Full Text View
Tabular View
Contacts and Locations
No Study Results Posted
Related Studies
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
Sponsored by: 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

Drug Information available for: Erythromycin Gluceptate Erythromycin Erythromycin stearate Erythromycin ethylsuccinate Erythromycin estolate
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
  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  
Health Authority: Israel: Ministry of Health

Study placed in the following topic categories:
Erythromycin stearate
Erythromycin Estolate
Esophageal disorder
Postoperative Complications
Erythromycin Ethylsuccinate
Esophageal Diseases
Erythromycin

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2009