NCT01750385

Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Achalasia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-04-01
• Completion: 2013-08-01
• First posted: 2012-12-17
• Last updated: 2012-12-17