Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT01750385
First received: November 20, 2012
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Esophageal Achalasia
Drug: no antibiotic prophylaxis
Drug: second-generation cephalosporin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia

Resource links provided by NLM:


Further study details as provided by Shanghai Zhongshan Hospital:

Primary Outcome Measures:
  • Blood culture positive incidence [ Time Frame: after 12 hours of POEM ] [ Designated as safety issue: Yes ]
    To compare the positive incidence of blood cultures between antibiotic prophylaxis and no antibiotic prophylaxis.


Secondary Outcome Measures:
  • procalcitonin level [ Time Frame: after 12 hours of POEM ] [ Designated as safety issue: Yes ]

    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.



Other Outcome Measures:
  • clinical manifestation [ Time Frame: during hospital stay and up to 1 week ] [ Designated as safety issue: Yes ]
    To observe the changes of temperature, heart rate, respiratory rate, white blood cell counts, neutrophile granulocyte counts in perioperative period.


Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01750385

Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
Study Director: Ping-Hong Zhou, M.D,PhD Fudan University
  More Information

No publications provided

Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT01750385     History of Changes
Other Study ID Numbers: B2012-089
Study First Received: November 20, 2012
Last Updated: December 12, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai Zhongshan Hospital:
Esophageal Achalasia
antibiotic prophylaxis
blood culture
procalcitonin levels

Additional relevant MeSH terms:
Bacteremia
Esophageal Achalasia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Bacterial Agents
Cephalosporins
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on September 22, 2014