Faculty Bibliography

Introduction: Pseudomelanosis of the upper gastrointestinal tract (GI) is a rare condition characterized by a diffuse black-brown speckled pigmentation within the intestinal mucosa. Usually identified incidentally on endoscopy, upper intestinal pseudomelanosis is more frequently seen in the duodenum, but can rarely also be seen in the gastric body and jejunum. While this condition has been reported in literature, pathogenesis and clinical course are still largely unknown. Here we describe a case of pseudomelanosis in a patient referred for iron deficiency anemia. Case Description/Methods: An 80-year-old woman with a history notable for hypertension, type 2 diabetes, chronic kidney disease, coronary artery disease, gastroesophageal reflux disease, hypothyroidism, and celiac disease was referred for evaluation of iron deficiency anemia. On review, she had undergone screening colonoscopy 2 years ago, notable for scattered diverticulosis, and upper endoscopy 5 years ago notable only for mild gastritis. Medications included: aspirin, hydralazine, metoprolol, losartan, atorvastatin, pantoprazole, ferrous sulfate, and insulin glargine. She initially underwent video capsule endoscopy, revealing mild non-erosive gastropathy and scattered black pigmentation in the duodenum (Figure 1A). She subsequently underwent upper endoscopy demonstrating scattered pigmentation in the gastric antrum, duodenum, and proximal jejunum (Figure 1B). Duodenal biopsies revealed pigment laden macrophages within the mucosa consistent with pseudomelanosis duodeni (Figure 1C).
Discussion(s): Pseudomelanosis of the upper intestinal tract is a rare and poorly understood condition. While considered benign, it has been associated with various conditions including hypertension, diabetes mellites, chronic kidney disease, gastrointestinal bleeding, and with medications including oral iron supplements and diureticsmany of which were seen in this case. Unlike colonic pseudomelanosis, which is histologically characterized by accumulation of lipofuscin within the colonic mucosa and is associated with laxative use, pseudomelanosis of the upper intestinal tract is histologically distinct, characterized by accumulation of ferrous sulfate containing compounds. To date, pathogenesis of the condition remains unclear. Given the rarity of upper intestinal pseudomelanosis, prognosis and treatment have also yet to be determined. This reports aims to increase awareness of this rare and incompletely understood condition

BACKGROUND:This analysis characterized changes in sodium levels in patients receiving the 1 L polyethylene glycol-based preparation NER1006. METHODS:Data were pooled from three phase III, randomized clinical trials. A post hoc subanalysis included adults who received a 2-day split-dose (evening/morning) NER1006 regimen, a 1-day split-dose (morning only) regimen, or evening-before regimen and had an increase in sodium concentrations from normal to above the upper limit of normal (143-148 mmol/L) at ≥ 1 of three post-treatment visits. Blood samples were collected at baseline, day of colonoscopy (visit 2), 2 ± 1 days post-colonoscopy (visit 3), and 7 ± 1 days post-colonoscopy (visit 4). RESULTS:A total of 214 of 1028 patients were included. Of the 214 patients, sodium concentration increased from a mean baseline value of 141.8 mmol/L to a mean of 147.1 mmol/L (median increase from baseline of approximately 5 mmol/L). The mean sodium concentration was within normal range at visit 3 (142.3 mmol/L) and visit 4 (142.4 mmol/L), as was the median sodium concentration. Overall, ~ 90% of patients had a normal serum concentration at visits 3 and 4. Based on day of colonoscopy test results, there were four adverse events involving hypernatremia (0.4% of 1028), which were mild and did not require medical intervention; sodium levels returned to normal range by visit 3. CONCLUSION/CONCLUSIONS:NER1006 was associated with small, transient increases in sodium levels that were not considered clinically significant. Trial registration NOCT (ClinicalTrials.gov: NCT02254486 [registered October 2, 2014]), MORA (ClinTrials.gov: NCT02273167 [registered October 23, 2014]; EudraCT number: 2014-002185-78 [registered August 13, 2014]), DAYB (ClinicalTrials.gov: NCT02273141 [registered October 23, 2014]; EudraCT Number: 2014-002186-30 [registered August 12, 2014]).

Patients with chronic idiopathic constipation and irritable bowel syndrome with constipation experience an array of gastrointestinal symptoms. Given the subjective nature of these disorders, patient self-reporting is critical to diagnosis and monitoring response to therapy. Unfortunately, many patients are reluctant to discuss bowel symptoms with their healthcare providers. Differences in sex, health literacy, and age can influence symptom reporting. Negative patient-physician relationships and dissatisfaction with care lead patients to seek alternative treatments, switch healthcare providers, or discontinue care. Thus, adopting a patient-centered communication style can help create a shared understanding of patients' symptoms, achieve accurate symptom reporting, expedite diagnosis, and facilitate appropriate treatment plans. Currently, there are multiple symptom and quality-of-life scales available to assist healthcare providers in this endeavor. These scales also allow for the monitoring of constipation-related symptoms and symptom severity. When using patient self-assessments to measure treatment responses, scale selection may depend on the number of symptoms being assessed, the duration and frequency of assessments, and patients' comprehension and language skills.

Chronic idiopathic constipation and irritable bowel syndrome with constipation are complex, overlapping conditions. Although multiple guidelines have informed healthcare providers on appropriate treatment options for patients with chronic idiopathic constipation and irritable bowel syndrome with constipation, little direction is offered on treatment selection. First-line treatment options usually include fiber and over-the-counter osmotic laxatives; however, these are insufficient for many individuals. When these options fail, prescription secretagogues (plecanatide, linaclotide, lubiprostone, and tenapanor [pending commercial availability]), or serotonergic agents (prucalopride and tegaserod) are generally preferred. Individuals experiencing concurrent abdominal pain and/or bloating may experience greater overall improvements from prescription therapies because these agents have been proven to reduce concurrent abdominal and bowel symptoms. Should initial prescription treatments fail, retrying past treatment options (if not adequately trialed initially), combining agents from alternative classes, or use of adjunctive therapies may be considered. Given the broad spectrum of available agents, therapy should be tailored by mutual decision-making between the patient and practitioner. Overall, patients need to be actively monitored and managed to maximize clinical outcomes.

Introduction: Colorectal cancer is the third most common cancer for both men and women1. Despite the effectiveness of colon cancer screening only 44% of eligible patients get screened. Often related to not wanting an invasive procedure or not wanting to be sedated. Current non-invasive option include stool based tests, pillcam colon and CT colonography, both requiring a bowel cleanse. Recently there is a new x-ray capsule, which does not require a bowel cleanse prior to ingestion. The case below shows the correlation between x-ray capsule and optical colonoscopy for colon polyp detection. Case Description/Methods: A 55 year old male with no significant medical problems present for colon cancer screening. He has no family history of colon cancer or polyps. He denies any gastrointestinal complaints. Prior to undergoing colonoscopy, the patient ingests the x-ray capsule, using ultra-low dose x-ray imaging 3-dimensional (3D) images of the colon are created. This is accomplished without needing a bowel cleanse. Scans are taken during capsule motion in the colon and transmitted data to an external recorder unit attached to the patients' lower back. Using both data colon scans and the capsule position tracking a reconstructed 3D colon segments are generated. A 10 mm polyp was identified in the ascending colon. A subsequent colonoscopy was performed identifying the lesion, which was removed by snare polypectomy (Figure 1).
Discussion(s): Colon cancer screening has decreased the mortality of colon cancer. Colonoscopy is the gold standard, but some patients prefer non-invasive option. X-ray capsule is able to achieve 3D imaging using ultra low dose radiation. Future studies are needed to determine of this technology will play a role in colon cancer screening

Introduction: Multiple recent outbreaks of multidrug resistant organisms (MDRO) related to contaminated duodenoscopes have led to increased scrutiny of duodenoscope standard reprocessing methods. A key component of duodenoscope reprocessing is the cleaning step that occurs before high-level disinfection (HLD) or sterilization. Perfect adherence to manufacturer Instructions for Use (IFU) for manual cleaning can be difficult to achieve due to technical complexity and is open to human factor error. Adequate cleaning is measured against FDA and industry maximum allowed contaminants post cleaning of protein<6.4 ug/cm^2 and carbohydrates<2.2 ug/cm^2. Inadequate cleaning increases the risk for inadequate high-level disinfection and the possibility of procedures being performed with contaminated duodenoscopes. A new cleaning process has been developed to fully automate the cleaning step using turbulent flow technology.
Method(s): A total of 48 therapeutic ERCP procedures were performed utilizing Olympus TJF-Q180V duodenoscopes. After bedside point of use cleaning, 21 duodenoscopes were manually cleaned by trained technicians following the manufacturer IFU. 27 duodenoscopes were cleaned using the automated cleaning system. Duodenoscope instrument channels and distal elevator areas were sampled for residual protein and carbohydrates after cleaning.
Result(s): The automated cleaning process resulted in a lower average level of residual protein and carbohydrate compared to standard manual cleaning (Table 1). Using FDA and industry standards as a benchmark, the automated cleaning process reduced levels of protein and carbohydrate below safety threshold levels on all study duodenoscopes, while manual cleaning resulted in 4/21 (19%) duodenoscopes having protein or carbohydrate levels above FDA standards (p= 0.03).
Conclusion(s): Recent outbreaks of MDRO organisms transmitted after ERCP have brought to light the risk to patients when reusable duodenoscopes are not sufficiently reprocessed. The complex design of the device-involving multiple channels and an elevator mechanism at the distal tip-makes proper cleaning difficult. Without sufficient cleaning, subsequent HLD or sterilization can fail to adequately remove contaminants. As seen in this study, manual cleaning can be prone to error. With no incidents of elevated bioburden post cleaning, a fully automated cleaning technology appears to be a viable alternative for replacement of manual cleaning of duodenoscopes

Understanding pathophysiological causes of constipation is worthwhile in directing therapy and improving symptoms. This review aims to identify and fill gaps in the understanding of the pathophysiology of constipation, understand its prevalence, review diagnostic tools available to primary care physicians (PCPs), and highlight patients' expectations for the management of this common spectrum of disorders. Literature searches conducted via PubMed included terms related to constipation, diagnosis, and patient perceptions. Case studies were developed to highlight the differences between patients who may be appropriately managed in the primary care setting and those requiring specialty consultation. Myriad pathophysiological factors may contribute to constipation, including stool consistency, altered intestinal motility, gut microbiome, anorectal abnormalities, as well as behavioral and psychological factors. Common diagnoses of "primary constipation" include slow-transit constipation, defecation disorders, irritable bowel syndrome with constipation, and chronic idiopathic constipation. A detailed medical history should be conducted to exclude alarm features and PCPs should be familiar with pathophysiological factors that cause constipation, available diagnostic tools, alarm signs, and the various classification criteria for constipation subtypes in order to diagnose and treat patients accordingly. PCPs should understand when a referral to a gastroenterologist, anorectal specialist, pelvic floor physical therapist, and/or mental health specialist is appropriate.

BACKGROUND:, Salix Pharmaceuticals, Bridgewater, NJ) is a 1 L polyethylene glycol bowel preparation indicated for colonoscopy in adults. A US online survey assessed real-world ease of use and treatment satisfaction in individuals who received NER1006. METHODS:Adults were recruited from 444 US community gastrointestinal practices and provided a kit number for enrollment into an online survey to be completed within 2 weeks. Survey questions evaluated colonoscopy history and prior bowel preparation(s) prescribed, patient experience during NER1006 administration, and patient satisfaction with the bowel preparation process. A 9-point predefined grading scale was used to evaluate ease of NER1006 preparation and consumption (range, 1 "very difficult" to 9 "very easy"); the perceived importance of volume requirement and clear liquid options (range, 1 "not important at all" to 9 "very important"); and patient satisfaction (range, 1 "not satisfied at all" to 9 "very satisfied"). RESULTS:1630 patients were enrolled, 1606 underwent colonoscopy, and 1598 completed the survey between September 15, 2018 and February 28, 2019. Among 1606 patients who had a colonoscopy, 62.5% were female, and the mean patient age was 54.4 years (range 18-89 years). Most patients (74.7%) did not report a family history of colon cancer, 62.6% had undergone prior colonoscopy, and 64.8% were undergoing colonoscopy for routine colorectal cancer screening. A majority (76.1%) of patients who completed the survey reported that NER1006 was very easy to prepare and take, and 89.9% were very or moderately satisfied with NER1006 overall. Most (97.6%) patients reported consuming all or most of the bowel preparation. Among 1005 patients with previous bowel preparation use, 84.7% indicated that their experience with NER1006 was much better or better (65.3%) or about the same (19.4%) compared with previously used bowel preparations, while only 15.3% rated NER1006 as worse or much worse. CONCLUSIONS:In this first real-world, US multicenter survey, patient-reported experience with NER1006 as a bowel preparation for colonoscopy was favorable and adherence was high. The majority of patients were very or moderately satisfied with the overall experience and found it much better/better than previously used bowel preparations. TRIAL REGISTRATION/BACKGROUND:Not applicable.