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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by Kaplan Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Kaplan Medical Center
ClinicalTrials.gov Identifier:
NCT00373919
First received: September 7, 2006
Last updated: March 2, 2007
Last verified: August 2006
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind

Resource links provided by NLM:


Further study details as provided by Kaplan Medical Center:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

ClinicalTrials.gov processed this record on October 20, 2014