Publications by authors named "Ala I Sharara"

106 Publications

Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status.

Clin Gastroenterol Hepatol 2021 Mar 5. Epub 2021 Mar 5.

Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

Background & Aims: Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We summarize efficacy and safety data of tofacitinib 5 or 10 mg twice daily (BID) in the UC clinical program, stratified by prior tumor necrosis factor inhibitor (TNFi) failure status.

Methods: Efficacy was assessed in the pooled Phase 3 OCTAVE Induction 1&2 studies (N=1,139), the Phase 3 OCTAVE Sustain maintenance study (N=593), and the dose escalation subpopulation of the open-label, long-term extension OCTAVE Open study (N=59). Safety was assessed in OCTAVE Sustain, the dose escalation subpopulation, and the Overall Cohort, which included patients from OCTAVE Induction 1&2, OCTAVE Sustain, and OCTAVE Open (N=1,124; no prior TNFi failure N=541; prior TNFi failure N=583; Phase 2 data were excluded when stratified by prior TNFi failure status). The dose escalation subpopulation received tofacitinib 10 mg BID in OCTAVE Induction 1&2, tofacitinib 5 mg BID in OCTAVE Sustain, and tofacitinib 10 mg BID in OCTAVE Open.

Results: Tofacitinib had greater efficacy than placebo, regardless of prior TNFi failure status. In OCTAVE Sustain and the Overall Cohort, herpes zoster [HZ] (non-serious and serious) rates were numerically higher in tofacitinib-treated patients with vs without prior TNFi failure. Dose escalation to tofacitinib 10 mg BID generally recaptured clinical response for most patients. HZ (non-serious and serious) rates were numerically higher in the dose escalation subpopulation vs the Overall Cohort.

Conclusion: Tofacitinib was efficacious in patients with UC regardless of prior TNFi failure status. HZ (non-serious and serious) rates were numerically higher in patients who had previously failed TNFi. ClinicalTrials.gov: A3921063 (NCT00787202); OCTAVE Induction 1 (NCT01465763); OCTAVE Induction 2 (NCT01458951); OCTAVE Sustain (NCT01458574); OCTAVE Open (NCT01470612).
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http://dx.doi.org/10.1016/j.cgh.2021.02.043DOI Listing
March 2021

Nomenclature and definition of metabolic-associated fatty liver disease: a consensus from the Middle East and north Africa.

Lancet Gastroenterol Hepatol 2021 01 9;6(1):57-64. Epub 2020 Nov 9.

Egyptian Liver Research Institute and Hospital, Mansoura, Egypt; Tropical Medicine Department, Faculty of Medicine, Port Said University, Port Said, Egypt.

With the increasing prevalence of obesity and type 2 diabetes, fatty liver disease associated with metabolic dysfunction is a global health problem, especially because it is one of the earliest consequences of obesity and it precedes diabetes development. Fatty liver disease associated with metabolic dysfunction is of particular concern in the Middle East and north Africa, where its prevalence is greater than that in the rest of the world. Despite the magnitude of the problem, no regional guidelines have been developed to address this disease. This Review describes suggestions of redefining fatty liver disease associated with metabolic dysfunction, including its terminology and criteria for diagnosis. Experts have raised serious concerns on the current nomenclature, which labels the disease as non-alcoholic fatty liver disease (NAFLD), and its diagnostic criteria. The panel reached a consensus that the disease should be renamed as metabolic-associated fatty liver disease (MAFLD) and that the disease should be diagnosed by positive criteria. The aim is now to work with authorities across the region to implement these proposed changes and reflect them in health-care policy and to improve health care for patients in this region.
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http://dx.doi.org/10.1016/S2468-1253(20)30213-2DOI Listing
January 2021

Identification and management of Lynch syndrome in the Middle East and North African countries: outcome of a survey in 12 countries.

Fam Cancer 2020 Oct 24. Epub 2020 Oct 24.

Department of Gastroenterology and Hepatology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.

Background: Lynch syndrome (LS), the most common inherited form of colorectal cancer (CRC), is responsible for 3% of all cases of CRC. LS is caused by a mismatch repair gene defect and is characterized by a high risk for CRC, endometrial cancer and several other cancers. Identification of LS is of utmost importance because colonoscopic surveillance substantially improves a patient's prognosis. Recently, a network of physicians in Middle Eastern and North African (ME/NA) countries was established to improve the identification and management of LS families. The aim of the present survey was to evaluate current healthcare for families with LS in this region.

Methods: A questionnaire was developed that addressed the following issues: availability of clinical management guidelines for LS; attention paid to family history of cancer; availability of genetic services for identification and diagnosis of LS; and assessment of knowledge of LS surveillance. Members of the network and authors of recent papers on LS from ME/NA and neighbouring countries were invited to participate in the survey and complete the online questionnaire.

Results: A total of 55 individuals were invited and 19 respondents from twelve countries including Algeria, Azerbaijan, Cyprus, Egypt, Iran, Jordan, Kuwait, Lebanon, Morocco, Palestine, Tunisia, and Turkey completed the questionnaire. The results showed that family history of CRC is considered in less than half of the surveyed countries. Guidelines for the management of LS are available in three out of twelve countries. The identification and selection of families for genetic testing were based on clinical criteria (Amsterdam criteria II or Revised Bethesda criteria) in most countries, and only one country performed universal screening. In most of the surveyed countries genetic services were available in few hospitals or only in a research setting. However, surveillance of LS families was offered in the majority of countries and most frequently consisted of regular colonoscopy.

Conclusion: The identification and management of LS in ME/NA countries are suboptimal and as a result most LS families in the region remain undetected. Future efforts should focus on increasing awareness of LS amongst both the general population and doctors, and on the improvement of the infrastructure in these countries.
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http://dx.doi.org/10.1007/s10689-020-00211-3DOI Listing
October 2020

Risk prediction rule for advanced neoplasia on screening colonoscopy for average-risk individuals.

World J Gastroenterol 2020 Oct;26(37):5705-5717

Department of Internal Medicine, American University of Beirut, Beirut 1107 2020, Lebanon.

Background: In resource-limited countries, risk stratification can be used to optimize colorectal cancer screening. Few prospective risk prediction models exist for advanced neoplasia (AN) in true average-risk individuals.

Aim: To create and internally validate a risk prediction model for detection of AN in average-risk individuals.

Methods: Prospective study of asymptomatic individuals undergoing first screening colonoscopy. Detailed characteristics including diet, exercise and medications were collected. Multivariate logistic regression was used to elucidate risk factors for AN (adenoma ≥1 cm, villous histology, high-grade dysplasia or carcinoma). The model was validated through bootstrapping, and discrimination and calibration of the model were assessed.

Results: 980 consecutive individuals (51% F; 49% M) were enrolled. Adenoma and AN detection rates were 36.6% (F 29%: M 45%; < 0.001) and 5.1% (F 3.8%; M 6.5%) respectively. On multivariate analysis, predictors of AN [OR (95%CI)] were age [1.036 (1.00-1.07); 0.048], BMI [overweight 2.21 (0.98-5.00); obese 3.54 (1.48-8.50); 0.018], smoking [< 40 pack-years 2.01 (1.01-4.01); ≥ 40 pack-years 3.96 (1.86-8.42); 0.002], and daily red meat consumption [2.02 (0.92-4.42) 0.079]. Nomograms of AN risk were developed in terms of risk factors and age separately for normal, overweight and obese individuals. The model had good discrimination and calibration.

Conclusion: The prevalence of adenoma and AN in average-risk Lebanese individuals is similar to the West. Age, smoking, and BMI are important predictors of AN, with obesity being particularly powerful. Though external validation is needed, this model provides an important platform for improved risk-stratification for screening programs in regions where universal screening is not currently employed.
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http://dx.doi.org/10.3748/wjg.v26.i37.5705DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7545395PMC
October 2020

Confirmatory Testing for Eradication of Helicobacter pylori: Challenges and Opportunities.

Authors:
Ala I Sharara

Clin Gastroenterol Hepatol 2021 Feb 31;19(2):232-234. Epub 2020 May 31.

Division of Gastroenterology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.

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http://dx.doi.org/10.1016/j.cgh.2020.05.051DOI Listing
February 2021

Characteristics and outcome of patients presenting with acute Pancreatitis: A one-year descriptive study from a tertiary care center in Lebanon.

Arab J Gastroenterol 2020 Jun 12;21(2):106-110. Epub 2020 May 12.

Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon; Division of Gastroenterology, American University of Beirut Medical Center, Beirut, Lebanon. Electronic address:

Aim: To determine the aetiology, hospital course, and outcome of patients diagnosed with acute pancreatitis (AP) presenting to the Emergency Department (ED) of a tertiary care center in Lebanon.

Patients And Methods: Using a retrospective cross-sectional study design, records of all patients presenting to the ED with elevated lipase over one calendar year (2016) were reviewed. Patients diagnosed with AP according to the revised Atlanta classification were identified.

Results: Over one year, a total of 24,133 adult patients visited the ED and 4,976 had serum lipase determination. Of those, 75 patients (mean age 59.4 ± 16.1; range 20-95; M:F 2.1) had confirmed AP accounting for 0.3% of adult ED visits. The most common etiologies were biliary (36%), idiopathic (16%), drugs (13%), and alcohol (11%). Intake of drugs known to be associated with AP was identified in 26% of patients. Alcoholic pancreatitis was more common in males, while biliary pancreatitis was more common in females (p less than 0.05 in both). 63 patients (84%) required regular hospital admission and only 1 (1.3%) required intensive care unit admission and passed away after multiorgan failure. Mean hospital stay was 4.0 ± 4.0 days (range 0-23) with mean hospital charges of $6,637 ± 8,496.

Conclusion: Acute pancreatitis accounts for a relatively small number of emergency visits in Lebanon. Leading etiologies are biliary and drugs, with a low contribution of alcohol compared to the West. The economic burden of AP is important, but outcomes appear largely favorable with an overall mortality of less than 2%.
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http://dx.doi.org/10.1016/j.ajg.2020.04.015DOI Listing
June 2020

Treatment of Chronic HCV Infection in Patients With Thalassemia.

Clin Liver Dis (Hoboken) 2019 Dec 29;14(6):199-202. Epub 2020 Jan 29.

Division of Gastroenterology, Department of Internal Medicine American University of Beirut Medical Center Beirut Lebanon.

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http://dx.doi.org/10.1002/cld.853DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6988433PMC
December 2019

Incidence, outcome, and risk factors for recurrence of nosocomial Clostridioides difficile infection in adults: A prospective cohort study.

J Infect Public Health 2020 Apr 11;13(4):485-490. Epub 2019 Dec 11.

Division of Gastroenterology, American University of Beirut Medical Center, Beirut, Lebanon. Electronic address:

Background: Nosocomial Clostridioides difficile infection (CDI) complicates up to 1% of all hospital admissions and is associated with considerable health burden.

Aims: To determine the incidence and outcomes of nosocomial CDI at a major University Medical Center.

Methods: Consecutive adult nosocomial CDI cases were prospectively identified. Stool samples were collected for ribotyping and antibiotic resistance testing. Patients were followed for eight weeks after discharge for relapse.

Results: Over a 2-year period, 215 patients developed nosocomial CDI (incidence 2:1000) and 200 (mean age 62.2±19.6 years) gave informed consent. Mean hospital stay was 23.3±28.9 days (range 0-278). Infection was diagnosed within 7 days of admission (range 0-95) in 129 patients (64.5%). More than two-thirds (69.0%) were previously hospitalized within 12 weeks of the index hospitalization. Twenty five percent received prior antibiotics within eight weeks. Fifty-two patients (26.0%) did not receive antibiotics prior to diagnosis. Considerable comorbidities (Charlson Comorbidity Index ≥8) were noted in 33.5% of patients. Recurrence occurred in 43 patients (21.5%). On multivariate logistic regression, fluoroquinolone exposure was the only predictor of recurrence (OR=2.9, 95%CI 1.1-7.7). Overall mortality was 14.0% and CCI ≥8 was the only predictor on multivariate analysis (p=0.004). Genotyping did not identify any known hypervirulent strains and all isolates were susceptible to metronidazole and vancomycin.

Conclusion: Antibiotic exposure, comorbidities, and prior hospitalization constitute the major risk factors for nosocomial CDI. Recurrence is common and is associated with fluoroquinolones exposure. High baseline comorbidity score was the only predictor of increased mortality in this prospective cohort.
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http://dx.doi.org/10.1016/j.jiph.2019.11.005DOI Listing
April 2020

Significant elevations in serum lipase in the emergency department: When it is not pancreatitis!

Am J Emerg Med 2020 05 18;38(5):1033-1034. Epub 2019 Nov 18.

Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon; Division of Gastroenterology, American University of Beirut Medical Center, Beirut, Lebanon. Electronic address:

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http://dx.doi.org/10.1016/j.ajem.2019.10.014DOI Listing
May 2020

Mechanism-Based Treatment Strategies for IBD: Cytokines, Cell Adhesion Molecules, JAK Inhibitors, Gut Flora, and More.

Inflamm Intest Dis 2019 Aug 9;4(3):79-96. Epub 2019 Jul 9.

Department of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland.

Background: Although TNF inhibitors revolutionized the therapy of inflammatory bowel disease (IBD), we have been reaching a point where other therapies with different mechanisms of action are necessary. A rising number of elderly IBD patients with contraindications to established therapies and a growing group of patients losing response to anti-TNF therapy compel us to find safer, better-tolerated, and, ideally, personalized treatment options. However, in order to choose the right drug to fit a patient, it is indispensable to understand the pathomechanism involved in IBD.

Summary: The aim of this review is to explain the inflammatory signaling pathways in IBD and how to inhibit them with current and future therapeutic approaches. Next to biologic agents targeting inflammatory cytokines (anti-TNF agents, anti-IL-12/-23 agents, and specific inhibitors of IL-23), biologics blocking leukocyte trafficking to the gut (anti-integrin antibodies) are available nowadays. More recently, small molecules inhibiting the JAK-STAT pathway (JAK inhibitors) or preventing lymphocyte trafficking (sphingosine-1-phosphate modulators) have been approved or are under investigation. Furthermore, modifying the microbiota has potential therapeutic effects on IBD, and autologous hematopoietic or mesenchymal stem cell transplantation may be considered for a highly selected group of IBD patients.

Key Message: Physicians should understand the different mechanisms of action of the potential therapies for IBD to select the right drug for the right patient.
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http://dx.doi.org/10.1159/000500721DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6751442PMC
August 2019

Gastroesophageal reflux disease, obesity and laparoscopic sleeve gastrectomy: The burning questions.

World J Gastroenterol 2019 Sep;25(33):4805-4813

Division of Gastroenterology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut 1107 2020, Lebanon.

Obesity is a global health epidemic with considerable economic burden. Surgical solutions have become increasingly popular following technical advances leading to sustained efficacy and reduced risk. Sleeve gastrectomy accounts for almost half of all bariatric surgeries worldwide but concerns regarding its relationship with gastroesophageal reflux disease (GERD) has been a topic of debate. GERD, including erosive esophagitis, is highly prevalent in the obese population. The role of pre-operative endoscopy in bariatric surgery has been controversial. Two schools of thought exist on the matter, one that believes routine upper endoscopy before bariatric surgery is not warranted in the absence of symptoms and another that believes that symptoms are poor predictors of underlying esophageal pathology. This debate is particularly important considering the evidence for the association of laparoscopic sleeve gastrectomy (LSG) with and/or worsening GERD compared to the less popular Roux-en-Y gastric bypass procedure. In this paper, we try to address 3 burning questions regarding the inter-relationship of obesity, GERD, and LSG: (1) What is the prevalence of GERD and erosive esophagitis in obese patients considered for bariatric surgery? (2) Is it necessary to perform an upper endoscopy in obese patients considered for bariatric surgery? And (3) What are the long-term effects of sleeve gastrectomy on GERD and should LSG be done in patients with pre-existing GERD?
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http://dx.doi.org/10.3748/wjg.v25.i33.4805DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6737315PMC
September 2019

Clinical utility and economic burden of routine serum lipase determination in the Emergency Department.

Int J Clin Pract 2019 Aug 27:e13409. Epub 2019 Aug 27.

Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.

Background: Serum lipase is a rapid and reliable laboratory test central to diagnosing acute pancreatitis (AP). Routine use in the emergency department (ED) setting for all cases of abdominal pain or as part of a standard laboratory biochemical profile may lead to unnecessary expenses.

Aim: To examine the utility of serum lipase determination at a tertiary care centre ED.

Methods: Retrospective cross-sectional study of ED patients having serum lipase determination over a 12-month period. Electronic medical records were reviewed for indication and interpretation leading to additional diagnostic imaging, specialist consultation, interventions or hospital admission.

Results: A total of 24 133 adult patients visited the ED during the study period: 4976 (20.6%) had serum lipase determination, 614 (12.4%) had abnormal lipase, 130 of which (21.1%) were above the diagnostic threshold for acutre pancreatitis (AP) (>3× ULN). A total of 75 patients had confirmed AP (0.3% of all adult ED visits). The positive and negative predictive values of serum lipase (>3× ULN) for AP were 43.6% and 99.6%, respectively. One thousand eight hundred and ninety patients (38.0%) had no abdominal pain on history or physical examination. In this group, the total charge associated with lipase determination was $51 030 with 251 (13.3%) elevated lipase values triggering cross-sectional abdominal imaging in 61 (24.3%) patients and unwarranted gastroenterology consultation in three (1.2%) for an additional charge of $28 975.

Conclusions: Serum lipase is widely overutilised in the emergency setting resulting in unnecessary expenses and investigations. Evidence-based review of clinical guidelines and more restrictive testing can result in substantial cost savings and improved patient care.
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http://dx.doi.org/10.1111/ijcp.13409DOI Listing
August 2019

Prevalence of gastroesophageal reflux and risk factors for erosive esophagitis in obese patients considered for bariatric surgery.

Dig Liver Dis 2019 10 7;51(10):1375-1379. Epub 2019 May 7.

Division of General Surgery, Department of Surgery, American University of Beirut Medical Center, Beirut, Lebanon.

Background: Gastroesophageal reflux disease (GERD) is common in obese individuals. Prospective studies investigating validated GERD questionnaires and clinical parameters at identifying erosive esophagitis (EE) in this population are limited.

Objective: To prospectively evaluate the prevalence of GERD in obese patients considered for bariatric surgery and identify risk and predictive factors for EE.

Methods: Eligible patients completed two validated questionnaires: GERDQ and Nocturnal Symptom Severity Impact (N-GSSIQ) before routine esophagogastroduodenoscopy.

Results: 242 consecutive patients were enrolled (130 females; mean age 37.8 ± 11.8 years; mean BMI 40.4 ± 5.3 kg/m). The overall prevalence of gastroesophageal reflux (GERDQ ≥ 8, EE and/or PPI use) was 62.4%. EE was identified in 82 patients (33.9%) including 13/62 (21.0%) receiving PPIs at baseline. Multivariate logistic regression identified GERDQ ≥ 8 (OR = 6.3, 95%CI 3.0-13.1), hiatal hernia (OR = 4.2, 95%CI 1.6-10.7), abnormal Hill grade (OR = 2.7, 95%CI 1.4-5.4), and tobacco use (OR = 2.5, 95%CI 1.2-4.9) as independent risk factors for EE. A pre-endoscopic composite assessment including GERDQ ≥ 8 and presence of severe nocturnal reflux symptoms had 90% specificity and 20.7% sensitivity in identifying EE (NPV 68.9% and PPV 51.5%).

Conclusion: GERD is highly prevalent in obese patients. Anthropometric data and GERD questionnaires have limited accuracy at predicting erosive disease. Pre-operative endoscopic assessment in this population appears warranted.
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http://dx.doi.org/10.1016/j.dld.2019.04.010DOI Listing
October 2019

Gastric Duplication Cyst Presenting as Massive Gastrointestinal Bleeding.

Pediatr Gastroenterol Hepatol Nutr 2019 Mar 27;22(2):189-192. Epub 2019 Feb 27.

Division of Gastroenterology, American University of Beirut Medical Center, Beirut, Lebanon.

Gastric duplication cysts (GDCs) are rare congenital anomalies. Presentation of GDCs varies from an asymptomatic abdominal mass to fulminant or massive gastrointestinal (GI) bleeding. Herein, we describe a case of a GDC in a 10-month-old infant presenting with unexplained massive GI hemorrhage and hematemesis. An abdominal ultrasound was negative, while computerized tomography was, initially, inaccessible. Through a series of repeated esophagogastroduodenoscopies, we documented penetration of the GDC into the gastric cavity that was later confirmed by computerized tomography. The patient was treated successfully with surgical resection.
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http://dx.doi.org/10.5223/pghn.2019.22.2.189DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6416390PMC
March 2019

Early Detection for Colorectal Cancer: ASCO Resource-Stratified Guideline.

J Glob Oncol 2019 02;5:1-22

The University of Puerto Rico, San Juan, Puerto Rico, and MD Anderson Cancer Center, Houston, TX.

Purpose: To provide resource-stratified, evidence-based recommendations on the early detection of colorectal cancer in four tiers to clinicians, patients, and caregivers.

Methods: American Society of Clinical Oncology convened a multidisciplinary, multinational panel of medical oncology, surgical oncology, surgery, gastroenterology, health technology assessment, cancer epidemiology, pathology, radiology, radiation oncology, and patient advocacy experts. The Expert Panel reviewed existing guidelines and conducted a modified ADAPTE process and a formal consensus-based process with additional experts (Consensus Ratings Group) for two round(s) of formal ratings.

Results: Existing sets of guidelines from eight guideline developers were identified and reviewed; adapted recommendations form the evidence base. These guidelines, along with cost-effectiveness analyses, provided evidence to inform the formal consensus process, which resulted in agreement of 75% or more.

Conclusion: In nonmaximal settings, for people who are asymptomatic, are ages 50 to 75 years, have no family history of colorectal cancer, are at average risk, and are in settings with high incidences of colorectal cancer, the following screening options are recommended: guaiac fecal occult blood test and fecal immunochemical testing (basic), flexible sigmoidoscopy (add option in limited), and colonoscopy (add option in enhanced). Optimal reflex testing strategy for persons with positive screens is as follows: endoscopy; if not available, barium enema (basic or limited). Management of polyps in enhanced is as follows: colonoscopy, polypectomy; if not suitable, then surgical resection. For workup and diagnosis of people with symptoms, physical exam with digital rectal examination, double contrast barium enema (only in basic and limited); colonoscopy; flexible sigmoidoscopy with biopsy (if contraindication to latter) or computed tomography colonography if contraindications to two endoscopies (enhanced only).
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http://dx.doi.org/10.1200/JGO.18.00213DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6426543PMC
February 2019

Treatment of Patients With Early-Stage Colorectal Cancer: ASCO Resource-Stratified Guideline.

J Glob Oncol 2019 02;5:1-19

New York-Presbyterian/Weill Cornell Medical Center, New York, NY.

Purpose: To provide resource-stratified, evidence-based recommendations on the treatment and follow-up of patients with early-stage colorectal cancer.

Methods: ASCO convened a multidisciplinary, multinational Expert Panel that reviewed existing guidelines and conducted a modified ADAPTE process and a formal consensus process with additional experts for one round of formal ratings.

Results: Existing sets of guidelines from 12 guideline developers were identified and reviewed; adapted recommendations from six guidelines form the evidence base and provide evidence to inform the formal consensus process, which resulted in agreement of 75% or more on all recommendations.

Recommendations: For nonmaximal settings, the recommended treatments for colon cancer stages nonobstructing, I-IIA: in basic and limited, open resection; in enhanced, adequately trained surgeons and laparoscopic or minimally invasive surgery, unless contraindicated. Treatments for IIB-IIC: in basic and limited, open en bloc resection following standard oncologic principles, if not possible, transfer to higher-level facility; in emergency, limit to life-saving procedures; in enhanced, laparoscopic en bloc resection, if not possible, then open. Treatments for obstructing, IIB-IIC: in basic, resection and/or diversion; in limited or enhanced, emergency surgical resection. Treatment for IIB-IIC with left-sided: in enhanced, may place colonic stent. Treatment for T4N0/T3N0 high-risk features or stage II high-risk obstructing: in enhanced, may offer adjuvant chemotherapy. Treatment for rectal cancer cT1N0 and cT2n0: in basic, limited, or enhanced, total mesorectal excision principles. Treatment for cT3n0: in basic and limited, total mesorectal excision, if not, diversion. Treatment for high-risk patients who did not receive neoadjuvant chemotherapy: in basic, limited, or enhanced, may offer adjuvant therapy. Treatment for resectable cT3N0 rectal cancer: in enhanced, base neoadjuvant chemotherapy on preoperative factors. For post-treatment surveillance, a combination of medical history, physical examination, carcinoembryonic antigen testing, imaging, and endoscopy is performed. Frequency depends on setting. Maximal setting recommendations are in the guideline. Additional information can be found at www.asco.org/resource-stratified-guidelines .

Notice: It is the view of the American Society of Clinical Oncology that health care providers and health care system decision makers should be guided by the recommendations for the highest stratum of resources available. The guidelines are intended to complement but not replace local guidelines.
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http://dx.doi.org/10.1200/JGO.18.00214DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6426503PMC
February 2019

The Natural History of Colonic Diverticulosis: Much Ado about Nothing?

Inflamm Intest Dis 2018 Dec 12;3(2):69-74. Epub 2018 Jul 12.

Division of Gastroenterology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.

Background: Colonic diverticulosis is the most common incidental lesion found on routine colonoscopy. However, its true natural history is unclear. The aim of this review is to examine the epidemiology of colonic diverticulosis and the incidence of complications, namely acute diverticulitis and diverticular hemorrhage.

Summary: Many studies have evaluated the epidemiology and risk factors of diverticulosis. Despite the common nature of this entity, little is known about the risk of complications in asymptomatic individuals. It has been suggested that the lifetime risk of acute diverticulitis is 10-25% and that of diverticular hemorrhage is 3-5%. These risk estimates were based on older literature without accurate studies on true prevalence. Three recent retrospective observational cohort studies including subjects identified at colonoscopy have addressed this issue, providing information on the long-term risk of complications of colonic diverticulosis. Cumulative data from these studies support an incidence of acute diverticulitis of 1.5-6.0 per 1,000 patient-years and 0.46 per 1,000 patient-years for diverticular hemorrhage.

Key Messages: Diverticulosis is a very common condition in individuals > 50 years of age. Based on population-based colonoscopy studies, the natural history of colonic diverticulosis appears favorable with a far lower incidence of complications than previously thought.
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http://dx.doi.org/10.1159/000490054DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6361501PMC
December 2018

Diverticular Disease of the Colon.

Authors:
Ala I Sharara

Inflamm Intest Dis 2018 Dec 13;3(2):53-54. Epub 2018 Nov 13.

Ala I. Sharara, Beirut.

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http://dx.doi.org/10.1159/000495019DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6361497PMC
December 2018

The Natural History of Incidental Colonic Diverticulosis on Screening Colonoscopy.

Can J Gastroenterol Hepatol 2018 6;2018:3690202. Epub 2018 Dec 6.

Division of Gastroenterology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.

Background: The natural history of colonic diverticulosis is unclear.

Methods: Patients with incidental diverticulosis identified in a previous prospective cross-sectional screening colonoscopy study were evaluated retrospectively for clinic or hospital visit(s) for diverticular disease (DD= acute diverticulitis or diverticular bleeding) using review of electronic health records and patient phone interview.

Results: 826 patients were included in the screening colonoscopy study. Three were excluded for prior DD. In all, 224 patients (27.2%; mean age 62.3 ± 8.2) had incidental diverticulosis distributed in the left colon (67.4%), right colon (5.8%), or both (22.8%). Up-to-date information was available on 194 patients. Of those, 144 (74.2%) could be reached for detailed interview and constituted the study population. Over a mean follow-up of 7.0 ± 1.7 years, DD developed in 6 out of 144 patients (4.2%) (4 acute cases of diverticulitis, 1 probable case of diverticular bleeding, and 1 acute case of diverticulitis and diverticular bleeding). Two patients were hospitalized, and none required surgery. The time to event was 5.1 ± 1.6 years and the incidence rate was 5.9 per 1000 patient-years. On multivariate analysis, none of the variables collected at baseline colonoscopy including age, gender, obesity, exercise, fiber intake, alcohol use, constipation, or use of NSAIDs were associated with DD.

Conclusion: The natural history of incidental diverticulosis on screening colonoscopy was highly favorable in this well-defined prospectively identified cohort. The common scenario of incidental diverticulosis at screening colonoscopy makes this information clinically relevant and valuable to physicians and patients alike.
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http://dx.doi.org/10.1155/2018/3690202DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6304544PMC
May 2019

Dexlansoprazole is Effective in Relieving Heartburn during the Fasting Month of Ramadan.

Dig Dis 2019 9;37(3):188-193. Epub 2019 Jan 9.

Division of Gastroenterology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon,

Background And Aims: Proton pump inhibitors are effective at reducing heartburn. No studies have evaluated their efficacy in Ramadan. Dexlansoprazole has a unique active formulation independent of time-of-day dosing or food. The aim is to investigate the efficacy of dexlansoprazole 60 mg during Ramadan in patients with symptomatic heartburn.

Methods: Subjects recruited using poster, radio, and SMS advertisements completed a diary using a mobile-friendly application and received daily SMS reminders. Dexlansoprazole was started on day 8 for 3 weeks. No placebo arm was used in this trial. Primary endpoint was relief of heartburn expressed as mean 24-h free heartburn percentage (24FH%) per weekly period.

Results: A total of 32 patients were enrolled. During week 1, only 1 person (3.1%) was heartburn-free and mean 24FH% was 41.1 ± 24.8%. On dexlansoprazole, mean 24FH% rose to 63.4 ± 23.8 and 81.6 ± 24.5% in weeks 2 and 4, respectively (p < 0.001 for both). Median 24FH% increased from 35.7% in week 1 to 71.4 and 85.7% in weeks 2 and 4, respectively. Mean Gastroesophageal Reflux Disease Questionnaire (GERDQ) scores decreased from 10.0 ± 3.2 in week 1 to 6.53 ± 2.2 in week 2 (p < 0.001) and 5.87 ± 2.1 in week 4 (p < 0.001). Mean heartburn severity score decreased from 2.5 ± 1.0 to 1.7 ± 0.8 (p = 0.001). Early response was higher in patients with GERDQ scores ≥8 (p = 0.012).

Conclusion: Dexlansoprazole is effective in the treatment of heartburn during Ramadan. Clinicaltrials.gov number: NCT03079050.
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http://dx.doi.org/10.1159/000496091DOI Listing
March 2019

Bowel Cleansing Strategies After Suboptimal Bowel Preparation.

Clin Gastroenterol Hepatol 2019 06 6;17(7):1239-1241. Epub 2019 Jan 6.

Division of Gastroenterology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.

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http://dx.doi.org/10.1016/j.cgh.2018.12.042DOI Listing
June 2019

Sofosbuvir/velpatasvir for chronic hepatitis C infection in patients with transfusion-dependent thalassemia.

Am J Hematol 2019 02 29;94(2):E43-E45. Epub 2018 Nov 29.

Division of Hematology/Oncology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.

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http://dx.doi.org/10.1002/ajh.25339DOI Listing
February 2019

Epidemiology, disease burden, and treatment challenges of ulcerative colitis in Africa and the Middle East.

Expert Rev Gastroenterol Hepatol 2018 Sep 10;12(9):883-897. Epub 2018 Aug 10.

h Department of Medicine , King Abdulaziz University , Jeddah , Kingdom of Saudi Arabia.

Introduction: Ulcerative colitis is an idiopathic, chronic, inflammatory bowel disorder characterized by an unpredictable course of alternating cycles of relapse and remission. Traditionally viewed as a disease of Western countries, the prevalence of ulcerative colitis is reported to be increasing in the developing world. In these regions, there is the potential to further explore the etiology of the disease, mainly through genetic studies. With this in mind, we consider available data relating to the epidemiology, clinical manifestations, and disease course of ulcerative colitis in Africa and the Middle East. Current treatment approaches in these countries are also reviewed and discussed in the context of new, small molecule, orally administered therapies. Areas covered: Available data on the epidemiology, clinical manifestations, and risk factors of ulcerative colitis in Africa and the Middle East are reviewed using a PubMed database search. Expert commentary: Epidemiologic studies from African and Middle Eastern countries suggest disease trends similar to the West, and an important health and economic burden. The management of ulcerative colitis within these developing countries is challenging, with the need to improve early diagnosis, access to healthcare, and patient education, along with facilitation of access to treatment options and improvement of medication adherence.
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http://dx.doi.org/10.1080/17474124.2018.1503052DOI Listing
September 2018

Molecular characterization, toxin detection and resistance testing of human clinical Clostridium difficile isolates from Lebanon.

Int J Med Microbiol 2018 Apr 22;308(3):358-363. Epub 2018 Feb 22.

Institute of Medical Microbiology and Hygiene, National Reference Laboratory for Clostridium difficile, Saarland University, Kirrberger Straße, Building 43, 66421 Homburg/Saar, Germany.

Clostridium (Clostridioides) difficile is the main cause for nosocomial diarrhoea in industrialised nations. Epidemiologic data on the pathogen's occurrence in other world regions are still scarce. In this context we characterized with phenotypic and molecular genetic methods C. difficile isolates stemming from hospitalised patients with diarrhoea in Lebanon. From 129 stool samples of symptomatic patients at a tertiary care University hospital in Lebanon, a total of 107 C. difficile strains were cultivated and underwent ribotyping, toxin gene detection and antibiotic resistance testing. Ribotype 014 (RT014, 16.8%) predominated, followed by RT002 (9.3%), RT106 (8.4%) and RT070 (6.5%). Binary toxin gene-positive isolates (RT023, RT078 and RT126) were rarely detected and RT027 was absent. Interestingly, within one isolate only the toxin A gene (tcdA) was detected. Multiple-locus variable-number tandem repeat analysis (MLVA) revealed strong strain diversity in most RTs. The isolates were sensitive to metronidazole and vancomycin, and only a small proportion of strains displayed resistance against moxifloxacin, rifampicin, and clarithromycin (5.6%, 1.9%, and 2.8%), respectively. The data indicate that the genetic strain composition of Lebanese strains differs markedly from the situation seen in Europe and North America. Especially the epidemic RTs seen in the latter regions were almost absent in Lebanon. Interestingly, most strains showed almost no resistance to commonly used antibiotics that are suspected to play a major role in the development of C. difficile infection, despite frequent use of these antibiotics in Lebanon. Thus, the role of antimicrobial resistance as a major driving force for infection development remains uncertain in this area.
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http://dx.doi.org/10.1016/j.ijmm.2018.01.004DOI Listing
April 2018

Non-O1, non-O139 Vibrio cholerae septicemia at a tertiary care center in Beirut, Lebanon; a case report and review.

J Infect Public Health 2018 Sep - Oct;11(5):601-604. Epub 2018 Jan 20.

Division of Infectious Diseases, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon. Electronic address:

More clinical infections with non-O1, non-O139 Vibrio cholerae have been recently reported. These pathogens usually do not cause the epidemic and pandemic cases of cholera seen with choleragenic vibrios. However, they can still cause intestinal as well as extra-intestinal disease and can be associated with significant mortality. Herein, we present the first case of non-O1, non-O139 Vibrio cholerae septicemia reported in Lebanon since the beginning of the Lebanese waste crisis.
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http://dx.doi.org/10.1016/j.jiph.2018.01.001DOI Listing
November 2018

Systematic Review and Meta-analysis: Adalimumab Monotherapy Versus Combination Therapy with Immunomodulators for Induction and Maintenance of Remission and Response in Patients with Crohn's Disease.

Inflamm Bowel Dis 2017 08;23(8):1316-1327

*Division of Gastroenterology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon; and †Division of Gastroenterology, Department of Internal Medicine, Staten Island University Hospital, Northwell Health, New York, New York.

Background: It is unclear whether the combination of adalimumab (ADA) and immunomodulators is superior to ADA monotherapy in patients with Crohn's disease.

Methods: PubMed, Medline, Embase, Web of Science, and other databases were searched. Randomized controlled trials, open-label, prospective cohort, and retrospective studies, and pooled analyses were included. Primary outcomes were induction (≤12 wk) and maintenance (up to 56 wk) of remission and response. Secondary outcomes were severe adverse events, opportunistic infections, and development of antibodies to adalimumab.

Results: Twenty-four of 1194 articles were eligible for inclusion. No significant difference was noted between regimens for induction of remission (odds ratio [OR] 0.86; 95% confidence interval [CI]: 0.70-1.06; P = 0.19) and response (OR 1.01; 95% CI: 0.62-1.65; P = 0.96). Similarly, no difference was noted for maintenance of remission (OR 0.97; 95% CI: 0.79-1.14; P = 0.75) or response (OR 0.91; 95% CI: 0.54-1.54; P = 0.74). Severe adverse events and opportunistic infections were not different between arms. Patients on combination therapy had lower odds of developing antibodies to adalimumab (OR 0.24; 95% CI: 0.07-0.82; P = 0.02). Subgroup and sensitivity analyses showed significantly higher odds of successful induction (OR 1.26; 95% CI: 1.06-1.49, P = 0.008) and opportunistic infections (OR 2.44; 95% CI: 1.07-5.54, P = 0.03) in anti-TNF-experienced patients.

Conclusions: The combination of ADA and immunomodulators does not seem superior to ADA monotherapy for induction and maintenance of remission and response in Crohn's disease. Combination therapy is associated with lower immunogenicity. Analyses associating combination therapy with better induction of remission in anti-TNF-experienced patients and a higher rate of opportunistic infections deserve further evaluation.
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http://dx.doi.org/10.1097/MIB.0000000000001203DOI Listing
August 2017

A new hereditary colorectal cancer network in the Middle East and eastern mediterranean countries to improve care for high-risk families.

Fam Cancer 2018 04;17(2):209-212

Department of Gastroenterology & Hepatology, Leiden University Medical Centre, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.

Colorectal cancer (CRC) has a very high incidence in the western world. Data from registries in the Middle East showed that the incidence of CRC is relatively low in these countries. However, these data also showed that CRC incidence has increased substantially over the past three decades and that a high proportion of cases are diagnosed at an early age (<50 years). In view of these findings, more attention should be paid to prevention. Because of the often limited financial resources, focused screening of individuals with hereditary CRC, in particular those with Lynch syndrome, appears to be the most cost-effective strategy. During recent meetings of the Palestinian Society of Gastroenterology and the Mediterranean Task force for Cancer Control (MTCC) in Jericho, and the Patient's Friends Society of Jerusalem in Hebron the issue of hereditary CRC in the Middle East was discussed and the idea was conceived to establish a network on hereditary colorectal cancer (HCCN-ME) with the goal of improving care for high-risk groups in the Middle East and (Eastern) Mediterranean Countries.
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http://dx.doi.org/10.1007/s10689-017-0018-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5893664PMC
April 2018

Adherence to systemic therapies for immune-mediated inflammatory diseases in Lebanon: a physicians' survey from three medical specialties.

Patient Prefer Adherence 2017 15;11:939-945. Epub 2017 May 15.

Department of Internal Medicine, Division of Gastroenterology, American University of Beirut Medical Center, Beirut, Lebanon.

Background: Immune-mediated inflammatory diseases (IMIDs) are chronic conditions that may cause tissue damage and disability, reduced quality of life and increased mortality. Various treatments have been developed for IMIDs, including immune modulators and targeted biologic agents. However, adherence remains suboptimal.

Methods: An adherence survey was used to evaluate physicians' beliefs about adherence to medication in IMID and to evaluate if and how they manage adherence. The survey was distributed to 100 randomly selected physicians from three different specialties. Results were analyzed by four academic experts commissioned to develop an action plan to address practical and perceptual barriers to adherence, integrating it into treatment goals to maximize outcomes in IMID, thereby elevating local standards of care.

Results: Eighty-two physicians participated in this study and completed the questionnaire. Most defined adherence as compliance with prescribed treatment. Although the majority of surveyed physicians (74%) did not systematically measure adherence in their practice, 54% identified adherence as a treatment goal of equal or greater importance to therapeutic endpoints. Lack of time and specialized nursing support was reported as an important barrier to measuring adherence. The expert panel identified four key areas for action: 360° education (patient-nurse-physician), patient-physician communication, patient perception and concerns, and market access/cost. An action plan was developed centered on education and awareness, enhanced benefit-risk communication, development of adherence assessment tools and promotion of patient support programs.

Conclusion: Nonadherence to medication is a commonly underestimated problem with important consequences. A customized target-based strategy to address the root causes of non-adherence is essential in the management of chronic immune-mediated diseases.
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http://dx.doi.org/10.2147/PPA.S124721DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5440070PMC
May 2017

A Customized Mobile Application in Colonoscopy Preparation: A Randomized Controlled Trial.

Clin Transl Gastroenterol 2017 Jan 5;8(1):e211. Epub 2017 Jan 5.

Division of Gastroenterology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.

Objectives: Adherence with diet and prescribed purgative is essential for proper cleansing with low-volume bowel preparations. The aim of this work was to assess the effect of a customized mobile application (App) on adherence and quality of bowel preparation.

Methods: One hundred and sixty (160) eligible patients scheduled for elective colonoscopy were randomly assigned to paper (control) or App-based instructions. The preparation consisted of low-fiber diet for 2 days, clear fluids for one day and split-dose sodium picosulfate/magnesium citrate (SPS). Before colonoscopy, information was collected regarding adherence with, and utility of the provided instructions. The colonoscopists, blinded to assignment, graded bowel preparation using the Aronchick, Ottawa, and Chicago preparation scales. The primary endpoint was adherence with instructions. Quality of preparation was a secondary endpoint.

Results: No difference in overall adherence or bowel cleanliness was observed between the study arms. Adherence was reported in 82.4% of App vs. 73.4% of controls (P=0.40). An adequate bowel preparation on the Aronchick scale was noted in 77.2 vs. 82.5%, respectively (P=0.68). Mean scores on the Ottawa and Chicago scales were also similar. Gender, age, time of colonoscopy, and BMI did not influence preparation or adherence. Compliance with the clear fluid diet component was noted in 94% of patients with BMI<30 vs. 77% with BMI≥30 (P<0.01). SPS was well tolerated by 81.9% of patients. The App was user-friendly and received higher overall rating in this respect than paper instructions (P<0.01).

Conclusions: SPS is well tolerated and effective for bowel cleansing regardless of instruction method. Customized smartphone applications are effective, well-accepted and could replace standard paper instructions for bowel preparation.ClinicalTrials.gov: NCT02410720.
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http://dx.doi.org/10.1038/ctg.2016.65DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5288599PMC
January 2017