The Effect of Erythromycin on Occurrence of Leaks From Cervical Esophageal-Gastric Anastomosis After Trans-Hiatal Esophagectomy

This study is not yet open for participant recruitment.

Verified by Kaplan Medical Center, August 2006

First Received: September 7, 2006 Last Updated: March 2, 2007 History of Changes

Sponsor:	Kaplan Medical Center
Information provided by:	Kaplan Medical Center
ClinicalTrials.gov Identifier:	NCT00373919

Purpose

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

Condition	Intervention
Esophagectomy Postoperative Complications	Drug: intravenous (IV) administration of erythromycin

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Resource links provided by NLM:

Drug Information available for: Erythromycin Gluceptate Erythromycin Erythromycin stearate Erythromycin ethylsuccinate Erythromycin estolate

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373919

Contacts

Contact: Yoram Klein, MD

972-50-8213221

yoramkl@clalit.org.il

Sponsors and Collaborators

Kaplan Medical Center

Investigators

Principal Investigator:

Koram Klein, MD

Kaplan Medical Center

More Information

No publications provided

Study ID Numbers:	erythro-esophagus
Study First Received:	September 7, 2006
Last Updated:	March 2, 2007
ClinicalTrials.gov Identifier:	NCT00373919 History of Changes
Health Authority:	Israel: Ministry of Health

Additional relevant MeSH terms:

Erythromycin stearate
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Erythromycin Ethylsuccinate
Gastrointestinal Agents
Enzyme Inhibitors
Erythromycin

Pharmacologic Actions
Protein Synthesis Inhibitors
Anti-Bacterial Agents
Pathologic Processes
Postoperative Complications
Erythromycin Estolate
Therapeutic Uses

ClinicalTrials.gov processed this record on November 09, 2009