Effect of Erythromycin Before Endoscopy of Patients With Subtotal Gastrectomy (STG), High Risk of Gastric Stasis
Information source: The Catholic University of Korea
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Subtotal Gastrectomy; Stomach Cancer
Intervention: Erythromycin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: The Catholic University of Korea Official(s) and/or principal investigator(s):
Myung-Gyu Choi, M.D., Principal Investigator, Affiliation: Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea
Summary
Erythromycin has a prokinetic effect through Motilin receptor. It evokes migrating motor
complex with longer and stronger contraction.
In patients with upper gastrointestinal bleeding, It has been shown that erythromycin could
clear the stomach of blood, so visual examination could be improved.
Frequent food stasis is encounted when we examine patients with subtotal gastrectomy. It is
postulated that erythromycin reduce food stasis and help to improve endoscopy in these
cases.
Clinical Details
Official title: Effect of Erythromycin Before Endoscopy of Patients With Subtotal Gastrectomy (STG), High Risk of Gastric Stasis : Randomized and Prospective Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: degree of food stasis
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients who undergone STG (billroth I, billroth II, R-Y STG) within 5 years to treat
gastric cancer
- Stage of T1-2N0M0
Exclusion Criteria:
- concomitant therapy with astemizole, cisapride, dihydroergotamine, ergotamine,
pimozide, or terfenadine, narcotics, alpha-2-adrenergic agonist, TCA, CCB, dopamine
agonist, muscarinic cholinergic antagonists, octreotide, exenatide and GLP-1 agonist,
phenothiazines
- chemotherapy Hx.
- hypersensitivity to erythromycin or any component of the product
- pregnancy or lactation
- comobidity : DM, AIDS, neurologic disease(parkinsonism, multiple sclerosis, brainstem
stroke or tumor, diabetic or amyloid neuropathy, or primary dysautonomias)
scleroderma and other connective tissue disease, recent viral enteritis history
- recurrence
Locations and Contacts
Seoul St. Mary hospital, Seoul, Korea, Republic of
Additional Information
Related publications: Sarna SK, Soergel KH, Koch TR, Stone JE, Wood CM, Ryan RP, Arndorfer RC, Cavanaugh JH, Nellans HN, Lee MB. Gastrointestinal motor effects of erythromycin in humans. Gastroenterology. 1991 Dec;101(6):1488-96. Annese V, Janssens J, Vantrappen G, Tack J, Peeters TL, Willemse P, Van Cutsem E. Erythromycin accelerates gastric emptying by inducing antral contractions and improved gastroduodenal coordination. Gastroenterology. 1992 Mar;102(3):823-8. Bruley des Varannes S, Parys V, Ropert A, Chayvialle JA, Rozé C, Galmiche JP. Erythromycin enhances fasting and postprandial proximal gastric tone in humans. Gastroenterology. 1995 Jul;109(1):32-9. Ramirez B, Eaker EY, Drane WE, Hocking MP, Sninsky CA. Erythromycin enhances gastric emptying in patients with gastroparesis after vagotomy and antrectomy. Dig Dis Sci. 1994 Nov;39(11):2295-300. Kendall BJ, Chakravarti A, Kendall E, Soykan I, McCallum RW. The effect of intravenous erythromycin on solid meal gastric emptying in patients with chronic symptomatic post-vagotomy-antrectomy gastroparesis. Aliment Pharmacol Ther. 1997 Apr;11(2):381-5. Frossard JL, Spahr L, Queneau PE, Giostra E, Burckhardt B, Ory G, De Saussure P, Armenian B, De Peyer R, Hadengue A. Erythromycin intravenous bolus infusion in acute upper gastrointestinal bleeding: a randomized, controlled, double-blind trial. Gastroenterology. 2002 Jul;123(1):17-23. Erratum in: Gastroenterology 2002 Dec;123(6):2162. Altraif I, Handoo FA, Aljumah A, Alalwan A, Dafalla M, Saeed AM, Alkhormi A, Albekairy AK, Tamim H. Effect of erythromycin before endoscopy in patients presenting with variceal bleeding: a prospective, randomized, double-blind, placebo-controlled trial. Gastrointest Endosc. 2011 Feb;73(2):245-50. doi: 10.1016/j.gie.2010.09.043. Epub 2010 Dec 8. Kubo M, Sasako M, Gotoda T, Ono H, Fujishiro M, Saito D, Sano T, Katai H. Endoscopic evaluation of the remnant stomach after gastrectomy: proposal for a new classification. Gastric Cancer. 2002;5(2):83-9.
Starting date: April 2012
Last updated: February 20, 2013
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