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NCT00373919 Clinical Trial

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

Postoperative Complications Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00373919
Other study ID # erythro-esophagus
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 7, 2006
Last updated March 2, 2007

Study information
Verified date August 2006
Source Kaplan Medical Center
Contact Yoram Klein, MD
Phone 972-50-8213221
Email yoramkl@clalit.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

Intervention

Drug:
• intravenous (IV) administration of erythromycin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Kaplan Medical Center
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