New research was presented at DDW 2019, the annual Digestive Disease Week, from May 18-21 in San Diego. The features below highlight some of the studies that emerged from the conference.
Rectal Exam Underused for Constipation
Although the American Gastroenterological Association recommends digital rectal exams for constipation workup, it has been speculated that many physicians miss performing the procedure in this patient population due to time constraints or unawareness of its importance in this setting. However, such examinations can determine if patients with complaints of constipation have dyssynergic defecation, which has been shown to cause 20% to 80% of chronic constipation. For a study, researchers retrospectively reviewed the constipation workups of patients treated at two community hospitals. Among the office visits in the records of participants, only 7% included digital rectal exams and none included comments on maneuvers testing for dyssynergia. On average, digital rectal exams were not performed until the third visit. Among those who received a rectal exam, 50% underwent imaging— including x-ray (32%), CT scan (18%), and colonoscopy (36%)—and all received an average of 1.8 laxatives before the exam. Patients who made more office visits or had more tests overall were more likely to undergo digital rectal exams. The study authors note that this testing and laxative prescribing could be avoided for many patients who have dyssynergic defecation.
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Intrahepatic Cholestasis in Pregnancy & NAFLD
Previous studies indicate that bile acids are relevant signaling molecules that regulate certain metabolic pathways in non-alcoholic fatty liver disease (NAFLD). Other research suggests that women with intraheptatic cholestasis (ICP)—in which bile acids accumulate in circulation and cause intense itching—have increased rates of metabolic risk factors when compare with women without ICP. With bile acid levels known to be increased in NAFLD and ICP, study investigators sought to evaluate a potential relationship between the conditions. Women with a confirmed ICP diagnosis were matched and compared with pregnant women in a control group who did not have bile acid level test orders, a marker that they had no indication of ICP. Patients with NAFLD or steatosis on liver imaging were more likely to develop ICP when compared with those with no evidence of fatty liver (odds ratio [OR], 5.7); those with NAFLD were also more likely to develop ICP if they had biliary disease prior to pregnancy (OR, 3.29) or alanine transaminase levels more than twice the upper limit of normal (50 U/L). No significant differences in metabolic risk factors for fatty liver disease between women with ICP and the control group indicates a direct link between NAFLD and ICP, note the study authors. However, prospective evaluations of matched samples in which all patients receive liver imaging and bile acid measurement are needed to confirm the findings.
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Continue Aspirin in Patients With Lower GI Bleeding?
The American College of Gastroenterology recommends that in patients with established high-risk cardiovascular disease and a history of lowering GI bleeding (LGIB), “aspirin used for secondary prevention should not be discontinued. Aspirin for primary prevention of cardiovascular events should be avoided in most patients with LGIB.” However, evidence and professional experience suggest that physicians’ opinions on aspirin therapy cessation differ. To better understand these differences, researchers analyzed patients who presented with confirmed LGIB from 2010 to 2018 at Beth Israel Deaconess. Among the 48% of study patients who were on aspirin therapy, physicians discontinued this therapy in 35%. While patients on aspirin at admission were older and had more risk of comorbidity-associated mortality, outcomes between these two groups were not statistically significant. In aspirin users and non-users, respectively, rates for ICU stays were 41% and 32%, rebleeding during hospitalization were 16% for both, transfusion rates were 55% and 50%, and therapeutic intervention were 19% and 26%. The study authors suggest that the findings indicate that aspirin should be continued during hospitalization in this patient population.
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Exercise & Liver-Related Mortality Risk
Prior research indicates that physical inactivity and obesity increase the risk for liver disease progression, liver cancer development, all-cause mortality, and liver-specific mortality. While several short-term and small trials suggest that short-term exercise interventions can improve liver histology, data are lacking to support the hypothesis that this translates to a survival benefit. Data on weekly physical activity from 1986 to 2010 on more than 121,000 women and more than 51,000 men with no known cirrhosis or viral hepatitis were assessed for a study. Incident viral hepatitis or cirrhosis were reported at 2-year intervals, and liver-related mortalities were confirmed through health records and death certificates. After adjusting for multiple factors, patients in the highest quintile of physical activity had a 51% lower risk of liver disease-related mortality when compared with sedentary adults; risk reduction levels were similar between those who exercised vigorously and moderately, with those who walked a minimum of 4 hours/week (>85% of participants) enjoying a greater than 40% reduced risk and the greatest benefit observed in those who combined such levels of walking with strength training. With similar benefits from physical activity seen across all BMI levels, the study authors speculate that the associations observed in the study do not appear to be related to excess body weight but instead potential effects of exercise on insulin resistance, muscle mass, or other factors central to obesity.
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Limiting Inappropriate Proton Pump Inhibitor Prescriptions
Data indicate that prescription rates for proton pump inhibitors (PPIs) increased from 1.6% of ambulatory care visits in 1998 to 7.6% in 2015. Evidence also suggests that an often poor understanding of PPIs among residents can lead to over-prescription, with which can come increased reports of adverse events. In an effort to reduce PPI prescriptions in an internal-medicine-resident-run primary care clinic, researchers developed and tested an intervention consisting of question-and-answer sessions, education highlighting indications for PPIs and the consequences of long-term use, a taper tool in the EMR system, a 4-week PPI taper order, and a de-prescribing algorithm developed from evidence-based guidelines. The taper order called for a decrease to every other day for 2 weeks, then every 4 days for 2 weeks, and then cessation if the PPI was not prescribed for Barrett’s esophagus, severe esophagitis, peptic stricture from reflux esophagitis, Zollinger-Ellison syndrome, a history of a bleeding gastrointestinal ulcer, or chronic NSAID use in patients with bleeding risk factors. During the study period, PPI dispensing fell 16%, while PPI prescription deemed inappropriate fell from 77% to 52%. Inappropriate PPI prescriptions were mostly associated with GERD (65.0%), followed by NSAID prophylaxis (8.5%) and dyspepsia (8.1%).
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Blinded Independent Validation Study Highlights Effectiveness of Tissue Systems Pathology Test in Predicting Risk of Progression to Esophageal Cancer in Patients with Barrett’s Esophagus
Clinicians at Cleveland Clinic and the University of Pittsburgh School of Medicine conducted the study in which validated previous findings that a tissue systems pathology test more accurately predicts disease progression risk for patients with Barrett’s esophagus (BE) compared with current histology-based risk assessments. TissueCypher is the first diagnostic test of its kind that predicts the risk of developing esophageal cancer (EC) in patients with BE. The technology uses digitally scanned images of a biopsy to measure and analyze cellular and molecular changes that precede structural changes within the tissue. The study authors conclude that a tissue systems pathology test identifies patients with ND BE who are at increased risk for progression to HGD/EC and may benefit from increased surveillance, and potentially early therapeutic intervention to prevent progression.
Positive Clinical Results from REDUCE Study Evaluating Pure-Vu® System in Hospitalized Colonoscopy Patients. Pure-Vu® System achieved primary endpoint demonstrating safety and effectiveness, showing statistically significant improvement in bowel cleanliness. Adequate bowel preparation rate improved from 38% to 96% following use of Pure-Vu® System
The REDUCE study was a multi-center inpatient prospective trial designed to evaluate Pure-Vu® System’s ability to consistently and reliably improve bowel preparation to facilitate a successful colonoscopy in a timely manner in patients who were indicated for a diagnostic colonoscopy. The study enrolled 95 hospitalized patients on schedule regardless of their level of pre-procedural bowel preparation. The primary endpoint for the study was improvement of bowel preparation from baseline to post procedure as assessed by the Boston Bowel Preparation Scale (“BBPS”), which assesses the cleanliness of each of the three segments of the colon on a 0 to 3 scale and requires a minimum score of 2 or better per segment to be considered adequately prepped. The analysis from the REDUCE study showed statistically significant improvement in each colon segment after Pure-Vu® System use. The per segment BBPS improved from an average baseline of 1.74, 1.74 and 1.5 to 2.89, 2.91 and 2.86, respectively, with a statistically significant p value of .001 for all three segments of the colon. Inpatients that received Pure-Vu® System, adequate bowel preparation improved from a baseline of 38% to 96% in segments evaluated.
Durability of Successful Eradication of Barrett’s Esophagus with Liquid Nitrogen Spray Cryotherapy: Results of a U.S Multicenter Registry
Researchers at University of North Carolina at Chapel Hill School of Medicine evaluated rates of recurrence of intestinal metaplasia after complete eradication in patients who had undergone liquid nitrogen spray cryotherapy while enrolled prospectively in a multicenter national registry, thereby assessing the durability of this procedure in the setting of BE. Among the 214 patients, 114 were 365 days beyond initial cryotherapy. Of these 114 patients, 74 (65%) achieved complete eradication of intestinal metaplasia; 56 of these 74 patients had post-eradication surveillance biopsies and were included in the data analysis. Key study findings included: 1). The most common pathology at baseline was high-grade dysplasia (50%), followed by intramucosal adenocarcinoma (30%), low-grade dysplasia/indefinite dysplasia (18%), and non-dysplastic BE (2%). 2). Mean BE segment length was 2.7 ± 2.4 cm. 3). Over an average of 9 months, patients were treated with one to six spray cryotherapy sessions at a median treatment dosimetry of two (range: 1 to 4) cycles with a spray time of 20 (range: 18 to 30) seconds/site. 4). Average follow-up time after complete eradication of intestinal metaplasia was 20.4 ± 11.5 months. 5). Intestinal metaplasia recurred in 19.6% (11 patients) of those who initially achieved complete eradication; 14.3% of recurrent intestinal metaplasia was non-dysplastic.The authors concluded that the durability of successful treatment of intestinal metaplasia with liquid nitrogen spray cryotherapy is comparable to that of other ablation modalities.
Neoadjuvant Cryotherapy Improves Dysphagia and Increases Remission Rates in Advanced Esophageal Cancer
Researchers at the Hunter Holmes McGuire VA Medical Center, Virginia Commonwealth University, Richmond, Virginia, conducted a prospective, pilot clinical trial to assess the safety and efficacy of liquid nitrogen spray cryotherapy administered prior to chemoradiotherapy in treatment-naïve patients with dysphagia at the time of biopsy-proven squamous cell carcinoma or adenocarcinoma of the esophagus. The primary outcome measure was change in dysphagia at 1 and 2 weeks post-cryotherapy, as measured by the Mellow-Pinkas dysphagia score [0 = no dysphagia; 1 = moderate passage; 2 = poor passage; 3 = very poor passage; and 4 = no passage]; the secondary outcome measure was clinical complete response rate following chemoradiotherapy. A total of 21 patients were enrolled in the study, seven with metastatic EC and 14 with locally advanced disease (one stage 1B, seven stage 2B, three stage 3A, and three stage 3B), each of whom underwent a median of four freeze-thaw cycles during which cryotherapy was applied for 20 to 40 seconds at each cycle. Median tumor length was 5 cm (range: 2 to 12 cm). Key study findings included: 1). The primary outcome of dysphagia improvement ≥ 1 point on the Mellow-Pinkas dysphagia score occurred in 15/21 patients (71%) at 1 week and in 10/20 patients (50%) at 2 weeks. 2). There were no residual tumor cells identified on mucosal biopsy in 6/9 patients (67%) with locally advanced EC who completed chemoradiation, 5/9 (56%) of whom had a clinical complete response. 3). There were no serious cryotherapy-related complications. The authors concluded that liquid nitrogen spray cryotherapy provides safe and effective palliation for EC patients who present with dysphagia at the time of diagnosis. These results provide the rationale to pursue larger clinical trials to assess the potential synergistic effects of liquid nitrogen spray cryotherapy and chemoradiation.
WATS3D Provides Clinical Benefit in Detecting Residual/Recurrent Intestinal Metaplasia in Post-Barrett’s Esophagus Ablation Patients. Study shows that the addition of WATS3D increased the detection of residual/recurrent intestinal metaplasia by 79% and associated dysplasia by 224%
Michael S. Smith, MD, MBA, Chief of Gastroenterology and Hepatology at Mount Sinai West and Mount Sinai St. Luke’s Hospitals in New York City, evaluated the impact of WATS3D on the detection of RRIM and associated dysplasia in the post-BE ablation setting. A total of 802 patients with a history of BE ablation were included, comprising 913 post-ablation endoscopies performed by 118 endoscopists at 76 sites. The study authors concluded that identifying RRIM, especially when dysplasia is present, directly impacts the management of patients who have undergone BE ablation. They recommend that post BE-ablation tissue sampling should include both FB and WATS3D in order to maximize the detection of residual or recurrent disease. Patients with BE have an increased risk of developing EAC, one of the fastest growing and most fatal cancers in the United States. It is estimated that more than 16,000 deaths from EAC will occur this year. BE ablation removes the altered esophageal tissue that can give rise to EAC. Despite recent technical advances in endoscopic ablation of BE, a significant percentage of patients have RRIM on pathology, even with a negative endoscopy.
New Report Shows CRC Screening Rates Increased When a Medically Underserved Population is Offered Epi proColon® Blood Test. Shows 93.6% Acceptance Rate Among Patients Unwilling or Unable to Complete Other CRC Screening Tests
Participants attended free health fairs hosted by the University of Miami Mitchell Wolfson Sr. Department of Community Service (DOCS) in South Florida, between April 2017 and April 2018. Those eligible for screening and at average risk for CRC were offered a stool-based fecal immunohistochemical test (FIT), and those who declined FIT were then offered the Epi proColon blood test. Blood samples were drawn from participants who accepted Epi proColon and sent for analysis. Participants with positive Epi proColon results were contacted by student navigators to try to facilitate colonoscopy. Key findings from the report include: 1) Of 1,241 health fair attendees, 249 were eligible to participate in CRC screening. 2). A total of 233 eligible participants (93.6%) elected to undergo Epi proColon screening. 3). Of the 249 eligible participants, only 16 (6.4%) elected to receive a take-home FIT, of which only 1 was returned for processing. 4). In free health fairs conducted in the prior year, which only offered FIT, 414 accepted FIT and 52 (12.5%) were processed. The authors conclude that the availability of the Epi proColon blood test resulted in a marked increase in screening uptake compared with FIT in medically underserved patients.
Capturing the experience and impact of itch in patients with primary biliary cholangitis (PBC)
Highlighted results were presented from a qualitative study designed to understand the experience and impact of itch on PBC patients and to examine the validity of three existing pruritus patient-reported outcome (PRO) measures (Itch Numeric Rating Scale (NRS), 5-D Itch Scale, and the Itch Visual Analogue Scale (VAS)). A total of 12 PBC patients with a score ≥4 on the Itch NRS (0-10) were interviewed which involved completing the three PRO measures and describing their PBC itch experience. All participants reported receiving medication to manage their PBC. Most participants described their PBC severity as “moderate,” “moderate and severe,” or “severe.” Fifty percent of participants reported experiencing PBC-related itch a few times a day and generally described their itch as feeling like something crawling under the skin, having an involuntary reaction to scratch, or a tingling or creepy sensation that often wasn’t relieved with scratching. The most commonly reported impacts from itch were on sleeping, daily activities, and social functioning from scratching in public or having sores on skin. Participants considered the Itch NRS, 5-D Itch, and Itch VAS relevant instruments for assessing itch and found that a 3- to 5-point reduction in the Itch NRS score (>66.7%) and a 5- to 55-point (average -30 points) reduction in the Itch VAS (100%) reflect a meaningful change in treatment effectiveness.
