Video capsule endoscopy for triage of patients with acute upper GI hemorrhage: Is seeing believing?

Abstract

Despite effective endoscopic diagnostic and therapeutic modalities, acute upper GI tract hemorrhage (UGIH) continues to challenge clinicians.1Gralnek I.M. Barkun A.N. Bardou M. Management of acute bleeding from a peptic ulcer.N Engl J Med. 2008; 359: 928-937Crossref PubMed Scopus (297) Google Scholar In the United States, an estimated 400,000 patients each year come to emergency departments (ED) with acute UGIH, where subsequently 10% to 25% will experience rebleeding and 5% to 10% will die, and where the associated medical costs are estimated to be more than $1,000,000,000.2Barkun A.N. Bardou M. Kuipers E.J. et al.International consensus recommendations on the management of patients with nonvariceal upper gastrointestinal bleeding.Ann Intern Med. 2010; 152: 101-113Crossref PubMed Scopus (887) Google Scholar, 3Tsoi K.K.F. Chiu P.W.Y. Chan F.K.L. et al.The risk of peptic ulcer bleeding mortality in relation to hospital admission on holidays: a cohort study on 8,222 cases of peptic ulcer bleeding.Am J Gastroenterol. 2012; 107: 405-410Crossref PubMed Scopus (28) Google Scholar EGD remains the criterion standard for diagnosis and treatment in acute UGIH and is highly effective in this setting, resulting in fewer surgical procedures, fewer blood transfusions, and reduced hospital length of stay.4Loperfido S. Baldo V. Piovesana E. et al.Changing trends in acute upper-GI bleeding: a population-based study.Gastrointest Endosc. 2009; 70: 212-224Abstract Full Text Full Text PDF PubMed Scopus (150) Google Scholar, 5Spiegel B.M. Vakil N.B. Ofman J.J. Endoscopy for acute nonvariceal upper gastrointestinal tract hemorrhage: is sooner better? A systematic review.Arch Intern Med. 2001; 161: 1393-1404Crossref PubMed Scopus (158) Google Scholar Triaging patients into high-risk and low-risk groups to better guide the level of care, including the acuity of EGD, is important to ensure optimal patient care along with the most efficient use of medical resources. Pre-endoscopy clinical risk stratification tools such as the Glasgow-Blatchford Score (GBS) and the clinical Rockall Score, or an assessment of nasogastric (NG) tube aspirate, are often used to assist with triage.6Blatchford O. Murray W.R. Blatchford M. A risk score to predict need for treatment for upper-gastrointestinal haemorrhage.Lancet. 2000; 356: 1318-1321Abstract Full Text Full Text PDF PubMed Scopus (731) Google Scholar, 7Stanley A.J. Dalton H.R. Blatchford O. et al.Multicentre comparison of the Glasgow Blatchford and Rockall scores in the prediction of clinical end-points after upper gastrointestinal haemorrhage.Aliment Pharmacol Ther. 2011; 34: 470-475Crossref PubMed Scopus (121) Google Scholar, 8Aljebreen A.M. Fallone C.A. Barkun A.N. Nasogastric aspirate predicts high-risk endoscopic lesions in patients with acute upper-GI bleeding.Gastrointest Endosc. 2004; 59: 172-178Abstract Full Text Full Text PDF PubMed Scopus (116) Google Scholar These scoring tools have been extensively validated and are useful in excluding significant pathologic conditions when their score is low; yet, none have been universally adopted, and the use of NG tube aspirate is a poor gauge for determining bleeding severity, the timing of upper endoscopy, or both.8Aljebreen A.M. Fallone C.A. Barkun A.N. Nasogastric aspirate predicts high-risk endoscopic lesions in patients with acute upper-GI bleeding.Gastrointest Endosc. 2004; 59: 172-178Abstract Full Text Full Text PDF PubMed Scopus (116) Google Scholar Moreover, in actual everyday clinical practice, even in situations where the risk of poor patient outcome is determined to be low, most patients are admitted to the hospital for “observation,” early EGD (within 24 hours), or both.9Dulai G.S. Gralnek I.M. Oei T.T. et al.Over-utilization of healthcare resources for low-risk patients with acute, non-variceal upper gastrointestinal hemorrhage: an historical cohort study.Gastrointest Endosc. 2002; 55: 321-327Abstract Full Text Full Text PDF PubMed Scopus (45) Google Scholar, 10Oei T.T. Dulai G.S. Gralnek I.M. et al.Hospital care for low-risk patients with acute, non-variceal upper gastrointestinal hemorrhage: a comparison of neighboring community and tertiary care centers.Am J Gastroenterol. 2002; 97: 2271-2278Crossref PubMed Google Scholar, 11Gralnek I.M. Management of “low-risk” non-variceal upper gastrointestinal hemorrhage. Are we ready to put evidence into practice?.Gastrointest Endosc. 2002; 55: 131-134Abstract Full Text Full Text PDF PubMed Scopus (22) Google Scholar One of the primary reasons for admitting these “low-risk” UGIH patients to the hospital, instead of discharging them directly home from the ED, is so they can undergo a quick “look see” upper endoscopic evaluation to rule out any possible high-risk endoscopic lesion and thus determine the patient to be “very low risk.” This practice occurs despite a wealth of accumulated data showing the safety of discharging such low-risk patients directly home from the ED and recent evidence-based guidelines recommending that such low-risk patients do not require intervention.1Gralnek I.M. Barkun A.N. Bardou M. Management of acute bleeding from a peptic ulcer.N Engl J Med. 2008; 359: 928-937Crossref PubMed Scopus (297) Google Scholar, 2Barkun A.N. Bardou M. Kuipers E.J. et al.International consensus recommendations on the management of patients with nonvariceal upper gastrointestinal bleeding.Ann Intern Med. 2010; 152: 101-113Crossref PubMed Scopus (887) Google Scholar, 12Stanley A.J. Ashley D. Dalton H.R. et al.Outpatient management of patients with low-risk upper-gastrointestinal haemorrhage: multicentre validation and prospective evaluation.Lancet. 2009; 373: 42-47Abstract Full Text Full Text PDF PubMed Scopus (258) Google Scholar, 13Laine L. Jensen D.M. Management of patients with ulcer bleeding.Am J Gastroenterol. 2012; 104: 345-360Crossref Scopus (501) Google Scholar, 14Gralnek I.M. Dumonceau J.M. Kuipers E.J. et al.Diagnosis and management of non-variceal upper gastrointestinal hemorrhage. European Society of Gastrointestinal Endoscopy (ESGE) guideline.Endoscopy. 2015; 47: 1-46Crossref PubMed Scopus (492) Google Scholar Admitting these low-risk patients to the hospital is expensive, is potentially dangerous (eg, nosocomial infections, medical errors), and requires high use of resources. So, you may ask, why not just do a quick conventional upper endoscopy in the ED, demonstrate no high-risk endoscopic lesion, and then discharge the patient at that time? Others have attempted this strategy with only limited success.15Lee J.G. Turnipseed S. Romano C. et al.Endoscopy-based triage signifi cantly reduces hospitalization rates and costs of treating upper GI bleeding: a randomized controlled trial.Gastrointest Endosc. 1999; 50: 755-761Abstract Full Text Full Text PDF PubMed Scopus (220) Google Scholar, 16Bjorkman D.J. Zaman A. Fennerty M.B. et al.Urgent vs. elective endoscopy for acute non-variceal upper-GI bleeding: an effectiveness study.Gastrointest Endosc. 2004; 60: 1-8Abstract Full Text Full Text PDF PubMed Scopus (148) Google Scholar And let's face it, to be honest and true to ourselves, most on-call gastroenterologists tend to avoid such after-hours encounters with suspected low-risk patients and prefer to admit them to the hospital and perform the “look see” endoscopy in the morning. Therefore, the ability to conduct at the bedside, in real time, minimally invasive, direct visualization of the upper GI tract using a tool such as video capsule endoscopy (VCE), rather than relying on surrogate markers for predicting outcome risk, is quite attractive. In support of this paradigm shift are recent data to show that emergency medicine physicians have the requisite skill set to accurately identify, in real time, gross blood/coffee grounds in the upper GI tract by using VCE.17Meltzer A.C. Pinchbeck C. Burnett S. et al.Emergency physicians accurately interpret video capsule endoscopy findings in suspected upper gastrointestinal hemorrhage: a video survey.Acad Emerg Med. 2013; 20: 711-715Crossref PubMed Scopus (17) Google Scholar Thus, if we persist in our desire to have a quick “look see” endoscopic view before discharging the presumed low risk patient home, maybe VCE can serve as a reliable alternative to tube-based, conventional endoscopy? The use of VCE to evaluate patients with acute UGIH was first reported by Rubin et al.18Rubin M. Hussain S.A. Shalomov A. et al.Live view video capsule endoscopy enables risk stratification of patients with acute upper GI bleeding in the emergency room: a pilot study.Dig Dis Sci. 2011; 56: 786-791Crossref PubMed Scopus (35) Google Scholar In a randomized controlled trial, these investigators showed that VCE (with use of the Real-Time Viewer, Given Imaging, Yoqneam, Israel) can accurately identify high-risk and low-risk ED patients (n=24) presenting with signs and symptoms of acute UGIH, and they suggested that VCE could be a useful risk stratification tool for helping to determine the need for therapeutic intervention. Subsequently, in a prospective, multicenter, cohort study, Gralnek et al19Gralnek I.M. Ching J.Y.L. Maza I. et al.Capsule endoscopy in acute upper gastrointestinal hemorrhage: a prospective cohort study.Endoscopy. 2013; 45: 12-19Crossref PubMed Scopus (4) Google Scholar used a modified esophageal VCE with an extended battery life (90 minutes) to evaluate the entire upper GI tract in 49 ED patients with acute UGIH. In comparing VCE with NG tube aspiration (criterion standard), these investigators demonstrated that VCE in the ED was safe, effective, and significantly superior in correctly identifying acute UGIH with a sensitivity of VCE for detecting gross blood in the upper GI tract of 50%, specificity 66%, positive predictive value 20%, and negative predictive value 89%. Additional studies have confirmed the value of VCE in the ED for patients with acute UGIH20Meltzer A.C. Ali M.A. Kresiberg R.B. et al.Video capsule endoscopy in the emergency department: a prospective study of acute upper gastrointestinal hemorrhage.Ann Emerg Med. 2013; 61: 438-443Abstract Full Text Full Text PDF PubMed Scopus (31) Google Scholar, 21Chandran S. Testro A. Urquhart P. et al.Risk stratification of upper GI bleeding with an esophageal capsule.Gastrointest Endosc. 2013; 77: 891-898Abstract Full Text Full Text PDF PubMed Scopus (21) Google Scholar and have demonstrated that VCE is more accurate than clinical scoring tools in correctly predicting high-risk and low-risk endoscopic stigmata of recent hemorrhage,22Gutkin E. Shalomov A. Hussain S.A. et al.Pillcam ESO is more accurate than clinical scoring systems in risk stratifying emergency room patients with acute upper gastrointestinal bleeding.Therap Adv Gastroenterol. 2013; 6: 193-198Crossref PubMed Scopus (24) Google Scholar that VCE has high sensitivity for identifying UGIH in the ED by both expert gastroenterologists and VCE-trained ED physicians,17Meltzer A.C. Pinchbeck C. Burnett S. et al.Emergency physicians accurately interpret video capsule endoscopy findings in suspected upper gastrointestinal hemorrhage: a video survey.Acad Emerg Med. 2013; 20: 711-715Crossref PubMed Scopus (17) Google Scholar and that VCE may be cost effective in low-risk to moderate-risk patients with UGIH compared with other diagnostic strategies such as NG tube aspiration, clinical prediction tools, and an “admit all” strategy.23Meltzer A.C. Ward M.J. Gralnek I.M. et al.The cost-effectiveness analysis of video capsule endoscopy compared to other strategies to manage acute upper gastrointestinal hemorrhage in the emergency department.Am J Emerg Med. 2014; 32: 823-832Abstract Full Text Full Text PDF PubMed Scopus (30) Google Scholar In this issue of Gastrointestinal Endoscopy, Sung et al24Sung J.J.Y. Tang R.S.Y. Ching J.Y.L. et al.Use of capsule endoscopy in the emergency department as a triage of patients with GI bleeding.Gastrointest Endosc. 2016; 84: 907-913Abstract Full Text Full Text PDF PubMed Scopus (36) Google Scholar report on a single-center, randomized controlled trial comparing the treatment of patients presenting to the ED with acute UGIH using standard care (universal hospital admission) versus management based on results from VCE performed at the bedside in the ED. Importantly, it should be noted that this study was defined by the authors as a feasibility study and that suspected UGIH patients presenting with gross hematemesis, hemodynamic shock, history of upper or lower GI tract malignancy, or suspected esophagogastric variceal bleeding were excluded from the study. The initial bedside VCE review (in real time with use of the Real Time Viewer) was performed by “trained research personnel” to evaluate for fresh blood, blood clots, or coffee-ground material. This was later followed by a formal review after completion of the VCE by a staff gastroenterologist. The primary outcome of the study was the number of patients requiring hospital admission. Secondary outcomes included safety, clinical rebleeding rates, mortality, and comparison with hospital admission based on the GBS. The patients in the VCE group were admitted to the hospital if they were found to have evidence of coffee grounds, fresh blood (with or without active bleeding from an identifiable upper GI lesion), or any “serious” endoscopic finding such as peptic ulcer with Forrest I/II stigmata, esophageal or gastric varices, or UGI tract malignancy. The individuals who had no sign of active bleeding and no serious endoscopic finding, and who were hemodynamically stable for at least 6 hours after VCE, were discharged home directly from the ED. All patients in the VCE group who required hospital admission underwent conventional EGD within 24 hours. All patients in the VCE group who were able to be discharged directly home from the ED were scheduled for an outpatient EGD within the ensuing 3 days. A total of 71 patients were randomized, and the results from 68 patients were analyzed; thus, a “per protocol” analysis was conducted. At baseline, the 2 groups had comparable demographic and clinical characteristics. All patients (34/34, 100%) in the standard care arm were admitted to the hospital compared with only 7 of 34 (20.6%) in the VCE arm (significant finding on VCE). On VCE, these 7 patients had visible coffee-ground material in 2 (5.9%), peptic ulcer with Forrest Ib stigmata in 2 (5.9%), Forrest IIa in 2 (5.9%), and esophageal varices in 1 (3%). Thus, 27 of 34 (79.4%) patients with no significant finding at VCE were discharged home directly from the ED. None of these 27 individuals experienced clinical bleeding at home, and subsequent outpatient EGD identified peptic ulcers, gastritis/duodenitis, gastric/duodenal erosions, GI stromal tumors, and esophageal varices. One individual who was sent home after a negative VCE result was subsequently found to have a gastric ulcer with nonbleeding visible vessel (Forrest IIa) at outpatient EGD, yet had an uneventful clinical course while awaiting that outpatient endoscopy. The authors did attempt to evaluate the impact of the exclusion of the 3 patients randomized to VCE. If all 3 had been admitted to the hospital, the number admitted would have increased to 10 of 37 (27.0%), and the rate of direct discharge from the ED would have decreased to 27 of 37 (73.0%). If the GBS had been used as a lone risk stratification tool, it appears that 9 of 34 (26.5%) patients in the VCE arm would have been considered low risk (GBS = 0 or 1) and could have avoided hospital admission and potentially been discharged home from the ED. The use of VCE as a triage tool appears to have prevented 18 additional individuals from being admitted to the hospital because VCE showed no significant endoscopic findings. However, it is unclear from the reported results in this study whether all 9 of the GBS low-risk patients were also considered low risk by VCE. Overall, no differences in rebleeding rates or mortality within 30 days were observed between the 2 arms of the study. The limitations of this feasibility study include its small sample size, which was powered only to address the primary outcome: need for hospital admission. Whether a strategy of ED-delivered VCE as a triage tool is accurate and safe (ie, comparable morbidity and mortality) can be answered only by additional larger-scale studies. Second, applying this triage strategy on a large scale requires a dedicated infrastructure, including VCE training for nongastroenterology personnel (eg, emergency medicine physicians), availability of trained personnel round the clock to perform real-time evaluation of the VCE in the ED, and perhaps most importantly the ability to contact patients the next day and schedule an upper endoscopy in the ensuing days, thereby ensuring that no patient falls between the cracks. Importantly, and as noted by the authors, conventional gastroscopy is always required for final endoscopic diagnosis and treatment. Finally, this VCE triage strategy is likely applicable only to low-risk and moderate-risk patients. High-risk patients (ie, those presenting with hemodynamic instability, active hematemesis, or known esophagogastric varices) were excluded in this study, and they warrant hospitalization and timely EGD. So is seeing with VCE believing? Should we be considering a change in our practice? We believe the answer is a cautionary yes. In this same journal, 14 years ago, this coauthor (I.M.G.) editorialized on this same topic of outpatient treatment of low-risk UGIH patients and discussed the need to better identify such patients so that hospital stay could be limited or hospital admission could be avoided altogether.11Gralnek I.M. Management of “low-risk” non-variceal upper gastrointestinal hemorrhage. Are we ready to put evidence into practice?.Gastrointest Endosc. 2002; 55: 131-134Abstract Full Text Full Text PDF PubMed Scopus (22) Google Scholar Unfortunately, little in our approach to these low-risk patients has subsequently changed over time. This present randomized controlled study by Sung and colleagues provides additional evidence that the use of VCE as an endoscopic triage tool in patients coming to the ED with suspected acute UGIH is feasible and may significantly reduce hospital admissions in low-risk to moderate-risk patients and identify more low-risk patients compared with GBS.24Sung J.J.Y. Tang R.S.Y. Ching J.Y.L. et al.Use of capsule endoscopy in the emergency department as a triage of patients with GI bleeding.Gastrointest Endosc. 2016; 84: 907-913Abstract Full Text Full Text PDF PubMed Scopus (36) Google Scholar If we as medical care providers remain uncomfortable with discharging the “low-risk” patient from the ED on the basis of clinical gestalt and risk stratification tools, then perhaps the use of VCE as an additional endoscopic triage tool to further classify patients as “very low risk” may be advantageous. As was written 14 years ago, let us finally start to put evidence into practice! Dr. Gralnek is a consultant for, and has received research funding from, Medtronic and Given Imaging. Dr. Klein has been a consultant for Given Imaging. Use of capsule endoscopy in the emergency department as a triage of patients with GI bleedingGastrointestinal EndoscopyVol. 84Issue 6PreviewUpper GI bleeding (UGIB) still constitutes one of the major hospital admissions through emergency departments (EDs). This feasibility study aims to test whether capsule endoscopy (CE) can reduce unnecessary hospital admissions in patients with suspected UGIB. Full-Text PDF