Effect of Erythromycin Before Endoscopy of Patients With Subtotal Gastrectomy (STG), High Risk of Gastric Stasis

Stomach Cancer Clinical Trial

Official title:

Effect of Erythromycin Before Endoscopy of Patients With Subtotal Gastrectomy (STG), High Risk of Gastric Stasis : Randomized and Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01659619
• Other study ID #: KC12MISI0164
• Status: Completed
• Phase: Phase 2
• First received: April 10, 2012
• Last updated: February 20, 2013
• Start date: April 2012
• Est. completion date: October 2012

Study information

• Verified date: February 2013
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gastroparesis
• Stomach Cancer
• Stomach Neoplasms
• Subtotal Gastrectomy

Intervention

Drug:
• Erythromycin
125mg in normal saline single use infusion for 5 min.

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	degree of food stasis	ref> Gastric Cancer (2002) 5: 83-89	when endoscopy is performed.	No