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Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia

NCT ID: NCT01750385

Last Updated: 2012-12-17

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

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Esophageal Achalasia

Keywords

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Esophageal Achalasia antibiotic prophylaxis blood culture procalcitonin levels

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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no antibiotic prophylaxis

These patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically.

Group Type ACTIVE_COMPARATOR

no antibiotic prophylaxis

Intervention Type DRUG

These patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically.

second-generation cephalosporin

These patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically.

Group Type ACTIVE_COMPARATOR

second-generation cephalosporin

Intervention Type DRUG

These patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically.

Interventions

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no antibiotic prophylaxis

These patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically.

Intervention Type DRUG

second-generation cephalosporin

These patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ping-Hong Zhou, M.D,PhD

Role: STUDY_DIRECTOR

Fudan University

Other Identifiers

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B2012-089

Identifier Type: -

Identifier Source: org_study_id