The Effect of Erythromycin on Occurrence of Leaks From Cervical Esophageal-Gastric Anastomosis After Trans-Hiatal Esophagectomy
March 2, 2007 updated by: Kaplan Medical Center
Cervical anastomotic leak is one of the most common complications after trans-hiatal esophagectomy.
Hypothesis: An early post operative administration of a pro-kinetic dosage of erythromycin will reduce leak occurrence.
Design: This is a prospective, randomized, double blind, placebo controlled study.
Number of patients: 30.
Inclusion Criteria:
- Patients after trans-hiatal esophagectomy
Exclusion Criteria:
- Allergy to erythromycin
- Use of phenothiazine
- QT prolongation
- Liver function test (LFT) abnormalities
- Myasthenia gravis
- Cardiomyopathy
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients after trans-hiatal esophagectomy
Exclusion Criteria:
- Allergy to erythromycin
- Use of phenothiazine
- QT prolongation
- Liver function test (LFT) abnormalities
- Myasthenia gravis
- Cardiomyopathy
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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Koram Klein, MD, Kaplan Medical Center
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 Registration Dates
First Submitted
September 7, 2006
First Submitted That Met QC Criteria
September 7, 2006
First Posted (Estimate)
September 8, 2006
Study Record Updates
Last Update Posted (Estimate)
March 5, 2007
Last Update Submitted That Met QC Criteria
March 2, 2007
Last Verified
August 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- erythro-esophagus
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.