Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: April 2013

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.

Interventions

  • Drug: no antibiotic prophylaxis
    • These patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically.
  • Drug: second-generation cephalosporin
    • These patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically.

Arms, Groups and Cohorts

  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Zhongshan Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ping-Hong Zhou, M.D,PhD, Study Director, Fudan University

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