, length of stay, and overall treatment success. RESULTS: Of 361 patients, 34 (9.4%) were acute collections, 178 (49.3%) pseudocysts, and 149 (41.3%) walled-off necrosis (WON). DPDS was present in 167 (46.3%) patients, absent in 124 (34.3%), unknown in 70 (19.4%), and occurred more frequently in WON compared to other PFCs (68.3% vs 31.7%; P < 0.001). Although there was no difference in treatment success, more patients with DPDS required hybrid treatment (31.1% vs 4.8%, P < 0.001), reinterventions (30% vs 18.5%, P = 0.03), rescue-surgery (13.2% vs 4.8%, P = 0.02), and longer length of stay [median (interquartile range) days, 3 (2-10) vs 2 (1-4), P = 0.003]. PFC recurrence was lower in patients with DPDS with permanent transmural stents (17.4% vs 1.7%, P < 0.001). On multivariate logistic regression, DPDS [odds ratio (OR) 2.99], WON (OR 3.37), PFC size of 100 mm or more (OR 2.66), and multiple PFCs (OR 10.6) were associated with need for hybrid treatment. CONCLUSIONS: DPDS has a significant effect on endoscopic management of PFCs as more patients required hybrid treatment, reinterventions, and rescue surgery for achieving optimal clinical outcomes.

International consensus statements on early chronic Pancreatitis. Recommendations from the working group for the international consensus guidelines for chronic pancreatitis in collaboration with The International Association of Pancreatology, American Pancreatic Association, Japan Pancreas Society, PancreasFest Working Group and European Pancreatic Club.

BACKGROUND: Chronic pancreatitis (CP) is a progressive inflammatory disorder currently diagnosed by morphologic features. In contrast, an accurate diagnosis of Early CP is not possible using imaging criteria alone. If this were possible and early treatment instituted, the later, irreversible features and complications of CP could possibly be prevented. METHOD: An international working group supported by four major pancreas societies (IAP, APA, JPS, and EPC) and a PancreasFest working group sought to develop a consensus definition and diagnostic criteria for Early CP. Ten statements (S1-10) concerning Early CP were used to gauge consensus on the Early CP concept using anonymous voting with a 9 point Likert scale. Consensus required an alpha ≥0.80. RESULTS: No consensus statement could be developed for a definition of Early-CP or diagnostic criteria. There was consensus on 5 statements: (S2) The word "Early" in early chronic pancreatitis is used to describe disease state, not disease duration. (S4) Early CP defines a stage of CP with preserved pancreatic function and potentially reversible features. (S8) Genetic variants are important risk factors for Early CP and can add specificity to the likely etiology, but they are neither necessary nor sufficient to make a diagnosis. (S9) Environmental risk factors can provide evidence to support the diagnosis of Early CP, but are neither necessary nor sufficient to make a diagnosis. (S10) The differential diagnosis for Early CP includes other disorders with morphological and functional features that overlap with CP. CONCLUSIONS: Morphology based diagnosis of Early CP is not possible without additional information. New approaches to the accurate diagnosis of Early CP will require a mechanistic definition that considers risk factors, biomarkers, clinical context and new models of disease. Such a definition will require prospective validation.

Beyond Abdominal Pain: Pain Beliefs, Pain Affect, and Distress as Determinants of Quality of Life in Patients With Chronic Pancreatitis.

GOALS: To assess the relationship between pain, psychological processes, and quality of life (QOL) in chronic pancreatitis (CP). BACKGROUND: CP is a progressive inflammatory disorder of the pancreas characteristically resulting in abdominal pain and impairing QOL. Pain due to CP is poorly understood and frequently difficult to treat. This pain has historically been understood as a peripheral process originating from the pancreas itself, but a growing body of literature is revealing an important role offered by central influences. Viewed through the perspective of the biopsychosocial model of illness, cognitive variables strongly influence QOL. However, there is little understanding of variables that influence QOL in CP. STUDY: Patients with CP from the University of Alabama at Birmingham were administered a 165-question test battery which was comprised of questionnaires evaluating pain beliefs, disease-specific QOL, psychological distress, pain sensation, pain affect, and long-term suffering. RESULTS: Sixty-eight subjects completed the question battery between February 28, 2011 and January 16, 2014. Almost all (91.2%) reported taking pain medication. QOL was significantly associated with reported levels of pain intensity (r=-0.52, P<0.01) as well as perceived self-blame. CONCLUSIONS: The significant predictors of QOL impairment in CP are pain intensity and perceived self-blame for pain. Further research is needed to elucidate this relationship while also evaluating the effectiveness of systematic modification of these variables in an attempt to improve pain and QOL in CP.

Incidence of Venous Air Embolism During Endoscopic Retrograde Cholangiopancreatography.

BACKGROUND: Known complications of endoscopic retrograde cholangiopancreatography (ERCP) include pancreatitis, bleeding, duodenal perforation, and venous air embolism (VAE). The aim of this study was to determine the incidence of VAE during ERCP and be able to differentiate high-risk versus low-risk ERCP procedures. METHODS: This is a prospective cohort study consisting of patients who underwent ERCP and were monitored with a precordial Doppler ultrasound (PDU) for VAE. PDU monitoring was digitally recorded and analyzed to confirm the suspected VAE. Demographic and clinical data related to the anesthetic care, endoscopic procedure, and intraoperative hemodynamics were analyzed. RESULTS: A total of 843 ERCP procedures were performed over a 15-month period. The incidence of VAE was 2.4% (20 patients). All VAE's occurred during procedures in which stent placement, sphincterotomy, biopsy, duct dilation, gallstone retrieval, cholangioscopy, or necrosectomy occurred. Ten of 20 (50%) of VAEs were associated with hemodynamic alterations. None occurred if the procedure was only diagnostic or for stent removal. Subanalysis for the type of procedure showed that VAE was statistically more frequent when stents were removed and then replaced or if a cholangioscopy was performed. CONCLUSIONS: The high incidence of VAE highlights the need for practitioners to be aware of this potentially serious event. Use of PDU can aid in the detection of VAE during ERCP and should be considered especially during high-risk therapeutic procedures. Detection may allow appropriate interventions before serious adverse events such as cardiovascular collapse occur.

Incidence and predictors of post-ERCP pancreatitis in patients with suspected sphincter of Oddi dysfunction undergoing biliary or dual sphincterotomy: results from the EPISOD prospective multicenter randomized sham-controlled study.

BACKGROUND AND STUDY AIM: Pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP) is a significant and potentially life-threatening adverse event and is common in patients with suspected sphincter of Oddi dysfunction (SOD). Here we aimed to identify predictors of the risk in this population. PATIENTS AND METHODS: The Evaluating Predictors and Interventions in SOD (EPISOD) study prospectively enrolled 214 post-cholecystectomy patients with SOD type III in seven US centers. Patients were randomized, using a 2:1 allocation, to sphincterotomy or sham procedure, irrespective of the results of sphincter of Oddi manometry. Patients in the sphincterotomy arm who had elevated pancreatic sphincter pressure were randomized to biliary only or to dual (biliary and pancreatic) sphincterotomy. All but one patient received prophylactic pancreatic stents, but none received pharmacological prophylaxis. Post ERCP pancreatitis (PEP) was defined as acute pancreatitis within the subsequent 7 days. Blinded research coordinators at each site called patients at 1 week post-procedure. RESULTS: PEP occurred in 26 patients, in 10.6 % (15/141) in the sphincterotomy arm and 15.1 % (11/73) in the sham arm; unadjusted relative risk 0.71 (95 % confidence interval [95 %CI] 0.34 - 1.46). PEP rate was not significantly different in patients who received sphincterotomy compared with those undergoing sham treatment. In addition, the proportion was not statistically different in those who received biliary sphincterotomy alone (12/94; 12.8 % [95 %CI 6.0 % - 19.5 %]) compared with dual sphincterotomy (3/47; 6.4 % [95 %CI 0.0 % - 13.4 %]). Multivariate analysis identified an interaction between duration of ERCP and sedation type (P < 0.02). CONCLUSION: The performance of biliary or dual sphincterotomy does not increase the risk of PEP in patients suspected of SOD. However, the high rate of PEP in patients with suspected SOD, despite pancreatic stenting in expert centers, is confirmed in this prospective study. The combined effect of duration of ERCP and sedation type on the development of PEP should be further explored.Clinicaltrials.gov registration: NCT00688662.

Total pancreatectomy and islet autotransplantation in chronic pancreatitis: recommendations from PancreasFest.

DESCRIPTION: Total pancreatectomy with islet autotransplantation (TPIAT) is a surgical procedure used to treat severe complications of chronic pancreatitis or very high risk of pancreatic cancer while reducing the risk of severe diabetes mellitus. However, clear guidance on indications, contraindications, evaluation, timing, and follow-up are lacking. METHODS: A working group reviewed the medical, psychological, and surgical options and supporting literature related to TPIAT for a consensus meeting during PancreasFest. RESULTS: Five major areas requiring clinical evaluation and management were addressed: These included: 1) indications for TPIAT; 2) contraindications for TPIAT; 3) optimal timing of the procedure; 4) need for a multi-disciplinary team and the roles of the members; 5) life-long management issues following TPIAP including diabetes monitoring and nutrition evaluation. CONCLUSIONS: TPIAT is an effective method of managing the disabling complications of chronic pancreatitis and risk of pancreatic cancer in very high risk patients. Careful evaluation and long-term management of candidate patients by qualified multidisciplinary teams is required. Multiple recommendations for further research were also identified.

Prevalence of normal liver tests in patients with choledocholithiasis undergoing endoscopic retrograde cholangiopancreatography.

BACKGROUND/AIMS: Abnormal liver chemistry tests are a hallmark of common bile duct (CBD) stones. There is little information, however, on the prevalence of and predictors for normal liver chemistry tests in such patients. METHODS: Over an 11-year period, all patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) at our Center were prospectively identified. Patients in this study were those with CBD stones found at ERCP and where the indication for ERCP was CBD stones seen on imaging studies or when CBD stones were highly suspected based upon clinical presentation and radiographic and laboratory findings. Liver chemistry tests were recorded from those taken at the time of initial presentation as well as the time closest to ERCP. RESULTS: Of a total of 5,133 patients undergoing ERCP during the study period, the indication was suspicion for CBD stones or for radiographically identified CBD stones in 476 and 593, respectively, with 115 patients having both indications. Of these 1184 patients, 765 had CBD stones of whom 541 had liver tests. Of these 541, 29 patients (5.4%) were found to consistently have normal liver chemistry tests. Multivariate analysis identified two factors predictive of normal liver tests including age >55 years and the presence of abdominal pain. CONCLUSIONS: Although rare, liver tests can be normal in patients with CBD stones. Patients most likely to have normal liver tests included older patients and those with abdominal pain.

Upfront endoscopic necrosectomy or step-up endoscopic approach for infected necrotising pancreatitis (DESTIN): a single-blinded, multicentre, randomised trial.

BACKGROUND: Although the preferred management approach for patients with infected necrotising pancreatitis is endoscopic transluminal stenting followed by endoscopic necrosectomy as step-up treatment if there is no clinical improvement, the optimal timing of necrosectomy is unclear. Therefore, we aimed to compare outcomes between performing upfront necrosectomy at the index intervention versus as a step-up measure in patients with infected necrotising pancreatitis. METHODS: This single-blinded, multicentre, randomised trial (DESTIN) was done at six tertiary care hospitals (five hospitals in the USA and one hospital in India). We enrolled patients (aged ≥18 years) with confirmed or suspected infected necrotising pancreatitis with a necrosis extent of at least 33% who were amenable to endoscopic ultrasound-guided drainage. By use of computer-generated permuted block randomisation (block size four), eligible patients were randomly assigned (1:1) to receive either upfront endoscopic necrosectomy or endoscopic step-up treatment. Endoscopists were not masked to treatment allocation, but participants, research coordinators, and the statistician were. Lumen-apposing metal stents (20 mm diameter; 10 mm saddle length) were used for drainage in both groups. In the upfront group, direct necrosectomy was performed immediately after stenting in the same treatment session. In the step-up group, direct necrosectomy or additional drainage was done at a subsequent treatment session if there was no clinical improvement (resolution of any criteria of systemic inflammatory response syndrome or sepsis or one or more organ failure and at least a 25% percentage decrease in necrotic collection size) 72 h after stenting. The primary outcome was the number of reinterventions per patient to achieve treatment success from index intervention to 6 months' follow-up, which was defined as symptom relief in conjunction with disease resolution on CT. Reinterventions included any endoscopic or radiological procedures performed for necrosectomy or additional drainage after the index intervention, excluding the follow-up procedure at 4 weeks for stent removal. All endpoints and safety were analysed by intention-to-treat. This study is registered with ClinicalTrials.gov, NCT05043415 and NCT04113499, and recruitment and follow-up have been completed. FINDINGS: Between Nov 27, 2019, and Oct 26, 2022, 183 patients were assessed for eligibility and 70 patients (24 [34%] women and 46 [66%] men) were randomly assigned to receive upfront necrosectomy (n=37) or step-up treatment (n=33) and included in the intention-to-treat population. At the time of index intervention, seven (10%) of 70 patients had organ failure and 64 (91%) patients had walled-off necrosis. The median number of reinterventions was significantly lower for upfront necrosectomy (1 [IQR 0 to 1] than for the step-up approach (2 [1 to 4], difference -1 [95% CI -2 to 0]; p=0·0027). Mortality did not differ between groups (zero patients in the upfront necrosectomy group vs two [6%] in the step-up group, difference -6·1 percentage points [95% CI -16·5 to 4·5]; p=0·22), nor did overall disease-related adverse events (12 [32%] patients in the upfront necrosectomy group vs 16 [48%] patients in the step-up group, difference -16·1 percentage points [-37·4 to 7·0]; p=0·17), nor procedure-related adverse events (four [11%] patients in the upfront necrosectomy group vs eight [24%] patients in the step-up group, difference -13·4 percentage points [-30·8 to 5·0]; p=0·14). INTERPRETATION: In stabilised patients with infected necrotising pancreatitis and fully encapsulated collections, an approach incorporating upfront necrosectomy at the index intervention rather than as a step-up measure could safely reduce the number of reinterventions required to achieve treatment success. FUNDING: None.

A Rare Presentation of Multiple Hepatic Masses Due to Hepatic Adenoma: A Case Report.

Hepatic adenomas (HAs) are rare but benign neoplasms of the liver which predominantly present as solitary lesions in women of reproductive age. The incidence of HAs has increased dramatically since the introduction of oral contraceptive pills (OCPs) along with the rising incidence of obesity. Discontinuation of OCPs and lifestyle modifications, including weight loss regimens, are considered as conservative treatment options for HAs. Large lesions may result in malignant transformation with a higher propensity for hemorrhage. Importantly, larger lesions that do not respond to conservative management require surgical excision. We report a case of a patient presenting with multiple hepatic lesions that were subsequently confirmed as HAs.

Marijuana use and post-transplant complications and non-compliance in liver transplant patients.

BACKGROUND: Liver transplant (LT) is a lifesaving treatment for patients with end stage liver disease. Historically, institutions across the United States have deemed active marijuana use as an exclusion criterion for listing. This study aims to investigate LT outcomes in patients with history of marijuana use prior to LT. METHODS: We performed a retrospective review of 111 patients who tested positive for marijuana on urine drug screen during initial LT evaluation between February 2016 and January 2021. 100 non-marijuana users who underwent LT were cross matched for control. Patient demographics, substance use history, and transplant decisions were recorded. Post-LT variables were also collected up to 1 year post surgery including postoperative infections, issues with non-compliance, and continued substance use. Chi-square analysis was used to assess the association between pre-transplant marijuana use and post-transplant complications. Logistics regression was implemented to measure associations amongst the entire cohort. RESULTS: From 111 marijuana users, 32 (29%) received a transplant. There was no statistical difference in post-LT outcomes between marijuana and non-marijuana users, including incidence of cardiac, respiratory, renal, psychiatric, or neurological complications, as well as readmission rates post-surgery. There were no statistically significant associations between marijuana use with post-transplant bacterial or fungal infections, medication non-compliance, or continued substance use (all p>0.05). Marijuana use was associated with pre-LT tobacco use (p = 0.020). CONCLUSIONS: Our data indicates that marijuana is not associated with increased risk of postoperative noncompliance, other organ complications, infections, or death. As a single factor, marijuana may not need to be a contraindication for LT.

The effect of phosphoric acid pre-etching and thermocycling on self-etching adhesive enamel bonding.

STATEMENT OF PROBLEM: When inserting a resin-bonded prosthesis, it is not known whether pumicing, rinsing, and using a self-etching primer (SE) on prepared surfaces is sufficient or whether the use of an additional conventional acid etchant is warranted due to the increased time and risk of contamination. PURPOSE: The purpose of this study was to evaluate the effects of pre-etching with phosphoric acid (PA) and thermocycling (TC) on the enamel shear bond strength (SBS) of an autopolymerizing adhesive system on ground enamel. MATERIAL AND METHODS: Human teeth were embedded in phenolic rings with methyl methacrylate resin, and their enamel surfaces were ground flat to a 600 grit surface. The teeth were then divided into 4 subsets (n=22): 1) PSN, PA pre-etch with SE, no TC; 2) PST, PA pre-etch with self-etching primer and TC; 3) SEN, self-etching primer alone, no TC; and 4) SET, self-etching primer and TC. A multifactorial study design was used to evaluate 2 factors (pre-etching with PA and TC) at 2 levels (presence or absence) by grouping different subsets. Pre-etch consisted of teeth being etched for 30 seconds with PA, rinsed, re-etched, and rinsed. Self-etching consisted of 60 seconds with ED Primer. Rods of Rexillium III, airborne-particle abraded with 50 µm aluminum oxide, were bonded to enamel surfaces with Panavia 21 OP under a 19.6 N load. Thermocycling consisted of alternating between water baths of 5 ± 2°C and 55 ± 2°C for 5000 cycles. Shear bond strength (SBS) was determined by loading the specimens to failure at a crosshead speed of 1 mm/min. Mean values were analyzed with a 2-way ANOVA (factors were surface treatment and TC) at α=.05. RESULTS: Pre-etching with phosphoric acid showed greater SBS to enamel (P=.028) than the self-etching primer alone. Thermocycling did not have a significant effect (P=.424). CONCLUSIONS: There was a significant difference in SBS between pre-etching enamel surfaces with phosphoric acid in addition to the self-etching primer and using the self-etching primer exclusively. Thermocycling did not significantly affect SBS.

Presentation, response to lansoprazole therapy, and outcome of Zollinger-Ellison syndrome-like gastric acid hypersecretors.

OBJECTIVE: To evaluate the clinical characteristics, response to treatment and outcome of Zollinger?Ellison syndrome (ZES)-like gastric acid hypersecretors. METHODS: Over a 20-year period, patients with gastric acid hypersecretion in the absence of ZES were enrolled in an open label prospective trial evaluating the efficacy of lansoprazole. Following baseline evaluations, patients were treated with escalating doses of lansoprazole based on the results of gastric acid analysis. Following stabilization, patients were followed on a 6 monthly basis with interval history, physical examination, endoscopy with gastric biopsies, gastric acid analysis, and laboratory studies. RESULTS: The study group represented 21 patients (median age 47 years, 86% male, 91% Caucasian). Historically, complicated ulcer disease was frequent and symptoms had been present for a median of 10 years before study entry. All patients responded to lansoprazole (median dose 90 mg/day) with excellent control of gastric acid hypersecretion. Mucosal relapse was infrequent and no major complications developed while on therapy. CONCLUSIONS: ZES-like gastric acid hypersecretion presents similarly to the classic syndrome. Lansoprazole titrated to gastric acid output is effective in healing mucosal disease and preventing relapse.

Frequency of complications during EUS-guided drainage of pancreatic fluid collections in 148 consecutive patients.

BACKGROUND AND AIM: The aim of the present study was to evaluate the frequency of complications during endoscopic ultrasound (EUS)-guided drainage of pancreatic fluid collections (PFC), identify contributing factors, and report on management outcomes. METHODS: All patients who underwent EUS-guided PFC drainage over 7 years were enrolled. Indications, demographics, technical details, complications, surgical interventions, and final outcomes were prospectively recorded. RESULTS: Of 148 patients who underwent EUS, PFC was located in the pancreatic body in 84 (56.8%), in the tail in 45 (30.4%), in the head in 15 (10.1%), and in the uncinate region in four patients (2.7%). Perforation was encountered at the site of transmural stenting in two patients (1.3%, 95% confidence interval [CI]: 0.41-4.76) with a pseudocyst in the uncinate region that was drained transgastrically. When compared to other locations, perforation was more common with PFC involving the uncinate region (0% vs 50%, P = 0.0005). Other complications included bleeding in one (0.67%, 95% CI: 0.16, 3.68), stent migration in 1 (0.67%, 95% CI: 0.16, 3.68), and infection in four patients (2.7%, 95% CI: 1.09, 6.73). Bleeding occurred in a patient with underlying acquired factor VIII inhibitors, stent migration in a patient who underwent drainage via the gastric cardia, and infection in two patients with pseudocysts and two with necrosis. While two patients who developed post-procedural infection and one with stent migration were managed endoscopically, both perforations required surgery. Surgical debridement was performed in two patients who developed infection with successful outcomes in one, and death from underlying comorbidity in the other. CONCLUSIONS: Complications are rare during EUS-guided drainage of PFC and can be managed successfully in most patients.

Predoctoral implant education: the Creighton experience at 20 years.

The landscape of predoctoral implant education has changed dramatically in the short span of two decades. Documented success and increased patient demands have driven heightened expectations upon the educational community. Predoctoral education must play a pivotal role in preparing the profession to meet these new opportunities. The evolution of implant education in the predoctoral sector is examined, and a typical implant program is described.

Layperson/Plain Language Summaries: Can Sponsors, CROs, and Sites Deliver in 2020?

The much-anticipated 2014 European Union (EU) Clinical Trial Regulation requiring Layperson/ Plain Language Summaries (PLS) is slated for implementation in 2020. At the 10th Annual CNS Summit Conference (Fall 2019), a panel discussion was convened with the objective of evaluating the likelihood of the PLS legislation being implemented successfully in the EU and voluntarily (e.g., pro-actively) in the rest of the world. Points of the discussion embraced the notion that this is an excellent opportunity for the entire pharmaceutical industry. Moreover, in the United States, public opinion of the pharmaceutical industry hit an all-time low in 2019, surpassing the oil industry with regard to public distrust. For decades, clinical trial participants have stated that wanting to learn, in layperson terms, the results of the study was second only to wanting to learn the treatment group into which they were assigned under double-blind conditions. Our conclusion is that while confidentiality, commercial interests, total costs, regulatory concerns, as well as some operational aspects (i.e., patient access portals) are among the hurdles, our commentary strongly advocates systematic implementation not only within the EU, but that this should be implemented globally, without further delay.