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Glucose-like peptide-1-receptor agonists (GLP-1RAs) have become integral to the management of type 2 diabetes and obesity. GLP-1RAs work in part through delaying gastric emptying, raising concerns about retained gastric contents (RGC) during esophagogastroduodenoscopy (EGD).1 The American Society of Anesthesiologists currently recommends holding GLP-1RAs for 1 dosing cycle before elective procedures, however, the American Gastroenterological Association (AGA) advocates proceeding with endoscopy in asymptomatic patients adhering to standard perioperative protocols without medication withholding and suggests implementing a liquid diet the day before endoscopy in lieu of stopping the medication.2,3 This variability in recommendations stems largely from a lack of GLP-1RA outcomes data from which to draw evidence-based conclusions.
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BACKGROUND: Breast-conserving surgery (BCS) followed by adjuvant radiotherapy (RT) is a standard treatment for ductal carcinoma in situ (DCIS). A low-risk patient subset that does not benefit from RT has not yet been clearly identified. The DCISionRT test provides a clinically validated decision score (DS), which is prognostic of 10-year in-breast recurrence rates (invasive and non-invasive) and is also predictive of RT benefit. This analysis presents final outcomes from the PREDICT prospective registry trial aiming to determine how often the DCISionRT test changes radiation treatment recommendations. METHODS: Overall, 2496 patients were enrolled from February 2018 to January 2022 at 63 academic and community practice sites and received DCISionRT as part of their care plan. Treating physicians reported their treatment recommendations pre- and post-test as well as the patient's preference. The primary endpoint was to identify the percentage of patients where testing led to a change in RT recommendation. The impact of the test on RT treatment recommendation was physician specialty, treatment settings, individual clinical/pathological features and RTOG 9804 like criteria. Multivariate logisitc regression analysis was used to estimate the odds ratio (ORs) for factors associated with the post-test RT recommendations. RESULTS: RT recommendation changed 38% of women, resulting in a 20% decrease in the overall recommendation of RT (p < 0.001). Of those women initially recommended no RT (n = 583), 31% were recommended RT post-test. The recommendation for RT post-test increased with increasing DS, from 29% to 66% to 91% for DS <2, DS 2-4, and DS >4, respectively. On multivariable analysis, DS had the strongest influence on final RT recommendation (odds ratio 22.2, 95% confidence interval 16.3-30.7), which was eightfold greater than clinicopathologic features. Furthermore, there was an overall change in the recommendation to receive RT in 42% of those patients meeting RTOG 9804-like low-risk criteria. CONCLUSIONS: The test results provided information that changes treatment recommendations both for and against RT use in large population of women with DCIS treated in a variety of clinical settings. Overall, clinicians changed their recommendations to include or omit RT for 38% of women based on the test results. Based on published clinical validations and the results from current study, DCISionRT may aid in preventing the over- and undertreatment of clinicopathological 'low-risk' and 'high-risk' DCIS patients. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03448926 ( https://clinicaltrials.gov/study/NCT03448926 ).
Subject(s)
Breast Neoplasms , Carcinoma, Intraductal, Noninfiltrating , Mastectomy, Segmental , Humans , Female , Breast Neoplasms/radiotherapy , Breast Neoplasms/surgery , Breast Neoplasms/pathology , Carcinoma, Intraductal, Noninfiltrating/radiotherapy , Carcinoma, Intraductal, Noninfiltrating/surgery , Carcinoma, Intraductal, Noninfiltrating/pathology , Middle Aged , Radiotherapy, Adjuvant , Prognosis , Prospective Studies , Aged , Follow-Up Studies , Neoplasm Recurrence, Local/pathology , Clinical Decision-Making , Adult , Decision Making , Biomarkers, TumorABSTRACT
OBJECTIVES: Optimal management of obese patients with early-stage cervical cancer is debated despite evidence of non-inferior survival in obese patients undergoing radical hysterectomy with pelvic lymphadenectomy (RH) compared to primary radiation with or without radiosensitizing chemotherapy (RT). Objectives included describing patient factors affecting disposition to RH versus RT; comparing RH outcomes for obese (BMI >30 mg/m2) and non-obese patients; and comparing differences in recurrence free survival (RFS) and overall survival (OS). METHODS: This was a single institution cohort study of all cervical cancer patients who underwent RH or were candidates for RH based on clinical stage. Demographic, clinicopathologic and treatment outcomes were collected and analyzed. RESULTS: RT patients (n = 39, 15%) had a higher BMI (p = 0.004), older age (p < 0.001), more life-limiting comorbidities (LLC) (p < 0.001), larger tumor size (p = 0.001), and higher clinical stage (p = 0.013) compared to RH patients (n = 221, 85%). On multivariable survival analysis there was no difference in OS based on treatment modality; significant predictors of worse OS were larger tumor size, higher number of LLC and recurrence. Among the RH group, obese patients had a longer operative time (p = 0.01) and more LLC (p = 0.02); there were no differences in demographic or clinicopathologic characteristics, operative outcomes, RFS or OS compared to non-obese patients. CONCLUSION: In this cohort of RH-eligible cervical cancer patients, BMI was independently associated with disposition to RT. Studies demonstrate that RH is feasible and safe in obese patients with no difference in RFS or OS when compared to non-obese patients. Thus, the decision for disposition to RT should not be based on obesity alone.
Subject(s)
Uterine Cervical Neoplasms , Female , Humans , Cohort Studies , Uterine Cervical Neoplasms/surgery , Uterine Cervical Neoplasms/pathology , Neoplasm Staging , Obesity/complications , Obesity/pathology , Treatment Outcome , Hysterectomy , Retrospective Studies , Disease-Free SurvivalABSTRACT
GOALS: This systematic review aims to evaluate the risk factors, clinical features, and outcomes of bowel perforation caused by stent migration after endoscopic retrograde cholangiopancreatography (ERCP). BACKGROUND: Distal migration of biliary stents can occur after ERCP. Upon migration, most stents pass through the intestine without adverse events; however, bowel perforation has been reported. STUDY: A comprehensive literature search of PubMed, EMBASE, and Cochrane databases was conducted through October 2023 for articles that reported bowel perforation because of stent migration. Cases of incomplete stent migration and proximal stent migration were excluded. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines to identify full-length articles in English reporting. RESULTS: Of 2041 articles retrieved on the initial search, 92 met the inclusion criteria. A total of 132 cases of bowel perforation occurred due to stent migration after ERCP (56.1% female; average age: 66 y). The median time from initial ERCP to perforation was 44.5 days (IQR 12.5-125.5). Most cases of perforation occurred in the small bowel (64.4%) compared with the colon (34.8%). Stents were mostly plastic (87.1%) with a median diameter of 10 Fr (IQR 8.5-10) and median length of 10.3 cm (IQR 715). Surgical management was pursued in 52.3% and endoscopic management in 42.4%. Bowel resection was required for 25.8% of patients. The overall mortality rate was 17.4%. CONCLUSION: In summary, this study demonstrates that bowel perforation after ERCP stent migration primarily occurs within 44.5 days and most frequently with a 10 Fr plastic biliary stent. The overall mortality rate was 17.4%. It is important for endoscopists to be mindful of this rare but serious adverse event.
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OBJECTIVE: To investigate whether performing a lymph node dissection during hysterectomy improves overall survival in patients with clinical stage III endometrial cancer who received neoadjuvant chemotherapy. METHODS: The National Cancer Database was queried to identify all patients with clinical stage III endometrial cancer who had undergone pre-operative chemotherapy as first course of treatment followed by hysterectomy with or without lymph node dissection between the years 2004 and 2020. Univariable and multivariable models were performed to investigate prognostic factors on overall survival. RESULTS: This study analyzed 2882 patients with clinical stage III endometrial cancer who received upfront chemotherapy. Among those who underwent lymph node dissection, 38% had positive lymph nodes. Factors found to be independently associated with improved survival included lymph node dissection (p<0.001), adjuvant radiation (p<0.001), histology (p<0.001), tumor grade (p<0.001), pathologic node status (p<0.001), age (p<0.001), type of insurance (p=0.027), and race (p<0.001). Patients who underwent lymph node dissection at time of hysterectomy had a significantly better overall survival (107 vs 85 months; p<0.001). Multivariate and propensity score analyses robustly demonstrated that lymph node dissection significantly improved overall survival (HR 0.69, 95% CI 0.57 to 0.84, p<0.001), even among patients with pathologically negative lymph nodes. CONCLUSION: Our study suggests that performing lymph node dissection at the time of hysterectomy is associated with improved overall survival in all patients with stage III endometrial cancer who receive upfront chemotherapy, regardless of age, race, insurance status, histologic subtype, tumor grade, pathologic node status, adjuvant radiation or chemotherapy. Notably, patients with high-risk disease may particularly benefit from this approach.
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BACKGROUND AND AIMS: The COVID-19 pandemic has highlighted the importance of telemedicine in improving healthcare access and reducing costs. This study aimed to assess order compliance in the virtual versus in-person setting for the initial evaluation of abdominal pain (AP) prior to and during the pandemic. METHODS: A retrospective evaluation of virtual and in-person outpatient gastroenterology visits for AP were identified through natural language processing from January 2019 through September 2021 at the Cleveland Clinic main campus and regional hospitals in Ohio. We assessed the number and type of orders placed for patients and measured compliance through order completion. This study received Institutional Review Board approval (IRB 21-514). RESULTS: Among 20,356 patients at their initial visit, 79% had orders placed, of which 40% had pandemic in-person visits, 13% had pandemic virtual visits, and 47% had pre-pandemic in-person visits. Patients seen virtually were 65.1% less likely to complete orders compared to patients seen in-person (p < 0.001) during the pandemic. Patients seen in a pandemic virtual setting were 71.0% less likely to complete imaging orders (p < 0.001), 82.6% less likely to complete procedure orders (p < 0.001), and 60.5% less likely to complete lab orders (p < 0.001). CONCLUSION: Compared with in-person visits, patients seen virtually for their first presentation of AP were less likely to complete labs, imaging, and endoscopic evaluations. In-person visits were more successful with patient order completion during the pandemic. These findings highlight that virtual visits for AP, despite convenience, may compromise care delivery and warrant additional care coordination to achieve compliance with medical recommendations.
Subject(s)
COVID-19 , Telemedicine , Humans , COVID-19/epidemiology , Pandemics , Retrospective Studies , Abdominal Pain/diagnosis , Abdominal Pain/epidemiology , Abdominal Pain/etiology , OutpatientsABSTRACT
BACKGROUND & AIMS: Despite the high prevalence of asymptomatic gallstones (AGs), there are limited data on their natural history. We aimed to determine the rate of symptom development in a contemporary population, determine factors associated with progression to symptomatic gallstones (SGs), and develop a clinical prediction model. METHODS: We used a retrospective cohort design. The time to first SG was shown using Kaplan-Meier curves. Multivariable competing risk (death) regression analysis was used to identify variables associated with SGs. A prediction model for the development of SGs after 10 years was generated and calibration curves were plotted. Participants were patients with AGs based on ultrasound or computed tomography from the general medical population. RESULTS: From 1996 to 2016, 22,257 patients (51% female) with AGs were identified; 14.5% developed SG with a median follow-up period of 4.6 years. The cumulative incidence was 10.1% (±0.22%) at 5 years, 21.5% (±0.39%) at 10 years, and 32.6% (±0.83%) at 15 years. In a multivariable model, the strongest predictors of developing SGs were female gender (hazard ratio [HR], 1.50; 95% CI, 1.39-1.61), younger age (HR per 5 years, 1.15; 95% CI, 1.14-1.16), multiple stones (HR, 2.42; 95% CI, 2.25-2.61), gallbladder polyps (HR, 2.55; 95% CI, 2.14-3.05), large stones (HR, 2.03; 95% CI, 1.80-2.29), and chronic hemolytic anemia (HR, 1.90; 95% CI, 1.33-2.72). The model showed good discrimination (C-statistic, 0.70) and calibration. CONCLUSIONS: In general medical patients with AGs, symptoms developed at approximately 2% per year. A predictive model with good calibration could be used to inform patients of their risk of SGs.
Subject(s)
Gallstones , Humans , Female , Child, Preschool , Male , Gallstones/epidemiology , Longitudinal Studies , Retrospective Studies , Models, Statistical , Risk Factors , PrognosisABSTRACT
PURPOSE: To examine associations between ductal carcinoma in situ (DCIS) patients' characteristics, treating locations and DCIS treatments received and to pilot assessing quality-of-life (QoL) values among DCIS patients with diverse backgrounds. METHODS: We performed a retrospective tumor registry review of all patients diagnosed and treated with DCIS from 2018 to 2019 in the UPMC-integrated network throughout central and western Pennsylvania. Demographics, clinical information, and administered treatments were compiled from tumor registry records. We categorized contextual factors such as different hospital setting (academic vs. community), socioeconomic status based on the neighborhood deprivation index (NDI) as well as age and race. QoL survey was administered to DCIS patients with diverse backgrounds via QoL questionnaire breast cancer module 23 and qualitative assessment questions. RESULTS: A total of 912 patients were reviewed. There were no treatment differences noted for age, race, or NDI. Mastectomy rate was higher in academic sites than community sites (29 vs. 20.4%; p = 0.0045), while hormone therapy (HT) utilization rate was higher in community sites (74 vs. 62%; p = 0.0012). QoL survey response rate was 32%. Only HT side effects negatively affected in QoL scores and there was no significant difference in QoL domains and decision-making process between races, age, NDI, treatment groups, and treatment locations. CONCLUSION: Our integrated health network did not show chronically noted disparities arising from social determinates of health for DCIS treatments by implementing clinical pathways and system-wide peer review. Also, we demonstrated feasibility in collecting QoL for DCIS women with diverse backgrounds and different socioeconomic statuses.
Subject(s)
Breast Neoplasms , Carcinoma, Ductal, Breast , Carcinoma, Intraductal, Noninfiltrating , Humans , Female , Carcinoma, Intraductal, Noninfiltrating/epidemiology , Carcinoma, Intraductal, Noninfiltrating/therapy , Carcinoma, Intraductal, Noninfiltrating/pathology , Breast Neoplasms/epidemiology , Breast Neoplasms/therapy , Breast Neoplasms/pathology , Retrospective Studies , Mastectomy , Quality of Life , Patient Reported Outcome Measures , Carcinoma, Ductal, Breast/pathologyABSTRACT
BACKGROUND: Intra-operative radiotherapy (IORT) for brain metastases (BMs) and primary brain tumors has emerged as an adjuvant radiation modality that allows for consolidation of care into a single anesthetic episode with surgical resection. Yet, there is a paucity of data regarding the impact that IORT may have on peri-operative and long-term seizure risk. METHODS: A retrospective analysis of patients receiving IORT during tumor resection was performed via registry including data regarding peri-operative anti-seizure medications and anesthetic agents. Intra-operative neuromonitoring was performed using electrocorticography (ECoG) captured before-, during-, and after-IORT then analyzed for evidence of seizure or significant baseline changes. Kaplan-Meir estimations were used for overall survival analysis relative to documented clinical seizure incidence post-IORT. RESULTS: Of the 24 consecutive patients treated with IORT during tumor resection included, 18 (75%) patients were diagnosed with BMs while 6 (25%) had newly-diagnosed glioblastoma. Mean and median survival times were 487 and 372 days, respectively. Clinical seizures occurred in 3 patients post-IORT, 2 BMs patients within 9 months and 1 glioblastoma patient at 14 months. IORT time represented 9.5% of anesthetic time. ECoG recordings were available for 5 patients (4 BMs; 1 glioblastoma), with mean recording durations of 13% of the total anesthetic time and no evidence of high-frequency oscillations or seizure activity. CONCLUSIONS: IORT is an option for delivery of definitive radiation in surgically resected brain tumors without increasing the peri-operative or long-term risk of seizure. ECoG data during the delivery of radiation fail to demonstrate any electrophysiological changes in response to ionizing radiation.
Subject(s)
Brain Neoplasms , Glioblastoma , Humans , Electrocorticography , Glioblastoma/surgery , Retrospective Studies , Radiotherapy, Adjuvant , Brain Neoplasms/radiotherapy , Brain Neoplasms/surgery , Brain Neoplasms/secondary , Seizures/diagnosis , Seizures/etiologyABSTRACT
BACKGROUND: Portal vein thrombosis (PVT) is a rare complication of acute pancreatitis (AP) and might be associated with worse outcomes. We aimed to study trends, outcomes, and predictors of PVT in AP patients. METHODS: The National Inpatient Sample database was utilized to identify the adult patients (≥ 18 years) with primary diagnosis of AP from 2004 to 2013 using International Classification of Disease, Ninth Revision. Patients with and without PVT were entered into propensity matching model based on baseline variables. Outcomes were compared between both groups and predictors of PVT in AP were identified. RESULTS: Among the total of 2,389,337 AP cases, 7046 (0.3%) had associated PVT. The overall mortality of AP decreased throughout the study period (p trend ≤ 0.0001), whereas mortality of AP with PVT remained stable (1-5.7%, p trend = 0.3). After propensity matching, AP patients with PVT patients had significantly higher in-hospital mortality (3.3% vs. 1.2%), AKI (13.4% vs. 7.7%), shock (6.9% vs. 2.5%), and need for mechanical ventilation (9.2% vs. 2.5%) along with mean higher cost of hospitalization and length of stay (p < 0.001 for all). Lower age (Odd ratio [OR] 0.99), female (OR 0.75), and gallstone pancreatitis (OR 0.79) were negative predictors, whereas alcoholic pancreatitis (OR 1.51), cirrhosis (OR 2.19), CCI > 2 (OR 1.81), and chronic pancreatitis (OR 2.28) were positive predictors of PVT (p < 0.001 for all) in AP patients. CONCLUSION: PVT in AP is associated with significantly higher risk of death, AKI, shock, and need for mechanical ventilation. Chronic and alcoholic pancreatitis is associated with higher risk of PVT in AP.
Subject(s)
Acute Kidney Injury , Pancreatitis, Alcoholic , Venous Thrombosis , Adult , Humans , Female , Portal Vein , Pancreatitis, Alcoholic/complications , Acute Disease , Liver Cirrhosis/diagnosis , Venous Thrombosis/etiology , Venous Thrombosis/complications , Acute Kidney Injury/etiology , Retrospective StudiesABSTRACT
BACKGROUND AND AIMS: The recent surge in demand for screening endoscopy has led to an increased detection of gastric subepithelial tumors (SETs). According to current guideline, SETs less than 2 cm in size are recommended for periodic surveillance. In light of recent advancement in therapeutic endoscopy in resection of small SET, we analyzed the histopathological features and the effectiveness of endoscopic resection for these small SETs. METHODS: Retrospectively study was performed on 74 patients who underwent endoscopic resection of gastric small (≤ 2 cm) upper gastrointestinal tract SETs. The outcomes including histopathology and en bloc resection were analyzed. RESULTS: The mean SET size was 11.69 ± 5.11 mm. The mean procedure time was 81.26 ± 42.53 min. Of the 74 patients, 28 patients had leiomyomas, 26 had gastrointestinal stromal tumors (GISTs), 14 had ectopic pancreas, 4 had lipomas, and 2 had neuroendocrine tumors. Among those with GIST, two patients exhibited high-risk histology. All patients underwent successful and uneventful endoscopy. CONCLUSIONS: Endoscopic resection can be recommended even for the small gastric SETs. In our study, we found that SETs with a size of less than 2 cm have significant proportion of GISTs which harbor malignant transformation potential.
Subject(s)
Gastrointestinal Stromal Tumors , Leiomyoma , Stomach Neoplasms , Humans , Retrospective Studies , Stomach Neoplasms/pathology , Endoscopy, Gastrointestinal , Pancreas/pathology , Leiomyoma/surgery , Gastrointestinal Stromal Tumors/pathology , Treatment OutcomeABSTRACT
OBJECTIVES: Current trials for HPV-associated oropharyngeal SCCs (OP-SCCs) are evaluating treatment de-escalation including use of concurrent immunotherapy with radiation therapy (I-RT). Given limited prospective data following I-RT, we aimed to examine this question utilizing the National Cancer Data Base (NCDB). METHODS: The NCDB was queried for patients with HPV-associated OP-SCCs eligible for current de-escalation studies with AJCC 7th edition T1-T2/N1-N2b and T3/N0-N2b disease. Patients were stratified into I-RT, concurrent chemoradiation (C-RT), and radiation therapy alone (RT) arms. Kaplan-Meier analysis was utilized to compare overall survival (OS) between treatment arms followed by a Cox multivariate (MVA) proportional hazards model controlling for tumor and patient characteristics and propensity-score analyses with inverse probability treatment weighting (IPTW). RESULTS: We identified 4768 patients; 313 received I-RT, 3660 patients received C-RT, and 795 received RT. Median age was 62 years (range 27-90) with a median Charlson-Deyo co-morbidity score of 0 (range: 0-3). The vast majority were cN1-N2a (88.8%) and 26.5% were cT3. On MVA, inferior 3-year and 8-year OS was noted following I-RT (81.6% and 70.5%) vs. C-RT (90.6% and 79.4%) (HR = 1.69 (95% CI: 1.29-2.21); p < 0.0001) with no significant difference vs. RT (88.1% and 75.8%) (HR = 1.07; p = 0.80). This was also maintained on IPTW-analysis (HR = 1.62 (95% CI: 1.23-2.15); p = 0.001). CONCLUSIONS: I-RT was associated with significantly poorer OS vs. C-RT with no benefit compared to RT for HPV-associated OP-SCCs. I-RT is not recommended outside of currently accruing clinical trials.
Subject(s)
Head and Neck Neoplasms , Oropharyngeal Neoplasms , Papillomavirus Infections , Humans , Adult , Middle Aged , Aged , Aged, 80 and over , Squamous Cell Carcinoma of Head and Neck/therapy , Squamous Cell Carcinoma of Head and Neck/complications , Papillomavirus Infections/complications , Papillomavirus Infections/therapy , Papillomavirus Infections/pathology , Prospective Studies , Oropharyngeal Neoplasms/pathology , Head and Neck Neoplasms/complicationsABSTRACT
BACKGROUND & AIMS: Treatment of malignant biliary strictures with endoscopic retrograde cholangiopancreatography (ERCP) guided stent placement is highly effective. Our objective was to compare the efficacy and adverse outcomes between plastic stents (PS) and self-expandable metallic stents (SEMS). METHODS: A cohort study was performed of all consecutive patients who underwent ERCP with stent placement for the management of malignant biliary stricture. Comparisons on clinical success, patency duration, stent dysfunction, unplanned reintervention and adverse outcomes were performed. Univariate and multivariable analyses were performed to identify factors associated with clinical success, need for reintervention, and stent dysfunction. RESULTS: From 2012 to 2019, 1139 patients underwent ERCP with PS placement while 1008 patients received SEMS for the management of malignant biliary stricture. In distal strictures, SEMS reported a significantly higher rate of clinical success compared with PS (94.1% vs 87.4%, P < 0.001) and a lower rate of unplanned reintervention (17.1% vs 27.4%, P < 0.001). In hilar strictures, the rates of clinical success and unplanned intervention were comparable. The patency duration and time to unplanned reintervention were significantly longer with SEMS than PS, irrespective of stricture location. In distal stricture, PS was associated with a significantly higher rate of cholangitis than SEMS (6.9% vs 2.4%; P < .001) but a lower rate of pancreatitis (3.6% vs 6%; P = 0.021). CONCLUSION: Given superior efficacy, durability and lower rates of cholangitis, SEMS should be offered as the first line endoscopic treatment option for malignant distal biliary stricture. For malignant hilar stricture, SEMS is an attractive alternative to PS in some cases by offering a comparable efficacy with a superior durability.
Subject(s)
Cholestasis , Self Expandable Metallic Stents , Cholangiopancreatography, Endoscopic Retrograde , Cholestasis/etiology , Cholestasis/surgery , Cohort Studies , Constriction, Pathologic/etiology , Humans , Plastics , Retrospective Studies , Self Expandable Metallic Stents/adverse effects , Stents , Treatment OutcomeABSTRACT
BACKGROUND AND AIMS: Anesthesia assistance is commonly used for ERCP. General anesthesia (GA) may provide greater airway protection but may lead to hypotension. We aimed to compare GA versus sedation without planned intubation (SWPI) on the incidence of hypoxemia and hypotension. We also explored risk factors for conversion from SWPI to GA. METHODS: This observational study used data from the Multicenter Perioperative Outcomes Group. Adults with American Society of Anesthesiologists physical status class I to IV undergoing ERCP between 2006 and 2019 were included. We compared GA and SWPI on incidence of hypoxemia (oxygen saturation <90% for ≥3 minutes) and hypotension (mean arterial pressure <65 mm Hg for ≥5 minutes) using joint hypothesis testing. The association between anesthetic approach and outcomes was assessed using logistic regression. The noninferiority delta for hypoxemia and hypotension was an odds ratio of 1.20. One approach was deemed better if it was noninferior on both outcomes and superior on at least 1 outcome. To explore risk factors associated with conversion from SWPI to GA, we constructed a logistic regression model. RESULTS: Among 61,735 cases from 42 institutions, 38,830 (63%) received GA and 22,905 (37%) received SWPI. The GA group had 1.27 times (97.5% confidence interval, 1.19-1.35) higher odds of hypotension but .71 times (97.5% confidence interval, .63-.80) lower odds of hypoxemia. Neither group was noninferior to the other on both outcomes. Conversion from SWPI to GA occurred in 6.5% of cases and was associated with baseline comorbidities and higher institutional procedure volume. CONCLUSIONS: GA for ERCP was associated with less hypoxemia, whereas SWPI was associated with less hypotension. Neither approach was better on the combined incidence of hypotension and hypoxemia.
Subject(s)
Cholangiopancreatography, Endoscopic Retrograde , Hypotension , Adult , Anesthesia, General/adverse effects , Cholangiopancreatography, Endoscopic Retrograde/adverse effects , Cholangiopancreatography, Endoscopic Retrograde/methods , Humans , Hypotension/epidemiology , Hypotension/etiology , Hypoxia/epidemiology , Hypoxia/etiology , Hypoxia/prevention & control , Incidence , Retrospective StudiesABSTRACT
BACKGROUND AND AIMS: The outcomes of endoscopic submucosal dissection (ESD) for T1b esophageal cancer (EC) and its recurrence rates remain unclear in the West. Using a multicenter cohort, we evaluated technical outcomes and recurrence rates of ESD in the treatment of pathologically staged T1b EC. METHODS: We included patients who underwent ESD of T1b EC at 7 academic tertiary referral centers in the United States (n = 6) and Brazil (n = 1). We analyzed demographic, procedural, and histopathologic characteristics and follow-up data. Time-to-event analysis was performed to evaluate recurrence rates. RESULTS: Sixty-six patients with pathologically staged T1b EC after ESD were included in the study. A preprocedure staging EUS was available in 54 patients and was Tis/T1a in 27 patients (50%) and T1b in 27 patients (50%). En-bloc resection rate was 92.4% (61/66) and R0 resection rate was 54.5% (36/66). Forty-nine of 66 patients (74.2%) did not undergo surgery immediately after resection and went on to surveillance. Ten patients had ESD resection within the curative criteria, and no recurrences were seen in a 13-month (range, 3-18.5) follow-up period in these patients. Ten of 39 patients (25.6%) with noncurative resections had residual/recurrent disease. Of the 10 patients with noncurative resection, local recurrence alone was seen in 5 patients (12.8%) and metastatic recurrence in 5 patients (12.8%). On univariate analysis, R1 resection had a higher risk of recurrent disease (hazard ratio, 6.25; 95% confidence interval, 1.29-30.36; P = .023). CONCLUSIONS: EUS staging of T1b EC has poor accuracy, and a staging ESD should be considered in these patients. ESD R0 resection rates were low in T1b EC, and R1 resection was associated with recurrent disease. Patients with noncurative ESD resection of T1b EC who cannot undergo surgery should be surveyed closely, because recurrent disease was seen in 25% of these patients.
Subject(s)
Endoscopic Mucosal Resection , Esophageal Neoplasms , Brazil , Endoscopic Mucosal Resection/methods , Esophageal Neoplasms/pathology , Esophageal Neoplasms/surgery , Humans , Neoplasm Recurrence, Local/epidemiology , Neoplasm, Residual , Retrospective Studies , Treatment OutcomeABSTRACT
BACKGROUND: The difference in clinical outcomes after endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR) for early Barrett's esophagus (BE) neoplasia remains unclear. We compared the recurrence/residual tissue rates, resection outcomes, and adverse events after ESD and EMR for early BE neoplasia. METHODS: We included patients who underwent EMR or ESD for BE-associated high grade dysplasia (HGD) or T1a esophageal adenocarcinoma (EAC) at eight academic hospitals. We compared demographic, procedural, and histologic characteristics, and follow-up data. A time-to-event analysis was performed to evaluate recurrence/residual disease and a Kaplan-Meier curve was used to compare the groups. RESULTS: 243 patients (150 EMR; 93 ESD) were included. EMR had lower en bloc (43â% vs. 89â%; Pâ<â0.001) and R0 (56â% vs. 73â%; Pâ=â0.01) rates than ESD. There was no difference in the rates of perforation (0.7â% vs. 0; Pâ>â0.99), early bleeding (0.7â% vs. 1â%; Pâ>â0.99), delayed bleeding (3.3â% vs. 2.1â%; Pâ=â0.71), and stricture (10â% vs. 16â%; Pâ=â0.16) between EMR and ESD. Patients with non-curative resections who underwent further therapy were excluded from the recurrence analysis. Recurrent/residual disease was 31.4â% [44/140] for EMR and 3.5â% [3/85] for ESD during a median (interquartile range) follow-up of 15.5 (6.75-30) and 8 (2-18) months, respectively. Recurrence-/residual disease-free survival was significantly higher in the ESD group. More patients required additional endoscopic resection procedures to treat recurrent/residual disease after EMR (EMR 24.2â% vs. ESD 3.5â%; Pâ<â0.001). CONCLUSIONS: ESD is safe and results in more definitive treatment of early BE neoplasia, with significantly lower recurrence/residual disease rates and less need for repeat endoscopic treatments than with EMR.
Subject(s)
Adenocarcinoma , Barrett Esophagus , Endoscopic Mucosal Resection , Esophageal Neoplasms , Adenocarcinoma/pathology , Barrett Esophagus/pathology , Barrett Esophagus/surgery , Endoscopic Mucosal Resection/adverse effects , Endoscopic Mucosal Resection/methods , Esophageal Neoplasms/pathology , Humans , Neoplasm Recurrence, Local/epidemiology , Neoplasm Recurrence, Local/pathology , Neoplasm, Residual/etiology , Retrospective Studies , Treatment OutcomeABSTRACT
BACKGROUND AND AIM: Informed consent for endoscopy is variable across institutions and remains understudied in gastrointestinal endoscopy. This study aims to standardize informed consent for screening and diagnostic colonoscopies with a supplemental video tool that includes the key components of informed consent. METHODS: A video tool was developed that incorporated the key components of informed consent for colonoscopy. In addition, a 7-question survey was developed to query patients on core aspects of informed consent and satisfaction with the informed consent process. Patients undergoing elective outpatient colonoscopy with conscious sedation were randomized to traditional consent or consent with the addition of a video tool. A pilot study determined the sample size. Traditional consent was standard of practice before the procedure. Patients in the video tool group watched the video tool in the preprocedure area followed by traditional consent. Both groups had the opportunity to address questions with the attending physician before the procedure. All patients were contacted 1 to 2 days following the colonoscopy to answer the question survey. RESULTS: A total of 110 patients were eligible for participation, and 91 were included in the final data analysis. Subjects in the video tool group demonstrated significantly higher recall of key aspects of informed consent and higher satisfaction with the informed consent process versus the traditional consent group. The history of prior colonoscopy was similar between both groups. Mean endoscopy operation metrics were not negatively impacted by the inclusion of the video tool. CONCLUSION: Patients undergoing screening and diagnostic colonoscopies who received informed consent supplemented by a video tool had a higher recall of core aspects of informed consent and higher satisfaction with the process, with no impact on procedural times.
Subject(s)
Informed Consent , Patient Satisfaction , Colonoscopy , Humans , Pilot Projects , Surveys and QuestionnairesABSTRACT
GOALS: Our aim was to compare the diagnostic yield of endoscopic ultrasound guided fine needle aspiration (EUS-FNA) versus combined fine needle aspiration and fine needle biopsy (EUS-FNA + FNB) in the evaluation of solid pancreatic masses (SPMs). BACKGROUND: EUS-FNA and EUS-FNB are established methods to diagnose SPMs. No studies have evaluated the efficacy of combination of both (EUS-FNA + FNB). Our senior author (MRS) hypothesized that combining the two techniques by using a single FNB needle improves diagnostic yield and started combination technique in October 2016. STUDY: Patients who underwent EUS for SPMs by MRS during January 2014-September 2019 were included. They were divided into the EUS-FNA group and EUS-FNA + FNB group. EUS-FNA was performed using a 22 or 25 gauge Expect Slimline needle (Boston Scientific, Marlborough, MA) and EUS-FNA + FNB was performed using a single 22 or 25 gauge Shark-core needle (Medtronics, Minneapolis, MN, USA). Our primary outcome was to compare the diagnostic yield in the two groups. RESULTS: Among 105 patients included, 58 were in the EUS-FNA group and 47 were in the EUS-FNA + FNB group. EUS-FNA + FNB group had significantly higher diagnostic yield and required fewer needle passes compared to EUS-FNA group, 95.7% vs. 77.6%, p = .01: and 4 vs. 5, p = .002; respectively. Procedural duration was similar in both groups but the combined technique required less number of needles per procedure. There was no difference in adverse events in the two groups. CONCLUSION: Our study showed that combined EUS-FNA + FNB had higher diagnostic yield compared to EUS-FNA in SPMs along with less number of needle passes and needles required. Further prospective studies are needed to validate these findings and cost-effectiveness of this strategy.
Subject(s)
Pancreatic Neoplasms , Boston , Endoscopic Ultrasound-Guided Fine Needle Aspiration/methods , Endosonography , Humans , Pancreatic Neoplasms/diagnosis , Pancreatic Neoplasms/pathology , Prospective StudiesABSTRACT
BACKGROUND: Bariatric surgery (BSx) is one of the most common surgical procedures in North America. Readmissions may be associated with a high burden to the healthcare system. METHODS: Retrospective study of the 2016 National Readmission Database of adult patients readmitted within 30 days after an index admission for BSx. Outcomes were: 30-day readmission rate, mortality, healthcare-related utilization resources, and independent predictors of readmission. Comparison groups were index admission, readmitted, and non-readmitted patients. RESULTS: A total of 161,141 patients underwent BSx. The 30-day readmission rate was 3.3%. Main causes for readmission were dehydration, acute kidney injury, venous thromboembolism events, and sepsis. Readmitted patients were more likely to develop shock (0.5% vs. 0.1%; P < 0.01) with no differences in mechanical ventilation (1.9% vs. 2.0%; P = 0.83) during index admission compared to non-readmitted patients. Readmission was associated with higher in-hospital mortality rate (1.5% vs. 0.1%; P < 0.01) and prolonged length of stay (4.6 vs. 2.4 days; P < 0.01). The total in-hospital economic burden of readmission was $234 million in total charges and $58.7 million in total costs. Independent predictors of readmission were: Charlson comorbidity index of ≥ 3, longer length of stay, admission to larger bed size hospitals, discharge to nursing home, and acute kidney injury. Medicaid, private insurance, BMI of 30-39 kg/m2, and 40-44 kg/m2 were associated with lower odds for readmission. CONCLUSION: Readmissions after BSx are associated with higher in-hospital mortality rate and pose a high healthcare burden. We identified risk factors that can be targeted to decrease readmissions after BSx, healthcare burden, and patient morbidity and mortality.
Subject(s)
Acute Kidney Injury , Bariatric Surgery , Acute Kidney Injury/epidemiology , Acute Kidney Injury/etiology , Acute Kidney Injury/therapy , Adult , Bariatric Surgery/adverse effects , Databases, Factual , Female , Humans , Male , Patient Readmission , Retrospective Studies , Risk Factors , Time Factors , United States/epidemiologyABSTRACT
BACKGROUND: Symptomatic pancreatic duct (PD) strictures in chronic pancreatitis refractory to single plastic stenting are usually managed by placement of multiple plastic stents (MPS). Fully covered self-expanding metallic stents (FCSEMS) have also been used in the management of these patients. However, the overall efficacy and safety of different types of stents is unclear from the currently available studies. We performed this meta-analysis to assess the efficacy and complications from MPS and FCSEMS in patients with PD strictures refractory to treatment with single plastic stents. METHODS: Several electronic databases were searched for all the studies evaluating the outcome of placement of multiple plastic stents and fully covered metal stents in patients with PD strictures refractory to single plastic stenting. We calculated the Weighted Pooled Ratio (WPR) with Confidence Interval (CI) between the MPS and FCSEMS. RESULTS: A total of 13 studies (including 2 abstracts) were included in the analysis. MPS were placed in 106 patients and FCSEMS in 192 patients. Improvement in pain after stenting (P = 0.794), risk of recurrence of pain after removal of stent (P = 0.48) and stricture recurrence after stent removal (P = 0.52) were comparable between MPS and FCSEMS. Risk of endoscopic re-intervention was also comparable between metal stents and MPS. However, FCSEMS was associated with overall higher risk of adverse events (P < 0.0001). CONCLUSION: FCSEMS are comparable to multiple plastic stents in the treatment of symptomatic refractory PD strictures. However, use of FCSEMS is associated with increased risk of adverse events.