Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia

Shanghai Zhongshan Hospital60 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Esophageal Achalasia

Interventions

no antibiotic prophylaxisDRUG

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

second-generation cephalosporinDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Blood culture positive incidence

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

Time frame: after 12 hours of POEM

Secondary Outcomes

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.

Time frame: after 12 hours of POEM

Data from ClinicalTrials.gov

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