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

NCT ID: NCT00373919

Last Updated: 2007-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Esophagectomy Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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intravenous (IV) administration of erythromycin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaplan Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Koram Klein, MD

Role: PRINCIPAL_INVESTIGATOR

Kaplan Medical Center

Central Contacts

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Yoram Klein, MD

Role: CONTACT

972-50-8213221

Other Identifiers

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erythro-esophagus

Identifier Type: -

Identifier Source: org_study_id

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