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


Phase 2
N/A
N/A
Not Enrolling
Both
Subtotal Gastrectomy, Stomach Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

degree of food stasis

Outcome Description:

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

Outcome Time Frame:

when endoscopy is performed.

Safety Issue:

No

Principal Investigator

Myung-Gyu Choi, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

KC12MISI0164

NCT ID:

NCT01659619

Start Date:

April 2012

Completion Date:

October 2012

Related Keywords:

  • Subtotal Gastrectomy
  • Stomach Cancer
  • Stomach Neoplasms
  • Gastroparesis

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