Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia

Not Applicable

• Conditions: Esophageal Achalasia
• Interventions: Drug: no antibiotic prophylaxis; Drug: second-generation cephalosporin

• Registration Number: NCT01750385
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-20
• Status Verified: 2012-12
• Study First Submitted QC: 2012-12-12
• Last Update Submitted: 2012-12-12
• Study First Posted: 2012-12-17
• Last Update Posted: 2012-12-17
• Primary Completion: 2013-04
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
no antibiotic prophylaxis	no antibiotic prophylaxis	These patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically.
second-generation cephalosporin	second-generation cephalosporin	These patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically.

Primary Outcome Measures

Name	Time	Method
Blood culture positive incidence	after 12 hours of POEM	To compare the positive incidence of blood cultures between antibiotic prophylaxis and no antibiotic prophylaxis.

Secondary Outcome Measures

Name	Time	Method
procalcitonin level	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.