Neena S. Abraham

Palliation of malignant biliary obstruction: a prospective trial examining impact on quality of life

BACKGROUNDnEndoscopic decompression is used for palliation of patients with malignant biliary obstruction. Little is known of its effect on quality of life. The aims of this study were to determine clinical characteristics that have the greatest adverse impact on quality of life in patients with malignant biliary obstruction, and to quantify changes in the quality of life of patients with malignant biliary obstruction after successful decompression with a plastic stent.nnnMETHODSnPatients with malignant biliary obstruction without liver metastases considered nonsurgical candidates and referred to a tertiary university medical center for palliative endoscopic decompression were sequentially enrolled in this prospective cohort study. The SF-36 Health Survey questionnaire at baseline and 1 month after stent insertion was used to quantify quality of life. Results were correlated to clinical and laboratory parameters. Multivariate analyses were carried out to determine independent predictors of baseline quality of life and improvement after stent insertion.nnnRESULTSnFifty patients (20 men, 30 women; mean [SD] age 72.6 [10.6] years) with a mean weight of 62.4 (12.9) kg and mean body mass index of 23.4 (4.3) kg/m(2) were enrolled. Two thirds had a distal malignant lesion, 12.5% had mid bile duct obstruction, and the rest either hilar or intrahepatic cholangiocarcinoma. At baseline, 70% complained of pruritus and 98% were jaundiced (mean total bilirubin 15 [7] mg/dL). Mean duration of symptoms before decompression was 23 (25) days. Weight loss, and elevated bilirubin level had the greatest impact on baseline quality of life domains in both univariate and multivariate analysis. After biliary drainage, complete follow-up information was available for 51% of the initial cohort. Among these 26 patients, a 33% improvement in bilirubin level was documented in 84% of patients and was associated with significant improvements in social function (relative risk = 0.11; 95% CI [0.03, 0.19]) and mental health (relative risk = 0.036; 95% CI [0.011, 0.08]). A baseline bilirubin of greater than 14 mg/dL was associated with lack of improvement in social function at 1-month follow-up (p = 0.03).nnnCONCLUSIONSnWeight loss and hyperbilirubinemia are strongly predictive of poor quality of life before endoscopic decompression. Successful biliary drainage after stent insertion is associated with improvements in quality of life, although this is less true among patients with a baseline bilirubin over 13 mg/dL. These results may lead to better selection of patients for palliative biliary decompression and require prospective validation.

The management of antithrombotic agents for patients undergoing GI endoscopy.

Ruben D. Acosta, MD, Neena S. Abraham, MD, MSCE, FASGE (invited content expert, ad-hoc member), Vinay Chandrasekhara, MD, Krishnavel V. Chathadi, MD, Dayna S. Early, MD, FASGE, Mohamad A. Eloubeidi, MD, MHS, FASGE, John A. Evans, MD, Ashley L. Faulx, MD, FASGE, Deborah A. Fisher, MD, MHS, FASGE, Lisa Fonkalsrud, BSN, RN, CGRN, Joo Ha Hwang, MD, PhD, FASGE, Mouen A. Khashab, MD, Jenifer R. Lightdale, MD, MPH, FASGE, V. Raman Muthusamy, MD, FASGE, Shabana F. Pasha, MD, John R. Saltzman, MD, FASGE, Aasma Shaukat, MD, MPH, FASGE, Amandeep K. Shergill, MD, Amy Wang, MD, Brooks D. Cash, MD, FASGE, previous Committee Chair, John M. DeWitt, MD, FASGE, Chair

Sedation versus No Sedation in the Performance of Diagnostic Upper Gastrointestinal Endoscopy: A Canadian Randomized Controlled Cost-Outcome Study

BACKGROUND:Sedation is not required to perform a technically adequate gastroscopy (EGDE), but does improve patient satisfaction, comfort, and willingness to repeat particularly in the elderly and those with decreased pharyngeal sensitivity. The comparative cost-efficacy of sedation versus no sedation remains poorly characterized.AIM:To compare the cost-efficacy of diagnostic EGDE with and without sedation in an adult ambulatory Canadian population.METHODS:A double-blind randomized controlled trial assigned patients to sedation versus placebo. “Successful endoscopy” was considered an EGDE rated 4/4 in technical adequacy (1 = inadequate to 4 = totally adequate), and 1–2/5 in patient self-reported comfort (1 = acceptable to 5 = unacceptable). Secondary outcomes included recovery room time, patient satisfaction alone, and willingness to repeat the procedure. Cost data were obtained using a published, institutional activity-based costing methodology. Analysis was intention to treat using standard univariate and multivariate methods.RESULTS:419 patients (mean age 54.5, 48% male) were randomized (N = 210 active vs N = 209 placebo). Among patients randomized to active medication 76% of procedures were “successful” (placebo 46%), 79% were satisfied with their level of comfort (placebo 47%), and willingness to repeat was 81% (placebo 65%). We observed a 10% crossover rate from placebo to active medications. The use of sedation was the major determinant of successful endoscopy (OR = 3.8; 95% CI: 2.5–5.7), but contributed to an increased recovery room time (29 vs 15 min; p < 0.0001). The expected cost of an additional successful endoscopy using sedation was

Predicting which patients can undergo upper endoscopy comfortably without conscious sedation

90.06 (CDN). In a planned subgroup analysis, among the elderly (>75; N = 53) unsedated endoscopy became the dominant approach. Indeed, in this population, a trend was observed favoring the effectiveness of placebo (63%) versus active medication (57%) (OR = 0.75; 95% CI: 0.25–2.3) and was less costly resulting in

Receipt of recommended therapy by patients with advanced colorectal cancer.

450 savings/unsedated EGDE.CONCLUSIONS:In the average Canadian ambulatory adult population, sedated diagnostic EGDE is more costly but remains an efficacious strategy by increasing the rate of successful endoscopies, patient satisfaction, and willingness to repeat. However, among the elderly (>75 yr), an unsedated strategy may be more cost-efficacious.

Novel anticoagulants: bleeding risk and management strategies.

BACKGROUNDnEliminating conscious sedation for diagnostic endoscopy may be advantageous for patient safety and cost containment. The aim of this study was to identify and validate independent predictors of a comfortable, technically adequate, unsedated diagnostic upper endoscopy in Canadian patients.nnnMETHODSnPatients were consecutively enrolled in a prospective fashion. Data collected on an initial cohort of 268 patients included demographics, a validated anxiety questionnaire, use of sedatives/analgesics, upper endoscopy experience, pharyngeal sensitivity, technical adequacy, and patient assessment of comfort after the procedure. The main outcome measure was satisfactory upper endoscopy, a composite of optimal scores for patient comfort and technical adequacy. Univariate and multivariate analyses were performed to identify the optimal predictive model of a satisfactory unsedated diagnostic upper endoscopy. Once identified, 68 additional patients were enrolled in a similar fashion from an independent prospective sample for purposes of outcome validation. Multivariate analysis was then repeated with the total cohort (N = 336). These results were then compared for concordance with those obtained from the initial cohort.nnnRESULTSnAmong the initial 268 patients (54.3% women; mean age 51 +/- 17 years), 49% were anxious, 15% regularly used sedatives and analgesics, 28% experienced increased pharyngeal sensitivity, and 41% had previously undergone upper endoscopy. Endoscopy was completed in 94.7% of patients without sedation and was technically adequate in 97%, and 80.1% were willing to repeat the procedure under similar conditions. Satisfactory upper endoscopy was achieved in only 59% of the initial cohort. The only independent and significant predictors of a satisfactory upper endoscopy were advancing age (OR 1.2: 95% CI [1.1, 1.4]) and decreased pharyngeal sensitivity (OR 0.5: 95% CI [0.27, 0.93]). Concordance of results were noted after validation with the second cohort. Satisfactory endoscopy was achieved in only 59.5% of the total cohort (n = 336); only 61% reported a comfortable procedural experience.nnnCONCLUSIONSnThe proportion of patients who can comfortably undergo technically adequate unsedated upper endoscopy is modest. Unsedated upper endoscopy is most likely to be successful under these procedural conditions in patients of advancing age with decreased pharyngeal sensitivity. The generalizability of these findings to an American population requires further study and may assist in identifying a subgroup of patients in whom it is cost-effective to perform upper endoscopy comfortably without sedation.

Gastrointestinal bleeding in cardiac patients: epidemiology and evolving clinical paradigms.

OBJECTIVES:To evaluate utilization of surgery, chemotherapy, and radiation therapy among patients with stage II or III colon cancer and stage II/III rectal or rectosigmoid cancer, as recommended by current national guidelines.METHODS:This cross-sectional study at the Michael E. DeBakey Veterans Affairs Medical Center (Houston, TX) used 1999–2003 administrative data to identify patients with a diagnostic code for colorectal cancer. Medical charts were then abstracted to identify an incident cohort with stage II or III cancer. Outcome of interest was receipt of recommended therapy defined as surgery only (stage II colon) or surgery with adjuvant chemo- or radiotherapy (stage III colon or stage II/III rectal/rectosigmoid cancer). Potential determinants of receipt of recommended therapy were analyzed using logistic regressionRESULTS:Among 197 incident cases diagnosed or treated, mean age of patients was 66 yr (SD, 11 yr), 64% were Caucasian, and 98.5% were men. A gastroenterologist diagnosed 72.5% tumors including 62 stage II colon, 62 stage III colon, and 73 stage II/III rectal cancers. Referral to oncology occurred in 76% of stage II colon, 92% of stage III colon, and 99% of rectal cancers. 87% of stage II and 71% of stage III colon cancer patients received recommended therapy, compared to only 42.5% of rectal cancer patients. Predictors of receipt of recommended therapy among rectal cancers included being married (OR, 5.3; 95% CI: 1.6–17.1), presentation at tumor board (OR, 3.6; 95% CI: 1.2–11.2), or age < 65 yr (OR, 3.5; 95% CI: 1.3–9.3). When patients comorbidity and physicians decision-making process were considered in the assessment of the outcome, only presentation at tumor board remained predictive of receipt of recommended therapy.CONCLUSIONS:Most colon cancer patients at a major VA medical center receive recommended therapy. Among rectal cancer patients, those presented at tumor board are most likely to receive recommended therapy.

Gastrointestinal bleeding secondary to the new anticoagulants.

Purpose of review To quantify the novel oral anticoagulant (NOAC)-related gastrointestinal bleeding, summarize the management strategies and highlight the knowledge gaps. Recent findings Dabigatran, rivaroxaban and apixaban differ from warfarin with their fixed oral dose and no requirement for routine monitoring. Patients at highest risk of thromboembolism benefit most from NOACs; however, there is a clinically significant risk for NOAC-related gastrointestinal bleeding. The management of NOACs in the acute and elective setting differs from that used with warfarin. Summary The magnitude of gastrointestinal risk is still unclear because of paucity of literature. Current risk-stratification models are incomplete and cannot be used solely to predict future risk. The periendoscopic management requires an understanding of drug half-life, metabolism and patients ability to excrete the agent. Acute bleeding management relies on fluid resuscitation to promote renal excretion of active metabolite, withholding the doses and timely management of endoscopic stigmata. The administration of coagulation factors (fresh frozen plasma, prothrombin complex concentrates or recombinant activated FVII) is more successful in reversing the activity of the upstream inhibitors of coagulation (rivaroxaban and apixaban) than dabigatran which is a direct thrombin inhibitor.

150 Complex Antithrombotic Therapy (CAT) and the Risk of Upper Gastrointestinal Events (UGIE) Among Vulnerable Elders

Purpose of review Cardiac patients are a fast emerging population vulnerable to gastrointestinal bleeding (GIB) due to their use of antithrombotic medications. This review will quantify the GIB risk of cardiac patients prescribed antithrombotic medications, summarize risk-management strategies and highlight knowledge gaps. Recent findings As the American population ages, it is anticipated that there will be an increased incidence of upper and lower GIB related to age-specific disease, higher burden of comorbidity and increased use of anticoagulants, antiplatelets and aspirin to treat cardiac disease. New evidence has highlighted the significant and clinically relevant GIB risk. The increased use of aggressive antiplatelet and anticoagulant therapies will alter our current understanding of the epidemiology of GIB. Summary The magnitude of gastrointestinal risk in this vulnerable patient population is still relatively unexplored due to a paucity of literature. This review will highlight changing GIB trends and explore current knowledge regarding GIB risk in cardiac patients. An emphasis on a multidisciplinary approach to the care of these patients will be supported, which involves active patient participation and collaboration between cardiologists and gastroenterologists. Finally, risk-minimization strategies will be suggested and knowledge gaps will be identified.

New clinical paradigms for treating and preventing antiplatelet gastrointestinal bleeding

Purpose of review To quantify direct oral anticoagulants (DOACs) related gastrointestinal bleeding (GIB), characterize patients at greatest risk and provide a pragmatic approach for the management of these drugs. This review will also summarize risk-management strategies and highlight evolving areas of clinical knowledge. Recent findings DOACs permit anticoagulation with predictable dosing without the need for routine serum monitoring. Since their availability on the market, they have quickly emerged as a popular alternative for patients requiring short-term and lifelong anticoagulation. However, they are associated with an increased risk of GIB when compared with warfarin; thus, gastroenterologists must be prepared to manage DOAC-related GIB and prevent drug-related complications. This review will focus on acute and elective periendoscopic DOAC management, high-risk clinical groups for DOAC-related GIB, quantification of DOAC levels, use of reversal agents and minimization of thromboembolic risk associated with temporary interruption. Summary This review will highlight pragmatic strategies for the treatment of DOAC-related bleeding and the prevention of postendoscopic DOAC bleeding. It will address new and evolving areas of periendoscopic management and identify knowledge gaps requiring further research to inform clinical practice.