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

NCT ID: NCT01659619

Last Updated: 2013-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Subtotal Gastrectomy Stomach Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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erythromycin

Group Type EXPERIMENTAL

Erythromycin

Intervention Type DRUG

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

saline

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Erythromycin

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

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Myung-gui Choi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Myung-Gyu Choi, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Seoul St. Mary hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 1955115 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1537520 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7797033 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7956594 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9146779 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12105828 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21145052 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12111583 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24380989 (View on PubMed)

Other Identifiers

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KC12MISI0164

Identifier Type: -

Identifier Source: org_study_id

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