Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia

Fudan University

Status: Unknown

Conditions: Esophageal Achalasia

Treatments: Drug: no antibiotic prophylaxis; Drug: second-generation cephalosporin

Study type: Interventional

Funder types: Other

Identifiers

NCT01750385

B2012-089

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

no antibiotic prophylaxis

Active Comparator group

Description:

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

Treatment:

Drug: no antibiotic prophylaxis

second-generation cephalosporin

Active Comparator group

Description:

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

Treatment:

Drug: second-generation cephalosporin