The Effect of Erythromycin on Occurrence of Leaks From Cervical Esophageal-Gastric Anastomosis After Trans-Hiatal Esophagectomy
Information source: Kaplan Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Esophagectomy; Postoperative Complications
Intervention: intravenous (IV) administration of erythromycin (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Kaplan Medical Center Official(s) and/or principal investigator(s):
Koram Klein, MD, Principal Investigator, Affiliation: Kaplan Medical Center
Overall contact:
Yoram Klein, MD, Phone: 972-50-8213221, Email: yoramkl@clalit.org.il
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
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Yoram Klein, MD, Phone: 972-50-8213221, Email: yoramkl@clalit.org.il Additional Information
Last updated: March 2, 2007
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