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Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia

Primary Purpose

Esophageal Achalasia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
no antibiotic prophylaxis
second-generation cephalosporin
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Esophageal Achalasia focused on measuring Esophageal Achalasia, antibiotic prophylaxis, blood culture, procalcitonin levels

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    no antibiotic prophylaxis

    second-generation cephalosporin

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Blood culture positive incidence
    To compare the positive incidence of blood cultures between antibiotic prophylaxis and no antibiotic prophylaxis.

    Secondary Outcome Measures

    procalcitonin level
    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.

    Full Information

    First Posted
    November 20, 2012
    Last Updated
    December 12, 2012
    Sponsor
    Shanghai Zhongshan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01750385
    Brief Title
    Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia
    Official Title
    Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2012
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2012 (undefined)
    Primary Completion Date
    April 2013 (Anticipated)
    Study Completion Date
    August 2013 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Zhongshan Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophageal Achalasia
    Keywords
    Esophageal Achalasia, antibiotic prophylaxis, blood culture, procalcitonin levels

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    no antibiotic prophylaxis
    Arm Type
    Active Comparator
    Arm Description
    These patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically.
    Arm Title
    second-generation cephalosporin
    Arm Type
    Active Comparator
    Arm Description
    These patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically.
    Intervention Type
    Drug
    Intervention Name(s)
    no antibiotic prophylaxis
    Intervention Description
    These patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically.
    Intervention Type
    Drug
    Intervention Name(s)
    second-generation cephalosporin
    Intervention Description
    These patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically.
    Primary Outcome Measure Information:
    Title
    Blood culture positive incidence
    Description
    To compare the positive incidence of blood cultures between antibiotic prophylaxis and no antibiotic prophylaxis.
    Time Frame
    after 12 hours of POEM
    Secondary Outcome Measure Information:
    Title
    procalcitonin level
    Description
    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.
    Time Frame
    after 12 hours of POEM
    Other Pre-specified Outcome Measures:
    Title
    clinical manifestation
    Description
    To observe the changes of temperature, heart rate, respiratory rate, white blood cell counts, neutrophile granulocyte counts in perioperative period.
    Time Frame
    during hospital stay and up to 1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ping-Hong Zhou, M.D,PhD
    Organizational Affiliation
    Fudan University
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia

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