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

Tracking Information

First Received Date ^ICMJE

September 7, 2006

Last Updated Date

March 2, 2007

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00373919 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Brief Summary

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

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Esophagectomy
Postoperative Complications

Intervention ^ICMJE

Drug: intravenous (IV) administration of erythromycin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Yoram Klein, MD

972-50-8213221

yoramkl@clalit.org.il

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00373919

Responsible Party

Study ID Numbers ^ICMJE

erythro-esophagus

Study Sponsor ^ICMJE

Kaplan Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Koram Klein, MD

Kaplan Medical Center

Information Provided By

Kaplan Medical Center

Verification Date

August 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP