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

NCT01659619 | Completed Phase 2

• 1 other identifier: KC12MISI0164
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Subtotal Gastrectomy; Stomach Cancer

Outcome Measures

Primary Outcomes (1)

• degree of food stasis

  ref\> Gastric Cancer (2002) 5: 83-89

  when endoscopy is performed.

Study Arms (2)

erythromycin

EXPERIMENTAL

Drug: Erythromycin

saline

NO INTERVENTION

Interventions

Erythromycin DRUG

125mg in normal saline single use infusion for 5 min.

erythromycin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who undergone STG (billroth I, billroth II, R-Y STG) within 5 years to treat gastric cancer
• Stage of T1-2N0M0

You may not qualify if:

• 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

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (1)

Seoul St. Mary hospital

Seoul, South Korea

Location

Related Publications (9)

• 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. doi: 10.1016/0016-5085(91)90383-v.

  PMID: 1955115 BACKGROUND

• 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. doi: 10.1016/0016-5085(92)90164-t.

  PMID: 1537520 BACKGROUND

• Bruley des Varannes S, Parys V, Ropert A, Chayvialle JA, Roze C, Galmiche JP. Erythromycin enhances fasting and postprandial proximal gastric tone in humans. Gastroenterology. 1995 Jul;109(1):32-9. doi: 10.1016/0016-5085(95)90266-x.

  PMID: 7797033 BACKGROUND

• 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. doi: 10.1007/BF02087641.

  PMID: 7956594 BACKGROUND

• 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. doi: 10.1046/j.1365-2036.1997.148324000.x.

  PMID: 9146779 BACKGROUND

• 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. doi: 10.1053/gast.2002.34230.

  PMID: 12105828 BACKGROUND

• 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.

  PMID: 21145052 BACKGROUND

• 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. doi: 10.1007/s101200200014.

  PMID: 12111583 BACKGROUND

• Jun BY, Choi MG, Lee JY, Baeg MK, Moon SJ, Lim CH, Kim JS, Cho YK, Lee IS, Kim SW, Choi KY. Premedication with erythromycin improves endoscopic visualization of the gastric mucosa in patients with subtotal gastrectomy: a prospective, randomized, controlled trial. Surg Endosc. 2014 May;28(5):1641-7. doi: 10.1007/s00464-013-3364-y. Epub 2014 Jan 1.

  PMID: 24380989 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Erythromycin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Myung-Gyu Choi, M.D.

  Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: August 8, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 21, 2013

Record last verified: 2013-02

Locations

KR (1)