EsophagectomyNCT00373919
The Effect of Erythromycin on Occurrence of Leaks From Cervical Esophageal-Gastric Anastomosis After Trans-Hiatal Esophagectomy
A study testing intravenous (IV) administration of erythromycin in people with Esophagectomy and Postoperative Complications, run by Kaplan Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagectomy, Postoperative Complications
- What is being tested?
- intravenous (IV) administration of erythromycin
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients after trans-hiatal esophagectomy
Who cannot join
- Allergy to erythromycin
- Use of phenothiazine
- QT prolongation
- Liver function test (LFT) abnormalities
- Myasthenia gravis
- Cardiomyopathy
Trial locations and contacts
No sites are listed yet.
About this study
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
- Conditions
- Esophagectomy, Postoperative Complications
- Being tested
- intravenous (IV) administration of erythromycin
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous (IV) administration of erythromycinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsophagectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Koram Klein, MD, Principal investigator, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373919
- Sponsor's protocol ID
- erythro-esophagus
- Status last verified
- Aug 2006
- First submitted
- 7 Sep 2006
- Last updated
- 5 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Erythromycin on Occurrence of Leaks From Cervical Esophageal-Gastric Anastomosis After Trans-Hiatal Esophagectomy
- ClinicalTrials.gov ID
- NCT00373919
- Acronym / sponsor ID
- erythro-esophagus
- Conditions
- Esophagectomy, Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- First posted
- 8 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients after trans-hiatal esophagectomy
Key exclusion criteria (6 listed)
- Allergy to erythromycin
- Use of phenothiazine
- QT prolongation
- Liver function test (LFT) abnormalities
- Myasthenia gravis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous (IV) administration of erythromycin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koram Klein, MD principal investigator
Kaplan Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing intravenous (IV) administration of erythromycin in people with Esophagectomy and Postoperative Complications, run by Kaplan Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoram Klein, MD (972-50-8213221, yoramkl@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2007.