Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia

December 12, 2012 updated by: Shanghai Zhongshan Hospital
Peroral Endoscopic Myotomy (POEM) is a novel, promising endoscopic technique for achalasia because it is safer and more effective than traditional Heller's myotomy. However, the issue of antibiotic prophylaxis in POEM has evoked considerable controversy recently. Therefore, we conduct this study to elucidate the status of POEM-related bacteremia and procalcitonin levels in order to preliminary observe whether antibiotic prophylaxis is needed.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Objective: To elucidate the status of POEM-related bacteremia and procalcitonin levels in order to preliminary observe whether antibiotic prophylaxis is needed.

Interventions: Patients with achalasia diagnosed by symptoms, endoscopy and barium swallow eligible for POEM are randomized to either use antibiotic prophylactically or not.

Main outcome measurements: Blood culture positive incidence; secondary outcomes are procalcitonin levels, C-reactive protein levels, white blood cell counts and so on.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of esophageal achalasia
  • Ready to have the treatment as POEM and no contraindication of POEM
  • Ability to get informed consent

Exclusion Criteria:

  • Patients who had indications for antibiotic prophylaxis as determined by the American Society for Gastrointestinal Endoscopy
  • Patients who had received antibiotics for any reason within the previous 7days
  • Patients who had possible signs of any infection at the time of the procedure
  • Patients who had chronic inflammatory diseases need hormonotherapy : such as rheumatic arthritis or inflammatory bowel diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: no antibiotic prophylaxis
These patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically.
Drug: no antibiotic prophylaxis
These patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically.
Active Comparator: second-generation cephalosporin
These patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically.
Drug: second-generation cephalosporin
These patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood culture positive incidence
Time Frame: after 12 hours of POEM
To compare the positive incidence of blood cultures between antibiotic prophylaxis and no antibiotic prophylaxis.
after 12 hours of POEM

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
procalcitonin level
Time Frame: after 12 hours of POEM

To observe the changes of procalcitonin levels after POEM in which no antibiotic is administered.

To compare the procalcitonin levels between antibiotic prophylaxis and no antibiotic prophylaxis.
after 12 hours of POEM

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical manifestation
Time Frame: during hospital stay and up to 1 week
To observe the changes of temperature, heart rate, respiratory rate, white blood cell counts, neutrophile granulocyte counts in perioperative period.
during hospital stay and up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Study Director: Ping-Hong Zhou, M.D,PhD, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

April 1, 2013

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

November 20, 2012

First Submitted That Met QC Criteria

December 12, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Estimate)

December 17, 2012

Last Update Submitted That Met QC Criteria

December 12, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2012-089

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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