Clinical Trial: Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia
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 Summary:
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.
Sponsor: Shanghai Zhongshan Hospital
Current Primary Outcome: Blood culture positive incidence [ Time Frame: after 12 hours of POEM ]
Original Primary Outcome: Same as current
Current Secondary Outcome: procalcitonin level [ Time Frame: 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.
Original Secondary Outcome: Same as current
Information By: Shanghai Zhongshan Hospital
Dates:
Date Received: November 20, 2012
Date Started: October 2012
Date Completion: August 2013
Last Updated: December 12, 2012
Last Verified: December 2012
