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

The Catholic University of Korea

Status and phase: Completed; Phase 2

Conditions: Subtotal Gastrectomy; Stomach Cancer

Treatments: Drug: Erythromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT01659619

KC12MISI0164

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 2 patient groups

erythromycin

Experimental group

Treatment:

Drug: Erythromycin

saline

No Intervention group