Adverse events associated with EUS and EUS-guided procedures

Abstract

This document is intended to educate readers on the rates and predictors of adverse events in adult patients who undergo endoscopic ultrasound (EUS). Our goal is to assist endoscopists in providing accurate, evidence-based, and up-to-date information on the rates of adverse events to patients, caretakers, and trainees. The information provided should not be construed as encouraging or discouraging any particular treatment or technique. Clinical decision-making in any specific case involves a personalized and thorough analysis of the patient’s condition, available courses of action, local expertise, and the patient’s values and preferences. Therefore, certain clinical considerations could lead an endoscopist to take a course of action that varies from the guidance in this document. This document is an update of a previous guideline prepared by the Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy in 2013.1Early D.S. Acosta R.D. Chandrasekhara V. et al.Adverse events associated with EUS and EUS with FNA.Gastrointest Endosc. 2013; 77: 839-843Abstract Full Text Full Text PDF PubMed Scopus (129) Google Scholar EUS has become a frequently used diagnostic and therapeutic modality used by endoscopists in the United States and throughout the world. Yearly use of EUS in the United States has consistently increased, supplanting the volume of ERCPs performed.2Peery A.F. Crockett S.D. Murphy C.C. et al.Burden and cost of gastrointestinal, liver, and pancreatic diseases in the United States: update 2018.Gastroenterology. 2019; 156: 254-272Abstract Full Text Full Text PDF PubMed Google Scholar Indications for EUS are broad and include the diagnosis and staging of GI and non-GI malignancies, assessment of pancreatobiliary targets, and sampling and drainage of cystic structures. In addition, several EUS-guided procedures have become widely accepted in recent years, including management of pancreatic fluid collections (PFCs), EUS-guided biliary and gallbladder drainage (EUS-BD and EUS-GD, respectively), celiac plexus blockade and neurolysis (CPB/CPN), variceal management, and EUS-guided gastroenterostomy (EUS-GE) or enteroenterostomy. Given the associated skill profile including technical proficiency, image recognition, and cognitive skills, additional training beyond a GI fellowship is generally required to perform EUS safely. To optimize the overall quality of EUS procedures, evidence-based indicators specific to the performance of EUS have been established.3Wani S. Wallace M.B. Cohen J. et al.Quality indicators for EUS.Am J Gastroenterol. 2015; 110: 102-113Crossref PubMed Google Scholar The adverse event (AE) profile specifically associated with the performance of EUS must similarly be considered separately from those associated with other luminal endoscopic procedures. This document summarizes available evidence on AEs associated with EUS and EUS-guided procedures in adult patients. A comprehensive electronic database search was executed in conjunction with an expert healthcare librarian (M.V.) and was composed of 5 parts, each designed to capture specific AEs associated with (1) routine EUS with or without FNA or fine-needle biopsy sampling (FNB), (2) EUS with PFC management, (3) EUS-BD and EUS-GD, (4) EUS with CPB or CPN, and (5) other EUS-guided techniques including variceal management and EUS-GE. AEs related to sedation and/or anesthesia, which are not specific to EUS, were not reviewed in this document. An English-language search, whose full details are provided in Appendix 1 (available online at www.giejournal.org), was performed in PubMed, MEDLINE (Ovid), MEDLINE (EBSCO), the Excerpta Medica Database, Web of Science, the Cochrane Central Registry of Controlled Trials, and the Cumulative Index of Nursing and Allied Health Literature for citations published between January 1, 2000 to December 7, 2020 (deemed a suitable search period to reflect contemporary experiences with EUS). All citations initially identified were imported into DistillerSR (Evidence Partners, Ottawa, Ontario, Canada), and all duplicates were removed. In parallel, bibliographies of selected citations were searched, ad hoc supplementary PubMed database searches were performed, and experts were consulted for any potential studies not identified by the electronic strategy. Given that this document was not designed to answer any specific comparative questions but rather to update the state of knowledge on EUS-associated AEs, specific screening eligibility criteria were not required to be met for a study to be considered for inclusion. This decision was made given the variable amounts and quality of evidence available describing each separate EUS-guided technique. However, studies were generally considered for inclusion based on design in the descending order of the following: meta-analyses, randomized controlled trials (RCTs), prospective observational studies, retrospective observational studies, and case series or reports, with study size, study quality, and study recency factoring into the decision. In the first round of screening, we screened titles and abstracts and assigned studies to a designation of “possibly include” or “exclude” considering the above criteria. Any abstract labeled with the decision to possibly include the citation resulted in the study being included in the second round. After the title and abstract screen, we made the decision on whether to cite studies included in the second round in the final review document based on the above criteria. Data on AEs were then extracted from the full-text studies selected for inclusion and presented according to each EUS-guided procedure type. Of 3619 initial citations identified from the electronic search, 1284 were for routine EUS, 556 for EUS with drainage and/or stenting of PFCs, 623 for EUS-BD and EUS-GD, 475 for EUS with CPB or CPN, and 681 for EUS-guided variceal management, EUS-GE, and other miscellaneous and novel EUS-guided procedures. A review of the evidence for each major AE type is provided below, with an overview of estimated AE rates provided in Table 1. Predictors of overall and/or specific AEs were also considered and reported wherever possible.Table 1Summary of estimated common adverse event ranges for EUS-guided proceduresEUS-guided procedure typePerforation (%)Hemorrhage (%)Infection (%)Other/specific (%)Risk factors for adverse eventsRoutine EUS (with or without FNA/fine-needle biopsy sampling).02-.085Wang K.X. Ben Q.W. Jin Z.D. et al.Assessment of morbidity and mortality associated with EUS-guided FNA: a systematic review.Gastrointest Endosc. 2011; 73: 283-290Abstract Full Text Full Text PDF PubMed Scopus (241) Google Scholar, 6Razik R. James P. Khan R. et al.Risk of adverse events associated with upper and lower endoscopic ultrasound: a population-based cohort study.Endosc Int Open. 2021; 9: E1427-E1434Crossref PubMed Scopus (0) Google Scholar, 7Marchetti G. Ricardo V.D. Ardengh A.O. et al.Adverse events and mortality: comparative analysis between diagnostic and interventional endoscopic ultrasound.Scand J Gastroenterol. 2020; 55: 995-1001Crossref PubMed Scopus (0) Google Scholar, 8Eloubeidi M.A. Tamhane A. Lopes T.L. et al.Cervical esophageal perforations at the time of endoscopic ultrasound: a prospective evaluation of frequency, outcomes, and patient management.Am J Gastroenterol. 2009; 104: 53-56Crossref PubMed Scopus (47) Google Scholar, 9Das A. Sivak Jr., M.V. Chak A. Cervical esophageal perforation during EUS: a national survey.Gastrointest Endosc. 2001; 53: 599-602Abstract Full Text Full Text PDF PubMed Scopus (86) Google Scholar.13-.69∗Bleeding of variable clinical significance.,5Wang K.X. Ben Q.W. Jin Z.D. et al.Assessment of morbidity and mortality associated with EUS-guided FNA: a systematic review.Gastrointest Endosc. 2011; 73: 283-290Abstract Full Text Full Text PDF PubMed Scopus (241) Google Scholar,7Marchetti G. Ricardo V.D. Ardengh A.O. et al.Adverse events and mortality: comparative analysis between diagnostic and interventional endoscopic ultrasound.Scand J Gastroenterol. 2020; 55: 995-1001Crossref PubMed Scopus (0) Google Scholar,10Khan U. Abunassar M. Chatterjee A. et al.Advanced endoscopy trainee involvement early in EUS training may be associated with an increased risk of adverse events.J Can Assoc Gastroenterol. 2020; 3: 83-90Crossref PubMed Google Scholar,13Zhu H. Jiang F. Zhu J. et al.Assessment of morbidity and mortality associated with endoscopic ultrasound-guided fine-needle aspiration for pancreatic cystic lesions: a systematic review and meta-analysis.Dig Endosc. 2017; 29: 667-675Crossref PubMed Scopus (48) Google Scholar,14Hamada T. Yasunaga H. Nakai Y. et al.Severe bleeding and perforation are rare complications of endoscopic ultrasound-guided fine needle aspiration for pancreatic masses: an analysis of 3,090 patients from 212 hospitals.Gut Liver. 2014; 8: 215-218Crossref PubMed Scopus (32) Google Scholar.4-1.7%†When sampling of pancreatic cystic lesion was performed.,13Zhu H. Jiang F. Zhu J. et al.Assessment of morbidity and mortality associated with endoscopic ultrasound-guided fine-needle aspiration for pancreatic cystic lesions: a systematic review and meta-analysis.Dig Endosc. 2017; 29: 667-675Crossref PubMed Scopus (48) Google Scholar,31Colán-Hernández J. Sendino O. Loras C. et al.Antibiotic prophylaxis is not required for endoscopic ultrasonography-guided fine-needle aspiration of pancreatic cystic lesions, based on a randomized trial.Gastroenterology. 2020; 158: 1642-1649Abstract Full Text Full Text PDF PubMed Google Scholar,111Facciorusso A. Mohan B.P. Tacelli M. et al.Use of antibiotic prophylaxis is not needed for endoscopic ultrasound-guided fine-needle aspiration of pancreatic cysts: a meta-analysis.Expert Rev Gastroenterol Hepatol. 2020; 14: 999-1005Crossref PubMed Scopus (2) Google ScholarPancreatitis: .44-.92‡When sampling of pancreatic duct, cyst, or mass was performed.,5Wang K.X. Ben Q.W. Jin Z.D. et al.Assessment of morbidity and mortality associated with EUS-guided FNA: a systematic review.Gastrointest Endosc. 2011; 73: 283-290Abstract Full Text Full Text PDF PubMed Scopus (241) Google Scholar,13Zhu H. Jiang F. Zhu J. et al.Assessment of morbidity and mortality associated with endoscopic ultrasound-guided fine-needle aspiration for pancreatic cystic lesions: a systematic review and meta-analysis.Dig Endosc. 2017; 29: 667-675Crossref PubMed Scopus (48) Google ScholarPerforation7Marchetti G. Ricardo V.D. 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Kaffes A. et al.Management of pancreatic collections with a novel endoscopically placed fully covered self-expandable metal stent: a national experience (with videos).Gastrointest Endosc. 2015; 81: 127-135Abstract Full Text Full Text PDF PubMed Google ScholarStent occlusion: 0-17.744Fugazza A. Sethi A. Trindade A.J. et al.International multicenter comprehensive analysis of adverse events associated with lumen-apposing metal stent placement for pancreatic fluid collection drainage.Gastrointest Endosc. 2020; 91: 574-583Abstract Full Text Full Text PDF PubMed Scopus (30) Google Scholar,46Bang J.Y. Navaneethan U. Hasan M.K. et al.Non-superiority of lumen-apposing metal stents over plastic stents for drainage of walled-off necrosis in a randomised trial.Gut. 2019; 68: 1200-1209Crossref PubMed Scopus (95) Google Scholar,47Yang J. Chen Y.I. Friedland S. et al.Lumen-apposing stents versus plastic stents in the management of pancreatic pseudocysts: a large, comparative, international, multicenter study.Endoscopy. 2019; 51: 1035-1043Crossref PubMed Scopus (19) Google Scholar,62Lakhtakia S. Basha J. Talukdar R. et al.Endoscopic “step-up approach” using a dedicated biflanged metal stent reduces the need for direct necrosectomy in walled-off necrosis (with videos).Gastrointest Endosc. 2017; 85: 1243-1252Abstract Full Text Full Text PDF PubMed Scopus (62) Google ScholarPerforation45Sharaiha R.Z. Tyberg A. Khashab M.A. et al.Endoscopic therapy with lumen-apposing metal stents is safe and effective for patients with pancreatic walled-off necrosis.Clin Gastroenterol Hepatol. 2016; 14: 1797-1803Abstract Full Text Full Text PDF PubMed Scopus (134) Google Scholar: subsequent necrosectomyPerforation, hemorrhage43Lyu Y. Li T. Wang B. et al.Comparison between lumen-apposing metal stents and plastic stents in endoscopic ultrasound-guided drainage of pancreatic fluid collection: a meta-analysis and systematic review.Pancreas. 2021; 50: 571-578Crossref PubMed Scopus (0) Google Scholar,55Park C.H. Park S.W. Nam E. et al.Comparative efficacy of stents in endoscopic ultrasonography-guided peripancreatic fluid collection drainage: a systematic review and network meta-analysis.J Gastroenterol Hepatol. 2020; 35: 941-952Crossref PubMed Scopus (4) Google Scholar: lumen-apposing metal stent insertionInfection57Guo J. Feng L. Sun S. et al.Risk factors for infection after endoscopic ultrasonography-guided drainage of specific types of pancreatic and peripancreatic fluid collections (with video).Surg Endosc. 2016; 30: 3114-3120Crossref PubMed Scopus (4) Google Scholar: larger pancreatic fluid collection sizeEUS-guided biliary drainage0-3.168Paik W.H. Lee T.H. Park D.H. et al.EUS-guided biliary drainage versus ERCP for the primary palliation of malignant biliary obstruction: a multicenter randomized clinical trial. [Erratum appears in Am J Gastroenterol 2018 Aug 23;PMID: 30140030.].Am J Gastroenterol. 2018; 113: 1566PubMed Google Scholar, 69Park J.K. Woo Y.S. Noh D.H. et al.Efficacy of EUS-guided and ERCP-guided biliary drainage for malignant biliary obstruction: prospective randomized controlled study.Gastrointest Endosc. 2018; 88: 277-282Abstract Full Text Full Text PDF PubMed Scopus (80) Google Scholar, 70Bang J.Y. Navaneethan U. Hasan M. et al.Stent placement by EUS or ERCP for primary biliary decompression in pancreatic cancer: a randomized trial (with videos).Gastrointest Endosc. 2018; 88: 9-17Abstract Full Text Full Text PDF PubMed Scopus (92) Google Scholar0-8.368Paik W.H. Lee T.H. Park D.H. et al.EUS-guided biliary drainage versus ERCP for the primary palliation of malignant biliary obstruction: a multicenter randomized clinical trial. [Erratum appears in Am J Gastroenterol 2018 Aug 23;PMID: 30140030.].Am J Gastroenterol. 2018; 113: 1566PubMed Google Scholar, 69Park J.K. Woo Y.S. Noh D.H. et al.Efficacy of EUS-guided and ERCP-guided biliary drainage for malignant biliary obstruction: prospective randomized controlled study.Gastrointest Endosc. 2018; 88: 277-282Abstract Full Text Full Text PDF PubMed Scopus (80) Google Scholar, 70Bang J.Y. Navaneethan U. Hasan M. et al.Stent placement by EUS or ERCP for primary biliary decompression in pancreatic cancer: a randomized trial (with videos).Gastrointest Endosc. 2018; 88: 9-17Abstract Full Text Full Text PDF PubMed Scopus (92) Google Scholar,72Ogura T. Nishioka N. Ueno S. et al.Antiplatelet and/or anticoagulant treatment does not increase hemorrhagic adverse events during EUS-guided biliary drainage.Gastrointest Endosc. 2020; 92: 659-666Abstract Full Text Full Text PDF PubMed Scopus (5) Google ScholarNot reportedStent migration: 2.765Bishay K. Boyne D. Yaghoobi M. et al.Endoscopic ultrasound-guided transmural approach versus ERCP-guided transpapillary approach for primary decompression of malignant biliary obstruction: a meta-analysis.Endoscopy. 2019; 51: 950-960Crossref PubMed Scopus (0) Google ScholarStent occlusion: 0-14.368Paik W.H. Lee T.H. Park D.H. et al.EUS-guided biliary drainage versus ERCP for the primary palliation of malignant biliary obstruction: a multicenter randomized clinical trial. [Erratum appears in Am J Gastroenterol 2018 Aug 23;PMID: 30140030.].Am J Gastroenterol. 2018; 113: 1566PubMed Google Scholar, 69Park J.K. Woo Y.S. Noh D.H. et al.Efficacy of EUS-guided and ERCP-guided biliary drainage for malignant biliary obstruction: prospective randomized controlled study.Gastrointest Endosc. 2018; 88: 277-282Abstract Full Text Full Text PDF PubMed Scopus (80) Google Scholar, 70Bang J.Y. Navaneethan U. Hasan M. et al.Stent placement by EUS or ERCP for primary biliary decompression in pancreatic cancer: a randomized trial (with videos).Gastrointest Endosc. 2018; 88: 9-17Abstract Full Text Full Text PDF PubMed Scopus (92) Google ScholarNot well studiedEUS-guided gallbladder drainage1.271Oh D. Song T.J. Cho D.H. et al.EUS-guided cholecystostomy versus endoscopic transpapillary cholecystostomy for acute cholecystitis in high-risk surgical patients.Gastrointest Endosc. 2019; 89: 289-298Abstract Full Text Full Text PDF PubMed Scopus (45) Google Scholar1.3-8.373Tyberg A. Jha K. Shah S. et al.EUS-guided gallbladder drainage: a learning curve modified by technical progress.Endosc Int Open. 2020; 8: E92-E96Crossref PubMed Google Scholar, 74Teoh A.Y.B. Kongkam P. Bapaye A. et al.The use of a novel lumen apposing metallic stent for drainage of the bile duct and gallbladder: long term outcomes of a prospective international trial.Dig Endosc. 2020; (Online ahead of print (doi: 10.1111/den.13911))Google Scholar, 75Dollhopf M. Larghi A. Will U. et al.EUS-guided gallbladder drainage in patients with acute cholecystitis and high surgical risk using an electrocautery-enhanced lumen-apposing metal stent device.Gastrointest Endosc. 2017; 86: 636-643Abstract Full Text Full Text PDF PubMed Scopus (95) Google ScholarNot reportedStent migration: 0-2.773Tyberg A. Jha K. Shah S. et al.EUS-guided gallbladder drainage: a learning curve modified by technical progress.Endosc Int Open. 2020; 8: E92-E96Crossref PubMed Google Scholar, 74Teoh A.Y.B. Kongkam P. Bapaye A. et al.The use of a novel lumen apposing metallic stent for drainage of the bile duct and gallbladder: long term outcomes of a prospective international trial.Dig Endosc. 2020; (Online ahead of print (doi: 10.1111/den.13911))Google Scholar, 75Dollhopf M. Larghi A. Will U. et al.EUS-guided gallbladder drainage in patients with acute cholecystitis and high surgical risk using an electrocautery-enhanced lumen-apposing metal stent device.Gastrointest Endosc. 2017; 86: 636-643Abstract Full Text Full Text PDF PubMed Scopus (95) Google ScholarStent occlusion: 0-10.473Tyberg A. Jha K. Shah S. et al.EUS-guided gallbladder drainage: a learning curve modified by technical progress.Endosc Int Open. 2020; 8: E92-E96Crossref PubMed Google Scholar, 74Teoh A.Y.B. Kongkam P. Bapaye A. et al.The use of a novel lumen apposing metallic stent for drainage of the bile duct and gallbladder: long term outcomes of a prospective international trial.Dig Endosc. 2020; (Online ahead of print (doi: 10.1111/den.13911))Google Scholar, 75Dollhopf M. Larghi A. Will U. et al.EUS-guided gallbladder drainage in patients with acute cholecystitis and high surgical risk using an electrocautery-enhanced lumen-apposing metal stent device.Gastrointest Endosc. 2017; 86: 636-643Abstract Full Text Full Text PDF PubMed Scopus (95) Google ScholarNot well studiedCeliac plexus blockade and celiac plexus neurolysisSimilar to routine EUSSimilar to routine EUSSimilar to routine EUSDiarrhea: 0-2880Kanno Y. Koshita S. Masu K. et al.Efficacy of EUS-guided celiac plexus neurolysis compared with medication alone for unresectable pancreatic cancer in the oxycodone/fentanyl era: a prospective randomized control study.Gastrointest Endosc. 2020; 92: 120-130Abstract Full Text Full Text PDF PubMed Scopus (12) Google Scholar, 81LeBlanc J.K. Al-Haddad M. McHenry L. et al.A prospective, randomized study of EUS-guided celiac plexus neurolysis for pancreatic cancer: one injection or two?.Gastrointest Endosc. 2011; 74: 1300-1307Abstract Full Text Full Text PDF PubMed Scopus (76) Google Scholar, 82Wyse J.M. Carone M. Paquin S.C. et al.Randomized, double-blind, controlled trial of early endoscopic ultrasound-guided celiac plexus neurolysis to prevent pain progression in patients with newly diagnosed, painful, inoperable pancreatic cancer.J Clin Oncol. 2011; 29: 3541-3546Crossref PubMed Scopus (148) Google Scholar, 83Doi S. Yasuda I. Kawakami H. et al.Endoscopic ultrasound-guided celiac ganglia neurolysis vs. celiac plexus neurolysis: a randomized multicenter trial.Endoscopy. 2013; 45: 362-369Crossref PubMed Scopus (89) Google ScholarHypotension: 2-579Alvarez-Sánchez M.V. Jenssen C. Faiss S. et al.Interventional endoscopic ultrasonography: an overview of safety and complications.Surg Endosc. 2014; 28: 712-734Crossref PubMed Scopus (0) Google ScholarInebriation (celiac plexus neurolysis): 0-1480Kanno Y. Koshita S. Masu K. et al.Efficacy of EUS-guided celiac plexus neurolysis compared with m