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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01659619
First Posted: August 8, 2012
Last Update Posted: February 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Myung-gui Choi, The Catholic University of Korea
  Purpose

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.


Condition Intervention Phase
Subtotal Gastrectomy Stomach Cancer Drug: Erythromycin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Erythromycin Before Endoscopy of Patients With Subtotal Gastrectomy (STG), High Risk of Gastric Stasis : Randomized and Prospective Study

Resource links provided by NLM:


Further study details as provided by Myung-gui Choi, The Catholic University of Korea:

Primary Outcome Measures:
  • degree of food stasis [ Time Frame: when endoscopy is performed. ]
    ref> Gastric Cancer (2002) 5: 83-89


Enrollment: 114
Study Start Date: April 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: erythromycin Drug: Erythromycin
125mg in normal saline single use infusion for 5 min.
No Intervention: saline

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01659619


Locations
Korea, Republic of
Seoul St. Mary hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
The Catholic University of Korea
Investigators
Principal Investigator: Myung-Gyu Choi, M.D. Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Myung-gui Choi, Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01659619     History of Changes
Other Study ID Numbers: KC12MISI0164
First Submitted: April 10, 2012
First Posted: August 8, 2012
Last Update Posted: February 21, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Stomach Neoplasms
Gastroparesis
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action