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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Myung-gui Choi, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01659619
First received: April 10, 2012
Last updated: February 20, 2013
Last verified: February 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 The Catholic University of Korea:

Primary Outcome Measures:
  • degree of food stasis [ Time Frame: when endoscopy is performed. ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Additional 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
Study First Received: April 10, 2012
Last Updated: February 20, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014