Double-Blind Multicenter Randomized Clinical Trial Comparing Glucagon vs Placebo in the Resolution of Alimentary Esophageal Impaction.


Journal

The American journal of gastroenterology
ISSN: 1572-0241
Titre abrégé: Am J Gastroenterol
Pays: United States
ID NLM: 0421030

Informations de publication

Date de publication:
27 Oct 2023
Historique:
received: 15 07 2023
accepted: 03 09 2023
pubmed: 22 9 2023
medline: 22 9 2023
entrez: 21 9 2023
Statut: aheadofprint

Résumé

The aim of this study was to compare the effectiveness of glucagon vs placebo in resolving esophageal foreign body impaction (EFBI), as well as the length of the procedure and adverse events. This was a multicenter, randomized, double-blind trial involving consecutive patients diagnosed with alimentary EFBI. Participants were randomized to receive either 1 mg of intravenous glucagon or placebo. All patients underwent upper endoscopy, and adverse events were assessed through a protocolized telephonic interview 7 days later. The study included 72 subjects in the glucagon group and 68 in the placebo group. The foreign body was not identified in 23.6% of subjects in the glucagon group and 20.6% of subjects in the placebo group (difference 3%, 95% confidence interval -10.7% to 16.8%, P = 0.67). The median time required to remove the foreign body was similar in both groups 4 minutes (range 2-10) in the glucagon group and 3.5 minutes (range 2-7) in the placebo group (difference 0.5 minutes, 95% confidence interval -1.3 to 2.3; P = 0.59). The most common adverse event reported in both groups was mild pharyngeal pain. Glucagon is no more effective than placebo in resolving EFBI or shortening the time required to remove the foreign body (EUDRA-CT number 2019-004920-40).

Identifiants

pubmed: 37734342
doi: 10.14309/ajg.0000000000002511
pii: 00000434-990000000-00874
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2023 by The American College of Gastroenterology.

Références

Longstreth GF, Longstreth KJ, Yao JF. Esophageal food impaction: Epidemiology and therapy. A retrospective, observational study. Gastrointest Endosc 2001;53(2):193–8.
Ikenberry SO, Jue TL, Anderson MA, et al. Management of ingested foreign bodies and food impactions. Gastrointest Endosc 2011;73(6):1085–91.
Smith MT, Wong RKH. Foreign bodies. Gastrointest Endosc Clin N Am 2007;17(2):361–82, vii.
Leopard D, Fishpool S, Winter S. The management of oesophageal soft food bolus obstruction: A systematic review. Ann R Coll Surg Engl 2011;93(6):441–4.
Arora S, Galich P. Myth: Glucagon is an effective first-line therapy for esophageal foreign body impaction. CJEM 2017;11(2):169–71.
Bodkin RP, Weant KA, Baker Justice S, et al. Effectiveness of glucagon in relieving esophageal foreign body impaction: A multicenter study. Am J Emerg Med 2016;34(6):1049–52.
Anvari M, Richards D, Dent J, et al. The effect of glucagon on esophageal peristalsis and clearance. Gastrointest Radiol 1989;14(2):100–102.
Colon V, Grade A, Pulliam G, et al. Effect of doses of glucagon used to treat food impaction on esophageal motor function of normal subjects. Dysphagia 1999;14(1):27–30.
Birk M, Bauerfeind P, Deprez PH, et al. Removal of foreign bodies in the upper gastrointestinal tract in adults: European Society of Gastrointestinal Endoscopy (ESGE) clinical guideline. Endoscopy 2016;48(5):489–96.
Peksa GD, DeMott JM, Slocum GW, et al. Glucagon for relief of acute esophageal foreign bodies and food impactions: A systematic review and meta-analysis. Pharmacotherapy 2019;39(4):463–72.
Sodeman TC, Harewood GC, Baron TH. Assessment of the predictors of response to glucagon in the setting of acute esophageal food bolus impaction. Dysphagia 2004;19(1):18–21.
Haas J, Leo J, Vakil N. Glucagon is a safe and inexpensive initial strategy in esophageal food bolus impaction. Dig Dis Sci 2016;61(3):841–5.
Mehta DI, Attia MW, Quintana EC, et al. Glucagon use for esophageal coin dislodgment in children: A prospective, double-blind, placebo-controlled trial. Acad Emerg Med 2001;8(2):200–3.
Cotton PB, Eisen GM, Aabakken L, et al. A lexicon for endoscopic adverse events: Report of an ASGE workshop. Gastrointest Endosc 2010;71(3):446–54.
Dueck AC, Mendoza TR, Mitchell SA, et al. Validity and reliability of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). JAMA Oncol 2015;1(8):1051–9.
Trenkner W, Lehman GA, Chernish M, et al. Food Impaction 601–2.
Tibbling L, Bjorkhoel A, Jansson E, et al. Effect of spasmolytic drugs on esophageal foreign bodies. Dysphagia 1995;10(2):126–7.
Al-Haddad M, Ward EM, Scolapio JS, et al. Glucagon for the relief of esophageal food impaction does it really work? Dig Dis Sci 2006;51(11):1930–3.
Harris PA, Taylor R, Thielke R, et al. Research electronic data capture (REDCap): A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42(2):377–81.
Price RM, Bonett DG. Distribution-free confidence intervals for difference and ratio of medians. J Stat Comput Simul 2002;72(2):119–24.
Robbins MI, Shortsleeve MJ. Treatment of acute esophageal food impaction with glucagon, an effervescent agent, and water. Am J Roentgenol 1994;162(2):325–8.
Thimmapuram J, Oosterveen S, Grim R. Use of glucagon in relieving esophageal food bolus impaction in the era of Eosinophilic esophageal infiltration. Dysphagia 2013;28(2):212–6.
Müller TD, Finan B, Clemmensen C, et al. The new biology and pharmacology of glucagon. Physiol Rev 2017r;97(2):721–66.
Hogan WJ, Dodds WJ, Hoke SE, et al. Effect of glucagon on esophageal motor function. Gastroenterology 1975;69(1):160–5.
Lawrence AM. Glucagon in medicine: New ideas for an old hormone. Med Clin North Am 1970;54(1):183–90.
Lin AY, Tillman BN, Thatcher AL, et al. Comparison of outcomes in medical therapy vs surgical intervention of esophageal foreign bodies. Otolaryngol Head Neck Surg 2018;159(4):656–61.

Auteurs

Marina de Benito Sanz (M)

Department of Gastroenterology, Hospital Universitario Rio Hortega, Valladolid, Spain.

Javier Tejedor-Tejada (J)

Department of Gastroenterology, Hospital de Cabueñes, Gijón, Spain.

Carolina Mangas-Sanjuan (C)

Department of Gastroenterology, Hospital General Universitario de Alicante, Alicante, Spain.

Eva de la Santa (E)

Department of Gastroenterology, Hospital de Ciudad Real, Ciudad Real, Spain.

Irene Cebrian (I)

Emergency Department, Hospital Universitario Rio Hortega, Valladolid, Spain.

Raquel Talegón (R)

Emergency Department, Hospital Universitario Rio Hortega, Valladolid, Spain.

Ramón Sánchez-Ocaña (R)

Department of Gastroenterology, Hospital Universitario Rio Hortega, Valladolid, Spain.

José M Pérez-Pariente (JM)

Department of Gastroenterology, Hospital de Cabueñes, Gijón, Spain.

Manuel Pérez-Miranda (M)

Department of Gastroenterology, Hospital Universitario Rio Hortega, Valladolid, Spain.

Francisco Javier García-Alonso (FJ)

Department of Gastroenterology, Hospital Universitario Rio Hortega, Valladolid, Spain.

Classifications MeSH