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.

Setting minimum standards for training in EUS and ERCP: results from a prospective multicenter study evaluating learning curves and competence among advanced endoscopy trainees.

BACKGROUND AND AIMS: Minimum EUS and ERCP volumes that should be offered per trainee in "high quality" advanced endoscopy training programs (AETPs) are not established. We aimed to define the number of procedures required by an "average" advanced endoscopy trainee (AET) to achieve competence in technical and cognitive EUS and ERCP tasks to help structure AETPs. METHODS: American Society for Gastrointestinal Endoscopy (ASGE)-recognized AETPs were invited to participate; AETs were graded on every fifth EUS and ERCP examination using a validated tool. Grading for each skill was done using a 4-point scoring system, and learning curves using cumulative sum analysis for overall, technical, and cognitive components of EUS and ERCP were shared with AETs and trainers quarterly. Generalized linear mixed-effects models with a random intercept for each AET were used to generate aggregate learning curves, allowing us to use data from all AETs to estimate the average learning experience for trainees. RESULTS: Among 62 invited AETPs, 37 AETs from 32 AETPs participated. Most AETs reported hands-on EUS (52%, median 20 cases) and ERCP (68%, median 50 cases) experience before starting an AETP. The median number of EUS and ERCPs performed per AET was 400 (range, 200-750) and 361 (range, 250-650), respectively. Overall, 2616 examinations were graded (EUS, 1277; ERCP-biliary, 1143; pancreatic, 196). Most graded EUS examinations were performed for pancreatobiliary indications (69.9%) and ERCP examinations for ASGE biliary grade of difficulty 1 (72.1%). The average AET achieved competence in core EUS and ERCP skills at approximately 225 and 250 cases, respectively. However, overall technical competence was achieved for grade 2 ERCP at about 300 cases. CONCLUSION: The thresholds provided for an average AET to achieve competence in EUS and ERCP may be used by the ASGE and AETPs in establishing the minimal standards for case volume exposure for AETs during their training. (Clinical trial registration number: NCT02509416.).

Potential screening benefit of a colorectal imaging capsule that does not require bowel preparation.

INTRODUCTION: Check-Cap is a capsule device that images the colon using low-dose radiation (total dose equivalent to a plain abdominal radiograph) and does not require bowel preparation. Check-Cap is in development for colorectal cancer imaging. AIM: : To survey patients in a primary care setting for their preferences for Check-Cap versus fecal occult blood testing (FOBT), including among patients who decline colonoscopy. METHODS: Patients aged 50 and older presenting to the general medicine and family practice clinics of Indiana University Health sites within a 3-month period were approached during clinic visits. A total of 502 patients who agreed to participate were given the opportunity to complete an anonymous survey (Supplementary Appendix 1, http://links.lww.com/JCG/A71) regarding their preferences for colon cancer screening. The survey presented procedure descriptions and projected accuracies for colonoscopy, FOBT, and Check-Cap. For Check-Cap, projected sensitivity was 80% for cancer and 50% for large polyps. RESULTS: The mean age of the subjects was 61.6 years, 39% were males, 44% white, 62% of patients had prior colonoscopy, and 26% had prior polypectomy. We defined 3 groups of patients-those that had never had a colonoscopy (NC)-38%, those who had a colonoscopy but no polypectomy (CNP)-36%, and those who had a colonoscopy and polypectomy (CP)-26%. Overall, 284 patients (57%) were willing to undergo a future colonoscopy. Patients with prior colonoscopy and polypectomy were more willing to get another colonoscopy than the other 2 groups (CP:CNP:NC=78%:64%:38%; P<0.0001). Willingness to undergo colonoscopy decreased with age in all the 3 groups. Among those not willing to undergo colonoscopy, 30% were willing to undergo Check-Cap, 20% were willing for FOBT), 25% were willing to do both, and 24% were not willing for either test. Among those who declined future colonoscopy, 40% reported Check-Cap as their preferred screening test versus 22% for FOBT; P=0.0002. CONCLUSION: Our survey suggests that an imaging capsule like Check-Cap could contribute to screening adherence among patients who decline colonoscopy, provided that it can achieve projected sensitivities of 80% for cancer and 50% for large polyps.

Factors that predict short-term intensive care unit mortality in patients with cirrhosis.

BACKGROUND & AIMS: Despite advances in critical care medicine, the mortality rate is high among critically ill patients with cirrhosis. We aimed to identify factors that predict early (7 d) mortality among patients with cirrhosis admitted to the intensive care unit (ICU) and to develop a risk-stratification model. METHODS: We collected data from patients with cirrhosis admitted to the ICU at Indiana University (IU-ICU) from December 1, 2006, through December 31, 2009 (n = 185), or at the University of Pennsylvania (Penn-ICU) from May 1, 2005, through December 31, 2010 (n = 206). Factors associated with mortality within 7 days of admission (7-d mortality) were determined by logistic regression analyses. A model was constructed based on the predictive parameters available on the first day of ICU admission in the IU-ICU cohort and then validated in the Penn-ICU cohort. RESULTS: Median Model for End-stage Liver Disease (MELD) scores at ICU admission were 25 in the IU-ICU cohort (interquartile range, 23-34) and 32 in the Penn-ICU cohort (interquartile range, 26-41); corresponding 7-day mortalities were 28.3% and 53.6%, respectively. MELD score (odds ratio, 1.13; 95% confidence interval [CI], 1.07-1.2) and mechanical ventilation (odds ratio, 5.7; 95% CI, 2.3-14.1) were associated independently with 7-day mortality in the IU-ICU. A model based on these 2 variables separated IU-ICU patients into low-, medium-, and high-risk groups; these groups had 7-day mortalities of 9%, 27%, and 74%, respectively (concordance index, 0.80; 95% CI, 0.72-0.87; P < 10(-8)). The model was applied to the Penn-ICU cohort; the low-, medium-, and high-risk groups had 7-day mortalities of 33%, 56%, and 71%, respectively (concordance index, 0.67; 95% CI, 0.59-0.74; P < 10(-4)). CONCLUSIONS: A model based on MELD score and mechanical ventilation on day 1 can stratify risk of early mortality in patients with cirrhosis admitted to the ICU. More studies are needed to validate this model and to enhance its clinical utility.

De novo malignancy post-liver transplantation: a single center, population controlled study.

BACKGROUND: With the growing numbers of liver transplant recipients, it is increasingly important to understand the risks of de novo malignancy after liver transplantation. AIM: To characterize the incidence of de novo malignancy after liver transplantation compared with a control non-transplant population. METHODS: We studied 534 Indiana state residents undergoing liver transplantation at our center between 1997 and 2004, followed through August 2010. The incidence and predictors of malignancy were determined. The standardized incidence ratio (SIR) of cancer in our cohort was compared with age-, gender-, and period-matched state population using the Indiana State Cancer Registry. RESULTS: After a mean follow-up of 5.7 ± 3.2 yr, 73 patients (13.7%) developed 80 cancers, with five- and 10-yr incidence rates of 11.7% and 24.8%, respectively. These included 24 (30%) skin, 16 (20%) hematologic, and 40 (50%) solid tumors. The most common solid cancers were aerodigestive. Compared with matched state population, liver transplant recipients had significantly higher incidence of all cancers (SIR: 3.1, 95% CI [Confidence interval]: 2.9-3.2), skin (melanoma) (SIR: 5.8, 95% CI: 4.7-7.0), hematologic (SIR: 7.1, 95% CI: 6.3-8.0), and solid (SIR: 2.7, 95% CI: 2.5-2.8) tumors. CONCLUSION: There is a significantly increased risk of de novo malignancies after liver transplantation, highlighting the need for surveillance strategies in this population.

Dyslipidemia in patients with nonalcoholic fatty liver disease.

Patients with nonalcoholic fatty liver disease (NAFLD) often have dyslipidemia along with other features of metabolic syndrome such as obesity, diabetes mellitus, and hypertension. The dyslipidemia in NAFLD is characterized by increased serum triglycerides, increased small, dense low-density lipoprotein (LDL nontype A) particles, and low high-density lipoprotein (HDL) cholesterol. The pathogenesis of dyslipidemia in NAFLD is not well understood, but it is likely related to hepatic overproduction of the very low-density lipoprotein particles and dysregulated clearance of lipoproteins from the circulation. There is unequivocal evidence that cardiovascular disease is the most common cause of mortality in patients with NAFLD. Aggressive treatment of dyslipidemia plays a critical role in the overall management of patients with NAFLD. Statins are the first-line agents to treat high cholesterol and their dosage should be adjusted based on achieving therapeutic targets and tolerability. Although all statins appear to be effective in improving cholesterol levels in patients with NAFLD, there is more experience with atorvastatin in patients with NAFLD; furthermore, it is the only statin to date to show a reduced cardiovascular morbidity in patients with NAFLD. The risk for serious liver injury from statins is quite rare and patients with NAFLD are not at increased risk for statin hepatotoxicity. Omega-3 fatty acids are perhaps the first choice to treat hypertriglyceridemia because of their safety, tolerability, and efficacy in improving serum triglycerides, as well as their potential to improve liver disease.

Longitudinal Gastrectomy for Nonbariatric Indications.

BACKGROUND: Sleeve gastrectomy is the most commonly performed bariatric procedure. Laparoscopic longitudinal gastrectomy (LLG) may be indicated for other indications. Patients and Methods. Two men and two women aged 67, 72, 77, and 80 years underwent LLG for nonbariatric indications with two having normal weight, one being cachectic, and one severely obese. RESULTS: LLG was discussed with patients prior to surgery, but decision for LLG was made during surgery after contemplating other surgical options. A wide sleeve over a 42 French bougie was created with the staple line being oversewn with running 3-0 silk. Indications included a bleeding Dieulafoy lesion that failed endoscopic clipping, fundus gland polyposis found during paraesophageal hernia repair, fundus nodules suspected to be leiomyosarcoma metastases revealing splenosis on final pathology, and significant gastric dilatation associated with organoaxial gastric volvulus. Three patients had an uneventful recovery; the severely obese patient temporarily lost weight but died after two years from a stroke. The last patient developed dysphagia due to an alpha-loop in the sleeve, which was managed by endoscopic stenting. The device subsequently migrated and was laparoscopically removed, with a side-side gastrogastrostomy performed to straighten the alpha-loop. The patient tolerated food better and with overnight PEG tube feeds gained weight but continued heavy smoking. He died after one year from COPD exacerbation. CONCLUSION: LLG seems to be an appropriate intervention for various gastric pathologies. Training of residents and fellows in the minimally invasive surgical steps of LLG is encouraged.

Label-free multi-photon imaging of dysplasia in Barrett's esophagus.

Barrett's esophagus (BE) is a metaplastic disorder where dysplastic and early cancerous changes are invisible to the naked eye and where the practice of blind biopsy is hampered by large sampling errors. Multi-photon microscopy (MPM) has emerged as an alternative solution for fast and label-free diagnostic capability for identifying the histological features with sub-micron accuracy. We developed a compact, inexpensive MPM system by using a handheld mode-locked fiber laser operating at 1560nm to study mucosal biopsies of BE. The combination of back-scattered THG, back-reflected forward THG and SHG signals generate images of cell nuclei and collagen, leading to label-free diagnosis in Barrett's.

Use of sirolimus in the treatment of refractory autoimmune hepatitis.

BACKGROUND: Corticosteroids and azathioprine are widely accepted as the initial therapy for autoimmune hepatitis. However, the disease is refractory to steroids in about 10%-20% of patients, for whom currently there is no standardized treatment. Here we describe our experience with sirolimus in treatment of steroid refractory autoimmune hepatitis. METHODS: This is a longitudinal follow-up study. Between November 2007 and January 2014, 5 subjects with steroid refractory autoimmune hepatitis were treated with sirolimus at our institution. RESULTS: A response, defined as a sustained >50% fall in alanine aminotransferase (ALT) levels, was achieved in 4/5 patients. A complete response, sustained normalization of ALT levels, was achieved in 2/5 patients. The need for steroids was significantly reduced in all patients (P < .05). CONCLUSIONS: In this small series, sirolimus appears to be useful in the treatment of patients with steroid refractory autoimmune hepatitis.

Prevalence and morbidity associated with muscle cramps in patients with cirrhosis.

PURPOSE: Patients with cirrhosis often experience muscle cramps with varying severity. We investigated the factors associated with the prevalence and morbidity associated with muscle cramps. METHODS: A total of 150 adult patients with cirrhosis were enrolled consecutively. Cramp questionnaire with visual analogue scale for pain, Chronic Liver Disease Questionnaire (CLDQ), and blood for measurement of 25-(OH) vitamin D levels were obtained after informed consent. RESULTS: A total of 101 patients (67%) reported muscle cramps in the preceding 3 months. Patients with cramps had significantly lower serum albumin (3.1±0.6 g/dL vs 3.3±0.7 g/dL, P=.04) and CLDQ scores (107±37 vs 137±34, P<.0001) compared with those without cramps. The median composite symptom score, defined as product of frequency and severity of cramps, in the study cohort was 12 with a range of 0.3 to 200. There were no clinical or biochemical predictors for occurrence of any cramps or severe cramps (composite symptom score>12). Muscle cramps (P<.001) and hepatic encephalopathy (P=.009) were associated independently with decreased CLDQ scores. Vitamin D deficiency was seen in 66% of the study cohort, but the serum 25-(OH) vitamin D levels were not significantly different between patients with and without cramps (18.0±8.9 ng/mL vs 19.6±9.5 ng/mL, P=.49). CONCLUSIONS: Muscle cramps are associated with significantly diminished quality of life in patients with cirrhosis. More research is needed to better understand their mechanism to develop effective treatment.