Competence in Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography, From Training Through Independent Practice.

BACKGROUND & AIMS: It is unclear whether participation in competency-based fellowship programs for endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) results in high-quality care in independent practice. We measured quality indicator (QI) adherence during the first year of independent practice among physicians who completed endoscopic training with a systematic assessment of competence. METHODS: We performed a prospective multicenter cohort study of invited participants from 62 training programs. In phase 1, 24 advanced endoscopy trainees (AETs), from 20 programs, were assessed using a validated competence assessment tool. We used a comprehensive data collection and reporting system to create learning curves using cumulative sum analysis that were shared with AETs and trainers quarterly. In phase 2, participating AETs entered data into a database pertaining to every EUS and ERCP examination during their first year of independent practice, anchored by key QIs. RESULTS: By the end of training, most AETs had achieved overall technical competence (EUS 91.7%, ERCP 73.9%) and cognitive competence (EUS 91.7%, ERCP 94.1%). In phase 2 of the study, 22 AETs (91.6%) participated and completed a median of 136 EUS examinations per AET and 116 ERCP examinations per AET. Most AETs met the performance thresholds for QIs in EUS (including 94.4% diagnostic rate of adequate samples and 83.8% diagnostic yield of malignancy in pancreatic masses) and ERCP (94.9% overall cannulation rate). CONCLUSIONS: In this prospective multicenter study, we found that although competence cannot be confirmed for all AETs at the end of training, most meet QI thresholds for EUS and ERCP at the end of their first year of independent practice. This finding affirms the effectiveness of training programs. Clinicaltrials.gov ID NCT02509416.

Cohort study comparing the diagnostic yields of 2 different EUS fine-needle biopsy needles.

BACKGROUND AND AIMS: Two second-generation, flexible EUS fine-needle biopsy (FNB) needles have been marketed recently in the United States. Thus far, there have been no comparative studies of the diagnostic yield of these needles. The aim of this study was to compare the diagnostic yield achieved with FNB by using 1 needle during 1 time period and the other needle during a second time period. METHODS: Consecutive patients with solid lesions undergoing EUS-FNB by using 1 of two 22-gauge FNB needles (Franseen needle or fork-tip) at 2 different time intervals were included. The final diagnosis was based on positive pathology results. In cases of a negative pathology result, the final diagnosis was based on clinical and imaging follow-up. RESULTS: A total of 194 lesions (97 in each group) were sampled in 179 patients. Rapid on-site evaluation (ROSE) was used in 12% of cases. The overall diagnostic yield was lower in the Franseen needle group compared with the fork-tip needle group (61/97 [63%] vs 75/97 [77%], odds ratio (OR) 2.01, 1.07-3.8; P = .027). Similarly, subanalysis of the yield for solid pancreatic masses demonstrated a lower yield with the Franseen needle (34/53 [64%] vs 40/47 [85%], OR 3.4, 9.1-8.9; P = .017). Multivariate analysis controlling for the number of passes, site, and lesion size did not have any effect on diagnostic yield. There were no adverse events in either group. CONCLUSION: In this first, large, single-center comparative cohort study of 2 new, second-generation EUS-FNB needles of different design, the diagnostic yield when used primarily without ROSE was high in both groups but was significantly higher when a fork-tip needle was used.

Burden of Gastrointestinal, Liver, and Pancreatic Diseases in the United States.

BACKGROUND & AIMS: Gastrointestinal (GI), liver, and pancreatic diseases are a source of substantial morbidity, mortality, and cost in the United States. Quantification and statistical analyses of the burden of these diseases are important for researchers, clinicians, policy makers, and public health professionals. We gathered data from national databases to estimate the burden and cost of GI and liver disease in the United States. METHODS: We collected statistics on health care utilization in the ambulatory and inpatient setting along with data on cancers and mortality from 2007 through 2012. We included trends in utilization and charges. The most recent data were obtained from the Centers for Disease Control and Prevention, the Agency for Healthcare Research and Quality, and the National Cancer Institute. RESULTS: There were 7 million diagnoses of gastroesophageal reflux and almost 4 million diagnoses of hemorrhoids in the ambulatory setting in a year. Functional and motility disorders resulted in nearly 1 million emergency department visits in 2012; most of these visits were for constipation. GI hemorrhage was the most common diagnosis leading to hospitalization, with >500,000 discharges in 2012, at a cost of nearly $5 billion dollars. Hospitalizations and associated charges for inflammatory bowel disease, Clostridium difficile infection, and chronic liver disease have increased during the last 20 years. In 2011, there were >1 million people in the United States living with colorectal cancer. The leading GI cause of death was colorectal cancer, followed by pancreatic and hepatobiliary neoplasms. CONCLUSIONS: GI, liver and pancreatic diseases are a source of substantial burden and cost in the United States.

Burden of gastrointestinal disease in the United States: 2012 update.

BACKGROUND & AIMS: Gastrointestinal (GI) diseases account for substantial morbidity, mortality, and cost. Statistical analyses of the most recent data are necessary to guide GI research, education, and clinical practice. We estimate the burden of GI disease in the United States. METHODS: We collected information on the epidemiology of GI diseases (including cancers) and symptoms, along with data on resource utilization, quality of life, impairments to work and activity, morbidity, and mortality. These data were obtained from the National Ambulatory Medical Care Survey; National Health and Wellness Survey; Nationwide Inpatient Sample; Surveillance, Epidemiology, and End Results Program; National Vital Statistics System; Thompson Reuters MarketScan; Medicare; Medicaid; and the Clinical Outcomes Research Initiative's National Endoscopic Database. We estimated endoscopic use and costs and examined trends in endoscopic procedure. RESULTS: Abdominal pain was the most common GI symptom that prompted a clinic visit (15.9 million visits). Gastroesophageal reflux was the most common GI diagnosis (8.9 million visits). Hospitalizations and mortality from Clostridium difficile infection have doubled in the last 10 years. Acute pancreatitis was the most common reason for hospitalization (274,119 discharges). Colorectal cancer accounted for more than half of all GI cancers and was the leading cause of GI-related mortality (52,394 deaths). There were 6.9 million upper, 11.5 million lower, and 228,000 biliary endoscopies performed in 2009. The total cost for outpatient GI endoscopy examinations was $32.4 billion. CONCLUSIONS: GI diseases are a source of substantial morbidity, mortality, and cost in the United States.

A randomized, controlled, double-blind trial of air insufflation versus carbon dioxide insufflation during ERCP.

BACKGROUND: Visualization during GI endoscopy requires distention of the bowel lumen. Carbon dioxide (CO(2)) insufflation decreases postprocedure abdominal discomfort and distension after colonoscopy, but there have been few published studies on its use in ERCP. OBJECTIVE: To assess the safety and efficacy of CO(2) insufflation during ERCP. DESIGN: Double-blind, controlled, randomized trial. SETTING: Tertiary-care referral center. PATIENTS: This study involved consecutive patients referred for ERCP, excluding those with known CO(2) retention or with chronic use of opiate medications. INTERVENTION: Insufflation of CO(2) versus insufflation of air. MAIN OUTCOME MEASUREMENTS: Primary outcomes were abdominal pain assessed on a visual analogue scale and abdominal distension. Secondary outcomes included transcutaneous CO(2) levels (pCO(2)) and procedural complications. RESULTS: We analyzed 74 patients, 38 in the air group and 36 in the CO(2) group. Pain scores were similar in both groups 1-hour postprocedure (16 vs 11 mm in the CO(2) and air groups, respectively; P = .29) as well as over the subsequent 24 hours. There were also no significant differences between groups in abdominal distension or pCO(2) levels. There were 13 patients with complications in the air group and 5 in the CO(2) group (P = .04; nominal significance removed by Bonferroni correction), although most complications were minor in nature. LIMITATIONS: Single-center study. CONCLUSION: The use of CO(2) for insufflation during ERCP was safe in a tertiary-care referral population. However, use of CO(2) during ERCP did not lead to decreased postprocedural pain or less abdominal distension, so its role in this procedure remains in question. NCT00685386.

Bone health in a tertiary-care gastroenterology and hepatology population.

BACKGROUND: Glucocorticoid use is a major risk factor for osteoporosis. Overall rates of glucocorticoid use and bone health preventive measures in gastroenterology and hepatology populations are unknown. AIMS: We aimed to determine the rates of glucocorticoid use and bone health preventive measures, to evaluate an education-based quality improvement initiative on bone health and to assess improvement in health-care practices of providers in regard to bone health recommendations. METHODS: A cross-sectional survey was offered to all patients visiting a tertiary care gastroenterology and hepatology clinic. A bone health education intervention was performed, followed by a repeat cross-sectional survey. Pearson's Chi-square test statistic was used to evaluate interval improvement in bone health recommendations with the intervention. Predictive multiple logistic regression modeling was used to determine factors that influenced bone health recommendations by providers. RESULTS: A total of 552 patients and 725 patients completed the pre and post-intervention questionnaires, respectively. The prevalence of glucocorticoid use was 12.9%. Bone health recommendations to patients on glucocorticoids did not improve with the intervention (63.0% vs. 55.4%, p = 0.42). The strongest predictor of bone health recommendations was autoimmune hepatitis (OR 6.60 95%CI 3.13, 13.90), followed by inflammatory bowel disease (OR 6.06 95%CI 3.92, 9.38), liver disease (OR 3.70 95%CI 2.45, 5.59), current smoking (OR 3.31 95%CI 2.32, 4.73) and history of osteoporosis/osteopenia (OR 2.72 95%CI 1.83, 4.03). CONCLUSIONS: In spite of risk factors for osteoporosis in patients with digestive diseases, health-care practices by providers in regard to bone health recommendations warrant further improvement.

Lower endoscopic ultrasound in preoperative evaluation of rectosigmoid endometriosis.

Background and study aims Endometriosis affects a significant proportion of reproductive-aged women and involves the bowel in up to one-third of patients with the condition. Lower endoscopic ultrasound (LEUS) in assessment of endometriosis of the rectosigmoid colon was first described 20 years ago in European populations. The current study aimed to describe the diagnostic characteristics of this imaging modality at a tertiary US referral center in a large cohort and its impact on surgical planning. Patients and methods This was a retrospective cohort study of adult women evaluated for rectosigmoid endometriosis by LEUS at an American tertiary referral center between January 2003 through June 2017. The reference standard for rectosigmoid endometriosis was surgical evaluation regardless of whether tissue was obtained for histologic evaluation. Two separate analyses were run; one comparing EUS to laparoscopic findings and another comparing EUS to histologic findings. Results LEUS demonstrated a positive predictive value (PPV) of 93.8 % (CI:68.1,99.1) and negative predictive value (NPV) of 96.4 % (CI:87.8,99.0) in the diagnosis of rectosigmoid endometriosis. Test sensitivity was 88.2 % (CI:63.6,98.5) and specificity was 98.2 % (CI:90.1,99.9). Overall diagnostic accuracy of the test was 95.8 % (CI:88.1,99.1). Conclusions In this large cohort of women at an American tertiary referral center undergoing evaluation for rectosigmoid endometriosis, LEUS demonstrated high PPV and NPV as well as excellent diagnostic accuracy. In addition, the LEUS findings provided important information to the referring gynecologic surgeon. This minimally-invasive imaging modality should be utilized in preoperative evaluation of women undergoing surgery for suspected or known endometriosis.

Contributions of pain sensitivity and colonic motility to IBS symptom severity and predominant bowel habits.

OBJECTIVES: Irritable bowel syndrome (IBS) patients show pain hypersensitivity and hypercontractility in response to colonic or rectal distention. Aims were to determine whether predominant bowel habits and IBS symptom severity are related to pain sensitivity, colon motility, or smooth muscle tone. METHODS: One hundred twenty-nine patients classified as IBS with diarrhea (IBS-D, N = 44), IBS with constipation (IBS-C, N = 29), mixed IBS (IBS-M, N = 45), and unspecified IBS (IBS-U, N = 11) based on stool consistency, and 30 healthy controls (HC) were studied. A manometric catheter containing a 600-mL capacity plastic bag was positioned in the descending colon. Pain threshold was assessed using a barostat. Motility was assessed for 10 min with the bag minimally inflated (individual operating pressure [IOP]), 10 min at 20 mmHg above the IOP, and for 15-min recovery following bag inflation. Motility was also recorded for 30 min following an 810-kcal meal. RESULTS: Compared with HC, IBS patients had lower pain thresholds (medians 30 vs 40 mmHg, P < 0.01), but IBS subtypes were not different. IBS symptom severity was correlated with pain thresholds (rho =-0.36, P < 0.001). During distention, the motility index (MI) was significantly higher in IBS compared with HC (909 +/- 73 vs 563 +/- 78, P < 0.01). Average barostat bag volume at baseline was higher (muscle tone lower) in HC compared with IBS-D and IBS-M but not compared with IBS-C. The baseline MI and bag volume differed between IBS-D and IBS-C and correlated with symptoms of abdominal distention and dissatisfaction with bowel movements. Pain thresholds and MI during distention were uncorrelated. CONCLUSIONS: Pain sensitivity and colon motility are independent factors contributing to IBS symptoms. Treatment may need to address both, and to be specific to predominant bowel habit.

Increased Postprandial Colonic Motility and Autonomic Nervous System Activity in Patients With Irritable Bowel Syndrome: A Prospective Study.

BACKGROUND/AIMS: The prevalence and severity of irritable bowel syndrome (IBS) declines with age, but the cause of this is unknown. This study tested 2 hypotheses: (1) autonomic nervous system responses to eating and bowel distention, measured by heart rate variability (HRV), differs by age in IBS patients and (2) HRV is correlated with colonic motility and IBS symptoms. METHODS: One hundred and fifty-six Rome III positive IBS patients and 31 healthy controls underwent colonic manometry with bag distention in the descending colon, followed by ingestion of an 810-kcal meal. HRV, evaluated by low frequency (%LF; 0.04-0.15 Hz) component, high frequency (%HF; 0.15-0.40 Hz) component, and the LF/HF ratio, was measured during colonic distention and after the meal. Motility index and subjective symptom scores were simultaneously quantified. RESULTS: Both colonic distention and eating decreased %HF and increased the LF/HF ratio, and both indices of autonomic nervous system correlated with age. In IBS patients, %HF negatively correlated with the postprandial motility index after adjusting for age. The %HF and LF/HF ratios also correlated with psychological symptoms but not bowel symptoms in IBS patients. CONCLUSION: Decreased vagal activity is associated with increase in age and greater postprandial colonic motility in patients with IBS, which may contribute to postprandial symptoms.

Hematochezia due to a renal cell carcinoma metastasis to the rectum: A case report and review of the literature.

While primary tumors of the GI tract are a frequent cause of gastrointestinal bleeding, metastatic lesions to the bowel uncommonly present with hematochezia, and rectal involvement is particularly rare. We describe the case of a 70-year-old man with an exceedingly late recurrence of renal cell carcinoma who presented with hematochezia due to a metastasis in the rectum. This is the first report to include both endoscopic and endoscopic ultrasound images of such a lesion. In the correct clinical setting, metastatic disease to the rectum should be included on the differential diagnosis of lower gastrointestinal bleeding.

Inhibition of fried meat-induced colorectal DNA damage and altered systemic genotoxicity in humans by crucifera, chlorophyllin, and yogurt.

UNLABELLED: Dietary exposures implicated as reducing or causing risk for colorectal cancer may reduce or cause DNA damage in colon tissue; however, no one has assessed this hypothesis directly in humans. Thus, we enrolled 16 healthy volunteers in a 4-week controlled feeding study where 8 subjects were randomly assigned to dietary regimens containing meat cooked at either low (100°C) or high temperature (250°C), each for 2 weeks in a crossover design. The other 8 subjects were randomly assigned to dietary regimens containing the high-temperature meat diet alone or in combination with 3 putative mutagen inhibitors: cruciferous vegetables, yogurt, and chlorophyllin tablets, also in a crossover design. Subjects were nonsmokers, at least 18 years old, and not currently taking prescription drugs or antibiotics. We used the Salmonella assay to analyze the meat, urine, and feces for mutagenicity, and the comet assay to analyze rectal biopsies and peripheral blood lymphocytes for DNA damage. Low-temperature meat had undetectable levels of heterocyclic amines (HCAs) and was not mutagenic, whereas high-temperature meat had high HCA levels and was highly mutagenic. The high-temperature meat diet increased the mutagenicity of hydrolyzed urine and feces compared to the low-temperature meat diet. The mutagenicity of hydrolyzed urine was increased nearly twofold by the inhibitor diet, indicating that the inhibitors enhanced conjugation. Inhibitors decreased significantly the mutagenicity of un-hydrolyzed and hydrolyzed feces. The diets did not alter the levels of DNA damage in non-target white blood cells, but the inhibitor diet decreased nearly twofold the DNA damage in target colorectal cells. To our knowledge, this is the first demonstration that dietary factors can reduce DNA damage in the target tissue of fried-meat associated carcinogenesis. TRIAL REGISTRATION: ClinicalTrials.gov NCT00340743.

The burden of gastrointestinal and liver diseases, 2006.

BACKGROUND: Digestive and liver diseases are a source of significant morbidity, mortality, and health-care costs for the U.S. population. An annual report of the toll of these diseases could be helpful to clinicians, policymakers, and researchers. AIM: To describe the epidemiology of gastrointestinal and liver diseases in the United States using data from privately and publicly held databases. METHODS: We collected data from the National Center for Health Statistics, the National Ambulatory Medical Care Survey, the National Inpatient Sample, the Centers for Disease Control and Prevention, and the National Cancer Institute, as well as proprietary pharmaceutical databases to construct a report on the impact of gastrointestinal and liver diseases on the U.S. population. We compiled information on causes of death, hospitalization, clinic visits, cancer incidence, and mortality and infectious disease incidence from these databases, and extracted data specific to gastrointestinal diseases. Because of the high costs associated with medications used to treat gastrointestinal diseases, we also include in this year's report a special section on pharmacoepidemiology and pharmacoeconomics. RESULTS: Colorectal cancer continues to be the leading cause of GI-related death, although the data indicate a downward trend in deaths. Abdominal pain, diarrhea, vomiting, and nausea are the most common GI symptoms precipitating a visit to the physician, and GERD is the most common GI-related diagnosis given in office visits. Chest pain not specified to be cardiac in origin is the most common cause of inpatient admission possibly related to GI disease, with cholelithiasis and pancreatitis following. Americans spend in excess of US dollars 10 billion/yr on proton pump inhibitors (PPIs), and two of the top five selling drugs in the United States are PPIs. Trends in PPI use demonstrate turbulent changes, likely reflecting both new drug entries into the field, as well as drug marketing. The number of PPI prescriptions/yr in the United States has doubled since 1999. Twenty-three drugs used for gastrointestinal diseases are among the top 200 generic drugs used in the United States. CONCLUSIONS: Gastrointestinal and liver diseases are significant contributors to the morbidity, mortality, and health-care expenditures of the U.S. population.

Digestive and liver diseases statistics, 2004.

BACKGROUND & AIMS: Digestive and liver diseases are associated with substantial morbidity and mortality in the United States. Statistics about the incidence, prevalence, mortality, and resource utilization of digestive and liver diseases in the United States may be cumbersome to obtain because they are scattered in multiple sources. These data may be useful for policy makers, grant applicants, and authors. METHODS: Data on the most common gastrointestinal and liver diseases were collected from large publicly available national databases. Information was collected on inpatient and outpatient gastrointestinal complaints and diagnoses, gastrointestinal cancers, and deaths from common liver diseases. RESULTS: The leading gastrointestinal complaint prompting an outpatient visit is abdominal pain, with 12.2 million annual visits, followed by diarrhea, nausea, and vomiting. Abdominal pain is the leading outpatient gastrointestinal diagnosis, accounting for 5.2 million visits annually, followed by gastroesophageal reflux disease, with 4.5 million visits. Gallstone disease is the most common inpatient diagnosis, with 262,411 hospitalizations and a median inpatient charge of USD$11,584. Colorectal cancer is the most common gastrointestinal cause of death and is the most common gastrointestinal cancer, with an incidence of 54 per 100,000. Among gastrointestinal cancers, primary liver cancer had the highest increase in incidence from 1992 to 2000. CONCLUSIONS: Gastrointestinal and liver diseases are associated with significant outpatient and inpatient healthcare utilization. Following trends in utilization is important for determining allocation of resources for health care and research.