Overview

This trial is active, not recruiting.

Condition esophageal achalasia
Treatments no antibiotic prophylaxis, second-generation cephalosporin
Sponsor Shanghai Zhongshan Hospital
Start date October 2012
End date April 2013
Trial size 60 participants
Trial identifier NCT01750385, B2012-089

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(Active Comparator)
These patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically.
no antibiotic prophylaxis
These patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically.
(Active Comparator)
These patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically.
second-generation cephalosporin
These patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically.

Primary Outcomes

Measure
Blood culture positive incidence
time frame: after 12 hours of POEM

Secondary Outcomes

Measure
procalcitonin level
time frame: after 12 hours of POEM

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

Official title Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Shanghai Zhongshan Hospital.