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

February 20, 2013 updated by: Myung-gui Choi, The Catholic University of Korea

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: erythromycin
Drug: Erythromycin
125mg in normal saline single use infusion for 5 min.
NO_INTERVENTION: saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
degree of food stasis
Time Frame: when endoscopy is performed.
ref> Gastric Cancer (2002) 5: 83-89
when endoscopy is performed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

April 10, 2012

First Submitted That Met QC Criteria

August 3, 2012

First Posted (ESTIMATE)

August 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 21, 2013

Last Update Submitted That Met QC Criteria

February 20, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KC12MISI0164

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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