Safety and efficacy of physician-administered balanced-sedation for the endoscopic mucosal resection of large non-pedunculated colorectal polyps

Abstract

Background and study aims Because of concerns about peri-procedural adverse events (AEs), guidelines recommend anesthetist-managed sedation (AMS) for long and complex endoscopic procedures. The safety and efficacy of physician-administered balanced sedation (PA-BS) for endoscopic mucosal resection (EMR) of large non-pedunculated colorectal polyps (LNPCPs) ≥20 mm is unknown.

Patients and methods We compared PA-BS with AMS in a retrospective study of prospectively collected data from consecutive patients referred for management of LNPCPs (NCT01368289; NCT02000141). A per-patient propensity analysis was performed following a 1:2 nearest-neighbor (Greedy-type) match, based on age, gender, Charlson comorbidity index, and lesion size. The primary outcome was any peri-procedural AE, which included hypotension, hypertension, tachycardia, bradycardia, hypoxia, and new arrhythmia. Secondary outcomes were unplanned admissions, 28-day re-presentation, technical success, and recurrence.

Results Between January 2016 and June 2020, 700 patients underwent EMR for LNPCPs, of whom 638 received PA-BS. Among them, the median age was 70 years (interquartile range [IQR] 62–76 years), size 35 mm (IQR 25–45 mm), and duration 35 minutes (IQR 25–60 minutes). Peri-procedural AEs occurred in 149 (23.4%), most commonly bradycardia (116; 18.2%). Only five (0.8%) required an unplanned sedation-related admission due to AEs (2 hypotension, 1 arrhythmia, 1 bradycardia, 1 hypoxia), with a median inpatient stay of 1 day (IQR 1–3 days). After propensity-score matching, there were no differences between PA-BS and AMS in peri-procedural AEs, unplanned admissions, 28-day re-presentation rates, technical success or recurrence.

Conclusions Physician-administered balanced sedation for the EMR of LNPCPs is safe. Peri-procedural AEs are infrequent, transient, rarely require admission (<1%), and are experienced in similar frequencies to those receiving anesthetist-managed sedation.

Keywords

Sedation and monitoring - Quality and logistical aspects - Performance and complications

Publication History

Received: 24 December 2022

Accepted after revision: 17 August 2023

Accepted Manuscript online:
25 September 2023

Article published online:
05 January 2024

• References

• 1 Vargo JJ, Cohen LB, Rex DK. et al. Position statement: nonanesthesiologist administration of propofol for GI endoscopy. Gastrointest Endosc 2009; 70: 1053-1059 DOI: 10.1016/j.gie.2009.07.020. (PMID: 19962497)
• 2 Sethi S, Wadhwa V, Thaker A. et al. Propofol versus traditional sedative agents for advanced endoscopic procedures: A meta-analysis. Dig Endosc 2014; 26: 515-524 DOI: 10.1111/den.12219. (PMID: 24354404)
• 3 Lapidus A, Gralnek IM, Suissa A. et al. Safety and efficacy of endoscopist-directed balanced propofol sedation during endoscopic retrograde cholangiopancreatography. Ann Gastroenterol 2019; 32: 303
• 4 Bahin FF, Heitman SJ, Rasouli KN. et al. Wide-field endoscopic mucosal resection versus endoscopic submucosal dissection for laterally spreading colorectal lesions: a cost-effectiveness analysis. Gut 2018; 67: 1965-1973 DOI: 10.1136/gutjnl-2017-313823. (PMID: 28988198)
• 5 Ahlenstiel G, Hourigan LF, Brown G. et al. Actual endoscopic versus predicted surgical mortality for treatment of advanced mucosal neoplasia of the colon. Gastrointest Endosc 2014; 80: 668-676 DOI: 10.1016/j.gie.2014.04.015. (PMID: 24916925)
• 6 Jayanna M, Burgess NG, Singh R. et al. Cost analysis of endoscopic mucosal resection vs surgery for large laterally spreading colorectal lesions. J Clin Gastroenterol Hepatol 2016; 14: 271-278 DOI: 10.1016/j.cgh.2015.08.037. (PMID: 26364679)
• 7 Kaltenbach T, Anderson JC, Burke CA. et al. Endoscopic removal of colorectal lesions—recommendations by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology 2020; 158: 1095-1129 DOI: 10.1053/j.gastro.2019.12.018. (PMID: 32122632)
• 8 Ferlitsch M, Moss A, Hassan C. et al. Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) clinical guideline. Endoscopy 2017; 49: 270-297 DOI: 10.1055/s-0043-102569. (PMID: 28212588)
• 9 Jessica XY, Lin JL, Oliver M. et al. Trends in EMR for nonmalignant colorectal polyps in the United States. Gastrointest Endosc 2020; 91: 124-131
• 10 Shahidi N, Vosko S, Gupta S. et al. Previously attempted large nonpedunculated colorectal polyps are effectively managed by endoscopic mucosal resection. Am J Gastroenterol 2021; 116: 958-966 DOI: 10.14309/ajg.0000000000001096. (PMID: 33625125)
• 11 Shahidi N, Sidhu M, Vosko S. et al. Endoscopic mucosal resection is effective for laterally spreading lesions at the anorectal junction. Gut 2020; 69: 673-680 DOI: 10.1136/gutjnl-2019-319785. (PMID: 31719129)
• 12 Vosko S, Gupta S, Shahidi N. et al. Impact of technical innovations in endoscopic mucosal resection in the treatment of large nonpedunculated polyps involving the ileocecal valve (with video). Gastrointest Endosc 2021; 95: 959-968
• 13 Burgess NG, Bassan MS, McLeod D. et al. Deep mural injury and perforation after colonic endoscopic mucosal resection: a new classification and analysis of risk factors. Gut 2017; 66: 1779-1789 DOI: 10.1136/gutjnl-2015-309848. (PMID: 27464708)
• 14 Holt BA, Jayasekeran V, Sonson R. et al. Topical submucosal chromoendoscopy defines the level of resection in colonic EMR and may improve procedural safety (with video). Gastrointest Endosc 2013; 77: 949-953
• 15 Klein A, Tate DJ, Jayasekeran V. et al. Thermal ablation of mucosal defect margins reduces adenoma recurrence after colonic endoscopic mucosal resection. Gastroenterology 2019; 156: 604-613 DOI: 10.1053/j.gastro.2018.10.003. (PMID: 30296436)
• 16 Tate DJ, Bahin FF, Desomer L. et al. Cold-forceps avulsion with adjuvant snare-tip soft coagulation (CAST) is an effective and safe strategy for the management of non-lifting large laterally spreading colonic lesions. Endoscopy 2018; 41: 52-62
• 17 von Elm E, Altman DG, Egger M. et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med 2007; 147: 573-577 DOI: 10.1016/j.ijsu.2014.07.013. (PMID: 25046131)
• 18 Klein A, Bourke MJ. How to perform high-quality endoscopic mucosal resection during colonoscopy. Gastroenterology 2017; 152: 466-471 DOI: 10.1053/j.gastro.2016.12.029. (PMID: 28061339)
• 19 Moss A, Bourke MJ, Williams SJ. et al. Endoscopic mucosal resection outcomes and prediction of submucosal cancer from advanced colonic mucosal neoplasia. Gastroenterology 2011; 140: 1909-1918
• 20 Jideh B, Bourke MJ. How to perform wide-field endoscopic mucosal resection and follow-up examinations. Gastrointest Endosc Clin N Am 2019; 29: 629-646 DOI: 10.1016/j.giec.2019.05.002. (PMID: 31445687)
• 21 Klein A, Bourke MJ. Advanced polypectomy and resection techniques. Gastrointest Endosc Clin N Am 2015; 25: 303-333 DOI: 10.1016/j.giec.2014.11.005. (PMID: 25839688)
• 22 Bourke MJ, Bhandari P. How I remove polyps larger than 20 mm. Gastrointest Endosc 2019; 90: 877-880
• 23 Ching H-L, Lau MS, Azmy IA. et al. Performance measures for the SACRED team-centered approach to advanced gastrointestinal endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy 2022; 54: 712-722 DOI: 10.1055/a-1832-4232. (PMID: 35636453)
• 24 Gupta S, Sidhu M, Shahidi N. et al. Effect of prophylactic endoscopic clip placement on clinically significant post-endoscopic mucosal resection bleeding in the right colon: a single-centre, randomised controlled trial. Lancet Gastroenterol Hepatol 2021; 7: 152-160 DOI: 10.1016/S2468-1253(21)00384-8. (PMID: 34801133)
• 25 Cotton PB, Eisen GM, Aabakken L. et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446-454 DOI: 10.1016/j.gie.2009.10.027. (PMID: 20189503)
• 26 R Core Team. R: A language and environment for statistical computing. In. Vienna, Austria: R Foundation for Statistical Computing. https://www.r-project.org/ 2013
• 27 Inadomi JM, Gunnarsson CL, Rizzo JA. et al. Projected increased growth rate of anesthesia professional–delivered sedation for colonoscopy and EGD in the United States: 2009 to 2015. Gastrointest Endosc 2010; 72: 580-586 DOI: 10.1016/j.gie.2010.04.040. (PMID: 20630511)
• 28 Nathan J, Klein A, Gralnek I. et al. Endoscopist-directed balanced propofol sedation is safe and effective in patients undergoing outpatient colonoscopy. Dig Endosc 2015; 6: 158-162
• 29 Dumonceau J-M, Riphaus A, Schreiber F. et al. Non-anesthesiologist administration of propofol for gastrointestinal endoscopy: European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy nurses and associates guideline–updated June 2015. Endoscopy 2015; 47: 1175-1189 DOI: 10.1055/s-0034-1393414. (PMID: 26561915)
• 30 Lichtenstein D, Jagannath S, Baron T. Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy Guidelines. Gastrointest Endosc 2008; 68: 815-826 DOI: 10.1016/j.gie.2008.09.029. (PMID: 18984096)
• 31 Aronson WL, McAuliffe MS, Miller K. Variability in the American Society of Anesthesiologists physical status classification scale. AANA J 2003; 71: 265-276 (PMID: 13677221)
• 32 Sankar A, Johnson S, Beattie W. et al. Reliability of the American Society of Anesthesiologists physical status scale in clinical practice. Br J Anaesth 2014; 113: 424-432 DOI: 10.1093/bja/aeu100. (PMID: 24727705)
• 33 Goldstein A, Keats AS. The risk of anesthesia. Anesthesiology 1970; 33: 130-143 DOI: 10.1097/00000542-197008000-00006. (PMID: 4914777)
• 34 Lee CK, Lee S-H, Chung I-K. et al. Balanced propofol sedation for therapeutic GI endoscopic procedures: a prospective, randomized study. Gastrointest Endosc 2011; 73: 206-214 DOI: 10.1016/j.gie.2010.09.035. (PMID: 21168838)